This page shows what was measured, who it was measured in, and what that does not settle.
What Buprenorphine does in the body
Heroin and fentanyl turn it all the way up, which is what stops breathing at high doses.
Opioid receptors work like a dimmer switch. Buprenorphine turns it partway up and then refuses to go further, however much you take. It also grips the receptor far more tightly than other opioids, so it pushes them off and keeps them off. That is why it stops withdrawal without producing a full high, and also why taking it too soon after another opioid throws the person straight into withdrawal.
Why people take it. Used for opioid use disorder and, separately, severe long-term pain.
What happened in people
Across 31 studies, buprenorphine kept more people in treatment, while higher doses also reduced illicit opioid use.
✓ Reviewed first-read answer
Where this came from
A person wrote this and a reviewer approved it against this exact record. It carries no effect size.
A reviewer approved this against this record. The reviewed-claim record carrying the exact population and effect size does not exist yet.
No source is stored against this line.
The limit that matters most
Starting it too soon after a potent synthetic opioid can trigger sudden severe withdrawal.
Where it acts
Mu- and kappa-opioid receptors in brainstem respiratory centres, ventral tegmental area and dorsal horn
Kind of result
The kind of result is not recorded
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
Its recorded molecular formula is C29H41NO4, weighing 467.64.
US prescribing information · 186e3be6-8bc0-4bb9-96f5-429d53632f45 · read 2026-08-30
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
A reviewer approved this sentence against this exact record and its sources.
The limit a reviewer approved as the one that matters most here.
The four opening statements run to 113 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Retention in treatment and suppression of illicit opioid use
All-cause and overdose mortality in and out of treatment
✓ The study showed what it set out to show
Who was studied
Sordo mortality meta-analysis (19 cohorts pooled)
How many people
15831
Study design
Systematic review and meta-analysis of cohort studies
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Out-to-in all-cause rate ratio 2.20 (95% CI 1.34 to 3.61) for buprenorphine; 3.20 (2.65 to 3.86) for methadone
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. The authors state that confounding and selection bias are not fully accounted for and that between-drug comparisons should be treated with caution.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Sublingual tablet and film, transdermal patch, buccal film, and extended-release subcutaneous injection
Interval reported. 95% CI 1
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 3 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Buprenorphine
What a person takes: Sublingual tablet and film, transdermal patch, buccal film, and extended-release subcutaneous injection.
The measurement behind this step
Opioid use disorder is treated with sublingual tablets or films, usually combined with naloxone as a misuse deterrent, or with a monthly extended-release subcutaneous depot. Chronic pain uses entirely different products at far lower doses: a weekly transdermal patch and a twice-daily buccal film. These are not interchangeable.
Getting in
Dissolved under the tongue, not swallowed
The tablet or film goes under the tongue and is absorbed through the lining of the mouth, because the gut and liver would destroy almost all of it.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Sublingual administration bypasses extensive first-pass metabolism; oral bioavailability is very low. Suboxone combines buprenorphine with naloxone, which is poorly absorbed sublingually but active if the product is injected — a deterrent formulation rather than a therapeutic combination.
It grips the receptor much more tightly than heroin, morphine or fentanyl, and lets go very slowly.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Very high mu-opioid receptor affinity with slow dissociation kinetics. Metabolised by CYP3A4 to norbuprenorphine and by glucuronidation. The long receptor residence time is what allows every-other-day or thrice-weekly dosing in maintenance.
It activates the receptor only partially, and it blocks a second receptor associated with dysphoria.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Partial agonism at the mu-opioid receptor with submaximal intrinsic efficacy relative to a full agonist, and antagonism at the kappa-opioid receptor. The kappa antagonism is thought to contribute to mood effects and is one reason buprenorphine has been investigated in depression.
Taking more does not depress breathing further past a point, which is the property that makes it safe enough to prescribe outside a clinic.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Because intrinsic efficacy is submaximal, the dose-response curve for respiratory depression plateaus rather than continuing to rise as it does for full agonists. The ceiling is not absolute — it can be overwhelmed in combination with benzodiazepines, alcohol or other CNS depressants, and it does not apply to opioid-naive individuals in the same way.
Withdrawal suppressed, illicit use falls, mortality falls
Cravings and withdrawal are controlled, more people stay in treatment, and fewer of them die.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Measured endpoints are retention in treatment (RR 1.50 to 1.82 versus placebo depending on dose), suppression of illicit use on urinalysis (only at 16 mg or more), and all-cause mortality of 4.3 versus 9.5 per 1,000 person-years in versus out of treatment.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Adults and adolescents aged 16 and older with opioid use disorder. Separate transdermal and buccal formulations are used for chronic pain at much lower doses.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and efficacy of buprenorphine transdermal system in patients under 18 years of age has not been established.”
US prescribing information · 186e3be6-8bc0-4bb9-96f5-429d53632f45 · read 2026-08-30
On older people, the label states: “Of the total number of subjects in the clinical trials (5,415), buprenorphine transdermal system was administered to 1,377 patients aged 65 years and older.”
US prescribing information · 186e3be6-8bc0-4bb9-96f5-429d53632f45 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions ( 5.4 )] .”
US prescribing information · 186e3be6-8bc0-4bb9-96f5-429d53632f45 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with buprenorphine transdermal system.”
US prescribing information · 186e3be6-8bc0-4bb9-96f5-429d53632f45 · read 2026-08-30
On people with reduced liver function, the label states: “In a study utilizing intravenous buprenorphine, peak plasma levels (C max ) and exposure (AUC) of buprenorphine in patients with mild and moderate hepatic impairment did not increase as compared to those observed in subjects with normal hepatic function.”
US prescribing information · 186e3be6-8bc0-4bb9-96f5-429d53632f45 · read 2026-08-30
Where the result stopped carrying
Low- and medium-dose buprenorphine did not suppress illicit opioid use on urinalysis, despite retaining patients better than placebo
Flexible-dose buprenorphine retained fewer patients than methadone (RR 0.83), which is a real and consistently replicated disadvantage
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Given by a clinician
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Sublingual tablet and film, transdermal patch, buccal film, and extended-release subcutaneous injection
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S1, S5, S6.
No source is stored against this line.
What is in the pack
Opioid use disorder is treated with sublingual tablets or films, usually combined with naloxone as a misuse deterrent, or with a monthly extended-release subcutaneous depot. Chronic pain uses entirely different products at far lower doses: a weekly transdermal patch and a twice-daily buccal film. These are not interchangeable.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
Respiratory depression plateaus with dose because of partial agonism, but this ceiling can be overwhelmed by benzodiazepines, alcohol or other CNS depressants and does not protect opioid-naive individuals or children. Buprenorphine precipitates withdrawal if given while a full agonist still occupies the receptor. It is a Schedule III controlled substance in the United States. Neonatal opioid withdrawal syndrome occurs with use in pregnancy, and pregnancy is nonetheless an indication for treatment rather than a reason to stop.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Sublingual tablet and film, transdermal patch, buccal film, and extended-release subcutaneous injection
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Chronic pain uses entirely different products at far lower doses: a weekly transdermal patch and a twice-daily buccal film. These are not interchangeable.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
255 products list this as an active ingredient in the United States drug directory. 151 of them contain it and nothing else.
FDA National Drug Code directory · 72189-580 · read 2026-08-29
They are sold as film, film, soluble, injection, injection, solution, patch and patch, extended release, taken buccal, intramuscular, intravenous and subcutaneous.
FDA National Drug Code directory · 72189-580 · read 2026-08-29
The regulator's established pharmacologic class for it is partial opioid agonist [epc] and partial opioid agonists [moa].
FDA National Drug Code directory · 72189-580 · read 2026-08-29
106 published labels name it as an active ingredient. 51 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 4951ec29-609b-4836-b0e4-0d9c1d6ae6fe · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 4951ec29-609b-4836-b0e4-0d9c1d6ae6fe · read 2026-08-29
Buprenorphine is sublingual tablets at Sublingual tablet: 2 mg buprenorphine and 8 mg buprenorphine, recorded as prescription product; fda label in effect 2025-02-03 in the United States.
US prescribing information · 023c7816-21b1-4f85-be36-9e32d5935c19 · read 2026-08-27
Recorded price in US: 0.26477–57.31739 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 57 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Buprenorphine studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That the respiratory-depression ceiling makes overdose impossible — it plateaus the curve and can still be overwhelmed with benzodiazepines, alcohol or other depressants
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That eliminating the X-waiver in 2023 would by itself expand access, when pharmacy stocking, prior authorisation and prescriber confidence remain
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That induction protocols validated in the heroin era transfer unchanged to a supply dominated by high-potency synthetic opioids
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Buprenorphine are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
High-certainty evidence for retention in treatment at every dose tested
In plain words
Across 31 trials and 5,430 people, buprenorphine kept patients in treatment better than a dummy pill at low, medium and high doses. Only the high dose reliably reduced illicit opioid use.
What was measured
Retention in treatment, relative risk versus placebo by dose band
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Mattick et al. included 31 trials, 5,430 participants. High-certainty evidence that buprenorphine retained participants better than placebo at low dose 2-6 mg (RR 1.50, 95% CI 1.19 to 1.88; 5 studies, 1,131 participants), medium dose 7-15 mg (RR 1.74, 1.06 to 2.87; 4 studies, 887), and high dose 16 mg or more (RR 1.82, 1.15 to 2.90; 5 studies, 1,001). Moderate-certainty evidence that only high-dose buprenorphine suppressed illicit opioid use on urinalysis (SMD -1.17, 95% CI -1.85 to -0.49; 3 studies, 729), while low dose (SMD 0.10) and medium dose (SMD -0.08) did not. Against methadone, flexible-dose buprenorphine retained fewer patients (RR 0.83, 95% CI 0.72 to 0.95; 5 studies, 788) with no difference in suppression of use among those retained.
Written into the record, not signed off as a reviewed claim
All-cause mortality more than halves while a person is in buprenorphine treatment
In plain words
Pooling cohorts covering nearly 16,000 people on buprenorphine, the death rate was 4.3 per 1,000 person-years while in treatment and 9.5 while out of it.
What was measured
All-cause and overdose mortality per 1,000 person-years, in versus out of treatment
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Sordo et al. pooled 19 cohorts: 122,885 people treated with methadone over 1.3 to 13.9 years and 15,831 treated with buprenorphine over 1.1 to 4.5 years. Pooled all-cause mortality was 4.3 per 1,000 person-years in buprenorphine treatment and 9.5 out of it (unadjusted out-to-in rate ratio 2.20, 95% CI 1.34 to 3.61); for methadone, 11.3 in and 36.1 out (rate ratio 3.20, 2.65 to 3.86). Overdose mortality was 1.4 in and 4.6 out of buprenorphine treatment. All-cause mortality dropped sharply over the first four weeks of methadone treatment but remained stable during buprenorphine induction — the induction period is the dangerous one for methadone and not for buprenorphine. The authors flag confounding and selection bias as unresolved limitations of any between-drug comparison.
Written into the record, not signed off as a reviewed claim
After a non-fatal overdose, buprenorphine was associated with 37% lower all-cause mortality
In plain words
Among people who survived an opioid overdose, those who went on to receive buprenorphine were about a third less likely to die in the following year. Only 17% of them received it.
What was measured
Adjusted hazard ratio for all-cause and opioid-related mortality
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Larochelle et al. followed opioid overdose survivors in Massachusetts. In the 12 months after a non-fatal overdose, 3,022 people (17%) received buprenorphine for a median of four months. Compared with no medication for opioid use disorder, buprenorphine was associated with decreased all-cause mortality (adjusted hazard ratio 0.63, 95% CI 0.46 to 0.87) and opioid-related mortality (0.62, 0.41 to 0.92). Methadone showed 0.47 (0.32 to 0.71) and 0.41 (0.24 to 0.70). Overall cohort all-cause mortality was 4.7 deaths per 100 person-years. The authors note that only a minority of overdose survivors received any medication at all.
Written into the record, not signed off as a reviewed claim
X:BOT: easier to start than naltrexone, and equal once both were started
In plain words
Nearly all patients assigned to buprenorphine were able to start it, against fewer than three quarters assigned to naltrexone. Among those who started either drug, outcomes were the same.
What was measured
Induction success rate and 24-week relapse
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Lee et al. (NCT02032433) randomised 570 patients. Induction succeeded in 270 of 287 (94%) assigned to buprenorphine-naloxone against 204 of 283 (72%) assigned to extended-release naltrexone (P<0.0001). Intention-to-treat 24-week relapse was 163 of 287 (57%) versus 185 of 283 (65%), hazard ratio 1.36 (95% CI 1.10 to 1.68) favouring buprenorphine — but in the per-protocol population of 474 successfully inducted patients, relapse events were similar (P=0.44). Opioid-negative urine samples and abstinent days favoured buprenorphine on intention to treat and were similar per protocol. Self-reported craving was initially lower on naltrexone (P=0.0012) and converged by week 24.
Written into the record, not signed off as a reviewed claim
The X-waiver was eliminated in 2023, and access did not automatically follow
In plain words
For two decades, prescribing buprenorphine required a special federal waiver. That requirement was removed at the end of 2022, and the number of clinicians actually prescribing it did not jump the way the change implied it would.
What was measured
That eliminating the X-waiver would by itself substantially expand access to buprenorphine treatment
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Consolidated Appropriations Act, 2023 eliminated the DATA 2000 waiver requirement, so any clinician with a DEA registration to prescribe controlled substances may now prescribe buprenorphine for opioid use disorder. Saloner and colleagues argued in Substance Abuse that removing the waiver addresses only one of several barriers — the others being pharmacy stocking, insurance prior authorisation, clinician confidence with induction, and stigma — and that expanded prescribing authority is a necessary but not sufficient condition for expanded access. The audit point here is the inference: a regulatory barrier being removed is not the same as a treatment gap closing.
Written into the record, not signed off as a reviewed claim
The classical induction protocol was built for a drug landscape that no longer exists
In plain words
The standard advice on when to take the first dose was developed when the opioids people used cleared quickly. High-potency synthetic opioids behave differently, and precipitated withdrawal has become a more common problem.
What was measured
That induction protocols and effect estimates derived from a heroin-era treatment population transfer unchanged to a population using high-potency synthetic opioids
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Buprenorphine's very high mu-receptor affinity and slow dissociation displace full agonists from the receptor while only partly activating it. The classical induction protocols specify waiting for objective withdrawal, typically assessed with a structured scale, before the first dose. Those protocols were developed and validated in a population using heroin and prescription opioids. This page records that the Cochrane evidence base for buprenorphine retention and suppression of use predates the widespread presence of high-potency synthetic opioids in the illicit supply, and that the applicability of induction timing derived from that era is an assumption rather than a finding.
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What is not here
7 questions this page could not answer
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What was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
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The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
A tightly binding partial opioid agonist that keeps people in treatment better than placebo at every dose tested, and is associated with roughly a halving of all-cause mortality in the year after an overdose — with a ceiling on respiratory depression that is its defining safety property and a precipitated-withdrawal risk that is its defining practical problem.
Recorded evidence blocks (8)
Q2
On the Buprenorphine label: indicated for what?
"SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. SUBLOCADE should be used as part of a complete treatment plan that includes…": indications and usage on Buprenorphine's label. DailyMed label · 6189fb21-9432-45f8-8481-0bfaf3ccde95 · 2026-07-27
Q3
305 registered trials of Buprenorphine — at which phases?
Registered studies posting no result
185 of 305
305 registered studies of Buprenorphine: 99 phase2, 74 phase3, 73 phase4, 51 phase1, 15 na, 15 na or unstated, 3 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
Buprenorphine's half-life is 43 to 60 days — which schedules were studied?
43 to 60 days, the half-life Buprenorphine's label states: "The apparent terminal plasma half-life of buprenorphine following subcutaneous injection of SUBLOCADE ranged between 43 to 60 days as a result of the slow release of buprenorphine from the subcutaneous depot." DailyMed label · 6189fb21-9432-45f8-8481-0bfaf3ccde95 · 2026-07-27
tmax 24 hours.
Show the evidence
half lifepharmacokinetics
43 to 60 days; The apparent terminal plasma half-life of buprenorphine following subcutaneous injection of SUBLOCADE ranged between 43 to 60 days as a result of the slow release of buprenorphine from the subcutaneous depot.
tmaxpharmacokinetics
24 hours; After SUBLOCADE injection, an initial buprenorphine peak was observed and the median T max occurred at 24 hours after injection.
metabolismpharmacokinetics
Elimination Buprenorphine is metabolized and eliminated in urine and feces.
recorded 2026-07-27 · last checked 2026-09-04
Q7
Which 79 trials of Buprenorphine posted no result?
Posted no result
79 of 79 completed trials
Registrations
NCT00000214, NCT00000205, NCT00000357, NCT00000210, NCT00000211 and NCT00000355, and 73 more
Completion dates
oldest 1993-01; newest 2023-03-30
Show the evidence
Trial
NCT00000214
1993-01
NCT00000205
1993-09
NCT00000357
1993-10
NCT00000210
1996-02
NCT00000211
1996-02
NCT00000355
1996-03
14 further recorded trials
NCT00158236
1998-03
NCT00134914
1998-05
NCT00015041
1998-07
NCT00000311
1999-02
NCT00000320
1999-08
NCT00000341
2000-08
NCT00000219
2001-07
NCT00000220
2001-07
NCT00007527
2002-01
NCT00367874
2003-11
NCT00023283
2004-02
NCT00000216
2005-01
NCT00000319
2005-01
NCT00000334
2005-01-15
Q8
At the median, Buprenorphine's trials enrolled 46 people — anything larger?
Median enrolment
46
Largest enrolment
3000
Registered trials counted
304
Q9
Buprenorphine and CYP3A4: shared by which compounds?
Inhibitors of CYP3A4 Clinical Impact: The effects of co-administered CYP3A4 inhibitors on buprenorphine exposure in subjects treated with SUBLOCADE have not been studied and the effects may be dependent on the route of administration; however, such interactions have been established in studies using transmucosal buprenorphine.
drug_interactions
Buprenorphine is metabolized to norbuprenorphine primarily by CYP3A4; therefore, potential interactions may occur when SUBLOCADE is given concurrently with agents that affect CYP3A4 activity.
drug_interactions
The concomitant use of sublingual buprenorphine and CYP3A4 inhibitors (e.g., ketoconazole) can increase the plasma concentration of buprenorphine, resulting in increased or prolonged opioid effects.
drug_interactions
Intervention: Patients who transfer to SUBLOCADE treatment from a regimen of transmucosal buprenorphine used concomitantly with CYP3A4 inhibitors [e.g., azole antifungals such as ketoconazole, macrolide antibiotics such as erythromycin, and HIV protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)] should be monitored to ensure that the plasma buprenorphine level provided by SUBLOCADE…
drug_interactions
If patients already on SUBLOCADE require newly-initiated treatment with CYP3A4 inhibitors, the patients should be monitored for signs and symptoms of over-medication.
drug_interactions
Conversely, if a patient has been stabilized on SUBLOCADE in the setting of concomitant medication that is a CYP3A4 inhibitor, and the concomitant medication is discontinued, the patient should be monitored for withdrawal.
2 more recorded rows
Interaction statementdrug_interactions
Examples: Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir) CYP3A4 Inducers Clinical Impact: The effects of co-administered CYP3A4 inducers on buprenorphine exposure in subjects treated with SUBLOCADE have not been studied.
Interaction statementdrug_interactions
Buprenorphine is metabolized to norbuprenorphine primarily by CYP3A4; therefore, potential interactions may occur when SUBLOCADE is given concurrently with agents that affect CYP3A4 activity.
ClinicalTrials.gov — US Government work · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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