A Phase 3 interventional study of Buprenorphine Injection and Buprenorphine Sublingual Product in Opioid-Related Disorders, Drug Addiction and Pregnancy Related, sponsored by T. John Winhusen, PhD. Completed at 12 sites in United States. Open to female participants aged 18 Years to 41 Years. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by T. John Winhusen, PhD · Phase 3, Interventional, and Treatment
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Among 173 studies testing buprenorphine in Opioid-Related Disorders — 19 open to participants now, 21 under way, 5 of them phase 3. Buprenorphine · Opioid-Related Disorders.
Among the 173 studies testing buprenorphine in Opioid-Related Disorders, this one is the 35th largest by enrollment of the 172 interventional ones that give a count, is one of 6 that started in 2020, is one of 37 in phase 3, and was the 132nd registered.
1,473 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
Browse Opioid-Related Disorders studies →19 of the 173 studies testing buprenorphine in Opioid-Related Disorders are open now, in 2 countries. Recruiting first, the newest first:
Yale University · Sites in United States
Ages 18+
University of Alabama at Birmingham · Sites in United States
Ages 19+
Pouya Azar · Sites in Canada
Ages 19+
Rachel R. Luba · Sites in United States
Ages 18–65
Lifespan · Sites in United States
Ages 18+
By country, each count listing its studies:
Buprenorphine: first FDA approval 1981 (BUPRENEX), first EMA approval 2006. What it is approved for, and how studies give it, is on its page →
Of the 210 Opioid-Related Disorders studies recruiting now, 122 (58%) set no upper age limit and 74 (35%) stop at 75 or younger; 14 take children under 18; 53 take healthy volunteers.
This study: 18 Years to 41 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
173 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 24 · Phase 2 66 · Phase 3 47 · Phase 4 41
First in 1988; this study’s year is marked. 6 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 140 is above the median of 63 across 1,167 interventional studies indexed under Opioid-Related Disorders.
Median enrollment 19 across the 172 interventional studies. Of the 139 that completed or were terminated, 49 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
31 of 173 have an industry lead sponsor. The 10 most frequent:
T. John Winhusen, PhD is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
T. John Winhusen, PhD has 6 studies filed under Opioid-Related Disorders — fewer than ten, so there is no comparison to draw.
10 of the studies testing buprenorphine in Opioid-Related Disorders that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05011266Phase 3New York State Psychiatric InstituteEfficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder | 2027-01-01 |
| NCT06316830Phase 3Rhode Island HospitalIdentifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose | 2027-08-01 |
| NCT06494904Phase 3Yale UniversityStandard Versus High Dose ED-Initiated Buprenorphine Induction | 2027-09 |
| NCT06051890NYU Langone HealthAssessing Optimal XRB Initiation Points in Jail | 2026-12-01 |
| NCT04464980NYU Langone HealthOptimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) | 2026-12-31 |
Add all 10 to your calendar (.ics) → With an account.
Among the 173 studies testing buprenorphine in Opioid-Related Disorders, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary objective of this study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual buprenorphine (BUP-SL), on mother and infant outcomes. The primary hypothesis is that the BUP-XR group will not have greater illicit opioid use than the BUP-SL group during pregnancy (non-inferiority).
This is an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, estimated gestational age (EGA) at time of randomization (6 weeks-18 weeks vs. 19 weeks-30 weeks), and whether they are on BUP-SL at the time of randomization (yes vs. no). Participants will be provided with study medication and attend weekly medication visits through 12 months postpartum.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Potential participants must:
Exclusion Criteria:
Potential participants must not:
have a psychiatric condition that, in the judgment of the site medical clinician (MC), would make study participation unsafe or which would make treatment compliance difficult. Examples include:
have a medical condition that, in the judgment of the study MC, would make study participation unsafe or which would make treatment compliance difficult. Medical conditions that may compromise participant safety or study conduct include, but are not limited to, allergy/sensitivity to study medications and the following based on clinical labs:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Drug: Buprenorphine Injection
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Drug: Buprenorphine Sublingual Product
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
Also known as: CAM2038
Sublingual buprenorphine (BUP-SL), administered daily.
Also known as: Subutex, Suboxone
Percentage of Illicit Opioid-negative Urine Samples During Pregnancy
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.
Time frame: From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks
Percentage of Illicit Opioid-negative Urine Samples Postpartum
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites.
Time frame: Delivery through 12 months postpartum
Percentage of Days With Study Medication Adherence During Pregnancy
Adherence to treatment from screening to delivery, checked weekly. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.
Time frame: From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks
Percentage of Days With Study Medication Adherence - Postpartum
Adherence to treatment from delivery through 12 months postpartum, checked weekly.
Time frame: Delivery through 12 months postpartum
Percentage of Drug and Alcohol-negative Urine Samples During Pregnancy
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of alcohol, illicit drugs and/or their metabolites. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.
Time frame: From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks
Percentage of Drug and Alcohol-negative Urine Samples - Postpartum Phase
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of alcohol, illicit drugs and/or their metabolites, excluding cotinine.
Time frame: Delivery through 12 months postpartum
Opioid Craving Scale - Pregnancy
The scale consists of 3 items, measuring craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. The measure was assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery, average score reported.
Time frame: Assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery
Opioid Craving Scale - Postpartum
The scale measures craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving. The measure was assessed at months 1, 3, 6, 9, and 12 post-delivery, average score reported
Time frame: Assessed at months 1, 3, 6, 9, and 12 post-delivery
Adequacy of Prenatal Care Utilization Index
The information was derived from either medical records or the birth certificate. Information was not obtained for 74 participants.
Time frame: At delivery
Short Opiate Withdrawal Scale (SOWS)-Gossop - Pregnancy
Measure of maternal opioid withdrawal symptoms. The Short Opiate Withdrawal Scale-Gossop has scores rated on a scale of 0 (none) to 3 (severe) per question. The total score of the SOWS-Gossop ranges from 0-30. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. The measure was assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery, average score reported.
Time frame: Assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery
Short Opiate Withdrawal Scale (SOWS)-Gossop - Postpartum
Measure of maternal opioid withdrawal symptoms. The Short Opiate Withdrawal Scale-Gossop has scores rated on a scale of 0 (none) to 3 (severe) per question. The total score of the SOWS-Gossop ranges from 0-30. The measure was assessed at months 1, 3, 6, 9, and 12 post-delivery, average score reported.
Time frame: Assessed at months 1, 3, 6, 9, and 12 post-delivery
Opioid Medication for Neonatal Opioid Withdrawal Syndrome (NOWS) Symptoms
Use of opioid medication for NOWS symptoms will be abstracted from the medical record.
Time frame: Neonate discharge from hospital, typically within 1 month postpartum
Total Days of Neonatal Opioid Treatment During the Hospital Stay
Number of days of NOWS treatment for those infants that did receive it, abstracted from the medical record.
Time frame: Neonate discharge from hospital, typically within 1 month postpartum
Infant Hospital Length of Stay
Infant hospital length of stay (LOS) defined as the infant's age, in days, at discharge will be abstracted from the medical record. (all infants)
Time frame: Neonate discharge from hospital, typically within 1 month postpartum
Neonatal Opioid Withdrawal Syndrome (NOWS) Peak Score
NOWS peak score will be abstracted from the medical record. The scale used is the Finnegan-modified; the score ranges from 0-46, a score of 8 or higher indicates withdrawal.
Time frame: Neonate discharge from hospital, typically within 1 month postpartum
Custody at Discharge
For example, whether the infant is discharged in custody of mother, other relative, foster/adoptive family, etc. This will be abstracted from the medical record. Maternal custody - number \& percentage.
Time frame: Neonate discharge from hospital, typically within 1 month postpartum
Child Protective Services Open Case
Whether or not there is an open child protective services at discharge (yes/no) will be abstracted from the medical record. Percentage of cases open with child protective services.
Time frame: Neonate discharge from hospital, typically within 1 month postpartum
Ages and Stages Questionnaire, Third Edition (ASQ-3)
To screen for developmental issues in the infant. Developmental issues at 12 months - percentage. Developmental issues assessed with The Ages and Stages Questionnaire, third edition scores each item as Yes (10 points), Sometimes (5 points), or Not Yet (0 points), with total scores compared to cutoffs to identify delays.
Time frame: 12 months postpartum
| Milestone | BUP-XR | BUP-SL |
|---|---|---|
| Started | 69 | 71 |
| Completed | 57 | 57 |
| Not completed | 12 | 14 |
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.
| % Illicit opioid-negative urine samples | BUP-XR | BUP-SL |
|---|---|---|
| Percentage of Illicit Opioid-negative Urine Samples During Pregnancy | 82.5 ± 4.2 | 72.6 ± 4.2 |
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites.
| % Illicit opioid-negative urine samples | BUP-XR | BUP-SL |
|---|---|---|
| Percentage of Illicit Opioid-negative Urine Samples Postpartum | 60.2 ± 4.2 | 59.5 ± 4.1 |
Adherence to treatment from screening to delivery, checked weekly. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.
| percentage of expected days adherent | BUP-XR | BUP-SL |
|---|---|---|
| Percentage of Days With Study Medication Adherence During Pregnancy | 84.4 ± 3.1 | 84.9 ± 3.0 |
Adherence to treatment from delivery through 12 months postpartum, checked weekly.
| percentage of expected days adherent | BUP-XR | BUP-SL |
|---|---|---|
| Percentage of Days With Study Medication Adherence - Postpartum | 69.3 ± 4.3 | 75.5 ± 4.2 |
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of alcohol, illicit drugs and/or their metabolites. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.
| Percentage of negative urine samples | BUP-XR | BUP-SL |
|---|---|---|
| Percentage of Drug and Alcohol-negative Urine Samples During Pregnancy | 58.8 ± 3.4 | 52.2 ± 3.4 |
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of alcohol, illicit drugs and/or their metabolites, excluding cotinine.
| Percentage of negative urine samples | BUP-XR | BUP-SL |
|---|---|---|
| Percentage of Drug and Alcohol-negative Urine Samples - Postpartum Phase | 34.7 ± 3.3 | 35.0 ± 3.2 |
The scale consists of 3 items, measuring craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. The measure was assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery, average score reported.
| score on a scale | BUP-XR | BUP-SL |
|---|---|---|
| Opioid Craving Scale - Pregnancy | 1.9 ± 0.2 | 2.5 ± 0.2 |
The scale measures craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving. The measure was assessed at months 1, 3, 6, 9, and 12 post-delivery, average score reported
| score on a scale | BUP-XR | BUP-SL |
|---|---|---|
| Opioid Craving Scale - Postpartum | 1.5 ± 0.2 | 1.7 ± 0.2 |
The information was derived from either medical records or the birth certificate. Information was not obtained for 74 participants.
| percentage of participants | BUP-XR | BUP-SL |
|---|---|---|
| Inadequate | 36.7 ± 8.9 | 19.4 ± 6.7 |
| Intermediate | 13.3 ± 6.3 | 16.7 ± 6.3 |
| Adequate | 23.3 ± 7.9 | 13.9 ± 5.8 |
| Adequate Plus | 26.7 ± 8.2 | 50.0 ± 8.5 |
Measure of maternal opioid withdrawal symptoms. The Short Opiate Withdrawal Scale-Gossop has scores rated on a scale of 0 (none) to 3 (severe) per question. The total score of the SOWS-Gossop ranges from 0-30. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. The measure was assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery, average score reported.
| score on a scale | BUP-XR | BUP-SL |
|---|---|---|
| Short Opiate Withdrawal Scale (SOWS)-Gossop - Pregnancy | 5.6 ± 0.5 | 6.2 ± 0.5 |
Measure of maternal opioid withdrawal symptoms. The Short Opiate Withdrawal Scale-Gossop has scores rated on a scale of 0 (none) to 3 (severe) per question. The total score of the SOWS-Gossop ranges from 0-30. The measure was assessed at months 1, 3, 6, 9, and 12 post-delivery, average score reported.
| score on a scale | BUP-XR | BUP-SL |
|---|---|---|
| Short Opiate Withdrawal Scale (SOWS)-Gossop - Postpartum | 4.1 ± 0.5 | 5.3 ± 0.5 |
Use of opioid medication for NOWS symptoms will be abstracted from the medical record.
| Total amount of morphine for NOWS-mg | BUP-XR | BUP-SL |
|---|---|---|
| Opioid Medication for Neonatal Opioid Withdrawal Syndrome (NOWS) Symptoms | 10.0 ± 3.2 | 10.4 ± 3.2 |
Number of days of NOWS treatment for those infants that did receive it, abstracted from the medical record.
| Days of opioid treatment | BUP-XR | BUP-SL |
|---|---|---|
| Total Days of Neonatal Opioid Treatment During the Hospital Stay | 10.9 ± 2.2 | 14.8 ± 3.0 |
Infant hospital length of stay (LOS) defined as the infant's age, in days, at discharge will be abstracted from the medical record. (all infants)
| Hospital length of stay, days | BUP-XR | BUP-SL |
|---|---|---|
| Infant Hospital Length of Stay | 8.5 ± 0.9 | 9.5 ± 1.0 |
NOWS peak score will be abstracted from the medical record. The scale used is the Finnegan-modified; the score ranges from 0-46, a score of 8 or higher indicates withdrawal.
| score on a scale | BUP-XR | BUP-SL |
|---|---|---|
| Neonatal Opioid Withdrawal Syndrome (NOWS) Peak Score | 10.4 ± 0.8 | 10.0 ± 0.9 |
For example, whether the infant is discharged in custody of mother, other relative, foster/adoptive family, etc. This will be abstracted from the medical record. Maternal custody - number \& percentage.
| % of participants with maternal custody | BUP-XR | BUP-SL |
|---|---|---|
| Custody at Discharge | 90.9 ± 3.5 | 89.7 ± 3.7 |
Whether or not there is an open child protective services at discharge (yes/no) will be abstracted from the medical record. Percentage of cases open with child protective services.
| % Case with child protective services | BUP-XR | BUP-SL |
|---|---|---|
| Child Protective Services Open Case | 32.8 ± 5.9 | 38.8 ± 6.0 |
To screen for developmental issues in the infant. Developmental issues at 12 months - percentage. Developmental issues assessed with The Ages and Stages Questionnaire, third edition scores each item as Yes (10 points), Sometimes (5 points), or Not Yet (0 points), with total scores compared to cutoffs to identify delays.
| % infants w/ dev. issues | BUP-XR | BUP-SL |
|---|---|---|
| Ages and Stages Questionnaire, Third Edition (ASQ-3) | 17.3 ± 5.2 | 15.4 ± 5.0 |
Collected over Consent through 1 year postpartum, up to 1 year and 8 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BUP-XR | 0/69 (0%) | 9/69 (13%) | 49/69 (71%) |
| BUP-SL | 0/71 (0%) | 27/71 (38%) | 59/71 (83.1%) |
| BUP-XR - Neonates | 0/67 (0%) | 9/67 (13.4%) | — |
| BUP-SL - Neonates | 1/70 (1.4%) | 11/70 (15.7%) | — |
| Event | BUP-XR | BUP-SL | BUP-XR - Neonates | BUP-SL - Neonates |
|---|---|---|---|---|
| Gestational hypertensionPregnancy, puerperium and perinatal conditions | 0/69 | 4/71 | 0/67 | 0/70 |
| Pre-EclampsiaPregnancy, puerperium and perinatal conditions | 3/69 | 3/71 | 0/67 | 0/70 |
| OverdoseInjury, poisoning and procedural complications | 3/69 | 0/71 | 0/67 | 0/70 |
| Suicidal ideationPsychiatric disorders | 0/69 | 3/71 | 0/67 | 0/70 |
| Weight gain poorMetabolism and nutrition disorders | 0/69 | 0/71 | 2/67 | 0/70 |
| PyelonephritisInfections and infestations | 2/69 | 1/71 | 0/67 | 0/70 |
| Drug use disorderPsychiatric disorders | 0/69 | 2/71 | 0/67 | 0/70 |
| COVID-19Infections and infestations | 0/69 | 2/71 | 0/67 | 1/70 |
| HospitalisationSurgical and medical procedures | 0/69 | 2/71 | 0/67 | 0/70 |
| Pyloric StenosisCongenital, familial and genetic disorders | — | — | 1/67 | 0/70 |
| Event | BUP-XR | BUP-SL | BUP-XR - Neonates | BUP-SL - Neonates |
|---|---|---|---|---|
| COVID-19Infections and infestations | 9/69 | 15/71 | — | — |
| VomitingGastrointestinal disorders | 12/69 | 7/71 | — | — |
| Upper Respiratory Tract InfectionInfections and infestations | 10/69 | 11/71 | — | — |
| NauseaGastrointestinal disorders | 10/69 | 5/71 | — | — |
| Urinary Tract InfectionInfections and infestations | 4/69 | 9/71 | — | — |
| HeadacheNervous system disorders | 6/69 | 8/71 | — | — |
| ConstipationGastrointestinal disorders | 6/69 | 7/71 | — | — |
| GastroenteritisInfections and infestations | 6/69 | 3/71 | — | — |
| Abdominal painGastrointestinal disorders | 2/69 | 6/71 | — | — |
| Tooth abscessInfections and infestations | 1/69 | 6/71 | — | — |
| Age, Continuous(years) | BUP-XR | BUP-SL | Total |
|---|---|---|---|
| Mean | 31.1 ± 4.6 | 31.4 ± 4.7 | 31.2 ± 4.6 |
| Sex: Female, Male(Participants) | BUP-XR | BUP-SL | Total |
|---|---|---|---|
| Female | 69 | 71 | 140 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | BUP-XR | BUP-SL | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 6 | 10 |
| Not Hispanic or Latino | 65 | 65 | 130 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | BUP-XR | BUP-SL | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 3 | 3 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 3 | 7 | 10 |
| White | 59 | 57 | 116 |
| More than one race | 5 | 2 | 7 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Opioid Craving Scale(score on a scale) | BUP-XR | BUP-SL | Total |
|---|---|---|---|
| Mean | 2.7 ± 2.5 | 3.7 ± 3.0 | 3.2 ± 2.8 |
| Short Opioid Withdrawal Scale(score on a scale) | BUP-XR | BUP-SL | Total |
|---|---|---|---|
| Mean | 7.0 ± 7.0 | 5.8 ± 6.6 | 6.4 ± 6.8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data will be transmitted by the study Data and Statistics Center to the designated party for de-identification, posting, storing, and archiving on NIDA's Data Share website. Data Share is an online repository of data from studies funded by the National Institute on Drug Abuse. All de-identified individual participant data is expected to be made available.
Supporting information: Study protocol
Data sharing details ↗ · datashare.nida.nih.gov
Ran from Jul 2020 to primary completion in Jan 2025, 54 months.
Results were first posted in Jun 2026, 1 year 4 months after primary completion.
Of 31 phase 3 interventional studies under Opioid-Related Disorders, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 56. This study's 54 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Buprenorphine
T. John Winhusen, PhD