A Phase 4 interventional study of Buprenorphine/naloxone in Opioid Dependence and Substance-Related Disorders, sponsored by National Institute on Drug Abuse (NIDA). Completed at 5 sites in United States. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-12.
Sponsored by National Institute on Drug Abuse (NIDA) · Phase 4, Interventional, and Treatment
Among 173 studies testing buprenorphine in Opioid-Related Disorders — 19 open to participants now, 22 under way, 6 of them phase 3. Buprenorphine · Opioid-Related Disorders.
Among the 173 studies testing buprenorphine in Opioid-Related Disorders, this one is the 10th largest by enrollment of the 172 interventional ones, is one of 3 that started in 1999, is one of 41 in phase 4, and was the 47th registered.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 582 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →19 of the 173 studies testing buprenorphine in Opioid-Related Disorders are open now, in 2 countries. Each count lists the 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; 52 take healthy volunteers.
This study: 18 Years to 59 Years · all sexes · healthy volunteers too.
The full table on the hub →173 studies; the count open now beside each. This study's row is marked.
First in 1988; this study’s year is marked. 3 started in 1999.
Median enrollment 19 across the 172 interventional studies. Of the 138 that completed or were terminated, 49 (36%) have results posted.
31 of 173 have an industry lead sponsor. The 10 most frequent:
National Institute on Drug Abuse (NIDA) is the lead sponsor of 393 studies on the registry; 19 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
76 studies in Opioid-Related Disorders by National Institute on Drug Abuse (NIDA): 4 open now, 4 under way, none of them phase 3. Of 71 finished, 2 (3%) have results posted.
Among the 76 studies in Opioid-Related Disorders by National Institute on Drug Abuse (NIDA), this one has the largest enrollment of the 70 interventional ones, is one of 2 that started in 1999, is the only one in phase 4, and was the 36th registered.
National Institute on Drug Abuse (NIDA)’s Opioid-Related Disorders studies by the year they started, since 1989.
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 |
Among the 173 studies testing buprenorphine in Opioid-Related Disorders, from their registry updates:
Among National Institute on Drug Abuse (NIDA)’s 76 in Opioid-Related Disorders:
The purpose of this study is the safety and efficacy of Buprenorphine/Naloxone in the treatment of opioid dependence. A compassionate use study.
The objective of this study is to provide follow-up compassionate use treatment and evaluate long term safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment for subjects who have completed Cooperative Study 1008 A and B.
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.
Exclusion Criteria:
Drug: Buprenorphine/naloxone
Drug pages: Buprenorphine · Naloxone
Craving
Retention
Opioid withdrawal
Subjective rating
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Buprenorphine · Naloxone
National Institute on Drug Abuse (NIDA) →