Clinical trials: Buprenorphine
Opioid-Related Disorders, Drug Addiction
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1).
- Conditions
- Opioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse
- Trial name
- MOMs-CMA (NCT03911466)
- Testing
- Buprenorphine Injection, Buprenorphine Sublingual Product
- Where
- 12 sites in United States
- Volunteers
- 97 people
- Sponsor
- T. John Winhusen, PhD
Opioid-Related Disorders, Drug Addiction
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1).
- Conditions
- Opioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse
- Trial name
- MOMs-INO (NCT03911739)
- Testing
- Buprenorphine Injection, Buprenorphine Sublingual Product
- Where
- 10 sites in United States
- Volunteers
- 71 people
- Sponsor
- T. John Winhusen, PhD
Moderate to Severe Opioid Use Disorder
INDV-6001 Multiple-Dose Pharmacokinetic Study
This is a multicentre, open-label, multiple dose study of INDV-6001 in adult participants with moderate or severe OUD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5).
- Trial name
- NCT06576843
- Testing
- INDV-6001, Suboxone, Sublocade
- Where
- 11 sites in United States
- Volunteers
- 123 people
- Sponsor
- Indivior Inc.
Opioid Use Disorder, Fentanyl
Comparing Outpatient Treatment Retention Among Individuals Using Fentanyl Randomized to Low-dose and Direct-to-inject Buprenorphine Initiation
The goal of this pragmatic randomized controlled trial is to compare treatment outcomes of two strategies for initiating buprenorphine treatment (low-dose initiation and direct-to-inject) in adults with opioid use disorder (OUD)…
- Trial name
- COPILOT (NCT07469501)
- Testing
- Injectable buprenorphine, Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Francisco
Opioid Use Disorder
Inpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder
This study will examine the effect of a single high dose of psilocybin therapy (30 mg) versus a very low dose (1 mg) as an adjunctive therapy to individuals undergoing standard-of-care buprenorphine treatment for Opioid use…
- Trial name
- BIPOD-In (NCT06005662)
- Testing
- Psilocybin
- Where
- United States
- Sponsor
- Johns Hopkins University
Human Immunodeficiency Virus, Opioid Use Disorder
Combined Injectable Treatment for HIV and OUD
This is study seeks to evaluate perspectives of a combined injectable treatment for HIV and OUD. Specifically, with the development of new long-acting medications such as cabotegravir co-administered with rilpivirine (CAB/RPV)…
- Trial name
- CHOICE (NCT05991622)
- Testing
- Combined LAI Treatment: Cabenuva and Sublocade
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Rhode Island Hospital
Moderate to Severe Opioid-use Disorder
Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users
The primary objective of the induction phase of the study is to compare treatment retention of participants following rapid induction or standard of care (SoC) induction onto extended-release buprenorphine.
- Trial name
- NCT04995029
- Testing
- Transmucosal Buprenorphine, Extended-release Buprenorphine
- Where
- 29 sites in United States, Canada
- Volunteers
- 785 people
- Sponsor
- Indivior Inc.
Standard of Care, Standard of Care + CBT4CBT
An Integrated Intervention Involving Recovery Coaching and Cognitive Behavioral Therapy for Opioid Use Disorder
The Overcome II study is a randomized controlled trial among adults receiving sublingual buprenorphine to help prevent or reduce illicit drug use.
- Conditions
- Standard of Care, Standard of Care + CBT4CBT, Standard of Care + CBT4CBT + RC
- Trial name
- OVERCOME 2 (NCT06102200)
- Testing
- CBT4CBT, RC, Sandard of care
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- Prisma Health-Upstate
Opioid Use
Buprenorphine for Probationers and Parolees: Bridging the Gap Into Treatment
This five-year study will evaluate the effectiveness of the administration of buprenorphine bridge treatment (BBT) to probationers and parolees compared to treatment as usual (TAU), which consists of referral to a community…
- Trial name
- NCT03616236
- Testing
- Buprenorphine/Naloxone, Treatment as usual
- Where
- United States
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Friends Research Institute, Inc.
Post-operative Pain
Buprenorphine/Naloxone Micro-Dosing for Postoperative Pain Management in Opioid-Tolerant Patients
A randomized clinical study evaluating the effect of buprenorphine/naloxone (bup/nx) sublingual film on postoperative pain management in opioid-tolerant patients.
- Trial name
- NCT04771689
- Testing
- Buprenorphine/Naloxone
- Where
- United States
- Sponsor
- Massachusetts General Hospital
Analgesia, Abuse Opioids
Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia
The goal of this study is to compare the abuse potential of low-dose equianalgesic buccal buprenorphine to a commonly used full mu opioid receptor (MOR) agonist in a highly controlled experimental setting.
- Conditions
- Analgesia, Abuse Opioids, Pain
- Trial name
- NCT05988710
- Testing
- Buccal Buprenorphine 300 mcg, Buccal Buprenorphine 600 mcg, Buccal Buprenorphine 900 mcg
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center
Opioid-use Disorder, Opioid Use Disorder, Mild
Effect of Standard of Care Reduced Dose Versus Full Dose Buprenorphine/Naloxone in the Perioperative Period on Pain Control and Post-Operative Opioid Use Disorder Symptoms
The purpose of this research study is to compare two ways of managing pain in people who are taking buprenorphine and are scheduled to undergo surgery.
- Trial name
- NCT04091009
- Testing
- Buprenorphine/naloxone
- Sponsor
- Massachusetts General Hospital
Opioid-use Disorder, Opioid Use, Unspecified
Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
The objective of this study is to better understand the comprehensive integration of both clinical and genetic factors that will help to identify mothers who could be at an increased risk of poor response to opioid substitution…
- Conditions
- Opioid-use Disorder, Opioid Use, Unspecified, Buprenorphine Dependence
- Trial name
- Mother/BabyOUD (NCT03923374)
- Testing
- Subutex / Buprenorphine, Fetal & Neonatal MRI, DNA/Genetic/Pharmacokenetic Blood Draws
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Senthil Sadhasivam
Opiate Addiction
Onsite Buprenorphine Treatment at Syringe Exchange Programs
This trial will recruit syringe exchange participants with opioid use disorder in New York City and test whether starting buprenorphine treatment at the syringe exchange program is more effective than referral to a community…
- Trial name
- O-BMT (NCT03150173)
- Testing
- Onsite treatment, Enhanced referral, Buprenorphine
- Where
- 3 sites in United States
- Volunteers
- 97 people
- Sponsor
- Montefiore Medical Center
Substance Use Disorder, Opioid Use Disorder, Moderate
EXHIT ENTRE Comparative Effectiveness Trial
This study is a multi-site open-label randomized comparative effectiveness trial of a 28-day formulation of extended-release buprenorphine (XR-BUP) versus treatment as usual (TAU) for hospitalized patients with a moderate or…
- Conditions
- Substance Use Disorder, Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe
- Trial name
- EXHITENTRE (NCT04345718)
- Testing
- Extended Release Buprenorphine, Treatment as Usual
- Where
- 6 sites in United States
- Volunteers
- 344 people
- Sponsor
- Gavin Bart
Pancreatitis, Chronic
Optimal Timing of Endoscopic Intervention in the Treatment of Chronic Pancreatitis.
This study aims to determine the optimal timing of endoscopic intervention after extracorporeal shock wave lithotripsy(ESWL) of chronic pancreatitis with pancreatic stones.
- Trial name
- TEST (NCT05270434)
- Testing
- time interval between ESWL and ERCP is 12h, time interval between ESWL and ERCP is greater than 12h, morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid (Analgesics)
- Where
- China
- Volunteers
- 220 people
- Sponsor
- Changhai Hospital
Opioid Withdrawal, Chronic Pain
ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain
This study will sequentially evaluate three novel and scalable interventions for at-risk individuals on long term opioid therapy for chronic pain: (1) low-dose transdermal buprenorphine initiation without a period of opioid…
- Trial name
- ACTION (NCT06442566)
- Testing
- Buprenorphine Patch, Transcranial Magnetic Stimulation (TMS)
- Where
- United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
Opioid Use Disorder
Oral Buprenorphine as a Novel Low-dose Induction Strategy for Opioid Use Disorder
This is a human laboratory-based, randomized, cross-over study in which buprenorphine will be administered to healthy volunteers (n=22) in 3 separate inpatient 2-night visits, at least 1 week apart.
- Trial name
- NCT06086275
- Testing
- Buprenorphine
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Opioid Use Disorder
Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose
The investigators aim to test the effectiveness of a high maintenance daily dose of buprenorphine (24 mg) for improving outcomes among patients who used fentanyl compared to the standard daily dose (16 mg).
- Trial name
- Optimal Bup (NCT06316830)
- Testing
- Buprenorphine
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Rhode Island Hospital
Cocaine Use Disorder
Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)
This is an 8-week, double-blind, randomized placebo-controlled trial of the efficacy of a combination of extended-release naltrexone (XR-NTX) and extended-release buprenorphine (XR-BUP) compared to matched placebo injections…
- Trial name
- CURB-2 (NCT05262270)
- Testing
- Extended-Release Naltrexone, Extended Release Buprenorphine
- Where
- 12 sites in United States
- Volunteers
- 427 people
- Sponsor
- University of Texas Southwestern Medical Center