Actively Recruiting
Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder
Led by New York State Psychiatric Institute · Updated on 2025-05-13
180
Participants Needed
2
Research Sites
162 weeks
Total Duration
On this page
Sponsors
N
New York State Psychiatric Institute
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will evaluate the effectiveness of a new pharmacological approach to increase efficacy of treatment with extended release naltrexone (XR-naltrexone) for individuals with opioid use disorder by combining it with buprenorphine-naloxone. This is a two arm, double-blind, placebo-controlled study to examine whether addition of buprenorphine-naloxone will improve treatment retention, reduce opioid craving, and improve mood over 24 weeks of treatment with extended release naltrexone (XR-naltrexone) administered every four weeks for a total of 6 injections. The NYSPI site, which provides study oversight (no direct participant involvement) is currently paused and has been paused since an institutional pause on human subjects research began in June, 2023. The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.
CONDITIONS
Official Title
Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 18 to 65 years interested in antagonist-based relapse prevention treatment
- Meet current DSM-5 criteria for opioid use disorder lasting at least six months, supported by positive urine toxicology or naloxone challenge
- In generally good health with no significant medical abnormalities based on medical history, physical exam, vital signs, ECG, and lab tests
- Completed detoxification and received initial XR-naltrexone injection within 2 weeks prior to enrollment
- Seeking treatment with XR-naltrexone and considered suitable for naltrexone-based treatment by a physician
- Willing and able to provide written informed consent and understand treatment differences
You will not qualify if you...
- Methadone maintenance within 2 weeks before XR-naltrexone induction or any methadone use in the week prior
- Maintenance on buprenorphine or frequent buprenorphine use above 8 mg/day in the week before XR-naltrexone induction; any buprenorphine use after initial XR-naltrexone injection
- Serious medical, psychiatric, or substance use disorders making detoxification or study treatment unsafe
- Liver enzyme (AST/ALT) levels more than 3 times normal limit
- Pregnant, breastfeeding, or planning pregnancy; must have negative pregnancy test and agree to dual contraception
- Dependence on alcohol or sedative-hypnotics with withdrawal risk
- Allergic or adverse reactions to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam
- Painful medical conditions requiring ongoing opioid pain medication or planned surgery needing opioids
- Age over 60 with possible cognitive decline (Mini Mental Status Exam score below 25)
- Having 30 or more opioid-free days prior to randomization
- More than 2 weeks after initial XR-naltrexone injection from outside treatment setting
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Avery Road Treatment Center (ARTC)
Rockville, Maryland, United States, 20853
Actively Recruiting
2
Stars/Nyspi
New York, New York, United States, 10019
Active, Not Recruiting
Research Team
A
Adam Bisaga, md
CONTACT
M
Matisyahu Shulman, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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