Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder

Part of paid clinical trials in Rockville, Maryland.

Sponsor
New York State Psychiatric Institute
Study ID
NCT05011266
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Opioid-use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Buprenorphine/naloxone — DRUG
    5.7 mg buprenorphine/1.4 mg naloxone sub-lingual daily
  • Placebo — DRUG
    placebo sub-lingual tablet daily

Study Details

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.

Key Dates

Start date
Apr 18, 2023
Status verified
May 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Buprenorphine-naloxone
    Buprenorphine/naloxone 5.7 mg /1.4 mg/day sub-lingual tablets
  • Placebo Comparator: Placebo
    placebo sub-lingual tablet

Primary Outcome Measure

Proportion of participants receiving XR-naltrexone injections [ Time Frame: 20 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Avery Road Treatment Center (ARTC)RockvilleMaryland20853
Praveena Machineni
[email protected]
240-739-0626
Lauren Rudin
[email protected]
240-739-0601
Kevin Wenzel, PhD (PRINCIPAL_INVESTIGATOR)
Stars/NyspiNew YorkNew York10019-

Find similar trials in Rockville, MD

By research site
Avery Road Treatment Center (ARTC)· Rockville, MDStars/Nyspi· New York, NY

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