A Clinical Trial Comparing Buprenorphine Formulations for High Potency Synthetic Opioid Use

Part of paid clinical trials in New York, New York.

Sponsor
Rachel R. Luba
Study ID
NCT06726200
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Opioid Use Disorder

Eligibility Criteria

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

Interventions

  • Buprenorphine + naloxone (Suboxone) — DRUG
    Participants randomized to sublingual buprenorphine naloxone will initiate treatment based on clinical guidelines/standard of care
  • Buprenorphine Injection — DRUG
    Participants randomized to injectable buprenorphine naloxone will receive a 300mg injection after receiving/tolerating a single 4/1 mg sublingual buprenorphine/naloxone dose

Study Details

The goal of this clinical trial is to compare buprenorphine formulations (sublingual buprenorphine versus long-acting injectable buprenorphine) for treating opioid use disorder among individuals who use fentanyl and/or other high potency synthetic opioids. Individuals aged 18-65 will be eligible for enrollment. The main questions it aims to answer are: Are there differences in frequency of drug use after individuals start treatment with sublingual buprenorphine compared to injectable buprenorphine? Are there differences in rates of sustained relapse after individuals start treatment with sublingual buprenorphine compared to injectable buprenorphine? Investigators also seek to understand and explore: How factors like body fat, body weight, and quantity of fentanyl use before treatment influence treatment outcomes. How blood levels of buprenorphine and its metabolite norbuprenorphine early on in treatment may influence treatment outcomes. How factors like craving and opioid withdrawal symptoms influence treatment outcomes. Participants will: Complete a brief overnight hospital stay in an inpatient research unit. This hospital stay will enable participants to start treatment with either sublingual buprenorphine or injectable buprenorphine. Provide blood and urine samples while on the inpatient unit and at follow up. Complete in-person follow up visits at 1-, 2-, 3- and 4-weeks after leaving the hospital to measure drug use, craving, withdrawal, quality of life, and physical health.

Key Dates

Start date
Feb 25, 2026
Status verified
May 2026
Primary completion
Jan 15, 2029
Completion
Jan 15, 2029

Study Design

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

Arms

  • Experimental: Injectable Buprenorphine
    Long-Acting Injectable Buprenorphine administered after participants receive and tolerate a single 4/1 mg sublingual buprenorphine/naloxone dose
  • Active Comparator: Sublingual Buprenorphine/Naloxone
    Titration onto sublingual buprenorphine/naloxone (standard of care)

Primary Outcome Measure

Percentage of Days Abstinent from Opioids [ Time Frame: 4 week follow up period ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Substance Treatment and Research ServiceNew YorkNew York10019
Administrative assistant
[email protected]
646-774-8189

Find similar trials in New York, NY

By research site
Substance Treatment and Research Service· New York, NY

Related Studies