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

Phase 4
Waitlist Available
Research Sponsored by Rachel R. Luba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Aged 18 to 65
* Voluntarily seeking treatment for opioid use disorder (OUD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-week follow up period
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

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-,4-, 8- and 12-weeks after leaving the hospital to measure drug use, craving, withdrawal, quality of life, and physical health.

Eligible Conditions
  • Opioid Use Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 week follow up period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 week follow up period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Days Abstinent from Opioids
Sustained Relapse
Secondary study objectives
Dropout during induction
Peak Clinical Opiate Withdrawal Scale (COWS) score
Time to Peak Clinical Opiate Withdrawal Scale (COWS) score
Other study objectives
Exploratory Outcome 1: Craving
Exploratory Outcome 2: Clinical Opiate Withdrawal Scale (COWS) Score
Exploratory Outcome 3: Time to first use of illicit opioids

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Injectable BuprenorphineExperimental Treatment1 Intervention
Long-Acting Injectable Buprenorphine administered after participants receive and tolerate a single 4/1 mg sublingual buprenorphine/naloxone dose
Group II: Sublingual Buprenorphine/NaloxoneActive Control1 Intervention
Titration onto sublingual buprenorphine/naloxone (standard of care)

Find a Location

Who is running the clinical trial?

Rachel R. LubaLead Sponsor
National Institute on Drug Abuse (NIDA)NIH
2,597 Previous Clinical Trials
3,328,863 Total Patients Enrolled
~40 spots leftby Jan 2029