Clinical trial NCT06726200: A Clinical Trial Comparing Buprenorphine Formulations for High Potency Synthetic Opioid Use
Official title: A Randomized Controlled Trial Examining Extended-Release Injectable Buprenorphine in Those Who Use High Potency Synthetic Opioids
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Opioid Use Disorder
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-12-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Aged 18 to 65
* Voluntarily seeking treatment for opioid use disorder (OUD)
* Consistent use of fentanyl or other high potency synthetic opioids
* Meets DSM-5 criteria for OUD with at least moderate severity
* Able to provide written informed consent in English and willing to comply with study procedures

Exclusion Criteria:

* Meets DSM-5 criteria for another substance use disorder as the primary diagnosis
* Has an active, unmanaged psychiatric condition that would make participation hazardous (e.g., acute, psychosis, current suicidality, current manic episode)
* Has an active, unmanaged medical condition that would make participation hazardous or preclude use of buprenorphine or ancillary medications for withdrawal (e.g., unmanaged hypertension, unmanaged diabetes, clinically significant abnormality on ECG, acute hepatitis)
* Buprenorphine or methadone treatment in the past 30 days
* Known allergy, hypersensitivity or intolerance to buprenorphine
* Pregnancy, lactation, or unwillingness to use adequate contraceptive methods
* Current physiological dependence on sedative-hypnotics or alcohol that would require medically supervised detoxification
* Liver function tests \> 2x the upper limit of normal
* Use of medications or herbal products with known CYP3A4 inhibition or induction properties in the past 30 days

Primary outcomes:
measure: Percentage of Days Abstinent from Opioids
timeFrame: 12 week follow up period
measure: Sustained Relapse
timeFrame: 12 week follow up period
Secondary outcomes:
measure: Time to Peak Clinical Opiate Withdrawal Scale (COWS) score
timeFrame: During the inpatient induction period (approximately 1 overnight stay)
measure: Peak Clinical Opiate Withdrawal Scale (COWS) score
timeFrame: During the inpatient induction period (approximately 1 overnight stay)
measure: Dropout during induction
timeFrame: During the inpatient induction period (approximately 1 overnight stay)
Other outcomes:
measure: Exploratory Outcome 1: Craving
timeFrame: Induction Period (Overnight Inpatient Stay) and 12-week follow up period
measure: Exploratory Outcome 2: Clinical Opiate Withdrawal Scale (COWS) Score
timeFrame: Induction Period (Overnight Inpatient Stay) and 12-week follow up period
measure: Exploratory Outcome 3: Time to first use of illicit opioids
timeFrame: 12-week follow up period
Locations:
city: New York
country: United States
facility: Substance Treatment and Research Service
state: New York
Study officials:
References: