Opioid Use Disorder
Conditions
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- and 4-weeks after leaving the hospital to measure drug use, craving, withdrawal, quality of life, and physical health.
Interventions
Participants randomized to sublingual buprenorphine naloxone will initiate treatment based on clinical guidelines/standard of care
Participants randomized to injectable buprenorphine naloxone will receive a 300mg injection after receiving/tolerating a single 4/1 mg sublingual buprenorphine/naloxone dose
Sponsors
Rachel R. Luba
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Days Abstinent from Opioids | 4 week follow up period | Abstinence from Opioids (% days abstinent; continuous; longitudinal) during each week of the 4 week follow up period measured via the timeline follow back. |
| Sustained Relapse | 4 week follow up period | Sustained relapse during the 4 week follow up period (binary), defined as 5 consecutive days of illicit opioid use reported on the timeline follow back at any point during the 4 week follow up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Peak Clinical Opiate Withdrawal Scale (COWS) score | During the inpatient induction period (approximately 1 overnight stay) | The time to peak Clinical Opiate Withdrawal Scale (COWS) score during the induction period (time-to-event/survival). The COWS ranges from 0-48 with higher scores indicating more severe opioid withdrawal symptoms. |
| Peak Clinical Opiate Withdrawal Scale (COWS) score | During the inpatient induction period (approximately 1 overnight stay) | The peak Clinical Opiate Withdrawal Scale (COWS) score during the induction period (continuous). The COWS ranges from 0-48 with higher scores indicating more severe opioid withdrawal symptoms. |
| Dropout during induction | During the inpatient induction period (approximately 1 overnight stay) | Dropout during the induction period (binary) |
Countries
United States
Contacts
CONTACTRachel Luba, PhD
CONTACTJohn Mariani, MD
Outcome results
None listed