Buprenorphine Induction for Fentanyl Dependent Opioid Users

• Status: Not yet recruiting
• Trial end date: 2022-01-15
• Target enrollment: 0
• Participant gender: All

Summary

The overall goal of this pilot study is to characterize illicit fentanyl and combination fentanyl and opioid dependence explicitly, by assessing physiologic barriers to effective buprenorphine induction. Results from this pilot study may make a case for a larger feasibility study to be conducted through the Clinical Trials Network at the National Institutes of Drug Abuse.

The primary hypothesis is that individuals dependent on illicit fentanyl and combination fentanyl and opioids will have difficulty with standard buprenorphine induction, and will need a modified approach. The primary outcome measure will be retention on buprenorphine at seven days post induction. The secondary outcome measures will be objective precipitated withdrawal and the rate of patients requiring or requesting to initiate methadone due to intolerance of buprenorphine.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Treatments: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

Criteria

Inclusion Criteria:

1. 18 years of age or older

2. Diagnosis of opioid use disorder (OUD) as determined through routine clinical care

3. Positive for fentanyl on point of care urine drug screen

4. Ability to read, write, and comprehend English

5. Patients willing to start buprenorphine at the onset of treatment (e.g., clinical intake)

6. Patients who need to initiate a buprenorphine induction at home must have an operating smartphone or tablet device with video capability.

Exclusion Criteria:

1. Initiating maintenance treatment that does not include MAT or switching to a maintenance treatment that does not include MAT (i.e.: detoxification and counseling treatment only without MAT, or planning to enter methadone treatment).

2. Judged by the evaluating physician or allied clinician to need a higher level of care (i.e.: residential or inpatient treatment)

3. Pregnant

4. Patients desiring to start methadone or naltrexone at the onset of treatment (e.g., clinical intake)

5. Patients who are unable to stay in the clinic for the induction period.