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Buprenorphine Initiation for Opioid Use Disorder

(COPILOT Trial)

LW
Overseen ByLeslie W Suen, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of California, San Francisco
Must not be taking: Methadone, Buprenorphine
Disqualifiers: Pregnancy, Legal issues, Cognitive impairment, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this pragmatic randomized controlled trial is to compare treatment outcomes of two strategies for initiating buprenorphine treatment (low-dose initiation and direct-to-inject) in adults with opioid use disorder (OUD) who use fentanyl. This study aims to:

1. Compare effectiveness of each strategy on treatment retention in a real world, clinical setting, and

2. Assess differences between strategies in patient-reported outcomes, including withdrawal symptoms, cravings, drug use, treatment satisfaction, and overall acceptability.

Participants will:

1. Be randomized to initiate buprenorphine via a low-dose initiation or direct-to-inject protocol at an outpatient buprenorphine clinic,

2. Keep a diary of craving and withdrawal symptoms for the first 7 days after initiation, and

3. Visit the outpatient clinic 7, 30, and 90 days after initiation for urinary drug screen and follow-up surveys.

Who Is on the Research Team?

LW

Leslie W Suen, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Inclusion Criteria

I have San Francisco Medicaid or Medicare and can get prescriptions from CBHS Pharmacy.
Documentation of an OUD diagnosis as evidenced by meeting two or more of the DSM-5 Criteria for Opioid Use Disorder
Self-reported daily use of fentanyl ≥ 5 out of the past 7 days at baseline
See 3 more

Exclusion Criteria

Currently nursing, pregnant, or anticipating pregnancy in the next 6 months
Be unable to provide any locator or contact information at least one contact in addition to themselves
Any pending legal action that could prevent participation in study activities
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment Initiation

Participants are randomized to initiate buprenorphine via a low-dose initiation or direct-to-inject protocol at an outpatient buprenorphine clinic. They keep a diary of craving and withdrawal symptoms for the first 7 days.

7 days
1 visit (in-person) on day 1

Early Follow-up

Participants visit the outpatient clinic for urinary drug screen and follow-up surveys.

30 days
2 visits (in-person) on days 7 and 30

Extended Follow-up

Participants continue to receive monthly injections and are monitored for treatment retention and adverse events.

60 days
1 visit (in-person) on day 90

What Are the Treatments Tested in This Trial?

Interventions

  • Buprenorphine

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Direct-to-inject (DTI)Experimental Treatment1 Intervention
Group II: Low-dose initiation (LDI)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

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