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Opioid Replacement Therapy

Buprenorphine for Opioid Use Disorder (ROLDI Trial)

Phase 2

Recruiting

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Fentanyl positive on urine drug test

Ages 18 or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if buprenorphine can be safely started for opioid use disorder with fentanyl use without causing withdrawal symptoms. Participants with moderate or severe opioid use disorder and fentanyl in their

Who is the study for?

This trial is for adults with moderate to severe opioid use disorder who have used fentanyl, as confirmed by a urine test. Participants must understand English well enough to give informed consent. It's not suitable for those under 18 or unable to consent.

What is being tested?

The study tests if buprenorphine can be started in patients using fentanyl without causing withdrawal. One group follows standard care, waiting until experiencing withdrawal symptoms before starting treatment. The other uses a rapid low-dose method without waiting.

What are the potential side effects?

Buprenorphine may cause side effects like nausea, drowsiness, constipation, and sweating. In the context of this trial, there's also a risk of precipitated withdrawal when transitioning from fentanyl to buprenorphine.

Eligibility Criteria

Inclusion Criteria

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

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My urine test was positive for fentanyl.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Initiation of buprenorphine maintenance without precipitated withdrawal

Side effects data

From 2014 Phase 3 trial • 815 Patients • NCT01675167

17%

Nausea

Constipation

Vomiting

Headache

Dizziness

Somnolence

Drug withdrawal syndrome

100%

80%

60%

40%

20%

Study treatment Arm

OL Buprenorphine HCl Buccal Film

DB Buprenorphine HCl Buccal Film

DB Placebo Film

Awards & Highlights

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: Rapid outpatient low-dose initiationExperimental Treatment1 Intervention

Participants randomized to low-dose initiation will be instructed to arrive to the research unit without withdrawal. Participants with COWS \<4 will be admitted to the research unit to begin induction. They will be administered 0.5, 0.5, 1, 1, 1, 4, and then 8 mg as sublingual buprenorphine films with doses scheduled every 2 hours. They will then continue 8-12mg twice daily as maintenance treatment.

Group II: Standard initiationActive Control1 Intervention

Participants randomized to standard induction will be instructed to arrive to the research unit with mild withdrawal and to have abstained from opioids for at least 8 hours, per ASAM Guidelines. Participants with COWS 4 or higher on initial assessment will be admitted to the research unit to begin induction. Standard initiation will follow guidelines from the 2020 Focused Update of the ASAM National Practice Guidelines. Once participants have had at least 8 hours of abstinence and have reached COWS \>11, they will be given 2 mg sublingual buprenorphine, followed 2 hours later by 2 mg, followed 2 hours later by 4 mg, followed 2 hours later by 8 mg. They will then continue 8-12 mg twice daily as maintenance treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Buprenorphine

2014

Completed Phase 4

~2600

0 / 2Eligibility criteria met