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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
Select...
My urine test was positive for fentanyl.
Select...
I am 18 years old or older.

Timeline

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
8%
Constipation
7%
Vomiting
7%
Headache
5%
Dizziness
5%
Somnolence
1%
Drug withdrawal syndrome
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,571 Previous Clinical Trials
3,286,454 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,069 Previous Clinical Trials
42,713,815 Total Patients Enrolled
~40 spots leftby Dec 2025
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