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Opioid Agonist

Buprenorphine/Naloxone for Opioid Use Disorder

Phase 4

Recruiting

Research Sponsored by Friends Research Institute, Inc.

Eligibility Criteria Checklist

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

Must have

Able to come to the clinic every day for the first week of treatment

Must have a fentanyl positive urine test

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-7 days, 1 month, 3 month

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial will compare the effects of a low dose versus a high dose of buprenorphine in 40 individuals with Opioid Use Disorder who use fentanyl. The participants will be randomly

Who is the study for?

This trial is for adults over 18 with Opioid Use Disorder who have used fentanyl, as confirmed by a urine test. Participants must be able to visit the clinic daily for one week.

What is being tested?

The study is testing two different dosing strategies of buprenorphine/naloxone in treating OUD: a low-dose and a high-dose plan. Forty participants will be randomly assigned to either group and receive medication daily for one week.

What are the potential side effects?

Buprenorphine/naloxone can cause side effects like nausea, dizziness, sweating, headache, or constipation. Some people might also experience withdrawal symptoms if the dose isn't right.

Eligibility Criteria

Inclusion Criteria

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

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I can visit the clinic daily for the first week of treatment.

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My urine test was positive for fentanyl.

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I am an adult diagnosed with opioid use disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-7 days, 1 month, 3 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-7 days, 1 month, 3 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-7 days, 1 month, 3 month for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

pharmacotherapy adherence

Secondary study objectives

Adjunctive medications

Adverse events (AEs) reporting form

Clinical Opiate Withdrawl Scale (COWS)

+4 more

Side effects data

From 2007 Phase 4 trial • 60 Patients • NCT00684073

Fatigue

Headache

Hyperhidrosis

100%

80%

60%

40%

20%

Study treatment Arm

Subutex®/Suboxone®

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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: high doseExperimental Treatment1 Intervention

High dose: Participants randomized to the high dose group will receive on day 1 in the clinic an initial dose of 2 mg of buprenorphine/naloxone, followed by a 6 mg dose an hour later, followed by an 8 mg dose an hour later, followed by an 8 mg dose an hour later. On day 2 they will receive a 12 mg dose in the clinic and a 12 mg dose as take-home medication. On days 3 through 7 they will report to the clinic and receive their 12 mg morning dose and a 12 mg dose as a take-home for evening dosing. Thereafter, dosing adjustments can be made in the first three months of the trial.

Group II: low doseActive Control1 Intervention

Low dose: Participants randomized to the low dose group will receive 0.5 mg of buprenorphine/naloxone on day 1, 0.5 mg bid on day 2, 1.0 mg bid on day 3, 2.0 mg bid on day 4, 4.0 mg bid on day 5, 4.0 mg tid on day 6, and 8 mg bid on day 7. Thereafter, dosing adjustments can be made in the first three months of the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

buprenorphine/naloxone

2017

Completed Phase 4

~890

0 / 3Eligibility criteria met