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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 belowSelect...
I can visit the clinic daily for the first week of treatment.
Select...
My urine test was positive for fentanyl.
Select...
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
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 moreSide effects data
From 2007 Phase 4 trial • 60 Patients • NCT006840738%
Fatigue
6%
Headache
6%
Hyperhidrosis
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
Friends Research Institute, Inc.Lead Sponsor
58 Previous Clinical Trials
22,195 Total Patients Enrolled
MATClinicsUNKNOWN