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Opioid Agonist

high dose 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

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

pharmacotherapy adherence

Secondary outcome measures

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®

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

Find a Location

Who is running the clinical trial?

Friends Research Institute, Inc.Lead Sponsor

52 Previous Clinical Trials

20,568 Total Patients Enrolled

MATClinicsUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enroll participants in this medical study at the moment?

"Indeed, the details on clinicaltrials.gov reveal that this investigation is actively pursuing eligible participants. Initially shared on December 1st, 2023, and subsequently revised on February 21st, 2024. The research seeks to enroll a total of 40 patients from one designated site."

Answered by AI

What is the current number of individuals being admitted into this particular medical trial?

"Indeed, the details on clinicaltrials.gov indicate that this research study is presently seeking volunteers. The trial was initially posted on December 1st, 2023, and most recently revised on February 21st, 2024. The study aims to recruit 40 participants at a single site."

Answered by AI

Has the Food and Drug Administration officially sanctioned the use of high doses?

"Given that this intervention is approved and the trial falls within Phase 4, our team at Power rates high dose safety as a 3 on the established scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Low-dose Versus a High-dose Sublingual Buprenorphine Induction

2023. "Low-dose Versus a High-dose Sublingual Buprenorphine Induction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05944952.

All > Probuphine