Low-dose Versus a High-dose Sublingual Buprenorphine Induction

Last updated: March 13, 2025
Sponsor: Friends Research Institute, Inc.
Overall Status: Active - Not Recruiting

Phase

4

Condition

Opioid Use Disorder

Treatment

buprenorphine/naloxone

Clinical Study ID

NCT05944952
01
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study proposes to compare a low-dose versus a high-dose buprenorphine induction scheme in 40 fentanyl using people with Opioid Use Disorder (OUD). Study participants will be randomized to either the low-dose (n=20) or high dose (n=20) group and dispensed medication daily for one week.

Eligibility Criteria

Inclusion

Inclusion Criteria:

≥ 18 years of age) persons with a DSM-5 diagnosis of OUD;

  • Must have a fentanyl positive urine test;

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

Exclusion

Exclusion Criteria:

  • No exclusionary medical history or mental health issues as determined by theadmitting provider; e.g., patients with untreated or unstable serious mentalillness, including psychotic disorders;

  • Alcohol withdrawal requiring pharmacological management;

  • Urine positive for buprenorphine, benzodiazepines, or methadone; 4. Enrolled in amethadone treatment program in the past 14 days; 5. Inability to pass a studyenrollment quiz.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: buprenorphine/naloxone
Phase: 4
Study Start date:
June 20, 2024
Estimated Completion Date:
October 30, 2025

Study Description

This study proposes to compare a low-dose versus a high-dose buprenorphine induction scheme in 40 fentanyl using people with Opioid Use Disorder (OUD). Study participants will be randomized to either the low-dose (n=20) or high dose (n=20) group and dispensed medication daily for one week. Thereafter, they will be treated according to the MATClinics usual schedule of clinic visits. The number and timing of visits may vary according to whether the participant is still using illicit opioids. Follow-up visits for the study will be at one and three months.The primary objective is to determine whether patients randomly assigned to low versus high dose induction regimens are more likely to complete the 7-day induction period. Secondary outcomes are the number of patients who develop precipitated withdrawal or other adverse events, experience subjective opioid withdrawal symptoms, use adjunctive medications (hydroxyzine, loperamide, dicyclomine, clonidine, ibuprofen, methocarbamol, trazodone, ondansetron) provided by the clinic, recommendation of the medication induction scheme to other patients, and treatment retention at 1- and 3- months post induction.

Connect with a study center

  • MATClinics

    Dundalk, Maryland 21222
    United States

    Site Not Available

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