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Active, Not Recruiting

NCT Number: NCT05944952

Low-dose Versus a High-dose Sublingual Buprenorphine Induction

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

MATClinics

Dundalk, Maryland, 21222, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult male or female (≥ 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 criteria

  • No exclusionary medical history or mental health issues as determined by the admitting provider; e.g., patients with untreated or unstable serious mental illness, including psychotic disorders;
  • Alcohol withdrawal requiring pharmacological management;
  • Urine positive for buprenorphine, benzodiazepines, or methadone; 4. Enrolled in a methadone treatment program in the past 14 days; 5. Inability to pass a study enrollment quiz.

Treatment and study plan

buprenorphine/naloxone

Drug

Participants will be dosed with buprenorphine/ naloxone strips

Other names: suboxone

Primary outcomes

  1. pharmacotherapy adherence

    Time frame: 1-7 days

    completion of dose induction regimen (yes/no)

  2. pharmacotherapy adherence

    Time frame: out of 7 days

    number of days adherent to dose induction regiment

Secondary outcomes

  1. Clinical Opiate Withdrawl Scale (COWS)

    Time frame: 1-7 days

    Precipitated withdrawal symptoms score; 11-item scale Score: 5- 12 = mild; 1 3-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal

  2. Illicit opioid urine test results

    Time frame: baseline, 1-7 days, 1 month, 3month

    Positive opioid urine drug screen

  3. Time Line Follow-Back (TLFB) Self-reported illicit opioid use

    Time frame: baseline, 1-7 days, 1 month, 3 month

    Self-report daily during first week then number of days during the past 30 for 1 and 3 month follow-ups

  4. Subjective Opiate Withdrawal Scale (SOWS)

    Time frame: 1-7 days

    Subjective opioid withdrawal symptoms score (1-10, mild withdrawal; 11-20 moderate withdrawal; 21-30 severe withdrawal)

  5. Adjunctive medications

    Time frame: 1-7 days

    Use of any adjunctive meds by self-report

  6. Concomitant medications checklist

    Time frame: 1-7 days, 1 month, 3 month

    Any medication taken by the participant to treat a medical or psychiatric disorder

  7. Adverse events (AEs) reporting form

    Time frame: baseline, 1-7 days, 1 month, 3 month

    Any reaction, side effect, or untoward event that occurs during the clinical trial, including reported overdoses

Sponsors and collaborators

Lead sponsor

Friends Research Institute, Inc.

Other

Collaborators

  • MATClinics

Registry information

Official study title

A Pilot Study Comparing a Low-dose Versus a High-dose Sublingual Buprenorphine Induction Dosing Scheme in Fentanyl Using Patients With Opioid Use Disorder (OUD)

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 14, 2023
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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