Low-dose Versus a High-dose Sublingual Buprenorphine Induction

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Drug: buprenorphine/naloxone

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Dundalk, Maryland, United States, 21222
      • MATClinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high dose; 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.	Drug: buprenorphine/naloxone; Participants will be dosed with buprenorphine/ naloxone strips; Other Names: suboxone
Active Comparator: low dose; 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.	Drug: buprenorphine/naloxone; Participants will be dosed with buprenorphine/ naloxone strips; Other Names: suboxone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pharmacotherapy adherence	completion of dose induction regimen (yes/no)	1-7 days
pharmacotherapy adherence	number of days adherent to dose induction regiment	out of 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Opiate Withdrawl Scale (COWS)	Precipitated withdrawal symptoms score; 11-item scale Score: 5- 12 = mild; 1 3-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal	1-7 days
Illicit opioid urine test results	Positive opioid urine drug screen	baseline, 1-7 days, 1 month, 3month
Time Line Follow-Back (TLFB) Self-reported illicit opioid use	Self-report daily during first week then number of days during the past 30 for 1 and 3 month follow-ups	baseline, 1-7 days, 1 month, 3 month
Adjunctive medications	Use of any adjunctive meds by self-report	1-7 days
Concomitant medications checklist	Any medication taken by the participant to treat a medical or psychiatric disorder	1-7 days, 1 month, 3 month
Adverse events (AEs) reporting form	Any reaction, side effect, or untoward event that occurs during the clinical trial, including reported overdoses	baseline, 1-7 days, 1 month, 3 month
Subjective Opiate Withdrawal Scale (SOWS)	Subjective opioid withdrawal symptoms score (1-10, mild withdrawal; 11-20 moderate withdrawal; 21-30 severe withdrawal)	1-7 days

Collaborators and Investigators

• Sponsor: Friends Research Institute, Inc.
• Collaborators: MATClinics

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine, Naloxone Drug Combination; Buprenorphine; Naloxone
• Other Study ID Numbers: 01 (Miami VAHS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes