Low-dose Versus a High-dose Sublingual Buprenorphine Induction

NCT05944952 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Clinical Opiate Withdrawl Scale (COWS)

  1-7 days

• Illicit opioid urine test results

  baseline, 1-7 days, 1 month, 3month

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

  baseline, 1-7 days, 1 month, 3 month

• Subjective Opiate Withdrawal Scale (SOWS)

  1-7 days

• Adjunctive medications

  1-7 days

Study Arms (2)

high dose

EXPERIMENTAL

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

low dose

ACTIVE COMPARATOR

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

Interventions

buprenorphine/naloxone DRUG

Participants will be dosed with buprenorphine/ naloxone strips

Also known as: suboxone

high dose; low dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Friends Research Institute, Inc.: lead
• MATClinics: collaborator

Study Sites (1)

MATClinics

Dundalk, Maryland, 21222, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: June 27, 2023
• First Posted: July 14, 2023
• Study Start: June 20, 2024
• Primary Completion: December 31, 2024
• Study Completion: October 30, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-03

Locations

US (1)