Low-dose Versus a High-dose Sublingual Buprenorphine Induction

Opioid Use Disorder Clinical Trial

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05944952
• Other study ID #: 01
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Friends Research Institute, Inc.
• Contact: Michael S Gordon, DPA
• Phone: 41083703977
• Email: mgordon[@]friendsresearch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Drug:
• buprenorphine/naloxone
Participants will be dosed with buprenorphine/ naloxone strips

Locations

Country	Name	City	State
United States	MATClinics	Dundalk	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Friends Research Institute, Inc.	MATClinics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharmacotherapy adherence	completion of dose induction regimen (yes/no)	1-7 days
Primary	pharmacotherapy adherence	number of days adherent to dose induction regiment	out of 7 days
Secondary	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
Secondary	Illicit opioid urine test results	Positive opioid urine drug screen	baseline, 1-7 days, 1 month, 3month
Secondary	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
Secondary	Subjective Opiate Withdrawal Scale (SOWS)	Subjective opioid withdrawal symptoms score	1-7 days
Secondary	Adjunctive medications	Use of any adjunctive meds by self-report	1-7 days
Secondary	Concomitant medications checklist	Any medication taken by the participant to treat a medical or psychiatric disorder	1-7 days, 1 month, 3 month
Secondary	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