Low-dose Versus a High-dose Sublingual Buprenorphine Induction

• ClinicalTrials.gov Identifier: NCT05944952
• Recruitment Status: Recruiting
• First Posted: July 14, 2023
• Last Update Posted: February 22, 2024
• Sponsor: Friends Research Institute, Inc.
• Collaborator: MATClinics
• Information provided by (Responsible Party): Friends Research Institute, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Opioid Use Disorder	Drug: buprenorphine/naloxone	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: December 1, 2023
• Estimated Primary Completion Date: October 1, 2024
• Estimated Study Completion Date: December 31, 2024

Arms and Interventions

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 Name: 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 Name: suboxone

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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
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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Contacts

Contact: Michael S Gordon, DPA; 41083703977 ext 251; mgordon@friendsresearch.org

Contact: Frank J Vocci, PhD; 410-837-3977 ext 225; fvocci@friendsresearch.org

Locations

United States, Maryland

MATClinics; Recruiting

Dundalk, Maryland, United States, 21222

Contact: Michael Gordon, DPA 410-837-3977 mgordon@friendsresearch.org

Sponsors and Collaborators

Friends Research Institute, Inc.

MATClinics

More Information

• Responsible Party: Friends Research Institute, Inc.
• ClinicalTrials.gov Identifier: NCT05944952
• Other Study ID Numbers: 01
• First Posted: July 14, 2023
• Last Update Posted: February 22, 2024
• Last Verified: February 2024

• 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

Additional relevant MeSH terms:

Opioid-Related Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Narcotic Antagonists