Clinical trial NCT05944952: Low-dose Versus a High-dose Sublingual Buprenorphine Induction
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Opioid Use Disorder
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: MATClinics
First posted: 2023-07-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: pharmacotherapy adherence
timeFrame: 1-7 days
measure: pharmacotherapy adherence
timeFrame: out of 7 days
Secondary outcomes:
measure: Clinical Opiate Withdrawl Scale (COWS)
timeFrame: 1-7 days
measure: Illicit opioid urine test results
timeFrame: baseline, 1-7 days, 1 month, 3month
measure: Time Line Follow-Back (TLFB) Self-reported illicit opioid use
timeFrame: baseline, 1-7 days, 1 month, 3 month
measure: Subjective Opiate Withdrawal Scale (SOWS)
timeFrame: 1-7 days
measure: Adjunctive medications
timeFrame: 1-7 days
measure: Concomitant medications checklist
timeFrame: 1-7 days, 1 month, 3 month
measure: Adverse events (AEs) reporting form
timeFrame: baseline, 1-7 days, 1 month, 3 month
Other outcomes:
Locations:
city: Dundalk
country: United States
facility: MATClinics
state: Maryland
Study officials:
References: