Low-dose Versus a High-dose Sublingual Buprenorphine Induction
- Registration Number
- NCT05944952
- Lead Sponsor
- Friends Research Institute, Inc.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description low dose buprenorphine/naloxone 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. high dose buprenorphine/naloxone 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.
- Primary Outcome Measures
Name Time Method pharmacotherapy adherence out of 7 days number of days adherent to dose induction regiment
- Secondary Outcome Measures
Name Time Method Clinical Opiate Withdrawl Scale (COWS) 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
Subjective Opiate Withdrawal Scale (SOWS) 1-7 days Subjective opioid withdrawal symptoms score
Adjunctive medications 1-7 days Use of any adjunctive meds by self-report
Illicit opioid urine test results baseline, 1-7 days, 1 month, 3month Positive opioid urine drug screen
Time Line Follow-Back (TLFB) Self-reported illicit opioid use 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
Concomitant medications checklist 1-7 days, 1 month, 3 month Any medication taken by the participant to treat a medical or psychiatric disorder
Adverse events (AEs) reporting form baseline, 1-7 days, 1 month, 3 month Any reaction, side effect, or untoward event that occurs during the clinical trial, including reported overdoses
Trial Locations
- Locations (1)
MATClinics
🇺🇸Dundalk, Maryland, United States