Low-dose Versus a High-dose Sublingual Buprenorphine Induction

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Drug: buprenorphine/naloxone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high dose<br>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<br>* Participants will be dosed with buprenorphine/ naloxone strips<br>* Other names: suboxone;|
| Active Comparator: low dose<br>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<br>* Participants will be dosed with buprenorphine/ naloxone strips<br>* Other names: suboxone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Illicit opioid urine test results | Positive opioid urine drug screen | baseline, 1-7 days, 1 month, 3month | 
| 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 | 
| Subjective Opiate Withdrawal Scale (SOWS) | Subjective opioid withdrawal symptoms score | 1-7 days | 
| Adjunctive medications | Use of any adjunctive meds by self-report | 1-7 days | 
| Concomitant medications checklist | Any medication taken by the participant to treat a medical or psychiatric disorder | 1-7 days, 1 month, 3 month | 
| 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 |