Buspirone for Opioid Tapering

Study Overview
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Brief Summary
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This is a pilot study to collect preliminary data to support a grant application. The goal of the study is to evaluate whether the Food and Drug Administration (FDA)-approved and generically-available medication buspirone reduces symptoms of opioid withdrawal among patients undergoing a clinically-indicated and supervised taper from their opioid pain medications. This is premised on strong preclinical scientific support but has not yet be well-examined in humans.

Detailed Description
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Buspirone (Buspar) has shown initial efficacy in reducing symptoms of opioid withdrawal in animal studies and in human patients undergoing a methadone taper. Buspirone may have pharmacologic activity in specific neurotransmitter systems that preclinical evidence suggests may be implicated in the manifestation of opioid withdrawal symptoms. Administration of buspirone during an opioid taper may improve outcomes relative to placebo. The goal of this study is to collect preliminary feasibility and efficacy data from a sample of patients undergoing clinically-indicated opioid tapering. Participant enrollment will occur at the beginning of their residential stay on the Pain Treatment Unit at Johns Hopkins Hospital. Participants will be randomly assigned to receive buspirone (15 milligrams, three times daily, for daily dose of 45 milligrams) or placebo. Daily assessments for withdrawal and requests for additional symptomatic medications will be evaluated as evidence of initial efficacy. Feasibility measures include willingness to participate and study retention.

Official Title
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Buspirone as an Adjunctive Medication for Opioid Tapering

Conditions
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Opioid-Related Disorders, Dependency (Psychology), Pain, Chronic, Opiate Withdrawal Syndrome

Intervention / Treatment
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* Drug: Buspirone oral capsule
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years old Be undergoing taper of prescribed opioid pain medications at the study site Exclusion Criteria: Being pregnant or breastfeeding Past 7-day use of grapefruit juice or other strong Cytochrome (CYP) P450 inhibitors or inducers Have medical or psychiatric condition that is contraindicated with buspirone administration Current suicidality as assessed by clinic staff or the Columbia Suicide Severity Rating Scale

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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No

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: Patient completing a residential stay on the Pain Treatment Unit in which this study is being conducted will be enrolled and randomly assigned to receive either buspirone or placebo.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Buspirone oral capsule<br>Buspirone (15 milligrams) administered orally three times per day | Drug: Buspirone oral capsule<br>* 15 milligrams, three times daily<br>* Other names: Buspar;|
| Placebo Comparator: Placebo oral capsule<br>Placebo administered orally three times per day | Drug: Placebo oral capsule<br>* 0 milligrams (placebo), three times daily<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Taper Completion | Final day on which participant is enrolled in the clinic | 28 days | 
| Opioid Withdrawal Symptom Severity | Daily ratings of the Subjective Opiate Withdrawal Scale (SOWS)Total Score. The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely), and takes less than 10 minutes to complete. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Buspirone