Buspirone for Opioid Tapering

Phase 1

Completed

• Conditions: Dependency (Psychology); Opioid-Related Disorders; Pain, Chronic; Opiate Withdrawal Syndrome
• Interventions: Drug: Buspirone oral capsule; Drug: Placebo oral capsule

• Registration Number: NCT03521960
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-04-30
• Study First Submitted QC: 2018-05-09
• Study First Posted: 2018-05-11
• Study Start: 2018-05-30
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buspirone oral capsule	Buspirone oral capsule	Buspirone (15 milligrams) administered orally three times per day
Placebo oral capsule	Placebo oral capsule	Placebo administered orally three times per day

Primary Outcome Measures

Name	Time	Method
Taper Completion	28 days	Final day on which participant is enrolled in the clinic
Opioid Withdrawal Symptom Severity	28 days	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.

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States