NCT03521960

Buspirone for Opioid Tapering

Buspirone as an Adjunctive Medication for Opioid Tapering

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Buspirone oral capsule	15 milligrams, three times daily
DRUG	Placebo oral capsule	0 milligrams (placebo), three times daily

Timeline

• Start date: 2018-05-30
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2018-05-11
• Last updated: 2020-07-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study