Buspirone for Opioid Tapering

NCT ID: NCT03521960

Last Updated: 2020-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-30
• Study Completion Date: 2020-06-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Buspirone oral capsule

Buspirone (15 milligrams) administered orally three times per day

Group Type: ACTIVE_COMPARATOR

Buspirone oral capsule

Intervention Type: DRUG

15 milligrams, three times daily

Placebo oral capsule

Placebo administered orally three times per day

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

0 milligrams (placebo), three times daily

Interventions

Buspirone oral capsule

15 milligrams, three times daily

Intervention Type: DRUG

Placebo oral capsule

0 milligrams (placebo), three times daily

Intervention Type: DRUG

Other Intervention Names

Buspar; Placebo

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00125620

Identifier Type: -

Identifier Source: org_study_id