Buspirone for Opioid Tapering

Pain, Chronic Clinical Trial

Official title:

Buspirone as an Adjunctive Medication for Opioid Tapering

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03521960
• Other study ID #: IRB00125620
• Status: Completed
• Phase: Phase 1
• Start date: May 30, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Buspirone oral capsule
15 milligrams, three times daily
• Placebo oral capsule
0 milligrams (placebo), three times daily

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Taper Completion	Final day on which participant is enrolled in the clinic	28 days
Primary	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