Buspirone for Opioid Tapering

July 21, 2020 updated by: Johns Hopkins University

Buspirone as an Adjunctive Medication for Opioid Tapering

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Buspirone oral capsule
Buspirone (15 milligrams) administered orally three times per day
Drug: Buspirone oral capsule
15 milligrams, three times daily
Other Names:
  • Buspar
Placebo Comparator: Placebo oral capsule
Placebo administered orally three times per day
Drug: Placebo oral capsule
0 milligrams (placebo), three times daily
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Taper Completion
Time Frame: 28 days
Final day on which participant is enrolled in the clinic
28 days
Opioid Withdrawal Symptom Severity
Time Frame: 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.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2018

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

April 30, 2018

First Submitted That Met QC Criteria

May 9, 2018

First Posted (Actual)

May 11, 2018

Study Record Updates

Last Update Posted (Actual)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00125620

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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