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Buspirone for Opioid Tapering

Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT03521960
Collaborator
(none)
18
Enrollment
1
Location
2
Arms
25
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Buspirone oral capsule
  • Drug: Placebo oral capsule
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patient completing a residential stay on the Pain Treatment Unit in which this study is being conducted will be enrolled and randomly assigned to receive either buspirone or placebo.Patient completing a residential stay on the Pain Treatment Unit in which this study is being conducted will be enrolled and randomly assigned to receive either buspirone or placebo.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-blind placebo controlled study. Patients are randomized to receive either active buspirone or placebo, each of which is over-encapsulated to support blinding.
Primary Purpose:
Treatment
Official Title:
Buspirone as an Adjunctive Medication for Opioid Tapering
Actual Study Start Date :
May 30, 2018
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jun 30, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Taper Completion [28 days]

      Final day on which participant is enrolled in the clinic

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins University Baltimore Maryland United States 21205

    Sponsors and Collaborators

    • Johns Hopkins University

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT03521960
    Other Study ID Numbers:
    • IRB00125620
    First Posted:
    May 11, 2018
    Last Update Posted:
    Jul 23, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Johns Hopkins University
    Buspirone
    Additional relevant MeSH terms:
    Chronic Pain
    Opioid-Related Disorders
    Substance Withdrawal Syndrome
    Buspirone

    Study Results

    No Results Posted as of Jul 23, 2020