Study of Buspirone for Relapse-Prevention in Adults With Cocaine Dependence (BRAC)

December 18, 2014 updated by: Theresa Winhusen, University of Cincinnati

A Randomized Controlled Evaluation of Buspirone for Relapse-Prevention in Adults With Cocaine Dependence (BRAC)

The purpose of this study is to evaluate whether or not buspirone is effective in preventing relapse in cocaine-dependent adults in inpatient/residential treatment who are planning to enter outpatient treatment upon inpatient/residential discharge.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective is to evaluate the efficacy of buspirone, relative to placebo, in preventing relapse in cocaine-dependent adults in inpatient/residential treatment who are planning to enter outpatient treatment upon inpatient/residential discharge. Secondary objectives include evaluating the impact of buspirone, relative to placebo, on other drug-abuse outcomes and on factors that may mediate buspirone's efficacy as a relapse-prevention treatment.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

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
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Gateway Community Services
    • Ohio
      • Columbus, Ohio, United States, 43207
        • Maryhaven Inc
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Presbyterian
      • Pittsburgh, Pennsylvania, United States, 15213
        • Addiction Medicine Services
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Morris Village/LRADAC
    • Texas
      • Dallas, Texas, United States, 75228
        • Nexus Recovery Services

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. be 18 years of age or older
  2. be able to understand the study, and having understood, provide written informed consent in English
  3. meet DSM-IV-TR diagnostic criteria for current (within the last 12 months) dependence for cocaine, must self-report having used crack cocaine a minimum of four times in the 28 days prior to inpatient/residential admission, and must report that their typical pattern of use is at least once a week
  4. have a willingness to comply with all study procedures and medication instructions
  5. be enrolled in an inpatient/residential program at a participating CTP, scheduled to be in inpatient/residential treatment for 12-19 days when randomized, and planning to enroll in local outpatient treatment through the end of the active treatment phase (i.e., study week 15)

  6. if female and of child bearing potential, agree to use one of the following methods of birth control:

    • oral contraceptives
    • contraceptive patch
    • barrier (diaphragm or condom)
    • intrauterine contraceptive system
    • levonorgestrel implant
    • medroxyprogesterone acetate contraceptive injection
    • complete abstinence from sexual intercourse
    • hormonal vaginal contraceptive ring

Exclusion Criteria:

  1. meet DSM-IV-TR diagnostic criteria for current (within the last 12 months) opioid dependence

  2. have a medical or psychiatric condition that, in the judgment of the study physician, would make study participation unsafe or which would make treatment compliance difficult. Medical conditions that may compromise participant safety or study conduct include, but are not limited to:

    • AIDS according to the current CDC criteria for AIDS
    • liver function tests greater than 3X upper limit of normal
    • serum creatinine greater than 2 mg/dL
  3. have a psychiatric disorder requiring continued treatment with a psychotropic medication
  4. have a known or suspected hypersensitivity to buspirone
  5. be pregnant or breastfeeding
  6. have used any of the following medications within 14 days of randomization: monoamine oxidase (MAO) inhibitors such as phenelzine (Nardil), selegiline (Eldepryl), isocarboxazid (Marplan), or tranylcypromine (Parnate)
  7. be taking any medications which, in the judgment of the study physician, may produce interactions with buspirone that are sufficiently dangerous so as to exclude the patient from participating in the study. Alternatively, the study physician, in consultation with the patient and his or her physician, may elect to withdraw the patient from the problem medications before randomization. Some of the possible interactions are discussed in section 8.8.
  8. be anyone who, in the judgment of the investigator, would not be expected to complete the study protocol (e.g., due to relocation from the clinic area, probable incarceration, etc.)
  9. be a significant suicidal/homicidal risk

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 plus TAU
Buspirone titrated to 60 mg/day for the 15-week active study
Drug: Buspirone
Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated.
Other Names:
  • Buspirone hydrochloride, Buspar
Placebo Comparator: Placebo plus TAU
Placebo taken daily for the 15-week active study
Drug: Placebo
Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets.
Other Names:
  • Matched placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Days of Continuous Cocaine Abstinence
Time Frame: study week 16
The primary outcome measure selected for the present two-stage protocol is the maximum days of continuous cocaine abstinence during study weeks 4-15. The Timeline Follow-back (TLFB) procedure (Sobell and Sobell, 1992; Fals-Stewart, 2000) will be used to assess the participants' self-reported use of substances for each day of the study. A rapid UDS system that screens for drugs of abuse will be used to analyze the urine samples.
study week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cocaine-use Days
Time Frame: study week 16
Cocaine use days during days 22-105 as assessed by UDS and self-report combined with no imputation
study week 16

Collaborators and Investigators

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

Sponsor

University of Cincinnati

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Theresa Winhusen, PhD, University of Cincinnati, CTN Ohio Valley Node

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

July 10, 2012

First Submitted That Met QC Criteria

July 11, 2012

First Posted (Estimate)

July 16, 2012

Study Record Updates

Last Update Posted (Estimate)

January 7, 2015

Last Update Submitted That Met QC Criteria

December 18, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTN-0052
  • U10DA013732 (U.S. NIH Grant/Contract)

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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