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

Primary Purpose

Cocaine Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Buspirone
Placebo
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring Cocaine, Crack, Buspirone, Relapse Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gateway Community Services
  • Maryhaven Inc
  • Penn Presbyterian
  • Addiction Medicine Services
  • Morris Village/LRADAC
  • Nexus Recovery Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Buspirone plus TAU

Placebo plus TAU

Arm Description

Buspirone titrated to 60 mg/day for the 15-week active study

Placebo taken daily for the 15-week active study

Outcomes

Primary Outcome Measures

Maximum Days of Continuous Cocaine Abstinence
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.

Secondary Outcome Measures

Cocaine-use Days
Cocaine use days during days 22-105 as assessed by UDS and self-report combined with no imputation

Full Information

First Posted
July 10, 2012
Last Updated
December 18, 2014
Sponsor
University of Cincinnati
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01641159
Brief Title
Study of Buspirone for Relapse-Prevention in Adults With Cocaine Dependence
Acronym
BRAC
Official Title
A Randomized Controlled Evaluation of Buspirone for Relapse-Prevention in Adults With Cocaine Dependence (BRAC)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
Cocaine, Crack, Buspirone, Relapse Prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Buspirone plus TAU
Arm Type
Active Comparator
Arm Description
Buspirone titrated to 60 mg/day for the 15-week active study
Arm Title
Placebo plus TAU
Arm Type
Placebo Comparator
Arm Description
Placebo taken daily for the 15-week active study
Intervention Type
Drug
Intervention Name(s)
Buspirone
Other Intervention Name(s)
Buspirone hydrochloride, Buspar
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matched placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum Days of Continuous Cocaine Abstinence
Description
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.
Time Frame
study week 16
Secondary Outcome Measure Information:
Title
Cocaine-use Days
Description
Cocaine use days during days 22-105 as assessed by UDS and self-report combined with no imputation
Time Frame
study week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: be 18 years of age or older be able to understand the study, and having understood, provide written informed consent in English 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 have a willingness to comply with all study procedures and medication instructions 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) 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: meet DSM-IV-TR diagnostic criteria for current (within the last 12 months) opioid dependence 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 have a psychiatric disorder requiring continued treatment with a psychotropic medication have a known or suspected hypersensitivity to buspirone be pregnant or breastfeeding 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) 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. 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.) be a significant suicidal/homicidal risk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Winhusen, PhD
Organizational Affiliation
University of Cincinnati, CTN Ohio Valley Node
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gateway Community Services
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Maryhaven Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43207
Country
United States
Facility Name
Penn Presbyterian
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Addiction Medicine Services
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Morris Village/LRADAC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Nexus Recovery Services
City
Dallas
State/Province
Texas
ZIP/Postal Code
75228
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22613054
Citation
Winhusen T, Brady KT, Stitzer M, Woody G, Lindblad R, Kropp F, Brigham G, Liu D, Sparenborg S, Sharma G, Vanveldhuisen P, Adinoff B, Somoza E. Evaluation of buspirone for relapse-prevention in adults with cocaine dependence: an efficacy trial conducted in the real world. Contemp Clin Trials. 2012 Sep;33(5):993-1002. doi: 10.1016/j.cct.2012.05.003. Epub 2012 May 19.
Results Reference
background
PubMed Identifier
24911028
Citation
Winhusen TM, Kropp F, Lindblad R, Douaihy A, Haynes L, Hodgkins C, Chartier K, Kampman KM, Sharma G, Lewis DF, VanVeldhuisen P, Theobald J, May J, Brigham GS. Multisite, randomized, double-blind, placebo-controlled pilot clinical trial to evaluate the efficacy of buspirone as a relapse-prevention treatment for cocaine dependence. J Clin Psychiatry. 2014 Jul;75(7):757-64. doi: 10.4088/JCP.13m08862.
Results Reference
derived

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

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