Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01641159
Recruitment Status : Completed
First Posted : July 16, 2012
Results First Posted : December 17, 2014
Last Update Posted : January 7, 2015
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Theresa Winhusen, University of Cincinnati

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.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Drug: Buspirone Drug: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Evaluation of Buspirone for Relapse-Prevention in Adults With Cocaine Dependence (BRAC)
Study Start Date : August 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Matched placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01641159


Locations
Layout table for location information
United States, Florida
Gateway Community Services
Jacksonville, Florida, United States, 32204
United States, Ohio
Maryhaven Inc
Columbus, Ohio, United States, 43207
United States, Pennsylvania
Penn Presbyterian
Philadelphia, Pennsylvania, United States, 19104
Addiction Medicine Services
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Morris Village/LRADAC
Columbia, South Carolina, United States, 29203
United States, Texas
Nexus Recovery Services
Dallas, Texas, United States, 75228
Sponsors and Collaborators
University of Cincinnati
National Institute on Drug Abuse (NIDA)
Investigators
Layout table for investigator information
Principal Investigator: Theresa Winhusen, PhD University of Cincinnati, CTN Ohio Valley Node

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Theresa Winhusen, Associate Professor, Department of Psychiatry and Behavioral Neuroscience; CinARC Director, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01641159     History of Changes
Other Study ID Numbers: CTN-0052
U10DA013732 ( U.S. NIH Grant/Contract )
First Posted: July 16, 2012    Key Record Dates
Results First Posted: December 17, 2014
Last Update Posted: January 7, 2015
Last Verified: December 2014

Keywords provided by Theresa Winhusen, University of Cincinnati:
Cocaine
Crack
Buspirone
Relapse Prevention

Additional relevant MeSH terms:
Layout table for MeSH terms
Recurrence
Cocaine-Related Disorders
Disease Attributes
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Buspirone
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents