Overview

This trial is active, not recruiting.

Condition cocaine dependence
Treatments buspirone, placebo
Phase phase 2
Sponsor University of Cincinnati
Collaborator National Institute on Drug Abuse (NIDA)
Start date August 2012
End date May 2013
Trial size 60 participants
Trial identifier NCT01641159, CTN-0052

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
buspirone Buspirone hydrochloride, Buspar
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.
(Placebo Comparator)
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.

Primary Outcomes

Measure
Maximum Days of Continuous Cocaine Abstinence
time frame: study week 16

Secondary Outcomes

Measure
Time to First Cocaine Use
time frame: study week 16
Cocaine-free and Drug-Free Weeks
time frame: study week 16
Cocaine-use and Substance-use Days
time frame: study week 16
Cocaine Binging
time frame: study week 16

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized Controlled Evaluation of Buspirone for Relapse-Prevention in Adults With Cocaine Dependence (BRAC)
Principal investigator Theresa Winhusen, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by University of Cincinnati.