TY - JOUR
T1 - Evaluation of buspirone for relapse-prevention in adults with cocaine dependence
T2 - An efficacy trial conducted in the real world
AU - Winhusen, Theresa
AU - Brady, Kathleen T.
AU - Stitzer, Maxine
AU - Woody, George
AU - Lindblad, Robert
AU - Kropp, Frankie
AU - Brigham, Gregory
AU - Liu, David
AU - Sparenborg, Steven
AU - Sharma, Gaurav
AU - VanVeldhuisen, Paul
AU - Adinoff, Bryon
AU - Somoza, Eugene
N1 - Funding Information:
This work was supported by the National Institute on Drug Abuse , National Drug Abuse Treatment Clinical Trials Network , National Institutes of Health , by grants: U10-DA013732 to the University of Cincinnati (Theresa Winhusen), U10DA013727 (Kathleen Brady and John March), U10 DA013034 (Maxine L. Stitzer and Robert P. Schwartz), U10DA013043 (George Woody), U10DA020024-07 (Madhukar Trivedi) and through contract nos. HHSN271200522081C and HHSN271200900034C .
Funding Information:
Dr. Adinoff has served as a consultant for Shook, Hardy & Bacon LLP (medical malpractice consultant, tobacco companies) and Teva Pharmaceutical Industries Ltd. and has received funding from the National Institute on Drug Abuse , National Institute on Alcohol Abuse and Alcoholism , and the Department of Veterans Affairs .
PY - 2012/9
Y1 - 2012/9
N2 - Cocaine dependence is a significant public health problem for which there are currently no FDA-approved medications. Hence, identifying candidate compounds and employing an efficient evaluation process is crucial. This paper describes key design decisions made for a National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) study that uses a novel two-stage process to evaluate buspirone (60. mg/day) for cocaine-relapse prevention. The study includes pilot (N = 60) and full-scale (estimated N = 264) trials. Both trials will be randomized, double-blind, and placebo-controlled and both will enroll treatment-seeking cocaine-dependent participants engaged in inpatient/residential treatment and scheduled for outpatient treatment post-discharge. All participants will receive contingency management in which incentives are given for medication adherence as evaluated by the Medication Events Monitoring System (MEMS). The primary outcome measure is maximum days of continuous cocaine abstinence, as assessed by twice-weekly urine drug screens (UDS) and self-report, during the 15-week outpatient treatment phase. Drug-abuse outcomes include cocaine use as assessed by UDS and self-report of cocaine use, other substance use as assessed by UDS and self-report of substance use (i.e., alcohol and/or illicit drugs), cocaine bingeing, HIV risk behavior, quality of life, functioning, and substance abuse treatment attendance. Unique aspects of the study include conducting an efficacy trial in community treatment programs, a two-stage process to efficiently evaluate buspirone, and an evaluation of mediators by which buspirone might exert a beneficial effect on relapse prevention.
AB - Cocaine dependence is a significant public health problem for which there are currently no FDA-approved medications. Hence, identifying candidate compounds and employing an efficient evaluation process is crucial. This paper describes key design decisions made for a National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) study that uses a novel two-stage process to evaluate buspirone (60. mg/day) for cocaine-relapse prevention. The study includes pilot (N = 60) and full-scale (estimated N = 264) trials. Both trials will be randomized, double-blind, and placebo-controlled and both will enroll treatment-seeking cocaine-dependent participants engaged in inpatient/residential treatment and scheduled for outpatient treatment post-discharge. All participants will receive contingency management in which incentives are given for medication adherence as evaluated by the Medication Events Monitoring System (MEMS). The primary outcome measure is maximum days of continuous cocaine abstinence, as assessed by twice-weekly urine drug screens (UDS) and self-report, during the 15-week outpatient treatment phase. Drug-abuse outcomes include cocaine use as assessed by UDS and self-report of cocaine use, other substance use as assessed by UDS and self-report of substance use (i.e., alcohol and/or illicit drugs), cocaine bingeing, HIV risk behavior, quality of life, functioning, and substance abuse treatment attendance. Unique aspects of the study include conducting an efficacy trial in community treatment programs, a two-stage process to efficiently evaluate buspirone, and an evaluation of mediators by which buspirone might exert a beneficial effect on relapse prevention.
KW - Buspirone
KW - Cocaine
KW - Contingency management
KW - Relapse-prevention
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U2 - 10.1016/j.cct.2012.05.003
DO - 10.1016/j.cct.2012.05.003
M3 - Article
C2 - 22613054
AN - SCOPUS:84864294070
SN - 1551-7144
VL - 33
SP - 993
EP - 1002
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
IS - 5
ER -