Contemporary Clinical Trials 2012;33(5):993-1002. [doi: 10.1016/j.cct.2012.05.003]
Theresa M. Winhusen, PhD (University of Cincinnati/CinARC, OV Node), Kathleen T. Brady, MD, PhD (Medical University of South Carolina, SC Node), Maxine L. Stitzer, PhD (Johns Hopkins University School of Medicine, MA Node), George E. Woody, MD (University of Pennsylvania School of Medicine, DV Node), Robert Lindblad, MD (Clinical Coordinating Center, EMMES), Frankie B. Kropp, MS, LICDC (University of Cincinnati/CinARC, OV Node), Gregory S. Brigham, PhD (Maryhaven Inc., OV Node), David S. Liu, MD (Center for the CTN, NIDA), Steven Sparenborg, PhD (Center for the CTN, NIDA), Gaurav Sharma, PhD (Data & Statistics Center, EMMES), Paul C. VanVeldhuisen, PhD (Data and Statistics Center, EMMES), Bryon H. Adinoff, MD (University of Texas Southwestern Medica Center, TX Node), Eugene C. Somoza, MD, PhD (University of Cincinnati/CinARC, OV Node).
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 Drug Abuse Treatment Clinical Trials Network (CTN) study that uses a novel two-stage process to evaluate buspirone (60mg/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. Having a greater understanding of these mediators could facilitate future medication development efforts for a condition with serious consequences and for which there is currently no widely used, safe and effective medication. Study recruitment for the pilot phase is scheduled to start in August 2012. (Article (Peer-Reviewed), PDF, English, 2012)
Keywords: Buspirone | Cocaine | Community health services | CTN protocol development | Pharmacological therapy | Stimulant abuse | Contemporary Clinical Trials (journal)
Document No: 823, PMID: 22613054, PMCID: PMC3408816.
Submitted by Jack Blaine, MD, CCTN, NIDA, 5/19/12