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Design Considerations for a Study to Evaluate the Impact of Smoking Cessation Treatment on Stimulant Use Outcomes in Stimulant-dependent Individuals.

Contemporary Clinical Trials 2012;33(1):197-205. [doi: 10.1016/j.cct.2011.09.018]

Theresa M. Winhusen, PhD (University of Cincinnati/CinARC, OV 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), Gregory S. Brigham, PhD (Maryhaven, Inc., OV Node), Frankie B. Kropp, MS, LICDC (University of Cincinnati/CinARC, OV Node), Udi Ghitza, PhD (Center for the Clinical Trials Network, NIDA), Robert Lindblad, MD (EMMES Corporation, DSC), Bryon H. Adinoff, MD (University of Texas Southwestern Medical Center, TX Node), Cindy Green, PhD (Duke University Medical Center, DSC), Gaurav Sharma, MD (Duke University Medical Center, DSC), Eugene C. Somoza, MD, PhD (University of Cincinnati/CinARC, OV Node).

Cigarette smoking is prevalent in cocaine/methamphetamine-dependent patients and associated with significant morbidity and mortality, yet the provision of smoking cessation treatment in conjunction with substance use disorder (SUD) treatment is not standard practice. This is due, in part, to clinician concern that combining smoking cessation treatment with SUD treatment could lead to poorer SUD outcomes. The National Drug Abuse Treatment Clinical Trials Network is conducting a 10-week, two-group, randomized trial to evaluate the impact of providing smoking cessation treatment (SCT) with SUD treatment as usual (TAU), compared to TAU alone, in smokers who are in outpatient treatment for cocaine or methamphetamine dependence (protocol CTN-0046, S-CAST). Approximately 528 participants recruited from 12 community treatment programs will be randomized into the trial. This paper describes key design decisions make during protocol development. The trial is designed to evaluate the relationship between cigarette smoking and stimulant use, which prior research suggests is linked, and should contribute to our understanding of how best to address the co-occurring problems of nicotine dependence and cocaine/methamphetamine-dependence. Unique aspects of the trial include the primary question of interest, which concerns the impact of providing SCT on SUD outcomes rather than on smoking outcomes, and the intensity of the SCT chosen, which includes bupropion, nicotine replacement, and two psychosocial interventions. S-CAST is designed to answer questions of interest to clinicians as well as more basic researchers and should contribute significantly to our understanding of how best to address the co-occurring problems of nicotine and cocaine/methamphetamine dependence. (Article (Peer-Reviewed), PDF, English, 2012)

Keywords: Behavior therapy | Buprenorphine | Cocaine | Community health services | CTN protocol development | Methamphetamine | Nicotine replacement therapy | Research design | Smoking | Stimulant abuse | Contemporary Clinical Trials (journal)

Document No: 761, PMID: 22005174, PMCID: PMC3253873.

Submitted by Jack Blaine, MD, NIDA, 10/13/2011.

Adinoff, Bryon H. search mail
Brigham, Gregory S. search mail
Ghitza, Udi search mail
Green, Cindy search mail
Kropp, Frankie B. search mail
Lindblad, Robert search mail
Sharma, Gaurav search
Somoza, Eugene C. search mail
Stitzer, Maxine L. search mail
Winhusen, Theresa M. search mail
Woody, George E. search mail
NIDA-CTN-0046 search www
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