title: Design considerations for a study to evaluate the impact of smoking cessation treatment on stimulant use outcomes in stimulant-dependent individuals.
abstract: 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 NIDA 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. Approximately 528 participants, recruited from 12 community treatment programs, will be randomized into the trial. The present paper describes key design decisions made 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.
authors: Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3210 Jefferson Avenue, Cincinnati, OH 45220, USA. winhusen@carc.uc.edu
authors: Theresa
authors: T
authors: Winhusen
authors: Maxine
authors: M
authors: Stitzer
authors: George
authors: G
authors: Woody
authors: Gregory
authors: G
authors: Brigham
authors: Frankie
authors: F
authors: Kropp
authors: Udi
authors: U
authors: Ghitza
authors: Robert
authors: R
authors: Lindblad
authors: Bryon
authors: B
authors: Adinoff
authors: Cindy
authors: C
authors: Green
authors: Gaurav
authors: G
authors: Sharma
authors: Eugene
authors: E
authors: Somoza
mesh_terms: D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use; D016642:Bupropion / Q000627:therapeutic use*; D000697:Central Nervous System Stimulants / Q000009:adverse effects*; D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D006801:Humans; D009538:Nicotine / Q000627:therapeutic use*; D018722:Nicotinic Agonists / Q000627:therapeutic use; D012907:Smoking / Q000009:adverse effects*; D016540:Smoking Cessation / Q000379:methods*; D019966:Substance-Related Disorders / Q000150:complications / Q000188:drug therapy*; D014029:Tobacco Use Disorder / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D018687:Antidepressive Agents, Second-Generation; D000697:Central Nervous System Stimulants; D018722:Nicotinic Agonists; D016642:Bupropion; D009538:Nicotine