Design considerations for a study to evaluate the impact of smoking cessation treatment on stimulant use outcomes in stimulant-dependent individuals

Theresa Winhusen, Maxine L Stitzer, George Woody, Gregory Brigham, Frankie Kropp, Udi Ghitza, Robert Lindblad, Bryon Adinoff, Cindy Green, Gaurav Sharma, Eugene Somoza

Research output: Contribution to journalArticle


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.

Original languageEnglish (US)
Pages (from-to)197-205
Number of pages9
JournalContemporary Clinical Trials
Issue number1
Publication statusPublished - Jan 2012



  • Bupropion
  • Cocaine
  • Contingency management
  • Methamphetamine
  • Smoking cessation

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Medicine(all)

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