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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.

Publication ,  Journal Article
Winhusen, T; Stitzer, M; Woody, G; Brigham, G; Kropp, F; Ghitza, U; Lindblad, R; Adinoff, B; Green, C; Sharma, G; Somoza, E
Published in: Contemp Clin Trials
January 2012

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.

Duke Scholars

Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

January 2012

Volume

33

Issue

1

Start / End Page

197 / 205

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Tobacco Use Disorder
  • Substance-Related Disorders
  • Smoking Cessation
  • Smoking
  • Public Health
  • Nicotinic Agonists
  • Nicotine
  • Humans
  • General Clinical Medicine
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Winhusen, T., Stitzer, M., Woody, G., Brigham, G., Kropp, F., Ghitza, U., … Somoza, E. (2012). Design considerations for a study to evaluate the impact of smoking cessation treatment on stimulant use outcomes in stimulant-dependent individuals. Contemp Clin Trials, 33(1), 197–205. https://doi.org/10.1016/j.cct.2011.09.018
Winhusen, Theresa, Maxine Stitzer, George Woody, Gregory Brigham, Frankie Kropp, Udi Ghitza, Robert Lindblad, et al. “Design considerations for a study to evaluate the impact of smoking cessation treatment on stimulant use outcomes in stimulant-dependent individuals.Contemp Clin Trials 33, no. 1 (January 2012): 197–205. https://doi.org/10.1016/j.cct.2011.09.018.
Winhusen T, Stitzer M, Woody G, Brigham G, Kropp F, Ghitza U, et al. Design considerations for a study to evaluate the impact of smoking cessation treatment on stimulant use outcomes in stimulant-dependent individuals. Contemp Clin Trials. 2012 Jan;33(1):197–205.
Winhusen, Theresa, et al. “Design considerations for a study to evaluate the impact of smoking cessation treatment on stimulant use outcomes in stimulant-dependent individuals.Contemp Clin Trials, vol. 33, no. 1, Jan. 2012, pp. 197–205. Pubmed, doi:10.1016/j.cct.2011.09.018.
Winhusen T, Stitzer M, Woody G, Brigham G, Kropp F, Ghitza U, Lindblad R, Adinoff B, Green C, Sharma G, Somoza E. Design considerations for a study to evaluate the impact of smoking cessation treatment on stimulant use outcomes in stimulant-dependent individuals. Contemp Clin Trials. 2012 Jan;33(1):197–205.
Journal cover image

Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

January 2012

Volume

33

Issue

1

Start / End Page

197 / 205

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Tobacco Use Disorder
  • Substance-Related Disorders
  • Smoking Cessation
  • Smoking
  • Public Health
  • Nicotinic Agonists
  • Nicotine
  • Humans
  • General Clinical Medicine