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Use of Pharmacotherapy to Reduce Cue-Responsiveness in Smokers
This study has been completed.
Study NCT00133757   Information provided by Centre for Addiction and Mental Health
First Received: August 23, 2005   Last Updated: September 12, 2006   History of Changes

August 23, 2005
September 12, 2006
June 2005
 
  • Cue-responsiveness at pre, post, and during treatment
  • Craving at pre, post, and during treatment
Same as current
Complete list of historical versions of study NCT00133757 on ClinicalTrials.gov Archive Site
  • Attentional bias at pre and post treatment
  • Breath carbon monoxide levels at pre, post, and during treatment
  • Plasma cotinine levels at pre and post treatment
  • Puff topography measures at pre, post, and during treatment
Same as current
 
Use of Pharmacotherapy to Reduce Cue-Responsiveness in Smokers
Pharmacotherapy-Assisted Extinction (Pharmacoextinction): A Novel Approach to the Treatment of Nicotine Dependence in Humans

In this study we, the investigators at the Centre for Addiction and Mental Health, intend to explore whether bupropion is able to reduce smokers' responses to cigarette-related environmental cues, and craving. Previous studies have indicated that bupropion may be able to achieve these outcomes. Therefore, we predict that smokers treated with bupropion for several weeks will show reduced reactivity to cigarette cues and craving.

Current smoking cessation pharmacotherapy paradigms ignore the over-learned behaviour associated with smoking, thus contributing to the relatively poor absolute efficacy of pharmacotherapy. Chronic nicotine use causes adaptive changes in the brain that differ from the acute effects leading to craving when smoking is stopped. This is a key element of relapse. Thus, the development of more effective treatments involves a better understanding of craving and relapse by exploring the interaction between the psychology and neurobiology of nicotine addiction. Bupropion, an amphetamine derivative, has demonstrated efficacy in smoking cessation in motivated smokers. Its’ mechanism of action is unclear but may be mediated by extinction processes. We hypothesize that bupropion will reduce cue-responsiveness and subsequent cravings in current smokers who are not consciously attempting to quit or cut down on smoking. Fifty smokers (>10 cigarettes/day) of either sex will be recruited to take either oral placebo or bupropion 150 mg twice daily for a total of 42 days. Subjects will attend bi-weekly experimental sessions where cue-responsiveness will be measured using physiological and subjective responses to a variety of neutral and smoking-related cues. Subjective effects will be measured using the Questionnaire of Smoking Urges, the Tobacco Craving Questionnaire and Visual Analog Scales. Subjects will record smoking behaviour and subjective experiences daily in a smoking diary. Outcome variables include cue responsiveness, daily diary ratings, exhaled end tidal CO levels, plasma cotinine levels, and subjective effects. Gender effects will be assessed by using sex as a covariate in the analysis. This study will provide preliminary data on pharmacotherapy-assisted extinction as a novel approach to smoking cessation.

Phase I
Interventional
Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study
  • Nicotine Dependence
  • Tobacco Dependence
Drug: Bupropion SR
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
50
May 2006
 

Inclusion Criteria:

  • Males or females
  • At least 19 years of age
  • Smoking at least 10 cigarettes per day for at least 2 years
  • Never treated with bupropion/Zyban

Exclusion Criteria:

  • Co-morbid psychiatric disorder
  • History of psychotic disorder or eating disorder
  • Current alcohol or substance abuse/dependence (excluding nicotine, caffeine)
  • Brain injury
  • Seizure disorder
  • Pregnancy, lactation, or at risk of becoming pregnant
  • Current regular use of psychotropic drugs
  • Known allergy or sensitivity to bupropion
Both
19 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00133757
 
114/2005
Centre for Addiction and Mental Health
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Peter Selby, MD Centre for Addiction and Mental Health
Centre for Addiction and Mental Health
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP