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Sponsors and Collaborators: |
Centre for Addiction and Mental Health Canadian Institutes of Health Research (CIHR) |
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Information provided by: | Centre for Addiction and Mental Health |
ClinicalTrials.gov Identifier: | NCT00133757 |
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.
Condition | Intervention | Phase |
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Nicotine Dependence Tobacco Dependence |
Drug: Bupropion SR |
Phase I |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Pharmacotherapy-Assisted Extinction (Pharmacoextinction): A Novel Approach to the Treatment of Nicotine Dependence in Humans |
Estimated Enrollment: | 50 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | May 2006 |
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.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Centre for Addiction and Mental Health | |
Toronto, Ontario, Canada, M5S 2S1 |
Principal Investigator: | Peter Selby, MD | Centre for Addiction and Mental Health |
Study ID Numbers: | 114/2005 |
Study First Received: | August 23, 2005 |
Last Updated: | September 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00133757 History of Changes |
Health Authority: | Canada: Health Canada |
Tobacco Nicotine Bupropion Cue-reactivity Craving |
Nicotine polacrilex Dopamine Uptake Inhibitors Neurotransmitter Agents Tobacco Use Disorder Psychotropic Drugs Disorders of Environmental Origin Dopamine |
Mental Disorders Nicotine Bupropion Substance-Related Disorders Dopamine Agents Antidepressive Agents, Second-Generation Antidepressive Agents |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Tobacco Use Disorder Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Pharmacologic Actions |
Mental Disorders Therapeutic Uses Bupropion Substance-Related Disorders Dopamine Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |