Use of Pharmacotherapy to Reduce Cue-responsiveness in Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00133757
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : February 15, 2013
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Peter Selby, Centre for Addiction and Mental Health

Brief Summary:
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 or disease Intervention/treatment Phase
Nicotine Dependence Tobacco Dependence Drug: Bupropion SR Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Pharmacotherapy-assisted Extinction (Pharmacoextinction): A Novel Approach to the Treatment of Nicotine Dependence in Humans
Study Start Date : June 2005
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Primary Outcome Measures :
  1. Cue-responsiveness at pre, post, and during treatment
  2. Craving at pre, post, and during treatment

Secondary Outcome Measures :
  1. Attentional bias at pre and post treatment
  2. Breath carbon monoxide levels at pre, post, and during treatment
  3. Plasma cotinine levels at pre and post treatment
  4. Puff topography measures at pre, post, and during treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00133757

Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1
Sponsors and Collaborators
Centre for Addiction and Mental Health
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Peter Selby, MD Centre for Addiction and Mental Health

Responsible Party: Dr. Peter Selby, Principal Investigator, Centre for Addiction and Mental Health Identifier: NCT00133757     History of Changes
Other Study ID Numbers: 114/2005
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013

Keywords provided by Dr. Peter Selby, Centre for Addiction and Mental Health:

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors