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Use of Pharmacotherapy to Reduce Cue-Responsiveness in Smokers
This study has been completed.
First Received: August 23, 2005   Last Updated: September 12, 2006   History of Changes
Sponsors and Collaborators: Centre for Addiction and Mental Health
Canadian Institutes of Health Research (CIHR)
Information provided by: Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT00133757
  Purpose

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
Nicotine Dependence
Tobacco Dependence
Drug: Bupropion SR
Phase I

MedlinePlus related topics: Mental Health
Drug Information available for: Bupropion hydrochloride Bupropion
U.S. FDA Resources
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

Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Cue-responsiveness at pre, post, and during treatment
  • Craving at pre, post, and during treatment

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 50
Study Start Date: June 2005
Estimated Study Completion Date: May 2006
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00133757

Locations
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)
Investigators
Principal Investigator: Peter Selby, MD Centre for Addiction and Mental Health
  More Information

No publications provided

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

Keywords provided by Centre for Addiction and Mental Health:
Tobacco
Nicotine
Bupropion
Cue-reactivity
Craving

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009