- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00133757
Use of Pharmacotherapy to Reduce Cue-responsiveness in Smokers
February 13, 2013 updated by: Dr. Peter Selby, Centre for Addiction and Mental Health
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment
50
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5S 2S1
- Centre for Addiction and Mental Health
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Cue-responsiveness at pre, post, and during treatment
|
Craving at pre, post, and during treatment
|
Secondary Outcome Measures
Outcome Measure |
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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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Peter Selby, MD, Centre for Addiction and Mental Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Study Completion
May 1, 2006
Study Registration Dates
First Submitted
August 23, 2005
First Submitted That Met QC Criteria
August 23, 2005
First Posted (Estimate)
August 24, 2005
Study Record Updates
Last Update Posted (Estimate)
February 15, 2013
Last Update Submitted That Met QC Criteria
February 13, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Tobacco Use Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Dopamine Uptake Inhibitors
- Bupropion
Other Study ID Numbers
- 114/2005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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