Use of Pharmacotherapy to Reduce Cue-responsiveness in Smokers

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Peter Selby, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT00133757
First received: August 23, 2005
Last updated: February 13, 2013
Last verified: February 2013
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Pharmacotherapy-assisted Extinction (Pharmacoextinction): A Novel Approach to the Treatment of Nicotine Dependence in Humans

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Dr. Peter Selby, Principal Investigator, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT00133757     History of Changes
Other Study ID Numbers: 114/2005
Study First Received: August 23, 2005
Last Updated: February 13, 2013
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014