Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133757
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2005-08-23
Brief Title:
Use of Pharmacotherapy to Reduce Cue-responsiveness in Smokers
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
Pharmacotherapy-assisted Extinction Pharmacoextinction A Novel Approach to the Treatment of Nicotine Dependence in Humans
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 cigarettesday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None