Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation (ConNicBrain)
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Received Date ICMJE | June 12, 2011 | ||||||||
Last Updated Date | August 20, 2012 | ||||||||
Start Date ICMJE | July 2011 | ||||||||
Estimated Primary Completion Date | May 2015 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
The amygdala and ventral anterior cingulate gyrus (vACG) scans will be compared to evaluate significant differences [ Time Frame: change from baseline in whole brain blood-oxygen-level dependent (BOLD) contrast sensitive fMRI images collected during a cue-reactivity task following 2 weeks of pre-quit treatment ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT01406223 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
Days to First Cigarette Following Quitting Smoking [ Time Frame: 11 weeks post quit day and 6 months post quit day. ] [ Designated as safety issue: No ] Days to first cigarette (i.e. lapse) will be measured via self-report. Correlations between pre- and post-quit brain imaging measures and days to lapse will be examined to assess whether brain function can predict cessation outcomes. |
||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation | ||||||||
Official Title ICMJE | Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation | ||||||||
Brief Summary | The purpose of this study is to look at brain function in order to understand how different treatments to help people quit smoking work. In this study, the investigators will look at the effects of nicotine patches, Chantix alone or Chantix paired with Zyban. |
||||||||
Detailed Description | |||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
||||||||
Condition ICMJE | Nicotine Dependence | ||||||||
Intervention ICMJE |
|
||||||||
Study Arm (s) |
|
||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 1000 | ||||||||
Completion Date | |||||||||
Estimated Primary Completion Date | May 2015 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Potential subjects must agree to avoid the following during their participation in this study:
Exclusion Criteria:
|
||||||||
Gender | Both | ||||||||
Ages | 18 Years to 50 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
|
||||||||
Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01406223 | ||||||||
Other Study ID Numbers ICMJE | Pro00028331, 1P50DA027840-01A1 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | Duke University | ||||||||
Study Sponsor ICMJE | Duke University | ||||||||
Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||||||
Investigators ICMJE |
|
||||||||
Information Provided By | Duke University | ||||||||
Verification Date | August 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |