Extinction Based Treatment for Nicotine Dependence (Extinction01)
The purpose of this study is to test two quit smoking therapies and to study brain function while each therapy is being used. You will be randomly assigned (like flipping a coin) to one of the two groups. The first therapy is Extinction-Based therapy (EBT). If you are in this group, you will switch to smoking denicotinized cigarettes while wearing a 21 mg/d nicotine patch for one month prior to your quit date. The second therapy is a standard Nicotine Replacement therapy (NRT). If you are in this group, you will smoke your usual brand of cigarettes up to the quit date. Following the quit date, both groups will undergo standard nicotine replacement therapy (21 mg/d for 6 weeks; 14 mg/d for 2 weeks, 7 mg/d for 2 weeks).
In addition to the above, we will recruit a sample of former smokers who are now regular users of e-cigarettes. This group [ECIG] will undergo the same screening and baseline assessments as the EBT and NRT groups up to the completion of fMRI1.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Brain Substrates of Extinction Based Treatment for Nicotine Dependence|
- To test two quit smoking therapies and to study brain function while each therapy is being used. [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Extinction Based Group (EBT): switch to smoking denicotinized cigarettes while wearing a 21mg/day nicotine patch for one month prior to their quit date.
Drug: Nicotine Patches, Denicotinized Cigarettes
Both groups will receive standard Nicotine Replacement Therapy after the quit date. The Extinction Based group will receive Nicotine patches and denicotinized cigarettes before their quit date
No Intervention: 2
Nicotine Replacement Group (NRT): smoke their usual brand of cigarettes up to the quit date.
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|Contact: Matt Hallyburton, BAemail@example.com|
|Contact: Joseph McClernon, Ph.Dfirstname.lastname@example.org|
|United States, North Carolina|
|Duke Medical Center||Recruiting|
|Durham, North Carolina, United States, 27705|
|Contact: Matt Hallyburton, BA 919-684-9593 email@example.com|
|Principal Investigator:||Francis J McClernon, Ph.D||Duke University|