Extinction Based Treatment for Nicotine Dependence (Extinction01)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00831155|
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : April 20, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependence||Drug: Nicotine Patches, Denicotinized Cigarettes||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||257 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Brain Substrates of Extinction Based Treatment for Nicotine Dependence|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
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.
- To test two quit smoking therapies and to study brain function while each therapy is being used. [ Time Frame: 14 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00831155
|United States, North Carolina|
|Duke Medical Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Francis J McClernon, Ph.D||Duke University|