drugset / Trial / NCT00831155

Extinction Based Treatment for Nicotine Dependence

NCT00831155

Phase 1 Completed 257 enrolled Duke University
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2009-01
Primary completion
2014-12
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nicotine Unknown 21 mg Other

Indications