Extinction Based Treatment for Nicotine Dependence

Completed · Phase 1

Conditions studied: Nicotine Dependence

In brief

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.

Key facts

Study ID

NCT00831155

Run by

Duke University

People needed

257

Starts

2009-01-01

Expected to finish

2014-12-01

Last updated by the study team

2015-04-20

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• inability to attend all required experimental sessions,
• significant health problems (e.g., chronic hypertension (BP>150/90 sitting after 10 minutes), emphysema, seizure disorder, history of significant heart problems),
• use of psychoactive medications,
• use of smokeless tobacco,
• liver or kidney disorder (except kidney stones, gallstones)
• lung disorder (including but not limited to COPD, emphysema, and asthma)
• report of coronary heart disease; heart attack; cardiac rhythm disorder (irregular heart rhythm; chest pains; cardiac disorder (including but not limited to valvular heart disease, heart murmur, heart failure)
• current alcohol or drug abuse,
• use of illegal drugs as measured by urine drug screen,
• current use of nicotine replacement therapy or other smoking cessation treatment,
• presence of conditions that would make MRI unsafe (e.g., pacemaker, metal objects in the body, IUD, orthopedic pins or screws, etc.), or
• presence of conditions contraindicated for nicotine replacement therapy (e.g., skin allergies or disorders).

Where it is running

• Duke Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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