Status:
COMPLETED
Extinction Based Treatment for Nicotine Dependence
Lead Sponsor:
Duke University
Conditions:
Nicotine Dependence
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 gro...
Detailed Description
If you agree to be in this study, you will be asked to sign the consent form prior to any tests or procedures. You will be asked to come to the laboratory for a screening session. The screening sessio...
Eligibility Criteria
Inclusion
- Inclusion Criteria (conventional cigarette smokers):
- generally healthy,
- between the ages of 18 and 55,
- smoking of at least 10 cigarettes/day of a brand delivering \>0.5mg nicotine according to the standard Federal Trade Commission (FTC) method,
- an afternoon expired CO concentration of at least 10 ppm (to confirm inhalation),
- an interest in quitting smoking
- right-handed
- Inclusion Criteria (e-cigarette smokers):
- generally healthy,
- between the ages of 18 and 55,
- prior history of smoking of at least 10 conventional cigarettes/day for at least two years of a brand delivering \>0.5mg nicotine according to the standard Federal Trade Commission (FTC) method,
- no smoking of conventional cigarettes in the last 6 months;
- daily use of a nicotine-containing e-cigarette for at least 3 months;
- taking of at least 100 puffs per day from a nicotine-containing e-cigarette;
- an afternoon expired CO concentration \<5 ppm (to confirm they are not combustible cigarette users);
- nicotine test strip reading \>3
- right-handed
- Exclusion Criteria:
- 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).
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
257 Patients enrolled
Trial Details
Trial ID
NCT00831155
Start Date
January 1 2009
End Date
December 1 2014
Last Update
April 20 2015
Active Locations (1)
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1
Duke Medical Center
Durham, North Carolina, United States, 27705