Status:
COMPLETED
Effects of Quitting Study A Test of Pre-clinical Findings
Lead Sponsor:
University of Vermont
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Conditions:
Smoking
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The most widely-accepted animal model of nicotine withdrawal states stopping nicotine makes rewarding events become less rewarding. The current study will test if this is true in humans. If we find to...
Detailed Description
Study design We will recruit until we have 70 current smokers who want to quit at two sites (Univ of Vermont and Dartmouth Medical School). We will also recruit a comparison group of 70 long-time form...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- For all participants:
- 18 yrs old or older
- able to read and understand verbal English fluently
- citizen or resident alien
- agree to abstain from illegal drugs during the study
- For current smokers:
- currently smoke \>10 cigarettes daily for \> 1 yr
- want to quit smoking for good via abrupt cessation without treatment
- willing to quit 7-14 days from study entry and not reduce before quitting
- no reduction in cigs/day by \>25% in the last month
- agree to no use of non-cigarette tobacco, non-tobacco nicotine, marijuana, illegal drugs, electronic cigarettes, or smoking cessation medications during the study
- have carbon monoxide (CO) level \> or = 8 ppm at the time of consent
- no current use of prescribed psychoactive medications, including smoking cessation products.
- For former smokers:
- smoked \>10 cigarettes daily for \> 1 yr
- quit at least 1 yr ago
- use of cigarettes or e-cigarettes 5 or fewer times in past year
- no tobacco or nicotine-containing product in last month
- agree to no use of non-cigarette tobacco, non-tobacco nicotine, marijuana, illegal drugs, electronic cigarettes, or smoking cessation medications during the study
- have carbon monoxide (CO) level \< 8 ppm at the time of consent
- no current use of prescribed psychoactive medications, including smoking cessation products.
- Exclusion Criteria for all participants:
- History of hand or wrist problems that could be exacerbated by study participation or interferes with completion of tasks
- current (last year) mood or alcohol/drug-related psychiatric disorder or any neurological condition that could influence reward sensitivity; e.g. Parkinsonism
- used marijuana 2 or more times in the last month
- problems with the use of alcohol or illegal drugs in the last 6 months
- currently pregnant
- use of smokeless tobacco
- lacking the use of one or both hands
Exclusion
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT01824511
Start Date
April 1 2013
End Date
September 1 2015
Last Update
March 14 2016
Active Locations (2)
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1
Dartmouth College
Hanover, New Hampshire, United States, 03755
2
University of Vermont
Burlington, Vermont, United States, 05401