Smoking Cessation Clinical Trial
Official title:
Effects of Transdermal Nicotine on Tobacco Withdrawal and the Effects of Smoking-related Stimuli in Men and Women
Verified date | July 2012 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
Treatment studies have demonstrated that current smoking cessation techniques are less effective for women. The purpose of this study is to determine the role that gender plays in the effectiveness of nicotine replacement therapy. In addition, the purpose of this study is to determine whether men and women differ in their response to smoking-related stimuli (e.g., taste or smell of a lit cigarette). Conclusions drawn from this study may help to improve cessation interventions for all smokers, particularly women.
Status | Completed |
Enrollment | 80 |
Est. completion date | March 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria include, but are not limited to: 18-50 years of age Smokes 15 cigarettes/day for at least 2 years Healthy (as determined by a brief study physical with medical doctor) Displays understanding of cognitive tasks. Exclusion Criteria include, but are not limited to: History of chronic health problems or psychiatric conditions History of cardiovascular disease, low or high blood pressure, seizures, head injuries requiring hospital care, peptic ulcer, or diabetes Pregnancy (tested by urinalysis) Scores greater than 17 on the Beck Depression Inventory Lack of a high school degree or GED |
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University - Clinical Behavioral Pharmacology Laboratory | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subjective Effects | The full scale name is the "Urge to smoke" visual analog scale (VAS). It measures self-reported "urge to smoke". As with any VAS a word or phrase (in this case, "Urge to Smoke" is centered over a horizontal line anchored on the left by "not at all" and on the right by "extremely." In this study, participants used a mouse to produce a vertical mark on the horizontal line, and the score was the distance of the mark from the left anchor expressed as a percentage of total line length. Thus, the minimum was 0 ("not at all") and the maximum score was 100 ("extremely"). | 6 hours | No |
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