N/A
N=124
Examining the Effect of the Nicotine Patch in Male and Female Smokers - 3
Drug Addiction · Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT00390559 ↗Enrolled (actual)
124
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcome: Primary: Subjective Effects — 18.8; 23.1; 25.6; 24.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- nicotine transdermal system (Drug); Nicotine containing cigarette (Other); Placebo cigarette (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Effects |
18.8; 23.1; 25.6; 24.2 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00390559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.