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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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This study investigated whether being on transdermal hormone replacement therapy (HRT) influenced smoking cessation variables in postmenopausal women undergoing short-term abstinence from cigarettes. Women were recruited into two groups according to their pre-enrollment medication status - currently on HRT (n = 17) or not on HRT (n = 13). The HRT group had their prior medication replaced with a standard 0.1 mg estradiol transdermal system and 2.5 mg of Cycrin daily. Following two weeks of medication adjustment, participants continued smoking as usual for one week, at which time baseline measurements were taken. For the remaining two weeks, participants were instructed to quit smoking. They were provided with smoking cessation counseling and monitored for abstinence. Data were collected during five clinic visits on all dependent measures: Minnesota Nicotine Withdrawal Scale, Beck Depression Inventory (BDI) Scale, Profile of Mood States, Motor Speed Tasks, and Reaction Time Test.
Part II is identical to Part I, except it randomizes participants to use nicotine patch or not.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine Patch | Active Comparator | Nicotine Patch for Smoking Cessation |
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| Placebo Patch | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Part 2 | Behavioral | Comparing smoking symptomatology by HRT and nicotine patch status using a 2x2 randomized design. |
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| Measure | Description | Time Frame |
|---|---|---|
| During short term smoking abstinence, do the beneficial effects of nicotine replacement therapy on acute symptomatology differ in women who use and do not use hormone replacement therapy? | Outcome was measured after 1 baseline week and a 2 week quit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon S Allen, MD, PhD | University of Minnesota | Principal Investigator |
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