NCT01210586

Tobacco Cessation in Postmenopausal Women

Tobacco Cessation in Postmenopausal Women - Part I & Part II

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: Female
• Age: 40 Years – 79 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• HRT
• Non-HRT
• Continued Smoking
• Smoking Abstinence

Interventions

Type	Name	Description
BEHAVIORAL	Part 2	Comparing smoking symptomatology by HRT and nicotine patch status using a 2x2 randomized design.

Timeline

• Start date: 1999-01-01
• Primary completion: 2004-01-01
• Completion: 2008-01-01
• First posted: 2010-09-28
• Last updated: 2020-06-26