Tobacco Cessation in Postmenopausal Women

Not Applicable

Completed

• Conditions: HRT; Non-HRT; Smoking Abstinence; Continued Smoking
• Interventions: Behavioral: Part 2

• Registration Number: NCT01210586
• Lead Sponsor: University of Minnesota

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-01
• Primary Completion: 2004-01
• Study Completion: 2008-01
• Study First Submitted: 2010-09-27
• Study First Submitted QC: 2010-09-27
• Study First Posted: 2010-09-28
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-24
• Last Update Posted: 2020-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

• 40-79 years old
• Clinical Menopause
• > 15 cigarettes per day for at least one year
• Experienced nicotine withdrawal based on DSM IV

Exclusion Criteria

• Currently obtaining nicotine from other sources
• Abnormal vaginal bleeding
• unstable health
• history of stroke or embolism
• history of abnormal thyroid function
• significant skin disorders
• active psychiatric disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Patch	Part 2	-
Nicotine Patch	Part 2	Nicotine Patch for Smoking Cessation

Primary Outcome Measures

Name	Time	Method
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