Tobacco Cessation in Postmenopausal Women

Tobacco Cessation in Postmenopausal Women - Part I & Part II

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.

Study Overview

• Status: Completed
• Conditions: Smoking Abstinence; HRT; Non-HRT; Continued Smoking
• Intervention / Treatment: Behavioral: Part 2

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Patch	Behavioral: Part 2; Comparing smoking symptomatology by HRT and nicotine patch status using a 2x2 randomized design.
Active Comparator: Nicotine Patch; Nicotine Patch for Smoking Cessation	Behavioral: Part 2; Comparing smoking symptomatology by HRT and nicotine patch status using a 2x2 randomized design.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Sharon S Allen, MD, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start: January 1, 1999
• Primary Completion (Actual): January 1, 2004
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: September 27, 2010
• First Submitted That Met QC Criteria: September 27, 2010
• First Posted (Estimate): September 28, 2010

Study Record Updates

• Last Update Posted (Actual): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2002NT050