Tobacco Cessation in Postmenopausal Women

Smoking Abstinence Clinical Trial

Official title:

Tobacco Cessation in Postmenopausal Women - Part I & Part II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210586
• Other study ID #: 2002NT050
• Status: Completed
• Phase: N/A
• Start date: January 1999
• Est. completion date: January 2008

Study information

• Verified date: June 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2008
• Est. primary completion date: January 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Part 2
Comparing smoking symptomatology by HRT and nicotine patch status using a 2x2 randomized design.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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