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Completed

NCT Number: NCT01210586

Tobacco Cessation in Postmenopausal Women

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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Key information

Conditions

HRT Continued Smoking Non-HRT Smoking Abstinence

Age range

40 year–79 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Part 2

Behavioral

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

Primary outcomes

  1. 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?

    Time frame: Outcome was measured after 1 baseline week and a 2 week quit

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Tobacco Cessation in Postmenopausal Women - Part I & Part II

Important dates

Study start
1999
Primary completion
2004
Study completion
2008
First posted
Sep 28, 2010
Registry last updated
Jun 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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