Tobacco Cessation in Postmenopausal Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01210586
First received: September 27, 2010
Last updated: September 10, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
HRT
Non-HRT
Continued Smoking
Smoking Abstinence
Behavioral: Part 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tobacco Cessation in Postmenopausal Women - Part I & Part II

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: January 1999
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Placebo Comparator: Placebo Patch Behavioral: Part 2
Comparing smoking symptomatology by HRT and nicotine patch status using a 2x2 randomized design.

  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01210586

Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Sharon S Allen, MD, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01210586     History of Changes
Other Study ID Numbers: R01-DA08075 - 07
Study First Received: September 27, 2010
Last Updated: September 10, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 15, 2014