Tobacco Cessation in Postmenopausal Women

NCT01210586 | Completed

• 1 other identifier: 2002NT050
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HRT; Non-HRT; Continued Smoking; Smoking Abstinence

Outcome Measures

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?

  Outcome was measured after 1 baseline week and a 2 week quit

Study Arms (2)

Nicotine Patch

ACTIVE COMPARATOR

Nicotine Patch for Smoking Cessation

Behavioral: Part 2

Placebo Patch

PLACEBO COMPARATOR

Behavioral: Part 2

Interventions

Part 2 BEHAVIORAL

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

Nicotine Patch; Placebo Patch

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Institutes of Health (NIH): collaborator

Study Officials

• Sharon S Allen, MD, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2010
• First Posted: September 28, 2010
• Study Start: January 1, 1999
• Primary Completion: January 1, 2004
• Study Completion: January 1, 2008
• Last Updated: June 26, 2020

Record last verified: 2020-06