Tobacco Cessation in Postmenopausal Women

Tobacco Cessation in Postmenopausal Women - Part I & Part II

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01210586

Enrollment

160

Registered

2010-09-28

Start date

1999-01-31

Completion date

2008-01-31

Last updated

2020-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Continued Smoking, HRT, Non-HRT, Smoking Abstinence

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.

Interventions

BEHAVIORALPart 2

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 79 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026