NCT00061061

Brief Summary

The purpose of this study is to evaluate the effects of ERT on appetitive behavior and withdrawal in short-term smoking cessation compared to smoking ad lib in postmenopausal female smokers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 1997

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1997

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2003

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2015

Enrollment Period

6 years

First QC Date

May 21, 2003

Last Update Submit

December 1, 2015

Conditions

Tobacco Use Disorder

Keywords

Tobacco CessationPostmenopausal Women

Outcome Measures

Primary Outcomes (1)

  • Smoking Cessation Outcomes

    3 months

Interventions

Behavior TherapyBEHAVIORAL

Eligibility Criteria

Age40 Years - 79 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female smokers ages 40-79, smoking at least 15 cigarettes per day for at least one year, have natural menopause, have a transvaginal ultrasound to confirm loss of follicular activitiy, have a normal baseline mammogram, a normal chemistry at baseline, willing to take hormone replacement therapy for the duration of the study, normal thyroid function, and have a normal TSH.

You may not qualify if:

  • Women who have had formal dieting with or without pharmacological methods within the last three months; a weight change greater than or equal to 10 pounds within the last three months, BMI greater than or equal to 40, severe menopausal symptoms, active medical problems, alcohol or drug abuse, other forms of nicotine use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderTobacco Use Cessation

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sharon Allen, Ph.D., M.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2003

First Posted

May 22, 2003

Study Start

March 1, 1997

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

December 2, 2015

Record last verified: 2015-12

Locations

US(1)