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Tobacco Cessation in Postmenopausal Women (Part II) - 2

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nicotrol
Sponsored by
University of Minnesota
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Smoking

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: (Same as Part I) Exclusion Criteria: Same as Part I, with the addition of those who have had a past reaction to transdermal nicotine patch or have active skin diseases will be excluded.

Sites / Locations

  • University of Minnesota

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 21, 2003
Last Updated
December 1, 2015
Sponsor
University of Minnesota
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00061074
Brief Title
Tobacco Cessation in Postmenopausal Women (Part II) - 2
Official Title
The Effects of ERT on Appetitive Behavior and Withdrawal in Short-term Smoking Cessation in Postmenopausal Females on Transdermal Nicotine Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 1993 (undefined)
Primary Completion Date
March 2000 (Actual)
Study Completion Date
March 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effects of ERT on appetitive behavior and withdrawal in short-term smoking cessation in postmenopausal females on transdermal nicotine replacement

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Smoking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nicotrol

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (Same as Part I) Exclusion Criteria: Same as Part I, with the addition of those who have had a past reaction to transdermal nicotine patch or have active skin diseases will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Allen, Ph.D., M.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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Tobacco Cessation in Postmenopausal Women (Part II) - 2

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