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Sex Differences, Hormones & Smoking Cessation

Information source: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tobacco Cessation

Intervention: Placebo (Other); Progesterone (Drug); Smoking Cessation Behavioral Counseling (Other)

Phase: N/A

Status: Recruiting

Sponsored by: University of Minnesota - Clinical and Translational Science Institute

Official(s) and/or principal investigator(s):
Sharon S. Allen, M.D., Principal Investigator, Affiliation: Masonic Cancer Center, University of Minnesota

Overall contact:
Nicole Tosun, MS, Phone: 612-624-4566, Email: tosun004@umn.edu

Summary

Data suggest that progesterone may improve smoking cessation outcomes perhaps by reducing impulsive behavior. However, the clinical literature on this topic is lacking. Therefore, in Project I we are proposing a double-blind randomized controlled trial to assess the role of exogenous progesterone on impulsivity and smoking cessation in a sample of males and females who are motivated to quit smoking.

Clinical Details

Official title: Sex Differences & Progesterone: Association With Impulsivity and Smoking Cessation

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Comparison of Subjects Who Relapsed - Male and Female

Secondary outcome:

Comparison of Days to Relapse - All Subjects

Comparison of Days to Relapse - Males and Females

Comparison of Impulsivity Between Males and Females

Comparison of Serum Progesterone Levels Influencing Impulsivity

Detailed description: Subjects will be stratified by sex and then randomly assigned to active progesterone (PRO) or placebo (PBO). Telephone screening and visit invitation leads to the consent process and in-person screening including medical-psychiatric evaluation for inclusion/exclusion, then randomization and medication induction, stable medication with medication reduction and final evaluation for secondary outcomes.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male 18 to 60 years old

- Female 18 to 50 years old

- Self-report regular smoking

- Motivated to quit smoking

- In stable physical/mental health

- Self report of regular menstrual cycles (female only)

- English fluency

- Understand the study procedures and able to provide informed consent

- Ability to participate fully in research elements for the duration of the trial.

Exclusion Criteria:

- Current or recent (< 3 months) breastfeeding (females only)

- Current or planned pregnancy within the next three months (females only)

- Conditions contraindicated to progesterone treatment.

Locations and Contacts

Nicole Tosun, MS, Phone: 612-624-4566, Email: tosun004@umn.edu

Delaware Clinical Research Unit, University of Minnesota, Minneapolis, Minnesota 55455, United States; Recruiting
Nicole Tosun, Phone: 612-624-4566, Email: tosun004@umn.edu
Sharon S. Allen, M.D., Principal Investigator
Additional Information

Starting date: December 2012
Last updated: March 9, 2015

Page last updated: August 23, 2015

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