Sex Differences, Hormones & Smoking Cessation
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 12/30/2018 |
| Start Date: | December 2012 |
| End Date: | July 27, 2017 |
Sex Differences & Progesterone: Association With Impulsivity and Smoking Cessation
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.
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.
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.
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.
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.
We found this trial at
1
site
Minneapolis, Minnesota 55455
Principal Investigator: Sharon S. Allen, M.D.
Phone: 612-624-4566
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