Sex Differences, Hormones & Smoking Cessation

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.

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.

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.