NCT01744574

Sex Differences, Hormones & Smoking Cessation

Sex Differences & Progesterone: Association With Impulsivity and Smoking Cessation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Tobacco Cessation

Interventions

Type	Name	Description
OTHER	Placebo	Placebo - subjects will take 200 mg twice daily orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date.
DRUG	Progesterone	The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). All subjects will take 200 mg twice daily orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date.
OTHER	Smoking Cessation Behavioral Counseling	Subjects will receive weekly smoking cessation behavioral counseling.

Timeline

• Start date: 2012-12-01
• Primary completion: 2017-07-27
• Completion: 2017-07-27
• First posted: 2012-12-06
• Last updated: 2019-07-12
• Results posted: 2018-12-28

Locations

1 site across 1 country: United States