Sex Differences, Hormones & Smoking Cessation

Not Applicable

Completed

• Conditions: Tobacco Cessation
• Interventions: Other: Placebo; Drug: Progesterone; Other: Smoking Cessation Behavioral Counseling

• Registration Number: NCT01744574
• Lead Sponsor: University of Minnesota

Brief 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.

Study Timeline

• Study First Submitted: 2012-11-13
• Study Start: 2012-12
• Study First Submitted QC: 2012-12-05
• Study First Posted: 2012-12-06
• Primary Completion: 2017-07-27
• Study Completion: 2017-07-27
• Results First Submitted: 2018-10-08
• Results First Submitted QC: 2018-12-06
• Results First Posted: 2018-12-28
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-10
• Last Update Posted: 2019-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progesterone	Smoking Cessation Behavioral Counseling	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. They will also receive smoking cessation behavioral counseling.
Placebo	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. They will also receive smoking cessation behavioral counseling.
Placebo	Smoking Cessation Behavioral Counseling	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. They will also receive smoking cessation behavioral counseling.
Progesterone	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. They will also receive smoking cessation behavioral counseling.

Primary Outcome Measures

Name	Time	Method
Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Week 4	Week 4	7-day point prevalence abstinence from smoking defined as having no slips (i.e., a puff or more from a lit cigarette) in the seven days prior to week 4

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Continuous Abstinence From Smoking at Week 12	Week 12	continuous abstinence defined as having no slips at all prior to week 12
Average Number of Days to Relapse	Days 1 through 84	Days to relapse defined as the number of days from quit date to the first day with a slip
Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Weeks 8 and 12	Weeks 8 and 12	7-day point prevalence abstinence from smoking defined as having no slips (i.e., a puff or more from a lit cigarette) in the seven days prior to weeks 8 and 12
Number of Participants With Cotinine <50 ng/mL at Weeks 4, 8 and 12	Weeks 4, 8 and 12	urine cotinine \<50 ng/mL at weeks 4, 8 and 12
Number of Participants With Prolonged Abstinence From Smoking at Weeks 4, 8 and 12	Weeks 4, 8 and 12	Prolonged abstinence defined as having less than seven consecutive slips without a 24-hour period between any two slips prior to weeks 4, 8 and 12
Number of Participants With Breath Carbon Monoxide ≤5 Ppm at Weeks 4, 8 and 12	Weeks 4, 8 and 12	breath carbon monoxide ≤5 ppm at weeks 4, 8 and 12

Trial Locations

Locations (1)

Delaware Clinical Research Unit, University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States