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.

Study Overview

• Status: Completed
• Conditions: Tobacco Cessation
• Intervention / Treatment: Other: Placebo; Other: Smoking Cessation Behavioral Counseling; Drug: Progesterone

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 Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Delaware Clinical Research Unit, University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	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.; Other: Smoking Cessation Behavioral Counseling; Subjects will receive weekly smoking cessation behavioral counseling.
Experimental: 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.	Other: Smoking Cessation Behavioral Counseling; Subjects will receive weekly smoking cessation behavioral counseling.; 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 Names: Prometrium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With 7-day Point Prevalence Abstinence From Smoking at 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	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With 7-day Point Prevalence Abstinence From Smoking at 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	Weeks 8 and 12
Number of Participants With Prolonged Abstinence From Smoking at 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	Weeks 4, 8 and 12
Number of Participants With Continuous Abstinence From Smoking at Week 12	continuous abstinence defined as having no slips at all prior to week 12	Week 12
Number of Participants With Cotinine <50 ng/mL at Weeks 4, 8 and 12	urine cotinine <50 ng/mL at weeks 4, 8 and 12	Weeks 4, 8 and 12
Number of Participants With Breath Carbon Monoxide ≤5 Ppm at Weeks 4, 8 and 12	breath carbon monoxide ≤5 ppm at weeks 4, 8 and 12	Weeks 4, 8 and 12
Average Number of Days to Relapse	Days to relapse defined as the number of days from quit date to the first day with a slip	Days 1 through 84

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): July 27, 2017
• Study Completion (Actual): July 27, 2017

Study Registration Dates

• First Submitted: November 13, 2012
• First Submitted That Met QC Criteria: December 5, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: 2012NTLS074; P50DA033942-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO