Sex Differences, Hormones & Smoking Cessation

University of Minnesota216 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

216

Conditions

Tobacco Cessation

Interventions

PlaceboOTHER

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.

ProgesteroneDRUG

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.

Smoking Cessation Behavioral CounselingOTHER

Subjects will receive weekly smoking cessation behavioral counseling.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Delaware Clinical Research Unit, University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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

Time frame: Week 4

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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