Sex Differences, Hormones & Smoking Cessation

University of Minnesota (UMN)

Status: Completed

Conditions: Tobacco Cessation

Treatments: Drug: Progesterone; Other: Placebo; Other: Smoking Cessation Behavioral Counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01744574

2012NTLS074

P50DA033942-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Smoking Cessation Behavioral Counseling

Other: Placebo

Progesterone

Experimental group

Description:

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.

Treatment:

Drug: Progesterone

Other: Smoking Cessation Behavioral Counseling