Sex Differences, Hormones & Smoking Cessation

Tobacco Cessation Clinical Trial

Official title:

Sex Differences & Progesterone: Association With Impulsivity and Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01744574
• Other study ID #: 2012NTLS074
• Secondary ID: P50DA033942-01
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: July 27, 2017

Study information

• Verified date: July 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: July 27, 2017
• Est. primary completion date: July 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tobacco Cessation

Intervention

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.

Locations

Country	Name	City	State
United States	Delaware Clinical Research Unit, University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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