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Completed

NCT Number: NCT01744574

Sex Differences, Hormones & 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.

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Key information

Conditions

Tobacco Cessation Behavior Health Behavior Tobacco Use Cessation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Delaware Clinical Research Unit, University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Other

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.

Progesterone

Drug

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

Smoking Cessation Behavioral Counseling

Other

Subjects will receive weekly smoking cessation behavioral counseling.

Primary outcomes

  1. Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Week 4

    Time frame: 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 outcomes

  1. Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Weeks 8 and 12

    Time frame: 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

  2. Number of Participants With Prolonged Abstinence From Smoking at Weeks 4, 8 and 12

    Time frame: 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

  3. Number of Participants With Continuous Abstinence From Smoking at Week 12

    Time frame: Week 12

    continuous abstinence defined as having no slips at all prior to week 12

  4. Number of Participants With Cotinine <50 ng/mL at Weeks 4, 8 and 12

    Time frame: Weeks 4, 8 and 12

    urine cotinine <50 ng/mL at weeks 4, 8 and 12

  5. Number of Participants With Breath Carbon Monoxide ≤5 Ppm at Weeks 4, 8 and 12

    Time frame: Weeks 4, 8 and 12

    breath carbon monoxide ≤5 ppm at weeks 4, 8 and 12

  6. Average Number of Days to Relapse

    Time frame: Days 1 through 84

    Days to relapse defined as the number of days from quit date to the first day with a slip

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Sex Differences & Progesterone: Association With Impulsivity and Smoking Cessation

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Dec 6, 2012
Registry last updated
Jul 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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