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Sex Differences, Hormones & Smoking Cessation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01744574
First Posted: December 6, 2012
Last Update Posted: July 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  Purpose
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.

Condition Intervention
Tobacco Cessation Other: Placebo Drug: Progesterone Other: Smoking Cessation Behavioral Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Sex Differences & Progesterone: Association With Impulsivity and Smoking Cessation

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Comparison of Subjects Who Relapsed - Male and Female [ Time Frame: Week 4 ]
    Our primary outcome is the binary indicator of relapsed yes/no at the week 4 visit. An unadjusted assessment of the treatment effect will come from a logistic regression of this binary outcome on randomized treatment assignment, separately by sex. All persons randomized and with a measured primary outcome at the week 4 visit will be included in this analysis, regardless of whether or not they ever took any of their assigned treatment (intent-to-treat analysis).


Secondary Outcome Measures:
  • Comparison of Days to Relapse - All Subjects [ Time Frame: Day 1 Through Day 84 ]
    Our secondary outcomes include the binary indicator of relapsed yes/no at the week 12 visit and days to relapse.

  • Comparison of Days to Relapse - Males and Females [ Time Frame: Day 1 through Day 84 ]
    We will pool the male and female data and test for an interaction between sex and treatment assignment in an adjusted Cox regression for the days to relapse outcomes.

  • Comparison of Impulsivity Between Males and Females [ Time Frame: Day 1 through Day 84 ]

    Impulsivity Measures (Secondary Outcome): Subjects will complete three self-report measures.

    • Behavioral Inhibition/Activation scales (BIS/BAS): These short 20 items forms commonly used scales to study externalizing tendencies.
    • Barratt Impulsiveness Scale (BIS): This item contains 30 item self-report measure self-control.
    • Brief Self Control Scale (BSCS): This item consists of 13 questions rated on a 4-point scale from "very true" to "very false" on items reflecting the ability to control problematic behaviors.

  • Comparison of Serum Progesterone Levels Influencing Impulsivity [ Time Frame: Day 1 Through Day 84 ]

    Impulsivity Measures (Secondary Outcome): Subjects will complete three self-report measures.

    • Behavioral Inhibition/Activation scales (BIS/BAS): These short 20 items forms commonly used scales to study externalizing tendencies.
    • Barratt Impulsiveness Scale (BIS): This item contains 30 item self-report measure self-control.
    • Brief Self Control Scale (BSCS): This item consists of 13 questions rated on a 4-point scale from "very true" to "very false" on items reflecting the ability to control problematic behaviors.


Enrollment: 312
Study Start Date: December 2012
Study Completion Date: July 27, 2017
Primary Completion Date: July 27, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 Name: Prometrium
Other: Smoking Cessation Behavioral Counseling
Subjects will receive weekly smoking cessation behavioral counseling.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744574


Locations
United States, Minnesota
Delaware Clinical Research Unit, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Sharon S. Allen, M.D. Masonic Cancer Center, University of Minnesota
  More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01744574     History of Changes
Other Study ID Numbers: 2012NTLS074
P50DA033942-01 ( U.S. NIH Grant/Contract )
First Submitted: November 13, 2012
First Posted: December 6, 2012
Last Update Posted: July 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs