Sex Differences, Hormones & Smoking Cessation

This study is currently recruiting participants.
Verified July 2013 by Masonic Cancer Center, University of Minnesota
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01744574
First received: November 13, 2012
Last updated: July 25, 2013
Last verified: July 2013
  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 Blind (Subject, 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 Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Comparison of Subjects Who Relapsed - Male and Female [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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.


Estimated Enrollment: 200
Study Start Date: December 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 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.
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.
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.

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female between 18 and 40 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744574

Contacts
Contact: Lindsay Farnsworth 612-624-4566 farn0067@umn.edu
Contact: Alicia Allen, PhD, MPH 612-624-0896 alle0299@umn.edu

Locations
United States, Minnesota
Delaware Clinical Research Unit, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Lindsay Farnsworth    612-624-4566    farn0067@umn.edu   
Principal Investigator: Sharon S. Allen, M.D.         
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Sharon S. Allen, M.D. Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01744574     History of Changes
Other Study ID Numbers: 2012NTLS074, P50DA033942-01
Study First Received: November 13, 2012
Last Updated: July 25, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 16, 2014