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Sex Differences, Hormones & Smoking Cessation

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.
 
ClinicalTrials.gov Identifier: NCT01744574
Recruitment Status : Completed
First Posted : December 6, 2012
Results First Posted : December 28, 2018
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Minnesota

Brief 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.

Condition or disease Intervention/treatment Phase
Tobacco Cessation Other: Placebo Drug: Progesterone Other: Smoking Cessation Behavioral Counseling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Sex Differences & Progesterone: Association With Impulsivity and Smoking Cessation
Study Start Date : December 2012
Actual Primary Completion Date : July 27, 2017
Actual Study Completion Date : July 27, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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:   No
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.

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

Documents provided by University of Minnesota:
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01744574    
Other Study ID Numbers: 2012NTLS074
P50DA033942-01 ( U.S. NIH Grant/Contract )
First Posted: December 6, 2012    Key Record Dates
Results First Posted: December 28, 2018
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs