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Progesterone for Smoking Relapse Prevention Following Delivery

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ClinicalTrials.gov Identifier: NCT01972464
Recruitment Status : Completed
First Posted : October 30, 2013
Results First Posted : November 17, 2017
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Brief Summary:

Smoking is the main preventable cause of mortality in Western countries, contributing to over 430,000 deaths a year in the U.S. alone. Clinical and epidemiological studies show that women often decrease smoking in pregnancy, when progesterone levels are high. However, at least half resume pre-pregnancy smoking levels within weeks after delivery and when progesterone levels drop.

Data from preclinical and clinical studies suggest that progesterone may be effective in preventing relapse to smoking in non-postpartum women. Prior work has shown that progesterone decreases both craving for cigarettes and the subjective rewarding effects of smoking among recently abstinent female smokers. These findings led us to hypothesize that progesterone may have efficacy as a relapse prevention treatment for postpartum women.

We propose an 8-week, randomized pilot study to evaluate the safety and initial efficacy of progesterone. This will be a feasibility study that will compare progesterone to placebo for relapse prevention in 40 postpartum smokers. We will assess the feasibility and safety, including the potential effects on breastfeeding and infants exposed via breast milk, in addition to 7-day point prevalence of smoking abstinence after 8 weeks of treatment and at follow-up, 3-months after the end of the protocol.


Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: Progesterone Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Progesterone for Postpartum Smokers: Feasibility, Breastfeeding and Infant Safety
Study Start Date : November 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: placebo
In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.
Drug: Placebo
Experimental: Progesterone
In this group women will receive oral micronized progesterone twice a day.
Drug: Progesterone
oral micronized progesterone




Primary Outcome Measures :
  1. Feasibility of Progesterone as a Relapse Prevention Intervention for Postpartum Women With Pre-conception Smoking: Adherence to Treatment [ Time Frame: 8 weeks ]
    Feasibility will be shown by high adherence to treatment condition assessed by doses of study medication taken

  2. Feasibility of Progesterone as a Relapse Prevention Intervention for Postpartum Women With Pre-conception Smoking: Retention [ Time Frame: From randomization to 3-month follow-up: up to 5 months ]
    Feasibility in retention will be shown by at least 70% of women randomized to the progesterone group reamaining in the study at the 3-month follow-up


Secondary Outcome Measures :
  1. 7-day Point Prevalence of Abstinence at End of Treatment (Week 8) [ Time Frame: Week 8 of the trial period ]
    Abstinence was defined as self-report of no smoking in the past 7 days confirmed by a negative urine cotinine test (urine cotinine <100 ng/ml).



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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Need to be within 3 weeks of delivery because relapse to smoking happens early after childbirth
  • Aged 18 to 42 years
  • history of smoking, with smoking and other nicotine product abstinence achieved in the final two months of pregnancy and at delivery
  • In good health as verified by medical history
  • Using acceptable birth control methods other than hormonal contraceptives that contain progestins
  • Have biologically confirmed abstinence from tobacco and other nicotine products at randomization

Exclusion Criteria:

  • A history of major medical illnesses including liver diseases, suspected or known malignancy, thrombophlebitis, liver failure, or other medical conditions that the physician investigator deems will make study participation unsafe for the subject
  • Current or past history bipolar disorder or schizophrenia or current diagnosis of major depression, panic disorder or post-traumatic stress disorder
  • Dependence on and/or abuse of alcohol or other drugs of abuse in the month prior to randomization into the trial
  • the presence of suicidal or homicidal ideation, or significant impairment of social or occupational functioning, either at study baseline during the evaluation process, or during participation in the trial
  • inability to speak Spanish or English (our group is bilingual)
  • plans to move out of the area within 8 months after study screening since this will make follow-up difficult
  • Inability to understand study procedures or provide informed consent
  • Currently undergoing treatment with another pharmacological agent for smoking cessation
  • pending legal case that may result in incarceration since this would force abstinence and impede follow-up;
  • Pending case with child protective services that might lead removal of infant from mother's custody, as this would impede breastfeeding and infant follow-up
  • Unwilling to accept randomization
  • Subsequent pregnancy since that would be another source of progesterone
  • An acute general medical condition that would require imminent re-hospitalization since this would enforce abstinence (women may be randomized if they are discharged and still within the recruitment window)
  • Allergy to progesterone or peanuts (vehicle for micronized progesterone)
  • Currently undergoing treatment with ketoconazole or any other known strong CYP3A4 inhibitors

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): NCT01972464


Locations
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United States, Connecticut
Yale School of Medicine Dpt of Psychiatry
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Ariadna Forray, MD Yale School of Medicine

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01972464     History of Changes
Other Study ID Numbers: 1305012130
R21DA035924 ( U.S. NIH Grant/Contract )
First Posted: October 30, 2013    Key Record Dates
Results First Posted: November 17, 2017
Last Update Posted: January 17, 2018
Last Verified: January 2018

Keywords provided by Yale University:
Progesterone
Placebo
Postpartum
Tobacco
Pregnancy

Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs