Progesterone for Smoking Relapse Prevention Following Delivery
|ClinicalTrials.gov Identifier: NCT01972464|
Recruitment Status : Completed
First Posted : October 30, 2013
Results First Posted : November 17, 2017
Last Update Posted : January 17, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Placebo Comparator: placebo
In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.
In this group women will receive oral micronized progesterone twice a day.
oral micronized progesterone
- 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
- 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
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972464
|United States, Connecticut|
|Yale School of Medicine Dpt of Psychiatry|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Ariadna Forray, MD||Yale School of Medicine|