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Progesterone for Postpartum Smokers

Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tobacco Use Disorder

Intervention: Progesterone (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
Ariadna Forray, MD, Principal Investigator, Affiliation: Yale School of Medicine

Overall contact:
Cristine E Hine, LCSW, Phone: 203-764-8124, Email: crisine.hine@yale.edu

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.

Clinical Details

Official title: Progesterone for Postpartum Smokers: Feasibility, Breastfeeding and Infant Safety

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Feasibility of progesterone as a relapse prevention intervention for postpartum women with pre-conception smoking

Secondary outcome: Relapse to smoking after delivery

Eligibility

Minimum age: 18 Years. Maximum age: 42 Years. Gender(s): Female.

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 abstinence 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 need for emergency psychiatric

treatment

- Inability to understand study procedures or provide informed consent

- Currently undergoing treatment with another pharmacological agent for smoking

cessation

- 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)

Locations and Contacts

Cristine E Hine, LCSW, Phone: 203-764-8124, Email: crisine.hine@yale.edu

Yale School of Medicine Dpt of Psychiatry, New Haven, Connecticut 06510, United States; Recruiting
Ariadna Forray, MD, Principal Investigator
Additional Information

Starting date: November 2013
Last updated: July 14, 2015

Page last updated: August 23, 2015

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