Clinical trial NCT01972464: Progesterone for Smoking Relapse Prevention Following Delivery
Official title: Progesterone for Postpartum Smokers: Feasibility, Breastfeeding and Infant Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Use Disorder
Keywords: Progesterone
Placebo
Postpartum
Tobacco
Pregnancy
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-10-30
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Feasibility of Progesterone as a Relapse Prevention Intervention for Postpartum Women With Pre-conception Smoking: Adherence to Treatment
timeFrame: 8 weeks
measure: Feasibility of Progesterone as a Relapse Prevention Intervention for Postpartum Women With Pre-conception Smoking: Retention
timeFrame: From randomization to 3-month follow-up: up to 5 months
Secondary outcomes:
measure: 7-day Point Prevalence of Abstinence at End of Treatment (Week 8)
timeFrame: Week 8 of the trial period
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine Dpt of Psychiatry
state: Connecticut
Study officials:
affiliation: Yale University
name: Ariadna Forray, MD
role: PRINCIPAL_INVESTIGATOR
References: