Progesterone for Smoking Relapse Prevention Following Delivery

NCT ID: NCT01972464

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-09-30

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.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

placebo

In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Progesterone

In this group women will receive oral micronized progesterone twice a day.

Group Type: EXPERIMENTAL

Progesterone

Intervention Type: DRUG

oral micronized progesterone

Interventions

Progesterone

oral micronized progesterone

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ariadna Forray, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale School of Medicine Dpt of Psychiatry

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

R21DA035924

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1305012130

Identifier Type: -

Identifier Source: org_study_id