Overview

This trial is active, not recruiting.

Conditions tobacco use cessation, tobacco use disorder
Treatments progesterone, placebo
Sponsor University of Minnesota - Clinical and Translational Science Institute
Collaborator National Institutes of Health (NIH)
Start date June 2014
End date June 2015
Trial size 36 participants
Trial identifier NCT01798394, 2012NTLS059, R21DA034840

Summary

The primary goal of this project is to investigate the potential efficacy of exogenous progesterone (with supplemental relapse prevention counseling) on postpartum relapse in new mothers. Also to determine the feasibility of enhanced compliance monitoring and identification of collateral factors effecting outcomes.

United States Minnesota
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Active Comparator)
Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.
progesterone
Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.
(Placebo Comparator)
Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
placebo
Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.

Primary Outcomes

Measure
Relapse Rate
time frame: Week 4 Postpartum

Secondary Outcomes

Measure
Relapse Rate
time frame: Week 12
Days to Relapse
time frame: Day 0 to 84
Protocol Compliance
time frame: Gestational Week 35 and Weeks 2, 6, and 12 Postpartum
Compliance Determinants
time frame: Gestational Week 36 and Weeks 2, 6 and 12 Postpartum

Eligibility Criteria

Female participants from 18 years up to 35 years old.

Inclusion Criteria: - Pregnant women at 33-36 weeks gestation who have quit smoking during pregnancy - Confirmed uncomplicated single-gestation pregnancy - Established prenatal care - English fluency - Ability to provide informed consent

Additional Information

Official title Progesterone & Postpartum Relapse to Smoking
Principal investigator Sharon S. Allen, M.D., Ph.D.
Description Pregnant women will be recruited at gestational weeks 33-36 who have quit smoking during pregnancy and are motivated to maintain abstinence after delivery. At the time of delivery, women will be randomly assigned to receive 4 weeks of active or placebo exogenous progesterone starting on the 4th day postpartum. Participants will be in contact with study staff either by phone or clinic visits until 12 weeks postpartum to collect data on smoking status and protocol compliance, measure serum progesterone levels and receive behavioral counseling.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University of Minnesota - Clinical and Translational Science Institute.
Location data was received from the National Cancer Institute and was last updated in June 2016.