Progesterone & Postpartum Relapse to Smoking

Tobacco Use Disorder Clinical Trial

Official title:

Progesterone & Postpartum Relapse to Smoking

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01798394
• Other study ID #: 2012NTLS059
• Secondary ID: R21DA034840
• Status: Active, not recruiting
• Phase: N/A
• First received: February 21, 2013
• Last updated: November 25, 2015
• Start date: June 2014
• Est. completion date: June 2016

Study information

• Verified date: November 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tobacco Use Cessation
• Tobacco Use Disorder

Intervention

Drug:
• 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.

Other:
• Placebo
Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.

Locations

Country	Name	City	State
United States	University of Minnesota, 717 Delaware Street SE	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse Rate	Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.	Week 4 Postpartum	No
Secondary	Relapse Rate	Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.	Week 12	No
Secondary	Days to Relapse	Defined by continuous abstinence (CA) and prolonged abstinence (PA). CA defined as a single puff of a cigarette as a relapse. PA measure reflects sustained abstinence and defines relapse as seven consecutive slip (e.g., a puff or more) without a 24 hours period between any slip.	Day 0 to 84	No
Secondary	Protocol Compliance	Defined as the complete requirements (e.g.,number of visits attended, doses of medication taken, electronic data capture completed) divided by number possible multiplied by 100%.	Gestational Week 35 and Weeks 2, 6, and 12 Postpartum	No
Secondary	Compliance Determinants	This is a questionnaire assessing participant expectations, satisfaction and study protocol, study medication and electronic data capture. It contains 10 scaled items adapted from a published instrument; all questions are answered with a four-point Likert-type scale. The score of the feasibility questionnaire will be determined by computing a sum, yielding an acceptability score.	Gestational Week 36 and Weeks 2, 6 and 12 Postpartum	No