Progesterone & Postpartum Relapse to Smoking

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder; Tobacco Use Cessation
• Intervention / Treatment: Drug: Progesterone; Other: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota, 717 Delaware Street SE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Woman
• 18-35 years old
• Zero CPD for past 4 weeks
• 5 or more CPD for at least 6 out of past 12 months
• Motivated to remain abstinent (7 or higher out of 10)
• Stable physical/mental health
• Established prenatal care
• Stable physical/mental health
• Willing to take Progesterone
• Willing to use double-barrier protection if sexually active
• English fluency
• Able to provide informed consent

Exclusion Criteria:

• Psychotropic medications
• Illicit drugs
• Other types of tobacco, NRT, smoking cessation medications
• Pregnancy complications (Diabetes, Anomaly, Fetal growth restriction, HTN, Hx of >2 miscarriages)
• Current use of: Finasteroid (propecia), Efavirenz, Red Clover, Ketoconazole, CYP3A4 Inhibitors
• History of: Thrombophelitis, Deep vein thrombosis, Pulmonary embolus, Clotting disorder, Bleeding disorder, Heart disease, Diabetes, Stroke, Peanut allergy, Liver dysfunction, Hypersensitivity to progesterone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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 Names: Prometrium
Placebo Comparator: Placebo; Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Relapsed by Week 4 Postpartum	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Relapsed by Week 12 Postpartum	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 Postpartum
Number of Participants Who Relapsed at All During Postpartum (up to Day 84)	Defined by continuous abstinence (CA) defined as a single puff of a cigarette as a relapse.	Postpartum Day 0 to 84
Protocol Compliance - Number of Visits Attended	Compliance was measured as the number of visits attended (maximum of 5).	Gestational Week 36 - Postpartum Week 12
Compliance Determinants	This was determined by the Feasibility Questionnaire; a 10-item measure used to assess participant expectations, satisfaction of study protocol, study medication and electronic data capture. All questions were answered on a four-point Likert-type scale (1=low acceptability and 4=high acceptability). The total score was determined by adding up all the scores and dividing by 10.	Postpartum Week 12
Protocol Compliance - Doses of Medication Taken	Compliance was measured by doses of medication taken (maximum of 56).	Postpartum Week 0 - Week 12
Protocol Compliance - EDC's Completed	Compliance was measured as the number by number of EDCs completed (maximum of 84).	Gestational Week 36 - Postpartum Week 12

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Sharon S. Allen, M.D., Ph.D., Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: February 21, 2013
• First Submitted That Met QC Criteria: February 21, 2013
• First Posted (Estimate): February 25, 2013

Study Record Updates

• Last Update Posted (Estimate): January 9, 2017
• Last Update Submitted That Met QC Criteria: November 10, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: tobacco; pregnant; cigarette; smoker
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: 2012NTLS059; R21DA034840 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO