Progesterone & Postpartum Relapse to Smoking

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Progesterone & Postpartum Relapse to Smoking

Conditions
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Tobacco Use Cessation, Tobacco Use Disorder

Intervention / Treatment
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* Drug: Progesterone
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Progesterone<br>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<br>* Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.<br>* Other names: Prometrium;|
| Placebo Comparator: Placebo<br>Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4. | Other: Placebo<br>* Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnant, smoker, cigarette, tobacco