Clinical trial NCT01798394: Progesterone & Postpartum Relapse to Smoking
Official title: Progesterone & Postpartum Relapse to Smoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Tobacco Use Disorder
Keywords: pregnant
smoker
cigarette
tobacco
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2013-02-25
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Relapsed by Week 4 Postpartum
timeFrame: Week 4 Postpartum
Secondary outcomes:
measure: Number of Participants Who Relapsed by Week 12 Postpartum
timeFrame: Week 12 Postpartum
measure: Number of Participants Who Relapsed at All During Postpartum (up to Day 84)
timeFrame: Postpartum Day 0 to 84
measure: Protocol Compliance - Number of Visits Attended
timeFrame: Gestational Week 36 - Postpartum Week 12
measure: Compliance Determinants
timeFrame: Postpartum Week 12
measure: Protocol Compliance - Doses of Medication Taken
timeFrame: Postpartum Week 0 - Week 12
measure: Protocol Compliance - EDC's Completed
timeFrame: Gestational Week 36 - Postpartum Week 12
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, 717 Delaware Street SE
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Sharon S. Allen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: