N/A N=46 Randomized Double-blind Prevention

Progesterone & Postpartum Relapse to Smoking

Tobacco Use Cessation · Tobacco Use Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01798394 ↗

Enrolled (actual)

Serious AEs

2.2%

Results posted

Jan 2017

Primary outcome: Primary: Number of Participants Who Relapsed by Week 4 Postpartum — 6; 7 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Progesterone (Drug); Placebo (Other)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: University of Minnesota
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Relapsed by Week 4 Postpartum	6; 7	—
SECONDARY Number of Participants Who Relapsed by Week 12 Postpartum	11; 13	—
SECONDARY Number of Participants Who Relapsed at All During Postpartum (up to Day 84)	10; 13	—
SECONDARY Protocol Compliance - Number of Visits Attended	4.5; 4.4	—
SECONDARY Compliance Determinants	3.6; 3.5	—
SECONDARY Protocol Compliance - Doses of Medication Taken	38.9; 37.5	—
SECONDARY Protocol Compliance - EDC's Completed	60.9; 61.8	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01798394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.