Status:
COMPLETED
Progesterone & Postpartum Relapse to Smoking
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Conditions:
Tobacco Use Cessation
Tobacco Use Disorder
Eligibility:
FEMALE
18-35 years
Phase:
NA
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 dete...
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 rando...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01798394
Start Date
June 1 2014
End Date
June 1 2016
Last Update
January 9 2017
Active Locations (1)
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1
University of Minnesota, 717 Delaware Street SE
Minneapolis, Minnesota, United States, 55414