Progesterone & Postpartum Relapse to Smoking

Completed · Not applicable · Has a placebo group

Conditions studied: Tobacco Use Cessation, Tobacco Use Disorder

In brief

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.

Key facts

Study ID

NCT01798394

Run by

University of Minnesota

People needed

46

Starts

2014-06-01

Expected to finish

2016-06-01

Last updated by the study team

2017-01-09

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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