Progesterone & Postpartum Relapse to Smoking

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)
• Treatments: Progesterone

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