Progesterone & Postpartum Relapse to Smoking

University of Minnesota (UMN)

Status: Completed

Conditions: Tobacco Use Disorder; Tobacco Use Cessation

Treatments: Drug: Progesterone; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01798394

R21DA034840 (U.S. NIH Grant/Contract)

2012NTLS059

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups, including a placebo group

Progesterone

Active Comparator group

Description:

Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.

Treatment:

Drug: Progesterone

Placebo

Placebo Comparator group

Description:

Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.

Treatment:

Other: Placebo