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OpenTrials
Completed

NCT Number: NCT01798394

Progesterone & Postpartum Relapse to Smoking

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota, 717 Delaware Street SE

Minneapolis, Minnesota, 55414, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progesterone

Drug

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

Other names: Prometrium

Placebo

Other

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

Primary outcomes

  1. Number of Participants Who Relapsed by Week 4 Postpartum

    Time frame: Week 4 Postpartum

    Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.

Secondary outcomes

  1. Number of Participants Who Relapsed by Week 12 Postpartum

    Time frame: Week 12 Postpartum

    Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.

  2. Number of Participants Who Relapsed at All During Postpartum (up to Day 84)

    Time frame: Postpartum Day 0 to 84

    Defined by continuous abstinence (CA) defined as a single puff of a cigarette as a relapse.

  3. Protocol Compliance - Number of Visits Attended

    Time frame: Gestational Week 36 - Postpartum Week 12

    Compliance was measured as the number of visits attended (maximum of 5).

  4. Compliance Determinants

    Time frame: Postpartum Week 12

    This was determined by the Feasibility Questionnaire; a 10-item measure used to assess participant expectations, satisfaction of study protocol, study medication and electronic data capture. All questions were answered on a four-point Likert-type scale (1=low acceptability and 4=high acceptability). The total score was determined by adding up all the scores and dividing by 10.

  5. Protocol Compliance - Doses of Medication Taken

    Time frame: Postpartum Week 0 - Week 12

    Compliance was measured by doses of medication taken (maximum of 56).

  6. Protocol Compliance - EDC's Completed

    Time frame: Gestational Week 36 - Postpartum Week 12

    Compliance was measured as the number by number of EDCs completed (maximum of 84).

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Feb 25, 2013
Registry last updated
Jan 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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