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Progesterone & Postpartum Relapse to Smoking

Primary Purpose

Tobacco Use Cessation, Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Progesterone
Placebo
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tobacco Use Cessation focused on measuring pregnant, smoker, cigarette, tobacco

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts 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

Sites / Locations

  • University of Minnesota, 717 Delaware Street SE

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Progesterone

Placebo

Arm 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.

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

Outcomes

Primary Outcome Measures

Number of Participants Who Relapsed by 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 Outcome Measures

Number of Participants Who Relapsed by 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.
Number of Participants Who Relapsed at All During Postpartum (up to Day 84)
Defined by continuous abstinence (CA) defined as a single puff of a cigarette as a relapse.
Protocol Compliance - Number of Visits Attended
Compliance was measured as the number of visits attended (maximum of 5).
Compliance Determinants
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.
Protocol Compliance - Doses of Medication Taken
Compliance was measured by doses of medication taken (maximum of 56).
Protocol Compliance - EDC's Completed
Compliance was measured as the number by number of EDCs completed (maximum of 84).

Full Information

First Posted
February 21, 2013
Last Updated
November 10, 2016
Sponsor
University of Minnesota
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01798394
Brief Title
Progesterone & Postpartum Relapse to Smoking
Official Title
Progesterone & Postpartum Relapse to Smoking
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 determine the feasibility of enhanced compliance monitoring and identification of collateral factors effecting outcomes.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Cessation, Tobacco Use Disorder
Keywords
pregnant, smoker, cigarette, tobacco

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progesterone
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Intervention Type
Drug
Intervention Name(s)
Progesterone
Other Intervention Name(s)
Prometrium
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Primary Outcome Measure Information:
Title
Number of Participants Who Relapsed by Week 4 Postpartum
Description
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.
Time Frame
Week 4 Postpartum
Secondary Outcome Measure Information:
Title
Number of Participants Who Relapsed by Week 12 Postpartum
Description
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.
Time Frame
Week 12 Postpartum
Title
Number of Participants Who Relapsed at All During Postpartum (up to Day 84)
Description
Defined by continuous abstinence (CA) defined as a single puff of a cigarette as a relapse.
Time Frame
Postpartum Day 0 to 84
Title
Protocol Compliance - Number of Visits Attended
Description
Compliance was measured as the number of visits attended (maximum of 5).
Time Frame
Gestational Week 36 - Postpartum Week 12
Title
Compliance Determinants
Description
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.
Time Frame
Postpartum Week 12
Title
Protocol Compliance - Doses of Medication Taken
Description
Compliance was measured by doses of medication taken (maximum of 56).
Time Frame
Postpartum Week 0 - Week 12
Title
Protocol Compliance - EDC's Completed
Description
Compliance was measured as the number by number of EDCs completed (maximum of 84).
Time Frame
Gestational Week 36 - Postpartum Week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon S. Allen, M.D., Ph.D.
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota, 717 Delaware Street SE
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Progesterone & Postpartum Relapse to Smoking

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