Trial record 5 of 109 for:    Open Studies | "Tobacco Use Disorder"

Progesterone & Postpartum Relapse to Smoking

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Masonic Cancer Center, University of Minnesota
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01798394
First received: February 21, 2013
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Tobacco Use Cessation
Tobacco Use Disorder
Drug: Progesterone
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Progesterone & Postpartum Relapse to Smoking

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Relapse Rate [ Time Frame: Week 4 Postpartum ] [ Designated as safety issue: No ]
    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:
  • Relapse Rate [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.

  • Days to Relapse [ Time Frame: Day 0 to 84 ] [ Designated as safety issue: No ]
    Defined by continuous abstinence (CA) and prolonged abstinence (PA). CA defined as a single puff of a cigarette as a relapse. PA measure reflects sustained abstinence and defines relapse as seven consecutive slip (e.g., a puff or more) without a 24 hours period between any slip.

  • Protocol Compliance [ Time Frame: Gestational Week 35 and Weeks 2, 6, and 12 Postpartum ] [ Designated as safety issue: No ]
    Defined as the complete requirements (e.g.,number of visits attended, doses of medication taken, electronic data capture completed) divided by number possible multiplied by 100%.

  • Compliance Determinants [ Time Frame: Gestational Week 36 and Weeks 2, 6 and 12 Postpartum ] [ Designated as safety issue: No ]
    This is a questionnaire assessing participant expectations, satisfaction and study protocol, study medication and electronic data capture. It contains 10 scaled items adapted from a published instrument; all questions are answered with a four-point Likert-type scale. The score of the feasibility questionnaire will be determined by computing a sum, yielding an acceptability score.


Estimated Enrollment: 36
Study Start Date: November 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 - Progesterone Group
Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.
Drug: Progesterone
Placebo Comparator: Arm 2 - Placebo
Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Other: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women at 33-36 weeks gestation who have quit smoking during pregnancy
  • Confirmed uncomplicated single-gestation pregnancy
  • Established prenatal care
  • English fluency
  • Ability to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01798394

Contacts
Contact: Nicole L Tosun, M.S. 612-624-5350 tosun004@umn.edu

Locations
United States, Minnesota
University of Minnesota, 717 Delaware Street SE Recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Nicole L. Tosun, M.S.    612-624-5350    tosun004@umn.edu   
Principal Investigator: Sharon S. Allen, M.D., Ph.D.         
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Sharon S. Allen, M.D., Ph.D. Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01798394     History of Changes
Other Study ID Numbers: 2012NTLS059, R21DA034840
Study First Received: February 21, 2013
Last Updated: November 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Masonic Cancer Center, University of Minnesota:
pregnant
smoker
cigarette
tobacco

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014