Back to resultsProgesterone for Smoking Relapse Prevention Following Delivery
Primary Purpose
Tobacco Use Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Progesterone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Progesterone, Placebo, Postpartum, Tobacco, Pregnancy
Eligibility Criteria
Inclusion Criteria:
- Need to be within 3 weeks of delivery because relapse to smoking happens early after childbirth
- Aged 18 to 42 years
- history of smoking, with smoking and other nicotine product abstinence achieved in the final two months of pregnancy and at delivery
- In good health as verified by medical history
- Using acceptable birth control methods other than hormonal contraceptives that contain progestins
- Have biologically confirmed abstinence from tobacco and other nicotine products at randomization
Exclusion Criteria:
- A history of major medical illnesses including liver diseases, suspected or known malignancy, thrombophlebitis, liver failure, or other medical conditions that the physician investigator deems will make study participation unsafe for the subject
- Current or past history bipolar disorder or schizophrenia or current diagnosis of major depression, panic disorder or post-traumatic stress disorder
- Dependence on and/or abuse of alcohol or other drugs of abuse in the month prior to randomization into the trial
- the presence of suicidal or homicidal ideation, or significant impairment of social or occupational functioning, either at study baseline during the evaluation process, or during participation in the trial
- inability to speak Spanish or English (our group is bilingual)
- plans to move out of the area within 8 months after study screening since this will make follow-up difficult
- Inability to understand study procedures or provide informed consent
- Currently undergoing treatment with another pharmacological agent for smoking cessation
- pending legal case that may result in incarceration since this would force abstinence and impede follow-up;
- Pending case with child protective services that might lead removal of infant from mother's custody, as this would impede breastfeeding and infant follow-up
- Unwilling to accept randomization
- Subsequent pregnancy since that would be another source of progesterone
- An acute general medical condition that would require imminent re-hospitalization since this would enforce abstinence (women may be randomized if they are discharged and still within the recruitment window)
- Allergy to progesterone or peanuts (vehicle for micronized progesterone)
- Currently undergoing treatment with ketoconazole or any other known strong CYP3A4 inhibitors
Sites / Locations
- Yale School of Medicine Dpt of Psychiatry
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo
Progesterone
Arm Description
In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.
In this group women will receive oral micronized progesterone twice a day.
Outcomes
Primary Outcome Measures
Feasibility of Progesterone as a Relapse Prevention Intervention for Postpartum Women With Pre-conception Smoking: Adherence to Treatment
Feasibility will be shown by high adherence to treatment condition assessed by doses of study medication taken
Feasibility of Progesterone as a Relapse Prevention Intervention for Postpartum Women With Pre-conception Smoking: Retention
Feasibility in retention will be shown by at least 70% of women randomized to the progesterone group reamaining in the study at the 3-month follow-up
Secondary Outcome Measures
7-day Point Prevalence of Abstinence at End of Treatment (Week 8)
Abstinence was defined as self-report of no smoking in the past 7 days confirmed by a negative urine cotinine test (urine cotinine <100 ng/ml).
Full Information
NCT ID
NCT01972464
First Posted
October 17, 2013
Last Updated
January 12, 2018
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01972464
Brief Title
Progesterone for Smoking Relapse Prevention Following Delivery
Official Title
Progesterone for Postpartum Smokers: Feasibility, Breastfeeding and Infant Safety
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Smoking is the main preventable cause of mortality in Western countries, contributing to over 430,000 deaths a year in the U.S. alone. Clinical and epidemiological studies show that women often decrease smoking in pregnancy, when progesterone levels are high. However, at least half resume pre-pregnancy smoking levels within weeks after delivery and when progesterone levels drop.
Data from preclinical and clinical studies suggest that progesterone may be effective in preventing relapse to smoking in non-postpartum women. Prior work has shown that progesterone decreases both craving for cigarettes and the subjective rewarding effects of smoking among recently abstinent female smokers. These findings led us to hypothesize that progesterone may have efficacy as a relapse prevention treatment for postpartum women.
We propose an 8-week, randomized pilot study to evaluate the safety and initial efficacy of progesterone. This will be a feasibility study that will compare progesterone to placebo for relapse prevention in 40 postpartum smokers. We will assess the feasibility and safety, including the potential effects on breastfeeding and infants exposed via breast milk, in addition to 7-day point prevalence of smoking abstinence after 8 weeks of treatment and at follow-up, 3-months after the end of the protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Progesterone, Placebo, Postpartum, Tobacco, Pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.
Arm Title
Progesterone
Arm Type
Experimental
Arm Description
In this group women will receive oral micronized progesterone twice a day.
Intervention Type
Drug
Intervention Name(s)
Progesterone
Intervention Description
oral micronized progesterone
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Feasibility of Progesterone as a Relapse Prevention Intervention for Postpartum Women With Pre-conception Smoking: Adherence to Treatment
Description
Feasibility will be shown by high adherence to treatment condition assessed by doses of study medication taken
Time Frame
8 weeks
Title
Feasibility of Progesterone as a Relapse Prevention Intervention for Postpartum Women With Pre-conception Smoking: Retention
Description
Feasibility in retention will be shown by at least 70% of women randomized to the progesterone group reamaining in the study at the 3-month follow-up
Time Frame
From randomization to 3-month follow-up: up to 5 months
Secondary Outcome Measure Information:
Title
7-day Point Prevalence of Abstinence at End of Treatment (Week 8)
Description
Abstinence was defined as self-report of no smoking in the past 7 days confirmed by a negative urine cotinine test (urine cotinine <100 ng/ml).
Time Frame
Week 8 of the trial period
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Need to be within 3 weeks of delivery because relapse to smoking happens early after childbirth
Aged 18 to 42 years
history of smoking, with smoking and other nicotine product abstinence achieved in the final two months of pregnancy and at delivery
In good health as verified by medical history
Using acceptable birth control methods other than hormonal contraceptives that contain progestins
Have biologically confirmed abstinence from tobacco and other nicotine products at randomization
Exclusion Criteria:
A history of major medical illnesses including liver diseases, suspected or known malignancy, thrombophlebitis, liver failure, or other medical conditions that the physician investigator deems will make study participation unsafe for the subject
Current or past history bipolar disorder or schizophrenia or current diagnosis of major depression, panic disorder or post-traumatic stress disorder
Dependence on and/or abuse of alcohol or other drugs of abuse in the month prior to randomization into the trial
the presence of suicidal or homicidal ideation, or significant impairment of social or occupational functioning, either at study baseline during the evaluation process, or during participation in the trial
inability to speak Spanish or English (our group is bilingual)
plans to move out of the area within 8 months after study screening since this will make follow-up difficult
Inability to understand study procedures or provide informed consent
Currently undergoing treatment with another pharmacological agent for smoking cessation
pending legal case that may result in incarceration since this would force abstinence and impede follow-up;
Pending case with child protective services that might lead removal of infant from mother's custody, as this would impede breastfeeding and infant follow-up
Unwilling to accept randomization
Subsequent pregnancy since that would be another source of progesterone
An acute general medical condition that would require imminent re-hospitalization since this would enforce abstinence (women may be randomized if they are discharged and still within the recruitment window)
Allergy to progesterone or peanuts (vehicle for micronized progesterone)
Currently undergoing treatment with ketoconazole or any other known strong CYP3A4 inhibitors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariadna Forray, MD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale School of Medicine Dpt of Psychiatry
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Progesterone for Smoking Relapse Prevention Following Delivery
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