Tobacco Use Cessation, Tobacco Use Disorder
Conditions
Keywords
pregnant, smoker, cigarette, tobacco
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.
Interventions
DRUGProgesterone
Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.
OTHERPlacebo
Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Sponsors
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Relapsed by Week 4 Postpartum | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Relapsed at All During Postpartum (up to Day 84) | Postpartum Day 0 to 84 | Defined by continuous abstinence (CA) defined as a single puff of a cigarette as a relapse. |
| Protocol Compliance - Number of Visits Attended | Gestational Week 36 - Postpartum Week 12 | Compliance was measured as the number of visits attended (maximum of 5). |
| Number of Participants Who Relapsed by Week 12 Postpartum | 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. |
| Protocol Compliance - Doses of Medication Taken | Postpartum Week 0 - Week 12 | Compliance was measured by doses of medication taken (maximum of 56). |
| Protocol Compliance - EDC's Completed | Gestational Week 36 - Postpartum Week 12 | Compliance was measured as the number by number of EDCs completed (maximum of 84). |
| Compliance Determinants | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Progesterone Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.
Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4. | 24 |
| Placebo Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4. | 22 |
| Total | 46 |
Baseline characteristics
| Characteristic | Placebo | Progesterone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 24 Participants | 46 Participants |
| Age, Continuous | 26.7 years STANDARD_DEVIATION 5 | 26.2 years STANDARD_DEVIATION 5.5 | 26.5 years STANDARD_DEVIATION 5.2 |
| Gender Female | 22 Participants | 24 Participants | 46 Participants |
| Gender Male | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 22 participants | 24 participants | 46 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 22 |
| serious Total, serious adverse events | 0 / 24 | 1 / 22 |
Outcome results
Primary
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.
Time frame: Week 4 Postpartum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Progesterone | Number of Participants Who Relapsed by Week 4 Postpartum | 6 participants |
| Placebo | Number of Participants Who Relapsed by Week 4 Postpartum | 7 participants |
Secondary
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.
Time frame: Postpartum Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Progesterone | Compliance Determinants | 3.6 units on a scale | Standard Deviation 0.3 |
| Placebo | Compliance Determinants | 3.5 units on a scale | Standard Deviation 0.3 |
Secondary
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.
Time frame: Postpartum Day 0 to 84
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Progesterone | Number of Participants Who Relapsed at All During Postpartum (up to Day 84) | 10 participants |
| Placebo | Number of Participants Who Relapsed at All During Postpartum (up to Day 84) | 13 participants |
Secondary
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.
Time frame: Week 12 Postpartum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Progesterone | Number of Participants Who Relapsed by Week 12 Postpartum | 11 participants |
| Placebo | Number of Participants Who Relapsed by Week 12 Postpartum | 13 participants |
Secondary
Protocol Compliance - Doses of Medication Taken
Compliance was measured by doses of medication taken (maximum of 56).
Time frame: Postpartum Week 0 - Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Progesterone | Protocol Compliance - Doses of Medication Taken | 38.9 Doses of medication taken | Standard Deviation 22.3 |
| Placebo | Protocol Compliance - Doses of Medication Taken | 37.5 Doses of medication taken | Standard Deviation 18.3 |
Secondary
Protocol Compliance - EDC's Completed
Compliance was measured as the number by number of EDCs completed (maximum of 84).
Time frame: Gestational Week 36 - Postpartum Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Progesterone | Protocol Compliance - EDC's Completed | 60.9 EDC's completed | Standard Deviation 21.8 |
| Placebo | Protocol Compliance - EDC's Completed | 61.8 EDC's completed | Standard Deviation 24.3 |
Secondary
Protocol Compliance - Number of Visits Attended
Compliance was measured as the number of visits attended (maximum of 5).
Time frame: Gestational Week 36 - Postpartum Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Progesterone | Protocol Compliance - Number of Visits Attended | 4.5 Number of visits attended | Standard Deviation 1.1 |
| Placebo | Protocol Compliance - Number of Visits Attended | 4.4 Number of visits attended | Standard Deviation 1.2 |