N/A
Completed N=46
Progesterone & Postpartum Relapse to Smoking
Tobacco Use Cessation · Tobacco Use
Source: ClinicalTrials.gov NCT01798394 ↗
Enrolled (actual)
46
Serious AEs
2.2%
Results posted
Jan 2017
Primary outcomePrimary: Number of Participants Who Relapsed by Week 4 Postpartum — 6; 7 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Relapsed by Week 4 Postpartum |
6; 7 | — |
| SECONDARY Number of Participants Who Relapsed by Week 12 Postpartum |
11; 13 | — |
| SECONDARY Number of Participants Who Relapsed at All During Postpartum (up to Day 84) |
10; 13 | — |
| SECONDARY Protocol Compliance - Number of Visits Attended |
4.5; 4.4 | — |
| SECONDARY Compliance Determinants |
3.6; 3.5 | — |
| SECONDARY Protocol Compliance - Doses of Medication Taken |
38.9; 37.5 | — |
| SECONDARY Protocol Compliance - EDC's Completed |
60.9; 61.8 | — |
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
Data sourced from ClinicalTrials.gov (NCT01798394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.