Progesterone for Postpartum Cocaine Relapse
Summary
The investigators propose a placebo-controlled, randomized clinical trial that would enroll 50 postpartum women with a history of cocaine abuse or dependence to assess whether progesterone (100mgs twice daily) decreases postpartum cocaine use.
Timeline
- Start
- 2011-02
- Primary completion
- 2013-07
- Completion
- 2013-07
Outcome
Mixed primary results
registry MEAN Placebo: Week 12: 0.70 (Standard Deviation 2.11) number of days per week of cocaine use NCT01249274 ↗
registry MEAN Progesterone: Week 12: 0.24 (Standard Deviation 0.68) number of days per week of cocaine use NCT01249274 ↗
registry analysis (superiority or other test); Placebo vs Progesterone; p = 0.010; Risk Ratio (RR) 1.19 (95% CI 1.04 to 1.36); Generalized Estimating Equation NCT01249274 ↗
registry MEAN Placebo: End of Trial (Week 12): 0.2860 (0.1237 to 0.6609) days of cocaine use between visits NCT01249274 ↗
registry MEAN Progesterone: End of Trial (Week 12): 0.05550 (0.009978 to 0.3087) days of cocaine use between visits NCT01249274 ↗
registry analysis (superiority or other test); Placebo vs Progesterone; p = 0.003; Risk Ratio (RR) 30.39 (95% CI 3.18 to 290.04); Generalized Estimating Equation NCT01249274 ↗
registry analysis (superiority or other test); Placebo vs Progesterone; p = 0.038; Risk Ratio (RR) 16.65 (95% CI 1.18 to 235.52); Generalized Estimating Equation NCT01249274 ↗
registry analysis (superiority or other test); Placebo vs Progesterone; p = 0.99; Risk Ratio (RR) 1.00 (95% CI 0.87 to 1.15); Generalized Estimating Equation NCT01249274 ↗
registry analysis (superiority or other test); Placebo vs Progesterone; p = 0.75; Risk Ratio (RR) 1.34 (95% CI 0.23 to 7.88); Generalized Estimating Equation NCT01249274 ↗
registry analysis (superiority or other test); Placebo vs Progesterone; p = 0.84; Risk Ratio (RR) 1.18 (95% CI 0.24 to 5.84); Generalized Estimating Equation NCT01249274 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Progesterone | Other / unclassified | 100 mg | — |