title: Progesterone Reduces Cocaine Use in Postpartum Women with a Cocaine Use Disorder: A Randomized,Double-Blind Study.
abstract: BACKGROUND
  Progesterone modulates multiple brain functions implicated in the pathogenesis ofdrug addiction. During high endogenous progesterone states, women reduce use of cocaine. We sought to test whether progesterone replacement reduces cocaine use in postpartum women with a cocaine use disorder (CUD).
  
  
  METHODS
  A 12-week, double-blind, parallel, randomized, placebo-controlled pilot trial with a 3-month post trial follow-up. 25 women within 12 weeks of deliverywere randomized to placeboand 25 to100 mgs of oral micronized progesterone, administered twice daily. Participants were recruited from obstetrical clinics. Randomization and allocation were performed by the study biostatistician. Attrition was 18% and the analysis included all50participants. Outcomes were self-reported days of cocaine use and positive urine toxicology assays for cocaine metabolites.
  
  
  RESULTS
  Participants randomized to placebo compared to progesterone had increased likelihood of cocaine use per week (RR=1·19; 95% confidence interval (CI)=1·05 to 1·36; p<0·01). At the three-month post trial visit the difference between groups was not significant (Likelihood RatioΧ2=5·16; P=·08). There were no group differences in rates of submission of a positive urine test. A post hoc analysis showed a higher rate of relapse for participants randomized to placebo (HR=4·71; 95% CI= 1·09 to 20·5). We did not observe groups differences in the rate of adverse events.
  
  
  CONCLUSIONS
  These preliminary findings support the promise of progesterone treatment in postpartum women with a CUD and could constitute a therapeutic break through.
  
  
  BACKGROUND
  US National Institute on Drug Abuse; Veterans Administration.
authors.affiliation: Departments of Psychiatry, Obstetrics and Gynecology and School of Epidemiology and Public Health, Yale University School of Medicine,40 Temple Street, Suite 6B, New Haven, Connecticut, USA 06510.
authors.forename: Kimberly Ann
authors.initials: KA
authors.lastname: Yonkers
authors.affiliation: Department of Psychiatry, Yale University School of Medicine,40 Temple Street, Suite 6B, New Haven, Connecticut, USA 06510.
authors.forename: Ariadna
authors.initials: A
authors.lastname: Forray
authors.affiliation: Department of Psychiatry, Yale University School of Medicine, VA CT Healthcare System, 950 Campbell Avenue, West Haven, CT 06516.
authors.forename: Charla
authors.initials: C
authors.lastname: Nich
authors.affiliation: Department of Psychiatry, Yale University School of Medicine, VA CT Healthcare System, 950 Campbell Avenue, West Haven, CT 06516.
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Carroll
authors.affiliation: Department of Psychiatry, Yale University School of Medicine,40 Temple Street, Suite 6B New Haven, Connecticut, USA 06510.
authors.forename: Cristine
authors.initials: C
authors.lastname: Hine
authors.affiliation: Department of Psychiatry, Yale University School of Medicine,40 Temple Street, Suite 6B, New Haven, Connecticut, USA 06510.
authors.forename: Brian C
authors.initials: BC
authors.lastname: Merry
authors.affiliation: Department of Obstetrics and Gynecology, Yale New Haven Hospital, 1450 Chapel Street, New Haven, CT 06511.
authors.forename: Howard
authors.initials: H
authors.lastname: Shaw
authors.affiliation: Department of Obstetrics and Gynecology, Yale University School of Medicine, 20 York St, New Haven, CT 06511.
authors.forename: Julia
authors.initials: J
authors.lastname: Shaw
authors.affiliation: Department of Psychiatry, Yale University School of Medicine, VA CT Healthcare System, 950 Campbell Avenue, West Haven, CT 06516.
authors.forename: Mehmet
authors.initials: M
authors.lastname: Sofuoglu
keywords: Cocaine Abuse; Cocaine Dependence; Cocaine Use Disorder; Obstetrics and Gynecology; Postpartum; Progesterone; Women