Progesterone treatment for cocaine-dependent women: A pilot treatment trial

Abstract

Aims: This study evaluated the efficacy of oral micronized progesterone (PROG) for reducing cocaine use in women. Methods: A 10-week double-blind treatment trial compared PROG (up to 400mg/day, b.i.d.) to placebo (PBO) in cocaine-dependent women who were cocaine abstinent before randomization. Voucher incentives for attendance were used to enhance retention. Primary outcome measures included time to relapse, days of consecutive cocaine abstinence and retention. Response to a laboratory stressor, the Trier Social Stress Test (TSST) and treatment outcome was also explored. Results: Out of 227 women assessed, 25 women entered the trial, with 10 stratified to the PBOGroup and 11 to the PROGGroup. Thirteen women (62%) completed the entire 10-week trial. Five patients (2 in the PROG group and 3 in the PBO group) did not relapse, i.e., remained cocaine abstinent, during the trial. Two other women, one in each group, also did not relapse, but did not complete the trial. For the remainingwomen, themean number of days to relapse was 2.0 for the PROG group and 2.3 for the PBO group (p>0.05). Themean number of consecutive days of abstinence was 7.5 for the PROG group and 9.0 days for the PBO group (p>0.05). Among the 14 women who completed the TSST before randomization, increases in heart rate (r=−.33), anxiety scores (r=−.37) and cocaine craving (r=−.34) in response to stress were negatively correlated with the percentage of cocaine negative urines. Conclusions: PROG was well tolerated, but due to the small sample size it was not possible to adequately determine if PROG may be an effective treatment for cocaine-dependent women. Although cocaine-abstinence rates were low, they could be potentially improved using voucher incentives contingent on cocaine abstinence. Lastly, the preliminary findings showing that increased stress reactivity was related to low rates of cocaine abstinence suggest that stress-reduction techniques could improve treatment outcome. Financial support: NIDA grants RO1 DA022218 (SME), K24 DA029647 (FRL) and KO1 DA022282 (SCR). Medication was provided by the Women’s International Pharmacy.