Progesterone Treatment for Cocaine-dependent Women: A Pilot Study
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this pilot treatment trial is to evaluate the efficacy of oral micronized PROG
      in cocaine-dependent women. Since we have shown (Evans & Foltin, 2006) that oral micronized
      PROG attenuates the positive subjective effects of smoked cocaine in females, but not in
      males, and we have preliminary data indicating that oral micronized PROG also reduces smoked
      cocaine self-administration in the laboratory, PROG appears to be an ideal potential
      candidate medication to evaluate in cocaine-dependent women. Prior to randomization to
      treatment, women will reside inpatient for one week to ensure cocaine abstinence since one of
      the primary outcome measures will be time to cocaine relapse.
    

Detailed description: 
      Primary Aims: The primary aims will be directed at treatment efficacy. Relatively unique to
      cocaine treatment trials, one of the principal outcome measures will be time to cocaine
      relapse. We hypothesize that maintenance on PROG will increase the time to cocaine relapse
      compared to maintenance on placebo (PBO). Another cocaine-related efficacy endpoint will be
      the proportion of patients who achieve at least 2 consecutive weeks of cocaine abstinence
      (based on urine toxicology results) during the double-blind treatment phase. Lastly, the
      proportion of cocaine-negative urines collected throughout the treatment trial will be
      measured. We hypothesize that women in the PROG group will show a greater reduction in
      cocaine use compared to those in the PBO group.

      Secondary Aims: 1) Determine if response to laboratory stressors will predict treatment
      outcome. We hypothesize that those women with the greatest stress response will do worse in
      treatment and that maintenance on PROG will reduce stress/anxiety and thereby improve
      treatment outcome. 2) Determine if treatment retention is better in the PROG group compared
      to the PBO group and determine if maintenance on PROG improves overall functioning compared
      to maintenance on PBO based on the Clinical Global Inventory (CGI). We hypothesize that women
      in the PROG group will have better treatment retention and improvement in CGI scores compared
      to women in the PBO group.

      Tertiary Aims: To conduct exploratory analyses to determine whether 1) trauma history is
      related to treatment outcomes and 2) improvements in treatment outcome measures are related
      to decreases in HIV high-risk behaviors.
    

Intervention name(s): Oral micronized progesterone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral micronized progesterone (up to 400 mg/day), suspended in olive oil; matched placebo
Other intervention name(s): Progesterone
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cocaine; treatment; progesterone