At a glance
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Progesterone Treatment for Cocaine-dependent Women: A Pilot Study
In Brief
A Phase 3 clinical trial evaluating Oral micronized progesterone and Placebo for Cocaine Dependence. Completed, enrolled 21 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Oral micronized progesterone (up to 400 mg/day), suspended in olive oil
matched placebo