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Progesterone Treatment for Cocaine-dependent Women: A Pilot Study

NCT00632099 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2014-05-12

Study results available
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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.

Conditions

  • Cocaine Dependence

Interventions

DRUG

Oral micronized progesterone

Oral micronized progesterone (up to 400 mg/day), suspended in olive oil

DRUG

Placebo

matched placebo

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Suzette Evans, PhD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00632099 on ClinicalTrials.gov