Clinical Trials Logo
  1. Home
  2. Cocaine Dependence
  3. NCT00632099

Progesterone Treatment for Cocaine-dependent Women: A Pilot Study — PROG  

Cocaine Dependence Clinical Trial

Official title:
Progesterone Treatment for Cocaine-dependent Women: A Pilot Study

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00632099
Study type Interventional
Source New York State Psychiatric Institute
Contact
Status Completed
Phase Phase 2/Phase 3
Start date February 2008
Completion date September 2012
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04994821 - tDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study Phase 2
Completed NCT01601743 - Exercise as a Behavioral Treatment for Cocaine Dependence N/A
Completed NCT01402492 - Cocaine Use Reduction With Buprenorphine Phase 2/Phase 3
Completed NCT01176591 - HBPL Study of the Impact of the NK1 Antagonist Aprepitant Phase 2
Completed NCT00880997 - The Efficacy of Doxazosin for Cocaine Users Phase 1
Completed NCT00566969 - Cocaine Withdrawal and Pharmacotherapy Response N/A
Completed NCT00585520 - Sex Differences in Progesterone Effects on Responses to Stress and Drug Cues Phase 1
Completed NCT00368290 - Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior Phase 2
Completed NCT00385801 - Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence Phase 2
Completed NCT00322309 - Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects Phase 2
Completed NCT00167245 - Topiramate for Alcohol and Cocaine Dependence Phase 2
Completed NCT00842517 - Long Term Maintenance of Drug Abstinence Phase 1
Not yet recruiting NCT05974202 - rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder Phase 2
Completed NCT04411914 - Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid Phase 1
Active, not recruiting NCT03266939 - Rebalancing the Serotonergic System in Cocaine Dependence Phase 1
Completed NCT02563769 - Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study Phase 1
Recruiting NCT06159387 - Randomized, Double-blind, Placebo-controlled Cannabis Extract x Placebo for Cocaine Addicts Phase 4
Terminated NCT02935101 - Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants Phase 2
Completed NCT02018263 - Validation of a Remote Wireless Sensor Network (WSN) Approach to the Individualized Detection of Cocaine Use in Humans Phase 1
Withdrawn NCT01406522 - Tacrine Effects on Cocaine Self-Administration and Pharmacokinetics Phase 2