Progesterone Treatment for Cocaine-dependent Women: A Pilot Study (PROG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00632099|
Recruitment Status : Completed
First Posted : March 10, 2008
Results First Posted : May 12, 2014
Last Update Posted : May 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Dependence||Drug: Oral micronized progesterone Drug: Placebo||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Progesterone Treatment for Cocaine-dependent Women: A Pilot Study|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
Placebo Comparator: Placebo
Experimental: Oral micronized progesterone
Oral micronized progesterone (up to 400 mg/day)
Drug: Oral micronized progesterone
Oral micronized progesterone (up to 400 mg/day), suspended in olive oil
Other Name: Progesterone
- Cocaine Abstinence Based on Urine Toxicology Results [ Time Frame: during last 3 weeks of the trial ]Percentage of patients cocaine abstinent during last 3 weeks of the study (weeks 7-9)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632099
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Suzette Evans, PhD||Columbia University|