Progesterone Treatment for Cocaine-dependent Women: A Pilot Study (PROG)
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.
Drug: Oral micronized progesterone
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Progesterone Treatment for Cocaine-dependent Women: A Pilot Study|
- Cocaine use based on Urine toxicology results [ Time Frame: 3x/week during 10 weeks of the trial or study participation ] [ Designated as safety issue: No ]
- self reported cocaine use [ Time Frame: measured daily for 10 weeks of study or length of participation ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: 2
Oral micronized progesterone (up to 400 mg/day)
Drug: Oral micronized progesterone
Oral micronized progesterone (up to 400 mg/day), suspended in olive oil
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.
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Suzette Evans, PhD||Columbia University|