Progesterone Treatment for Cocaine-dependent Women: A Pilot Study
PROG
3 other identifiers
interventional
21
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2008
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 6, 2008
CompletedFirst Posted
Study publicly available on registry
March 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
May 12, 2014
CompletedMay 12, 2014
April 1, 2014
4.6 years
March 6, 2008
April 9, 2014
April 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cocaine Abstinence Based on Urine Toxicology Results
Percentage of patients cocaine abstinent during last 3 weeks of the study (weeks 7-9)
during last 3 weeks of the trial
Study Arms (2)
Placebo
PLACEBO COMPARATORmatched placebo
Oral micronized progesterone
EXPERIMENTALOral micronized progesterone (up to 400 mg/day)
Interventions
Oral micronized progesterone (up to 400 mg/day), suspended in olive oil
Eligibility Criteria
You may qualify if:
- \. Use cocaine by the smoked or intranasal route at least four days in the past month, with at least weekly cocaine use.
- \. Women with regular menstrual cycles (24-45 days) who are not pregnant, based on the results of a blood pregnancy test drawn at the time of screening. They must agree to use a barrier method of contraception with proven efficacy and agree not to become pregnant during the study. To confirm this, urine pregnancy tests will be conducted weekly.
- \. Women must be capable of giving informed consent and capable of complying with study procedures.
You may not qualify if:
- \. Meets DSM-IV-TR criteria for bipolar disorder, Schizophrenia, or any psychotic disorder other than transient psychosis due to drug abuse.
- \. Individuals with current major depressive disorder.
- \. Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) that require medical intervention will be excluded and referred for treatment. Individuals with severe alcohol dependence , even without physiological dependence, or with any known alcohol-related diseases will also be excluded.
- \. Females who have any of the following medical contraindications: undiagnosed abnormal genital bleeding, known or suspected history of breast or genital cancer, active deep vein thrombosis, pulmonary embolism, or history of these conditions, active or recent (within last year) arterial thromboembolic diseases (e.g., stroke, myocardial infarction), liver dysfunction.
- \. Females who are cognitively impaired or have a chronic organic mental disorder.
- \. Individuals with current suicidal risk.
- \. Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms.
- \. Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension (Blood pressure \> 150/ 90, or Heart Rate \> 100 when sitting quietly), acute hepatitis (patients with chronic mildly elevated transaminases \< 3x upper limit of normal are acceptable), or uncontrolled diabetes.
- \. Individuals with a history of seizures.
- \. Women who are pregnant or nursing.
- \. Individuals who are legally mandated (e.g., to avoid incarceration, monetary or other penalties, etc.) to participate in substance abuse treatment program.
- \. Females with a known or suspected hypersensitivity to oral micronized progesterone.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York State Psychiatric Institute
New York, New York, 10032, United States
Related Publications (1)
Oliva A, Reed SC, Brooks DJ, Levin FR, Evans SM. Safety and tolerability of progesterone treatment for women with cocaine use disorder: a pilot treatment trial. Am J Drug Alcohol Abuse. 2022 Sep 3;48(5):586-595. doi: 10.1080/00952990.2022.2114004. Epub 2022 Sep 12.
PMID: 36095308DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Given the limited sample size, it was not possible to adequately determine whether OM-PROG may be an effective treatment for cocaine-dependence in women, but it was well tolerated.
Results Point of Contact
- Title
- Dr. Suzette Evans
- Organization
- New York State Psychiatric Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Suzette Evans, PhD
Columbia University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2008
First Posted
March 10, 2008
Study Start
February 1, 2008
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
May 12, 2014
Results First Posted
May 12, 2014
Record last verified: 2014-04