Status:
COMPLETED
Cocaethylene as a Treatment for Cocaine Dependence - 1
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine-Related Disorders
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Cocaine has been cited as the primary drug threat in the United States. The purpose of this study is to determine if cocaethylene, used as a prototype drug, is a safe and effective treatment for cocai...
Detailed Description
Currently, there are no medications available to specifically treat cocaine addiction. Cocaethylene is an active metabolite of cocaine and has a similar chemical structure to cocaine. The purpose of t...
Eligibility Criteria
Inclusion
- Meets DSM-IV criteria for cocaine dependence
- Cocaine use of at least 0.5 grams each week during the three months prior to enrollment, confirmed by a positive urine test for cocaine metabolite
- Females are eligible if currently using adequate contraception, not planning to become pregnant, or surgically sterilized
- Females of child-bearing potential must have a negative pregnancy test prior to study entry
- Currently not physiologically dependent on alcohol, but may meet DSM-IV criteria for alcohol abuse or dependence
Exclusion
- Meets DSM-IV criteria for dependence on any drugs (other than nicotine or alcohol) within the year prior to enrollment
- Currently abuses other substances such as opiates, sedative-hypnotics, or amphetamines (excluding marijuana or nicotine) more than twice a week
- History of a serious medical illness or indication of a serious medical illness such as seizures, hypertension, heart disease, an abnormal ECG, anemia, diabetes, or abnormal blood flow sounds
- Meets DSM-IV criteria for a current major mental disorder, including major depression, bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, or organic mental syndrome
- Currently being treated with psychotropic medication
- At risk for suicide, as determined by a psychiatrist
- Greater than two times the normal level for liver or kidney function tests
- Currently seeking treatment for drug abuse
- Participants with liver function tests equal to or greater than three times the normal level will be discontinued from the study
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00124696
Start Date
December 1 2002
End Date
March 1 2005
Last Update
January 12 2017
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298