Cocaethylene as a Treatment for Cocaine Dependence - 1

Completed · Phase 1

Conditions studied: Cocaine-Related Disorders

In brief

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 cocaine dependence.

Key facts

Study ID

NCT00124696

Run by

National Institute on Drug Abuse (NIDA)

People needed

8

Starts

2002-12-01

Expected to finish

2005-03-01

Last updated by the study team

2017-01-12

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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