Cocaethylene as a Treatment for Cocaine Dependence - 1

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

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 cocaine dependence.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Drug Abuse (NIDA)
• Treatments: Cocaethylene; Cocaine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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