Cocaethylene as a Treatment for Cocaine Dependence - 1
Cocaethylene Substitution Therapy and Tolerance Induction in Treating Cocaine Dependence
3 other identifiers
interventional
8
1 country
1
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 cocaine dependence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2002
Typical duration for phase_1
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
December 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 22, 2005
CompletedFirst Posted
Study publicly available on registry
July 28, 2005
CompletedJanuary 12, 2017
August 1, 2005
July 22, 2005
January 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical physiological response to cocaine challenge - especially adverse effects measures
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elinore Mccance-Katz, M.D., Ph.D.
Yale Psychiatric Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
Study Record Dates
First Submitted
July 22, 2005
First Posted
July 28, 2005
Study Start
December 1, 2002
Study Completion
March 1, 2005
Last Updated
January 12, 2017
Record last verified: 2005-08