Status:
COMPLETED
Effectiveness of Tiagabine for Cocaine Dependence in Methadone-Maintained Individuals - 1
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine-Related Disorders
Opiate Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Many opioid-dependent individuals are also dependent on cocaine. Methadone is a widely used and effective method for treating opioid dependence. However, it is not effective in treating other drugs of...
Detailed Description
For over 30 years, methadone has been used to treat opioid addiction. Since methadone is effective in reducing withdrawal symptoms, it is used as a method of detoxification for opiate addicts. However...
Eligibility Criteria
Inclusion
- Currently not enrolled in methadone-maintenance treatment
- Demonstration of current opioid dependence as determined by the study physician, a self-reported history of opioid dependence for one year, and a positive urine test for opiates
- Current cocaine abuser with self-reported use of cocaine at least 1 time each week within the month prior to study entry, positive urine screen for cocaine, and score greater than 3 on the Severity Dependence Scale
- Women of childbearing age are eligible under the following conditions: negative pregnancy test at initial screening, adequate contraceptive use throughout the study, monthly pregnancy tests, and acknowledgement of fetal toxicity risks due to medication
Exclusion
- Current diagnosis of other drug or alcohol dependence (other than opiates, cocaine, or tobacco)
- Serious medical illness (e.g., major heart, kidney, endocrine, or liver disease, or serious neurological disorders, including history of seizures)
- Current diagnosis of a serious psychiatric illness or history of psychosis, schizophrenia, or bipolar type I disorder
- Suicidal or homicidal thoughts
- Currently taking psychotropic medications
- Women who are pregnant, nursing, refuse to use a reliable form of contraception, or refuse monthly pregnancy testing
- Greater than 3 times the normal level in liver screening function test (SGOT or SGPT)
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00129298
Start Date
December 1 2004
End Date
April 1 2007
Last Update
January 12 2017
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