Effectiveness of Tiagabine for Cocaine Dependence in Methadone-Maintained Individuals - 1

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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 abuse. The purpose of this study is to determine the effectiveness of another drug, tiagabine, for treating cocaine dependence in opioid-dependent individuals already receiving methadone treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)