Cocaine-Related Disorders Clinical Trial
Official title:
Tiagabine for the Treatment of Cocaine Dependence in Methadone-Maintained Individuals
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.
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, methadone is not effective in treating other drugs of abuse, such
as cocaine. Tiagabine is a drug that enhances levels of gamma aminobutyric acid (GABA), a
chemical found in the brain and spinal cord. The objective of this study is to determine the
effectiveness of tiagabine in modifying cocaine-using behavior and reducing opiate
withdrawal symptoms among newly admitted methadone-treated patients.
This 16-week, double-blind, placebo-controlled clinical trial will involve 120 participants
who are both cocaine- and opioid- dependent. Participants will be randomly assigned to
receive either tiagabine or placebo, while concurrently receiving methadone treatment.
Baseline cocaine use will be determined during the first two weeks of treatment. The study
will include three overlapping phases. The first phase will include a one-week fixed
methadone induction (Week 1), as well as flexible methadone stabilization (Weeks 2-13).
Phase two will consist of a 12-week treatment period (Weeks 2-13). This will consist of
tiagabine induction and stabilization. Phase three will include a 4-week taper,
detoxification, or transfer period (Weeks 14-17). After completion of treatment, a 3-month
follow-up visit will occur.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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