A Phase 2 interventional study of Tiagabine in Cocaine-Related Disorders and Opiate Dependence, sponsored by National Institute on Drug Abuse (NIDA). Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-01-12.
Sponsored by National Institute on Drug Abuse (NIDA) · Phase 2, Interventional, and Treatment
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.
415 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.
This study's enrollment of 80 is above the median of 60 across 312 interventional studies indexed under Cocaine-Related Disorders.
Browse Cocaine-Related Disorders studies →National Institute on Drug Abuse (NIDA) is the lead sponsor of 388 studies on the registry; 19 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
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Exclusion Criteria:
Tiagabine
Drug: Tiagabine
Matching placebo
Drug: Tiagabine
The tiagabine group will start receiving tiagabine 4mg in the evening of the first day on week 2. The dose will be titrated every third day, until the target dose of 32mg/day is achieved by week 5. The study medication must be titrated to 32 mg/day or to the subject's maximum tolerated dose (MTD).
Also known as: Gabatril
Thrice weekly Urine toxicology
Time frame: 13 weeks
Self reports of cocaine and opioid use.
Time frame: 13 weeks
Opioid withdrawal symptoms
Time frame: 13 weeks
Adverse events
Time frame: 13 weeks
cocaine craving
Time frame: 13 weeks
No study locations are listed for this record.
This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.
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National Institute on Drug Abuse (NIDA)