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

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00129298

Purpose

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.

Condition	Intervention	Phase
Cocaine-Related Disorders Opiate Dependence	Drug: Tiagabine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Tiagabine for the Treatment of Cocaine Dependence in Methadone-Maintained Individuals

Resource links provided by NLM:

Drug Information available for: Cocaine hydrochloride Methadone Tiagabine Tiagabine hydrochloride Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Thrice weekly Urine toxicology [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Self reports of cocaine and opioid use. [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Opioid withdrawal symptoms [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
cocaine craving [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Enrollment:	80
Study Start Date:	December 2004
Study Completion Date:	April 2007

Arms	Assigned Interventions
Experimental: 1 Tiagabine	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). Other Name: Gabatril
Placebo Comparator: 2 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). Other Name: Gabatril

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, 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129298

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Gerardo Gonzalez, M.D.

Yale University

More Information

No publications provided

Responsible Party:	Gerardo Gonzalez, MD, Yale University
ClinicalTrials.gov Identifier:	NCT00129298 History of Changes
Other Study ID Numbers:	NIDA-17782-1, R01-17782-1, DPMC
Study First Received:	August 4, 2005
Last Updated:	December 14, 2007
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

cocaine abuse
opiate dependent
tiagabine
methadone

Additional relevant MeSH terms:

Cocaine-Related Disorders
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Cocaine
Methadone
Tiagabine
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid
Analgesics
Antitussive Agents
Respiratory System Agents
Narcotics
Anticonvulsants
GABA Agonists

ClinicalTrials.gov processed this record on February 09, 2012