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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00129298
Recruitment Status : Completed
First Posted : August 11, 2005
Last Update Posted : January 12, 2017
Information provided by:
National Institute on Drug Abuse (NIDA)

Tracking Information
First Submitted Date  ICMJE August 4, 2005
First Posted Date  ICMJE August 11, 2005
Last Update Posted Date January 12, 2017
Study Start Date  ICMJE December 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2007)
Thrice weekly Urine toxicology [ Time Frame: 13 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 4, 2005)
Urine toxicology for cocaine
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2005)
Self reports of cocaine and other drug use and craving
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Effectiveness of Tiagabine for Cocaine Dependence in Methadone-Maintained Individuals - 1
Official Title  ICMJE Tiagabine for the Treatment of Cocaine Dependence in Methadone-Maintained Individuals
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 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Cocaine-Related Disorders
  • Opiate Dependence
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Tiagabine
  • Placebo Comparator: 2
    Matching placebo
    Intervention: Drug: Tiagabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2007)
Original Enrollment  ICMJE
 (submitted: August 4, 2005)
Actual Study Completion Date  ICMJE April 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
Administrative Information
NCT Number  ICMJE NCT00129298
Other Study ID Numbers  ICMJE NIDA-17782-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gerardo Gonzalez, MD, Yale University
Study Sponsor  ICMJE National Institute on Drug Abuse (NIDA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gerardo Gonzalez, M.D. Yale University
PRS Account National Institute on Drug Abuse (NIDA)
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP