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

NCT00129298 | Completed Phase 2

• 3 other identifiers: NIDA-17782-1R01-17782-1DPMC
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cocaine-Related Disorders; Opiate Dependence

Keywords

cocaine abuse; opiate dependent; tiagabine; methadone

Outcome Measures

Primary Outcomes (1)

• Thrice weekly Urine toxicology

  13 weeks

Secondary Outcomes (4)

• Self reports of cocaine and opioid use.

  13 weeks

• Opioid withdrawal symptoms

  13 weeks

• Adverse events

  13 weeks

• cocaine craving

  13 weeks

Study Arms (2)

1

EXPERIMENTAL

Tiagabine

Drug: Tiagabine

2

PLACEBO COMPARATOR

Matching placebo

Drug: Tiagabine

Interventions

Tiagabine DRUG

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

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

MeSH Terms

Conditions

Cocaine-Related Disorders; Opioid-Related Disorders

Interventions

Tiagabine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Intervention Hierarchy (Ancestors)

Nipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Gerardo Gonzalez, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 4, 2005
• First Posted: August 11, 2005
• Study Start: December 1, 2004
• Study Completion: April 1, 2007
• Last Updated: January 12, 2017

Record last verified: 2007-12