Cocaine-Related DisordersPhase 2NCT00129298
Effectiveness of Tiagabine for Cocaine Dependence in Methadone-Maintained Individuals - 1
A Phase 2 study testing Tiagabine in people with Cocaine-Related Disorders and Opiate Dependence, run by National Institute on Drug Abuse (NIDA).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine-Related Disorders, Opiate Dependence
- What is being tested?
- Tiagabine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Apr 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
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.
Read the 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.
- Conditions
- Cocaine-Related Disorders, Opiate Dependence
- Being tested
- Tiagabine
- Keywords
- cocaine abuse, opiate dependent, tiagabine, methadone
- Medical subject headings
- Cocaine-Related Disorders, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiagabineDrug
Also called Gabatril
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).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Tiagabine Receives: Drug: Tiagabine |
| 2 | Placebo comparator | Matching placebo Receives: Drug: Tiagabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrice weekly Urine toxicology
Measured: 13 weeks
Secondary outcomes (4)
Self reports of cocaine and opioid use.
Measured: 13 weeks
Opioid withdrawal symptoms
Measured: 13 weeks
Adverse events
Measured: 13 weeks
cocaine craving
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2005 (estimated)
- Study startDec 2004
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Gerardo Gonzalez, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129298
- Sponsor's protocol ID
- NIDA-17782-1
- Other IDs
- R01-17782-1, DPMC
- Status last verified
- Dec 2007
- First submitted
- 4 Aug 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tiagabine for the Treatment of Cocaine Dependence in Methadone-Maintained Individuals
- ClinicalTrials.gov ID
- NCT00129298
- Acronym / sponsor ID
- NIDA-17782-1
- Conditions
- Cocaine-Related Disorders, Opiate Dependence
- Keywords
- cocaine abuse, opiate dependent, tiagabine, methadone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Dec 2004
- Study completion
- Apr 2007 (actual)
- First posted
- 11 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TiagabineTiagabine |
| 2 | Placebo comparator | Drug: TiagabineMatching placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TiagabineAlso: GabatrilThe 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). | Drug | 1, 2 |
Primary outcome
Thrice weekly Urine toxicology
Time frame: 13 weeks
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerardo Gonzalez, M.D. principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tiagabine in people with Cocaine-Related Disorders and Opiate Dependence, run by National Institute on Drug Abuse (NIDA).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrice weekly Urine toxicology (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.