Cocaine DependencePhase 2KeppraNCT00593125
Levetiracetam (Keppra) Tolerability in Cocaine Abusing Methadone-maintained Patients.
A Phase 2 study testing levetiracetam in people with Cocaine Dependence and Opioid Dependence, run by Yale University at 1 site in United States.
Trial summary
The proposed investigation will use methadone maintained patients who have concurrent cocaine dependence in order to take advantage of the excellent (over 80%) treatment retention in this patient group and to maximize treatment compliance by daily observed medication with both methadone and levetiracetam. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Dependence, Opioid Dependence
- What is being tested?
- levetiracetam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Aug 2008
- 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
- Between the ages of 18-65 years.
- Participants must demonstrate current opioid dependence as determined by study physician, self-reported history of opioid dependence for one year and a positive urine of opiates. Participants may be transferred from other methadone maintenance programs, including the WHVA methadone program.
- Participants also must be current users of cocaine with self-reported use of cocaine > 1 time/week in at least one month preceding study entry, cocaine-positive urine screen and score over 3 as assessed with the Severity Dependence Scale (Kaye \& Darke 2002).
- Women of childbearing age are eligible to be included in the study if they have a negative pregnancy test at screening, agree to adequate contraception to prevent pregnancy, to have monthly pregnancy tests, and they understand the risk of fetal toxicity due to medication and cocaine.
Who cannot join
- Current diagnosis of other drug or alcohol dependence (other than opiates, cocaine or tobacco).
- Patients with serious medical illness (e.g., major cardiovascular, renal, endocrine, hepatic, and serious neurological disorders including any history of seizures).
- Patients with current serious psychiatric illness or history of psychosis, schizophrenia, bipolar type I disorder and subjects with suicidal or homicidal thoughts or taking psychotropic medications.
- Women who are pregnant, nursing or refuse to use a reliable form of birth control or refuse monthly testing.
- Screening liver function tests (SGOT or SGPT) greater than 3 times normal and renal function test (creatinine) greater than 1.5 mg/dl.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA CT Healthcare System
West Haven, Connecticut, 06516
About this study
Official title: Levetiracetam (Keppra) Tolerability and Efficacy in Cocaine Abusing Methadone-maintained Patients.
The proposed investigation will use methadone maintained patients who have concurrent cocaine dependence in order to take advantage of the excellent (over 80%) treatment retention in this patient group and to maximize treatment compliance by daily observed medication with both methadone and levetiracetam. In the initial patients we will explore the tolerability of escalating doses of levetiracetam as well as its potential role in reducing cocaine use, as monitored by self-report and verified by three-times weekly urine toxicology testing in methadone treated patients.The specific aim of this study is to evaluate the tolerability and efficacy of levetiracetam 3 grams/day in modifying cocaine-using behavior, reducing cocaine craving and attenuating cocaine's reinforcing effect among methadone-maintained patients
Read the detailed description
This 12-week open-label clinical trial will provide treatment for 15 cocaine-dependent opioid dependent patients. Participants, aged 18-65 years, will receive levetiracetam 3000 mg/day while concurrently receiving treatment with methadone. Baseline cocaine use will be determined during the first week of treatment participation.
The study design will have three overlapping phases that are summarized below: 1) A one week methadone fixed induction (week 1) and flexible stabilization phase (weeks 2-9); 2) an 8-week "treatment" phase (weeks 2-9), consisting of slow titration and stabilization on study medication; and 3) a four week "taper, detoxification or transfer" phase (weeks 9-12).
During the first week of induction onto methadone, participants will be administered fixed increasing doses of methadone starting at 30 mg daily and increased to 60 mg daily by the end of the first week. This methadone dose will be adjusted for stabilization of opiate withdrawal symptoms using a flexible dosing from 40 mg up to 150 mg. This range has been found to be adequate for the vast majority of patients receiving methadone in our program and is designed to accommodate participants who may not be able to tolerate the higher maintenance doses or may still experience withdrawal symptoms, respectively. We may increase or decrease this amount on a case-by-case basis based on physician assessment of self-reported and observed symptoms.
Starting on week 2 subjects will receive levetiracetam 500mg/day and this dose will be slowly titrated to a total of 3000mg/day or maximum tolerated dose (MTD). Subjects will remain on their full dosage through week 8.
At the end of week 8, participants will undergo detoxification from methadone over a 4-week period (weeks 8-12) and discontinuation from levetiracetam over a concurrent 2-week period. All participants will receive weekly 1-hour of individual psychotherapy (Cognitive Behavioral Treatment) with experienced clinicians specifically trained to deliver the therapy and who will receive ongoing supervision. The primary outcomes will be reported medication side effects (medication tolerability), and reduction in cocaine use, as assessed by self-report and thrice-weekly urinalyses. Secondary outcomes will include weeks in treatment (retention), and change in measures of: cocaine craving, anxiety symptoms and opiate withdrawal symptoms. This study will occur at the Outpatient Treatment Research Program in Building 36 at the VA CT Healthcare System.
- Conditions
- Cocaine Dependence, Opioid Dependence
- Being tested
- levetiracetam
- Keywords
- cocaine, opioids, heroin, levetiracetam
- 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.
levetiracetamDrug
Also called Keppra
The participants will start receiving Levetiracetam 500mg in the mornings of the first day on week 2. The dose will be titrated every third day, until the target dose of 3000mg/day is achieved by week 4. The study medication must be titrated to 3000 mg/day or to the subject's maximum tolerated dose (MTD). The physician overseeing this titration as well as all study staff will not be blind to the subject's medication administration. The medication will be discontinued over a two-week period
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | levetiracetam Receives: Drug: levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication emergent side-effects
Measured: 12-weeks
Secondary outcomes (2)
Thrice weekly urine toxicology
Measured: 12 weeks
Weekly self-report of cocaine and opioid use
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startJan 2007
- Primary completionAug 2007
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Investigators
- Gerardo Gonzalez, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593125
- Sponsor's protocol ID
- Yale-0508000534
- Other IDs
- UBC,Inc, VA HSS GG 0004
- Acronym
- Keppra
- Status last verified
- Sep 2016
- First submitted
- 31 Dec 2007
- 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
- Levetiracetam (Keppra) Tolerability and Efficacy in Cocaine Abusing Methadone-maintained Patients.
- ClinicalTrials.gov ID
- NCT00593125
- Acronym / sponsor ID
- Keppra / Yale-0508000534
- Conditions
- Cocaine Dependence, Opioid Dependence
- Keywords
- cocaine, opioids, heroin, levetiracetam
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 14 Jan 2008 (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.
The proposed investigation will use methadone maintained patients who have concurrent cocaine dependence in order to take advantage of the excellent (over 80%) treatment retention in this patient group and to maximize treatment compliance by daily observed medication with both methadone and levetiracetam. In the initial patients we will explore the tolerability of escalating doses of levetiracetam as well as its potential role in reducing cocaine use, as monitored by self-report and verified by three-times weekly urine toxicology testing in methadone treated patients.The specific aim of this study is to evaluate the tolerability and efficacy of levetiracetam 3 grams/day in modifying cocaine-using behavior, reducing cocaine craving and attenuating cocaine's reinforcing effect among methadone-maintained patients
Detailed description
This 12-week open-label clinical trial will provide treatment for 15 cocaine-dependent opioid dependent patients. Participants, aged 18-65 years, will receive levetiracetam 3000 mg/day while concurrently receiving treatment with methadone. Baseline cocaine use will be determined during the first week of treatment participation.
The study design will have three overlapping phases that are summarized below: 1) A one week methadone fixed induction (week 1) and flexible stabilization phase (weeks 2-9); 2) an 8-week "treatment" phase (weeks 2-9), consisting of slow titration and stabilization on study medication; and 3) a four week "taper, detoxification or transfer" phase (weeks 9-12).
During the first week of induction onto methadone, participants will be administered fixed increasing doses of methadone starting at 30 mg daily and increased to 60 mg daily by the end of the first week. This methadone dose will be adjusted for stabilization of opiate withdrawal symptoms using a flexible dosing from 40 mg up to 150 mg. This range has been found to be adequate for the vast majority of patients receiving methadone in our program and is designed to accommodate participants who may not be able to tolerate the higher maintenance doses or may still experience withdrawal symptoms, respectively. We may increase or decrease this amount on a case-by-case basis based on physician assessment of self-reported and observed symptoms.
Starting on week 2 subjects will receive levetiracetam 500mg/day and this dose will be slowly titrated to a total of 3000mg/day or maximum tolerated dose (MTD). Subjects will remain on their full dosage through week 8.
At the end of week 8, participants will undergo detoxification from methadone over a 4-week period (weeks 8-12) and discontinuation from levetiracetam over a concurrent 2-week period. All participants will receive weekly 1-hour of individual psychotherapy (Cognitive Behavioral Treatment) with experienced clinicians specifically trained to deliver the therapy and who will receive ongoing supervision. The primary outcomes will be reported medication side effects (medication tolerability), and reduction in cocaine use, as assessed by self-report and thrice-weekly urinalyses. Secondary outcomes will include weeks in treatment (retention), and change in measures of: cocaine craving, anxiety symptoms and opiate withdrawal symptoms. This study will occur at the Outpatient Treatment Research Program in Building 36 at the VA CT Healthcare System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: levetiracetamlevetiracetam |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between the ages of 18-65 years.
- Participants must demonstrate current opioid dependence as determined by study physician, self-reported history of opioid dependence for one year and a positive urine of opiates. Participants may be transferred from other methadone maintenance programs, including the WHVA methadone program.
- Participants also must be current users of cocaine with self-reported use of cocaine > 1 time/week in at least one month preceding study entry, cocaine-positive urine screen and score over 3 as assessed with the Severity Dependence Scale (Kaye \& Darke 2002).
- Women of childbearing age are eligible to be included in the study if they have a negative pregnancy test at screening, agree to adequate contraception to prevent pregnancy, to have monthly pregnancy tests, and they understand the risk of fetal toxicity due to medication and cocaine.
Key exclusion criteria (5 listed)
- Current diagnosis of other drug or alcohol dependence (other than opiates, cocaine or tobacco).
- Patients with serious medical illness (e.g., major cardiovascular, renal, endocrine, hepatic, and serious neurological disorders including any history of seizures).
- Patients with current serious psychiatric illness or history of psychosis, schizophrenia, bipolar type I disorder and subjects with suicidal or homicidal thoughts or taking psychotropic medications.
- Women who are pregnant, nursing or refuse to use a reliable form of birth control or refuse monthly testing.
- Screening liver function tests (SGOT or SGPT) greater than 3 times normal and renal function test (creatinine) greater than 1.5 mg/dl.
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 |
|---|---|---|
| levetiracetamAlso: KeppraThe participants will start receiving Levetiracetam 500mg in the mornings of the first day on week 2. The dose will be titrated every third day, until the target dose of 3000mg/day is achieved by week 4. The study medication must be titrated to 3000 mg/day or to the subject's maximum tolerated dose (MTD). The physician overseeing this titration as well as all study staff will not be blind to the subject's medication administration. The medication will be discontinued over a two-week period | Drug | 1 |
Primary outcome
Medication emergent side-effects
Time frame: 12-weeks
2 secondary outcomes
Thrice weekly urine toxicology
Time frame: 12 weeks
Weekly self-report of cocaine and opioid use
Time frame: 12-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, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing levetiracetam in people with Cocaine Dependence and Opioid Dependence, run by Yale University at 1 site in United States.
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 5 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.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Medication emergent side-effects (time frame: 12-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.