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Efficacy of Levetiracetam in Cocaine-Abusing Methadone Maintained Patients (Keppra-DB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00577005
First Posted: December 19, 2007
Last Update Posted: April 24, 2017
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.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University
Results First Submitted: September 8, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Cocaine Dependence
Opioid Dependency
Interventions: Drug: levetiracetam
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Thirty three cocaine and opioid dependent treatment seeking individuals were recruited by newspaper advertising, word-of -mouth and referrals from community-based substance abuse clinics. Research staff obtained informed consent and subjects were evaluated for study eligibility.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Twenty eight subjects were assigned to treatment groups while concurrently receiving treatment with methadone. Randomization was balanced with urn procedure on gender and severity of cocaine use score.

Reporting Groups
  Description
Levetiracetam 3000mg + Methadone

Participants were inducted onto methadone during the first week of study participation and then started on Levetiracetam 500mg in the mornings of the first day of week 2. The dose was titrated every third day on a twice day schedule, until the target dose of 3000mg/day was achieved or to the subject's maximum tolerated dose (MTD) by week 4.

Levetiracetam: 3000mg orally everyday for 12 weeks

Levetiracetam 0mg + Methadone

Participants were inducted onto methadone during the first week of study participation. Matching placebo capsules were started on week 2. The placebo capsules were given on a twice a day schedule until week 13.

Placebo: Placebo orally everyday for 13 weeks


Participant Flow:   Overall Study
    Levetiracetam 3000mg + Methadone   Levetiracetam 0mg + Methadone
STARTED   16   12 
COMPLETED   11   9 
NOT COMPLETED   5   3 
Lost to Follow-up                3                2 
Withdrawal by Subject                2                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Levetiracetam

Levetiracetam tablets

levetiracetam: 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 be blind to the subject's medication administration. The medication will be discontinued over a two-week period.

Placebo

matching placebo

Placebo

Total Total of all reporting groups

Baseline Measures
   Levetiracetam   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   12   28 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.1  (10.7)   33.6  (9.6)   34.4  (10.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      7  43.8%      5  41.7%      12  42.9% 
Male      9  56.3%      7  58.3%      16  57.1% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   15   11   26 
African American   0   1   1 
Hispanic   1   0   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change of Thrice Weekly Cocaine Free Urine Toxicology From Week 1 to 13   [ Time Frame: Weekly from baseline to week 12 ]

2.  Secondary:   Change of Thrice Weekly Opioid Free Urine Toxicology From Week 1 to 13   [ Time Frame: Weekly from baseline to week 12 ]

3.  Secondary:   Treatment Retention   [ Time Frame: Week 13 ]

4.  Secondary:   Cocaine Craving   [ Time Frame: Weekly from baseline to week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Gerardo Gonzalez, MD
Organization: University of Massachusetts Medical School
phone: 508 856 6480
e-mail: gerardo.gonzalez@umassmed.edu



Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00577005     History of Changes
Other Study ID Numbers: 5R01DA017782-04 ( U.S. NIH Grant/Contract )
NIDA-5R01DA017782-04
Yale-0508000534
VA-gg0006
First Submitted: December 17, 2007
First Posted: December 19, 2007
Results First Submitted: September 8, 2016
Results First Posted: April 24, 2017
Last Update Posted: April 24, 2017