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

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.
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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

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

Treatment Retention [ Time Frame: Week 13 ]

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4. Secondary:

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

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  Serious Adverse Events

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  Other Adverse Events

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  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:	0707002832; 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:	January 17, 2018