Levetiracetam XR in Very Heavy Drinkers
NCIG 002
A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy Of Levetiracetam Extended Release in Very Heavy Drinkers
1 other identifier
interventional
130
1 country
5
Brief Summary
The primary objectives of this study are to assess the efficacy of levetiracetam XR in increasing the percentage of subjects with no heavy drinking days and in reducing the weekly percentage of heavy drinking days in subjects with alcohol dependence confirmed by DSM-IV criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks per drinking day for women (designated as "very heavy" drinkers).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2009
Shorter than P25 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2009
CompletedFirst Posted
Study publicly available on registry
September 2, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
July 6, 2012
CompletedAugust 28, 2014
August 1, 2014
10 months
September 1, 2009
April 26, 2012
August 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 14.
A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.
Weeks 5-14
The Percentage of Heavy Drinking Days Per Week During Study Weeks 5 Through 14.
A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.
Study Weeks 5-14
Secondary Outcomes (1)
The Number of Drinks Per Drinking Day Study Weeks 5-14.
Study Weeks 5-14
Study Arms (2)
Levetiracetam XR
ACTIVE COMPARATORGroup received Levetiracetam
Sugar Pill
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- The subject must be at least 18 years of age.
- The subject must have a DSM-IV diagnosis of current alcohol dependence.
- The subject must be seeking treatment for alcohol dependence and desires a reduction or cessation of drinking.
- The subject must be able to verbalize understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
- If the subject is female and of child bearing potential, she must agree to use at least one of the following methods of birth control, or she must be surgically sterile or postmenopausal:
- oral contraceptives
- contraceptive sponge
- patch
- barrier (diaphragm or condom)
- intrauterine contraceptive system
- levonorgestrel implant
- medroxyprogesterone acetate contraceptive injection
- complete abstinence from sexual intercourse, and/or
- hormonal vaginal contraceptive ring.
- The subject must be able to take oral medication, willing to adhere to the medication regimen, and willing to return for regular visits.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Johns Hopkins School of Medicine
Baltimore, Maryland, 21224, United States
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
Dartmouth Medical School
Lebanon, New Hampshire, 03755, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Virginia
Charlottesville, Virginia, 22911, United States
Related Publications (1)
Fertig JB, Ryan ML, Falk DE, Litten RZ, Mattson ME, Ransom J, Rickman WJ, Scott C, Ciraulo D, Green AI, Tiouririne NA, Johnson B, Pettinati H, Strain EC, Devine E, Brunette MF, Kampman K, A Tompkins D, Stout R; NCIG 002 Study Group. A double-blind, placebo-controlled trial assessing the efficacy of levetiracetam extended-release in very heavy drinking alcohol-dependent patients. Alcohol Clin Exp Res. 2012 Aug;36(8):1421-30. doi: 10.1111/j.1530-0277.2011.01716.x. Epub 2012 Feb 10.
PMID: 22324516RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Megan Ryan - Clinical Trials Project Manager
- Organization
- NIAAA
Study Officials
- PRINCIPAL INVESTIGATOR
Raye Z Litten, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- PRINCIPAL INVESTIGATOR
Margaret M Mattson, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- PRINCIPAL INVESTIGATOR
Joanne E Fertig, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2009
First Posted
September 2, 2009
Study Start
October 1, 2009
Primary Completion
August 1, 2010
Study Completion
October 1, 2010
Last Updated
August 28, 2014
Results First Posted
July 6, 2012
Record last verified: 2014-08