Back to resultsLevetiracetam XR in Very Heavy Drinkers (NCIG 002)
Primary Purpose
Alcoholism
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BBCET
BBCET
Levetiracetam XR
Sugar Pill
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholism focused on measuring Alcoholism, Alcohol Drinking, Alcoholic Intoxication, Alcohol Abuse
Eligibility Criteria
Inclusion Criteria:
- 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.
- The subject must complete all psychological assessments required at screening and baseline.
- The subject must provide evidence of stable residence in the last 2 months prior to randomization, have reasonable transportation arrangements to the study site, and have no plans to move within the next 3 months or unresolved legal problems. Subjects must provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment.
- The subject must have a breath alcohol concentration (BAC) equal to 0.000 when s/he signed the informed consent document.
Sites / Locations
- Johns Hopkins School of Medicine
- Boston University School of Medicine
- Dartmouth Medical School
- University Of Pennsylvania
- University of Virginia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Levetiracetam XR
Sugar Pill
Arm Description
Group received Levetiracetam
Placebo
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
The Number of Drinks Per Drinking Day Study Weeks 5-14.
based on self report
Full Information
NCT ID
NCT00970814
First Posted
September 1, 2009
Last Updated
August 20, 2014
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT00970814
Brief Title
Levetiracetam XR in Very Heavy Drinkers
Acronym
NCIG 002
Official Title
A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy Of Levetiracetam Extended Release in Very Heavy Drinkers
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
Alcoholism, Alcohol Drinking, Alcoholic Intoxication, Alcohol Abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levetiracetam XR
Arm Type
Active Comparator
Arm Description
Group received Levetiracetam
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Behavioral
Intervention Name(s)
BBCET
Intervention Description
11 BBCET sessions
Intervention Type
Behavioral
Intervention Name(s)
BBCET
Intervention Description
11 BBCET Sessions
Intervention Type
Drug
Intervention Name(s)
Levetiracetam XR
Intervention Description
500mg - 2000mg Once per day 16 weeks
Intervention Type
Drug
Intervention Name(s)
Sugar Pill
Intervention Description
500mg - 2000mg Once per day 16 weeks
Primary Outcome Measure Information:
Title
The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 14.
Description
A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.
Time Frame
Weeks 5-14
Title
The Percentage of Heavy Drinking Days Per Week During Study Weeks 5 Through 14.
Description
A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.
Time Frame
Study Weeks 5-14
Secondary Outcome Measure Information:
Title
The Number of Drinks Per Drinking Day Study Weeks 5-14.
Description
based on self report
Time Frame
Study Weeks 5-14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
The subject must complete all psychological assessments required at screening and baseline.
The subject must provide evidence of stable residence in the last 2 months prior to randomization, have reasonable transportation arrangements to the study site, and have no plans to move within the next 3 months or unresolved legal problems. Subjects must provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment.
The subject must have a breath alcohol concentration (BAC) equal to 0.000 when s/he signed the informed consent document.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raye Z Litten, Ph.D.
Organizational Affiliation
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margaret M Mattson, Ph.D.
Organizational Affiliation
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joanne E Fertig, Ph.D.
Organizational Affiliation
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Dartmouth Medical School
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03755
Country
United States
Facility Name
University Of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22324516
Citation
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.
Results Reference
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Levetiracetam XR in Very Heavy Drinkers
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