Clinical trial NCT00970814: Levetiracetam XR in Very Heavy Drinkers
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholism
Keywords: Alcoholism
Alcohol Drinking
Alcoholic Intoxication
Alcohol Abuse
Lead sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sponsor class: NIH
First posted: 2009-09-02
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

1. The subject must be at least 18 years of age.
2. The subject must have a DSM-IV diagnosis of current alcohol dependence.
3. The subject must be seeking treatment for alcohol dependence and desires a reduction or cessation of drinking.
4. 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.
5. 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.
6. The subject must be able to take oral medication, willing to adhere to the medication regimen, and willing to return for regular visits.
7. The subject must complete all psychological assessments required at screening and baseline.
8. 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.
9. The subject must have a breath alcohol concentration (BAC) equal to 0.000 when s/he signed the informed consent document.

Primary outcomes:
measure: The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 14.
timeFrame: Weeks 5-14
measure: The Percentage of Heavy Drinking Days Per Week During Study Weeks 5 Through 14.
timeFrame: Study Weeks 5-14
Secondary outcomes:
measure: The Number of Drinks Per Drinking Day Study Weeks 5-14.
timeFrame: Study Weeks 5-14
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth Medical School
state: New Hampshire
city: Philadelphia
country: United States
facility: University Of Pennsylvania
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Raye Z Litten, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Margaret M Mattson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Joanne E Fertig, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.