Levetiracetam XR in Very Heavy Drinkers

Alcoholism Clinical Trial

— NCIG 002  

Official title:

A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy Of Levetiracetam Extended Release in Very Heavy Drinkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970814
• Other study ID #: NIAAA_DTRR-2009-LITTEN-02
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2009
• Last updated: August 20, 2014
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: August 2014
• Source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: October 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholic Intoxication
• Alcoholism

Intervention

Behavioral:
• BBCET
11 BBCET sessions
• BBCET
11 BBCET Sessions

Drug:
• Levetiracetam XR
500mg - 2000mg Once per day 16 weeks
• Sugar Pill
500mg - 2000mg Once per day 16 weeks

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland
United States	Boston University School of Medicine	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	Dartmouth Medical School	Lebanon	New Hampshire
United States	University Of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & 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, placeb — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	The Number of Drinks Per Drinking Day Study Weeks 5-14.	based on self report	Study Weeks 5-14	No