Alcoholism
Conditions
Keywords
Alcoholism, Alcohol Drinking, Alcoholic Intoxication, Alcohol Abuse
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).
Interventions
BEHAVIORALBBCET
11 BBCET sessions
DRUGLevetiracetam XR
500mg - 2000mg Once per day 16 weeks
DRUGSugar Pill
500mg - 2000mg Once per day 16 weeks
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 14. | Weeks 5-14 | 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. | Study Weeks 5-14 | A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Drinks Per Drinking Day Study Weeks 5-14. | Study Weeks 5-14 | based on self report |
Countries
United States
Participant flow
Recruitment details
Interested candidates responded by telephone to advertisements at 5 academic centers in the United States between November 2009 and May 2010.
Pre-assignment details
Must be alcohol dependent (DSM-IV criteria); and drinking very heavily (10 or more drinks/drinking day men; 8 or more drinks /drinking day women) 40% of the days during any consecutive 60-day interval during the 90-day period before the clinic screening visit, with at least 1 heavy drinking day occurring within the 14 days before randomization.
Participants by arm
| Arm | Count |
|---|---|
| Sugar Pill and BBCET Placebo and Brief Behavioral Compliance Enhancement Therapy | 66 |
| Levetiracetam and BBCET Levetiracetam and Brief Behavioral Therapy | 64 |
| Total | 130 |
Baseline characteristics
| Characteristic | Levetiracetam and BBCET | Sugar Pill and BBCET | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants | 66 Participants | 130 Participants |
| Age, Continuous | 41.7 years STANDARD_DEVIATION 11.7 | 47 years STANDARD_DEVIATION 11.5 | 44 years STANDARD_DEVIATION 11.9 |
| Region of Enrollment United States | 64 participants | 66 participants | 130 participants |
| Sex: Female, Male Female | 17 Participants | 14 Participants | 31 Participants |
| Sex: Female, Male Male | 47 Participants | 52 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 60 / 66 | 58 / 64 |
| serious Total, serious adverse events | 10 / 66 | 3 / 64 |
Outcome results
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.
Time frame: Study Weeks 5-14
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sugar Pill and BBCET | The Percentage of Heavy Drinking Days Per Week During Study Weeks 5 Through 14. | 41.2 percentage of heavy drinking days | Standard Error 4.39 |
| Levetiracetam and BBCET | The Percentage of Heavy Drinking Days Per Week During Study Weeks 5 Through 14. | 45.8 percentage of heavy drinking days | Standard Error 4.97 |
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.
Time frame: Weeks 5-14
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Sugar Pill and BBCET | The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 14. | 18.2 percentage of subjects | 12 |
| Levetiracetam and BBCET | The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 14. | 14.1 percentage of subjects | 9 |
Secondary
The Number of Drinks Per Drinking Day Study Weeks 5-14.
based on self report
Time frame: Study Weeks 5-14
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sugar Pill and BBCET | The Number of Drinks Per Drinking Day Study Weeks 5-14. | 6.3 drinks per day | Standard Error 0.58 |
| Levetiracetam and BBCET | The Number of Drinks Per Drinking Day Study Weeks 5-14. | 7.1 drinks per day | Standard Error 0.6 |