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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam XR | Active Comparator | Group received Levetiracetam |
|
| Sugar Pill | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBCET | Behavioral | 11 BBCET sessions |
| |
| BBCET |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Drinks Per Drinking Day Study Weeks 5-14. | based on self report | Study Weeks 5-14 |
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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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins School of Medicine | Baltimore | Maryland | 21224 | United States | ||
| Boston University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22324516 | Result | 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. |
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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.
Interested candidates responded by telephone to advertisements at 5 academic centers in the United States between November 2009 and May 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugar Pill and BBCET | Placebo and Brief Behavioral Compliance Enhancement Therapy |
| FG001 | Levetiracetam and BBCET | Levetiracetam and Brief Behavioral Therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugar Pill and BBCET | Placebo and Brief Behavioral Compliance Enhancement Therapy |
| BG001 | Levetiracetam and BBCET | Levetiracetam and Brief Behavioral Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of subjects | Weeks 5-14 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugar Pill and BBCET | Placebo and Brief Behavioral Compliance Enhancement Therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | MedDRA Pt |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA Pt | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Megan Ryan - Clinical Trials Project Manager | NIAAA | 301-443-4225 | mryan1@mail.nih.gov |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D000428 | Alcohol Drinking |
| D000435 | Alcoholic Intoxication |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| Behavioral |
11 BBCET Sessions |
|
| Levetiracetam XR | Drug | 500mg - 2000mg Once per day 16 weeks |
|
| Sugar Pill | Drug | 500mg - 2000mg Once per day 16 weeks |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | The Number of Drinks Per Drinking Day Study Weeks 5-14. | based on self report | Posted | Least Squares Mean | Standard Error | drinks per day | Study Weeks 5-14 |
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | percentage of heavy drinking days | Study Weeks 5-14 |
|
|
|
| 10 |
| 66 |
| 60 |
| 66 |
| EG001 | Levetiracetam and BBCET | Levetiracetam and Brief Behavioral Therapy | 3 | 64 | 58 | 64 |
| Alcohol Detoxification | Surgical and medical procedures | MedDRA Pt | Non-systematic Assessment |
|
| Head Injury | Injury, poisoning and procedural complications | MedDRA Pt | Non-systematic Assessment |
|
| Blood Clot | Vascular disorders | MedDRA Pt | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA Pt | Systematic Assessment |
|
| Masochism | Psychiatric disorders | MedDRA Pt | Systematic Assessment |
|
| Anaphylactic Reaction | Immune system disorders | MedDRA Pt | Non-systematic Assessment |
|
| Suicide Attempt | Psychiatric disorders | MedDRA Pt | Non-systematic Assessment |
|
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA Pt | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA Pt | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Pt | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Pt | Systematic Assessment |
|
| Cold Sweat | General disorders | MedDRA Pt | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA Pt | Systematic Assessment |
|
| Irritability | General disorders | MedDRA Pt | Systematic Assessment |
|
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA Pt | Systematic Assessment |
|
| Joint Injury | Injury, poisoning and procedural complications | MedDRA Pt | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Pt | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Pt | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Pt | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Pt | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Pt | Systematic Assessment |
|
| Agitation | Nervous system disorders | MedDRA Pt | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Pt | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Pt | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA Pt | Systematic Assessment |
|
| Restlessness | Nervous system disorders | MedDRA Pt | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Pt | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA Pt | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA Pt | Systematic Assessment |
|
| Depressed Mood | Psychiatric disorders | MedDRA Pt | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Pt | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Pt | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Pt | Systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA Pt | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Pt | Systematic Assessment |
|
| Alcohol Withdrawal Syndrome | Psychiatric disorders | MedDRA Pt | Systematic Assessment |
|
| Anger | Psychiatric disorders | MedDRA Pt | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA Pt | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Pt | Systematic Assessment |
|
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| D004327 | Drinking Behavior |
| D001519 | Behavior |