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This treatment study is a 16-weeks outpatient clinical trial where subjects with alcohol dependence will get medication, which might help them to reduce or stop their drinking, or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a "sugar pill").
This treatment study is a 16-weeks outpatient clinical trial where subjects will get medication, which might help them to reduce or stop their drinking or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a "sugar pill"). This study will recruit and randomize subjects who have expressed an interest in receiving treatment for alcohol dependence. Upon enrollment into this study there will be 11 outpatient visits. Each visit will last about 1-1.5 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin | Experimental | Gabapentin up to 1200 mg per day in 3 divided doses |
|
| placebo | Placebo Comparator | matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | gaba potentiating medication |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects With no Heavy Drinking Days (PSNHDD) | The primary dependent variable will be the percent of subjects with no heavy drinking days (4 or more standard drinks for women and 5 or more standard drinks for men). Participants will report their daily alcohol use with using a daily calendar. No heavy drinking days is corrected for %dCDT. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects With no Drinking Days (PSNDD) | The secondary dependent variable will be percent of subjects with no drinking days (total abstinence). Participants will report their daily alcohol use with using a daily calendar. Abstinence is corrected for %dCDT. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With No Drinking Days by AWS Score and Medication | This analysis examines the interaction of medication group with a median split of the baseline Alcohol Withdrawal Scale (AWS) scores on the primary outcome variable (no heavy drinking days, corrected for %dCDT). Participants will report their daily alcohol use with using a daily calendar. AWS ranges from 0 to 44 where higher values correspond with more serious withdrawal (worse outcome). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond F Anton, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38828963 | Derived | Hoffman M, Voronin K, Book SW, Prisciandaro J, Bristol EJ, Anton RF. Sleep as an Important Target or Modifier in Alcohol Use Disorder Clinical Treatment: Example From a Recent Gabapentin Randomized Clinical Trial. J Addict Med. 2024 Sep-Oct 01;18(5):520-525. doi: 10.1097/ADM.0000000000001316. Epub 2024 May 31. | |
| 34256607 | Derived |
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The discrepancy of 6 participants is due to those subjects either violating protocol or not having evaluable data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gabapentin | Gabapentin up to 1200 mg per day in 3 divided doses Gabapentin: gaba potentiating medication |
| FG001 | Placebo | matching placebo Placebo: a pill that looks exactly like the active medication but does not contain medication |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gabapentin | Gabapentin up to 1200 mg per day in 3 divided doses Gabapentin: gaba potentiating medication |
| BG001 | Placebo | matching placebo Placebo: a pill that looks exactly like the active medication but does not contain medication |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percent of Subjects With no Heavy Drinking Days (PSNHDD) | The primary dependent variable will be the percent of subjects with no heavy drinking days (4 or more standard drinks for women and 5 or more standard drinks for men). Participants will report their daily alcohol use with using a daily calendar. No heavy drinking days is corrected for %dCDT. | Posted | Count of Participants | Participants | 4 months |
|
Entire study - 16 weeks.
Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period.
We report the whole SAFTEE.
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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 | Gabapentin | Gabapentin up to 1200 mg per day in 3 divided doses Gabapentin: gaba potentiating medication |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michaela Hoffman | Medical University of South Carolina | 8437927758 | HoffmaMi@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 16, 2014 | Oct 15, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Placebo | Drug | a pill that looks exactly like the active medication but does not contain medication |
|
|
| 4 months |
| Prisciandaro JJ, Hoffman M, Brown TR, Voronin K, Book S, Bristol E, Anton RF. Effects of Gabapentin on Dorsal Anterior Cingulate Cortex GABA and Glutamate Levels and Their Associations With Abstinence in Alcohol Use Disorder: A Randomized Clinical Trial. Am J Psychiatry. 2021 Sep 1;178(9):829-837. doi: 10.1176/appi.ajp.2021.20121757. Epub 2021 Jul 14. |
| 32150232 | Derived | Anton RF, Latham P, Voronin K, Book S, Hoffman M, Prisciandaro J, Bristol E. Efficacy of Gabapentin for the Treatment of Alcohol Use Disorder in Patients With Alcohol Withdrawal Symptoms: A Randomized Clinical Trial. JAMA Intern Med. 2020 May 1;180(5):728-736. doi: 10.1001/jamainternmed.2020.0249. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| % Heavy Drinking Days | % heavy drinking days out of the 90 days reported via timeline followback. A heavy drinking day is defined as 4 or more drinks for females and 5 or more drinks for males in one day. | Mean | Standard Deviation | percent |
|
|
|
|
| Secondary | Percent of Subjects With no Drinking Days (PSNDD) | The secondary dependent variable will be percent of subjects with no drinking days (total abstinence). Participants will report their daily alcohol use with using a daily calendar. Abstinence is corrected for %dCDT. | Posted | Count of Participants | Participants | 4 months |
|
|
|
|
| Other Pre-specified | Number of Participants With No Drinking Days by AWS Score and Medication | This analysis examines the interaction of medication group with a median split of the baseline Alcohol Withdrawal Scale (AWS) scores on the primary outcome variable (no heavy drinking days, corrected for %dCDT). Participants will report their daily alcohol use with using a daily calendar. AWS ranges from 0 to 44 where higher values correspond with more serious withdrawal (worse outcome). | The data for this analysis were split into two subgroups, based on the median split of AWS. | Posted | Count of Participants | Participants | 4 months |
|
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 44 |
| 44 |
| EG001 | Placebo | matching placebo Placebo: a pill that looks exactly like the active medication but does not contain medication | 0 | 46 | 0 | 46 | 44 | 46 |
| Decreased Appetite | General disorders | Systematic Assessment |
|
| Decreased Libido | General disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Increased Appetite | General disorders | Systematic Assessment |
|
| Increased Libido | General disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Nervousness/Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Somnolence | General disorders | Systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002241 | Carbohydrates |
| Chi-squared |
| .67 |
| Superiority |