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| ID | Type | Description | Link |
|---|---|---|---|
| R21AA026681 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The purpose of this research study is to test the safety, tolerability, and effectiveness of the drug Perampanel when used in persons who drink and wish to stop drinking. Perampanel has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of seizures but has not yet been approved to treat alcohol use disorders. For this reason, it is considered an investigational drug. Some people in this study will receive Perampanel alone and some people will receive Perampanel and Disulfiram, this will be determined by the pharmacy.
Participants will be asked to take a medication (Perampanel or Perampanel + Disulfiram) every day for approximately 8 weeks and have weekly study visits. At these visits, participants will be asked questions about their medical history, drinking behavior and life events, have bloodwork checked routinely, have regular medication counseling, and perform some computer tasks. Throughout the study, there will be regular phone calls from staff. Participants will also be asked to use a device called "Soberlink" which is like an at-home breathalyzer test to help track progress throughout the study.
Participants will be randomly assigned (like the flip of a coin) to receive either Perampanel alone or Peramanel and Disulfiram.
Participation in this study will last up to 10 weeks. Approximately 20 individuals will participate in this study.
This study will sequence all or part of participant's DNA. This is a necessary part of the study.
Before starting the study, participants may be referred to an alcohol detoxification program (medical treatment of an alcoholic), if clinically indicated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| perampanel by itself | Active Comparator |
| |
| Perapanel with Disulfiram | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perampanel Tablet | Drug | Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Abstinent Days | Participant will report the number of alcoholic drinks they consumed during the previous weeks period. Participants will be accessed for the full 12 week titration plus treatment period. However, for the purposes of the study, the percent of days the participant was abstinent will be calculated and reported only for the 8 week active treatment period. | End of treatment, up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Alcohol Craving | Alcohol craving will be assessed using the Alcohol Urge Questionnaire (AUG). The AUG is an 8-item survey asking participants to rate their craving for alcohol on a 1 to 7 scale. The answers are summed yielding a score ranging from 7 to 56 with higher scores indicated higher alcohol craving. | Baseline to end of treatment, up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Arias, MD, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University Inst. for Drug and Alcohol Studies | Richmond | Virginia | 23219 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Perampanel by Itself | Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups |
| FG001 | Perapanel With Disulfiram | Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups Disulfiram: Disulfiram will be kept at 250mg daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Perampanel by Itself | Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups |
| BG001 | Perapanel With Disulfiram | Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups Disulfiram: Disulfiram will be kept at 250mg daily |
| 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 | Percent Abstinent Days | Participant will report the number of alcoholic drinks they consumed during the previous weeks period. Participants will be accessed for the full 12 week titration plus treatment period. However, for the purposes of the study, the percent of days the participant was abstinent will be calculated and reported only for the 8 week active treatment period. | Posted | Mean | Full Range | Percentage of days | End of treatment, up to 12 weeks |
|
At baseline and weekly for eight weeks
The Systematic Assessment for Treatment Emergent Events (SAFTEE) is a NIAAA developed assessment for adverse events in alcohol pharmacotherapy trials. The assessment was modified to assess for known side effects of perampanel.
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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 | Perampanel by Itself | Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vehicle accident | General disorders | Systematic Assessment | Vehicle accident due to Drowsiness without injury |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aggression/Anger | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Albert Arias, M.D. | Virginia Commonwealth University | (804) 828-5793 | albert.arias@vcuhealth.org |
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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 | Jun 30, 2021 | Sep 1, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 10, 2021 | May 17, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C551441 | perampanel |
| D004221 | Disulfiram |
| ID | Term |
|---|---|
| D004050 | Ditiocarb |
| D013859 | Thiocarbamates |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
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20 subjects with AUD will be randomized 1:1 to one of two groups; perampanel by itself, and perampanel combined with disulfiram.
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| Disulfiram | Drug | Disulfiram will be kept at 250mg daily |
|
| Percent Heavy Drinking Days | Participant will report the number of alcoholic drinks they consumed during the previous weeks period. Based on participant report, the percent of days the participant drank heavily will be calculated over the 8 week active treatment period. | End of treatment, Up to 8 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Alcohol Craving | Alcohol craving will be assessed using the Alcohol Urge Questionnaire (AUG). The AUG is an 8-item survey asking participants to rate their craving for alcohol on a 1 to 7 scale. The answers are summed yielding a score ranging from 7 to 56 with higher scores indicated higher alcohol craving. | Posted | Mean | Full Range | score on a scale | Baseline to end of treatment, up to 12 weeks |
|
|
|
| Secondary | Percent Heavy Drinking Days | Participant will report the number of alcoholic drinks they consumed during the previous weeks period. Based on participant report, the percent of days the participant drank heavily will be calculated over the 8 week active treatment period. | Posted | Mean | Full Range | percentage of days | End of treatment, Up to 8 weeks |
|
|
|
| 0 |
| 2 |
| 1 |
| 2 |
| 2 |
| 2 |
| EG001 | Perapanel With Disulfiram | Perampanel Tablet: Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups Disulfiram: Disulfiram will be kept at 250mg daily | 0 | 2 | 0 | 2 | 2 | 2 |
|
| Agitation | Psychiatric disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Breathing Diffuculties | General disorders | Systematic Assessment |
|
| Confusion/Slow Thinking | Psychiatric disorders | Systematic Assessment |
|
| Decreased Coordination | Nervous system disorders | Systematic Assessment |
|
| Depressed Mood | Psychiatric disorders | Systematic Assessment |
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| Dizziness | Ear and labyrinth disorders | Systematic Assessment |
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| Double Vision | Eye disorders | Systematic Assessment |
|
| Drowsiness | General disorders | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Hostility | Psychiatric disorders | Systematic Assessment |
|
| Irregular Heartbeat | Cardiac disorders | Systematic Assessment |
|
| Irritability | Psychiatric disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Lightheadedness | General disorders | Systematic Assessment |
|
| Loss of Appetite | Gastrointestinal disorders | Systematic Assessment |
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| Loss of Balance | General disorders | Systematic Assessment |
|
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Panic Attacks | Psychiatric disorders | Systematic Assessment |
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| Restlessness | Psychiatric disorders | Systematic Assessment |
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| Shortness of Breath | General disorders | Systematic Assessment |
|
| Speech Problems | Psychiatric disorders | Systematic Assessment |
|
| Trouble Speaking or Swallowing | Nervous system disorders | Systematic Assessment |
|
| Unsteady Walking | General disorders | Systematic Assessment |
|
| Unusual Skin Sensations | Nervous system disorders | Systematic Assessment |
|
| Weakness | General disorders | Systematic Assessment |
|
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D004220 | Disulfides |
| D013440 | Sulfides |
| D013457 | Sulfur Compounds |