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| Name | Class |
|---|---|
| San Francisco VA Health Care System | FED |
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The overall goal of the proposed project is to improve the treatment of individuals with AUD. The investigators will conduct the first pilot human laboratory study to assess the effects of two doses of lacosamide on alcohol drinking and craving. The investigators will assess its effects on reducing alcohol intake using a human laboratory method, the Yale Alcohol Drinking Paradigm (ADP). The investigators will also assess the feasibility of the Alcohol Drinking Paradigm (ADP) in order to position our research team to have the capacity to conduct future, larger, hypothesis-testing human laboratory-based experiments designed to test the efficacy of potential alcohol treatments.
Four heavy-drinking non-treatment seeking male community volunteers with a diagnosis of AUD will undergo 3 ADP sessions. In each of the 3 ADP sessions, they will receive one of the following 3 different interventions: either 100 mg of lacosamide, 200 mg of lacosamide or placebo.
The ADP session is a one day human laboratory session at the SFVA Medical Center. This human laboratory session involves the self-administration of alcoholic beverages by research participants under highly structured, observed conditions in order to evaluate the effects of the study drug interventions (either 100 mg lacosamide, 200 mg lacosamide, or placebo) on alcohol craving and alcohol consumption. The study follows a double-blind placebo-controlled crossover design in which each participant receives each of the 3 drug interventions in a randomly assigned sequence. There were 4 possible sequences representing the 4 arms of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crossover Sequence A: Placebo, then Lacosamide 200 mg, then Lacosamide 100 mg | Experimental | Participants receive a single dose of Placebo in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 200 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Lacosamide 100 mg. |
|
| Crossover Sequence B: Lacosamide 200 mg, then Lacosamide 100 mg, then Placebo | Experimental | Participants receive a single dose of Lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 100 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Placebo. |
|
| Crossover Sequence C: Lacosamide 200 mg, then Placebo, then Lacosamide 100 mg | Experimental | Participants receive a single dose of Lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Placebo. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Lacosamide 100 mg. |
|
| Crossover Sequence D: Lacosamide 100 mg, then Lacosamide 200 mg, then Placebo | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Oral medication |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Feasibility (Time, in Months,) Required to Recruit, Screen and Conduct the Study Procedures | Recruitment feasibility will be measured as the time (in months) required to recruit, screen and conduct the study procedures for a total of 4 participants. | 7 months |
| Retention Feasibility (Proportion of Participants Completing the Alcohol Drinking Paradigm (ADP) Sessions) | Retention feasibility will be measured by the proportion of participants completing the Alcohol Drinking Paradigm (ADP) Sessions 1, 2 and 3. | 6.5 weeks |
| Tolerability (Number of Participants With Mild, Moderate, or Severe Adverse Events) | Tolerability will be measured by the number of participants with mild, moderate, and severe adverse events for each of the 3 drug interventions (100 mg lacosamide, 200 mg lacosamide and placebo). | 3 days (1 day each for ADP Session 1, 2, and 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Craving | Alcohol craving will be measured during Alcohol Drinking Paradigm (ADP) sessions 1, 2 and 3 using the total score of the Alcohol Urge Questionnaire (AUQ). The AUQ has 8 items. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7; items 2 and 7 are reverse scored). Higher scores reflect greater craving. Total score range is from a minimum of 8 to a maximum of 56. The AUQ is administered before study medication and at various times after study medication. The AUQ score reported here is the highest AUQ score following administration of study medication. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven L. Batki, MD | UCSF/SFVAHCS/NCIRE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco VA Health Care System | San Francisco | California | 94121 | United States |
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4 of the 52 were randomized. Of the 48 not randomized, 5 declined to participate and 43 did not meet inclusion criteria.
52 participants who were community volunteers were screened for eligibility between September 17, 2018 and April 17, 2019 at the San Francisco VA Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Crossover Sequence A: Placebo, Then Lacosamide 200 mg, Then Lacosamide 100 mg | Participants receive a single dose of Placebo in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 200 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Lacosamide 100 mg. |
| FG001 | Crossover Sequence B: Lacosamide 200 mg, Then Lacosamide 100 mg, Then Placebo | Participants receive a single dose of Lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 100 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Placebo. |
| FG002 | Crossover Sequence C: Lacosamide 200 mg, Then Placebo, Then Lacosamide 100 mg | Participants receive a single dose of Lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Placebo. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Lacosamide 100 mg |
| FG003 | Crossover Sequence D: Lacosamide 100 mg, Then Lacosamide 200 mg, Then Placebo | Participants receives a single dose of Lacosamide 100 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 200 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ADP Session 1 |
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| ADP Session 2 |
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| ADP Session 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Crossover Sequence A: Placebo, Then Lacosamide 200 mg, Then Lacosamide 100 mg | Participant received single dose of placebo in ADP Session 1. After a 1 week washout period, they then underwent ADP Session 2 in which they received a single dose of lacosamide 200 mg. After another 1 week washout period, they underwent ADP Session 3 in which they received a single dose of lacosamide 100 mg. (2) 200 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions. (3) Placebo. A single dose is given at the beginning of 1 of 3 ADP sessions. Lacosamide: Oral medication Placebo: Oral medication |
| 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 | Recruitment Feasibility (Time, in Months,) Required to Recruit, Screen and Conduct the Study Procedures | Recruitment feasibility will be measured as the time (in months) required to recruit, screen and conduct the study procedures for a total of 4 participants. | Posted | Number | months | 7 months |
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Starting at baseline and ending at follow-up for a total of 5 weeks.
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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 | Placebo | A matching capsule of placebo. A single dose is given at the beginning of 1 of the 3 ADP sessions. Placebo: Oral medication |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Systematic Assessment |
1 participant withdrew prior to ADP Session 3 and therefore did not receive the drug intervention of Lacosamide 100 mg.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven L. Batki, MD | University of California, San Francisco/San Francisco VA Health Care System | 415-221-4810 | 23671 | steven.batki@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 13, 2019 | May 3, 2021 | Prot_SAP_ICF_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 |
|---|---|
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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Double-blind, placebo-controlled
Participants receives a single dose of Lacosamide 100 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 200 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Placebo.
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| Lacosamide 100 mg | Drug | Oral medication |
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| Lacosamide 200 mg | Drug | Oral medication |
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| 3 days (1 day each for ADP Session 1, 2, and 3. Each ADP Session included 1 dose of the drug intervention, either Placebo, Lacosamide 100 mg, or Lacosamide 200 mg). |
| Alcohol Consumption (Number of Standard Drinks Consumed) | Alcohol consumption is measured during each of the Alcohol Drinking Paradigm (ADP) sessions, 1, 2 and 3. In each session participants received one of the 3 drug interventions, Placebo, Lacosamide 100 mg, or Lacosamide 200 mg. Consumption was measured using the number of alcoholic standard drinks consumed during the ADP sessions. A standard drink per NIAAA definition is 14 grams of pure alcohol. | 3 days (1 day each for ADP Session 1, 2, and 3. Each ADP Session included 1 dose of the drug intervention, either Placebo, Lacosamide 100 mg, or Lacosamide 200 mg). |
| Subjective Effects of Alcohol Consumption | Subjective effects of alcohol consumption are measured during the Alcohol Drinking Paradigm (ADP) sessions 1, 2 and 3 using the Biphasic Alcohol Effects Scale (BAES), which has 2 subscales; the Stimulation Subscale range is 0 - 70, where 0 is the least and 70 is the greatest stimulation; the Sedation Subscale range is 0 - 70, where 0 is the least and 70 is the greatest sedation. The BAES was administered both before and at various timepoints after study medication administration in each of the ADP sessions. The BAES scores reported here are the peak Stimulation scores after medication administration and peak Sedation scores after medication administration for each of ADP sessions 1, 2 and 3. | 3 days (1 day each for ADP Session 1, 2, and 3. Each ADP Session included 1 dose of the drug intervention, either Placebo, Lacosamide 100 mg, or Lacosamide 200 mg). |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | Crossover Sequence B: Lacosamide 200 mg, Then Lacosamide 100 mg, Then Placebo | Participant received a single dose of lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they then underwent ADP Session 2 in which they received a single dose of lacosamide 100 mg. After another 1 week washout period, they underwent ADP Session 3 in which they received a single dose of placebo. |
| BG002 | Crossover Sequence C: Lacosamide 200 mg, Then Placebo, Then Lacosamide 100 mg | Participant received a single dose of lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they then underwent ADP Session 2 in which they received a single dose of placebo. After another 1 week washout period, they underwent ADP Session 3 in which they received a single dose of lacosamide 100 mg. |
| BG003 | Crossover Sequence D: Lacosamide 100 mg, Then Lacosamide 200 mg, Then Placebo | Participant received a single dose of lacosamide 100 mg in ADP Session 1. After a 1 week washout period, they then underwent ADP Session 2 in which they received a single dose of lacosamide 200 mg. After another 1 week washout period, they underwent ADP Session 3 in which they received a single dose of placebo. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Primary | Retention Feasibility (Proportion of Participants Completing the Alcohol Drinking Paradigm (ADP) Sessions) | Retention feasibility will be measured by the proportion of participants completing the Alcohol Drinking Paradigm (ADP) Sessions 1, 2 and 3. | Posted | Count of Participants | Participants | 6.5 weeks |
|
|
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| Primary | Tolerability (Number of Participants With Mild, Moderate, or Severe Adverse Events) | Tolerability will be measured by the number of participants with mild, moderate, and severe adverse events for each of the 3 drug interventions (100 mg lacosamide, 200 mg lacosamide and placebo). | Posted | Count of Participants | Participants | 3 days (1 day each for ADP Session 1, 2, and 3) |
|
|
|
| Secondary | Alcohol Craving | Alcohol craving will be measured during Alcohol Drinking Paradigm (ADP) sessions 1, 2 and 3 using the total score of the Alcohol Urge Questionnaire (AUQ). The AUQ has 8 items. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7; items 2 and 7 are reverse scored). Higher scores reflect greater craving. Total score range is from a minimum of 8 to a maximum of 56. The AUQ is administered before study medication and at various times after study medication. The AUQ score reported here is the highest AUQ score following administration of study medication. | Posted | Mean | Standard Deviation | score on a scale | 3 days (1 day each for ADP Session 1, 2, and 3. Each ADP Session included 1 dose of the drug intervention, either Placebo, Lacosamide 100 mg, or Lacosamide 200 mg). |
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| Secondary | Alcohol Consumption (Number of Standard Drinks Consumed) | Alcohol consumption is measured during each of the Alcohol Drinking Paradigm (ADP) sessions, 1, 2 and 3. In each session participants received one of the 3 drug interventions, Placebo, Lacosamide 100 mg, or Lacosamide 200 mg. Consumption was measured using the number of alcoholic standard drinks consumed during the ADP sessions. A standard drink per NIAAA definition is 14 grams of pure alcohol. | Posted | Mean | Standard Deviation | standard drinks | 3 days (1 day each for ADP Session 1, 2, and 3. Each ADP Session included 1 dose of the drug intervention, either Placebo, Lacosamide 100 mg, or Lacosamide 200 mg). |
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|
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| Secondary | Subjective Effects of Alcohol Consumption | Subjective effects of alcohol consumption are measured during the Alcohol Drinking Paradigm (ADP) sessions 1, 2 and 3 using the Biphasic Alcohol Effects Scale (BAES), which has 2 subscales; the Stimulation Subscale range is 0 - 70, where 0 is the least and 70 is the greatest stimulation; the Sedation Subscale range is 0 - 70, where 0 is the least and 70 is the greatest sedation. The BAES was administered both before and at various timepoints after study medication administration in each of the ADP sessions. The BAES scores reported here are the peak Stimulation scores after medication administration and peak Sedation scores after medication administration for each of ADP sessions 1, 2 and 3. | Posted | Mean | Standard Deviation | score on a scale | 3 days (1 day each for ADP Session 1, 2, and 3. Each ADP Session included 1 dose of the drug intervention, either Placebo, Lacosamide 100 mg, or Lacosamide 200 mg). |
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| 0 |
| 4 |
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | Lacosamide 100 mg | 100 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions. Lacosamide: Oral medication | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Lacosamide 200 mg | 200 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions. Lacosamide: Oral medication | 0 | 4 | 0 | 4 | 3 | 4 |
| Headache | Nervous system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Double Vision | Eye disorders | Systematic Assessment |
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| Sensation of spinning | Nervous system disorders | Systematic Assessment |
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| Sleepiness | General disorders | Systematic Assessment |
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| Tremor | Nervous system disorders | Systematic Assessment |
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| Loss of coordination of muscle movements | Nervous system disorders | Systematic Assessment |
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| Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| severe adverse events |
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