Lacosamide Effects on Alcohol Self Administration and Craving in Heavy Drinkers

Sponsor
Boston Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03271528
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
66
1
2
28.6
2.3

Study Details

Study Description

Brief Summary

This is a double-blind, randomized, placebo-controlled, crossover design trial tested the effect of lacosamide on alcohol self-administration and craving following a priming dose of alcohol. The specific objective of this study was to determine whether lacosamide, a novel anticonvulsant that is FDA-approved for treating partial seizures, has effects on alcohol craving and consumption.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

The present proposal was intended to answer the call for accelerating drug development by exploring the potential of a novel anticonvulsant, lacosamide, as a candidate medication for the treatment of alcohol use disorder (AUD). This drug, which is approved for the treatment of seizure disorders, has unique pharmacological actions that include enhancement of slow sodium channel inactivation and inhibition of collapsin response mediator protein-2 (CRMP-2). Alcohol consumption in mice that had knockdown of CRMP-2 within the nucleus accumbens was decreased from levels seen in control animals. In rodent studies, lacosamide administration has produced reductions in 'excessive' drinking and has experimentally-induced decreased expression of the CRMP-2 protein. These findings implicate CRMP-2 as playing a role in the regulation of alcohol consumption. None of the FDA-approved AUD medications or medications commonly used off-label to treat AUD target this CRMP-2 pathway, making lacosamide a promising compound for AUD drug development. The aims of this study were to: 1) test the effects of lacosamide on alcohol self-administration and craving, 2) test the effects of 7 days of lacosamide administration on cognitive function, and 3) test the effects of lacosamide on alcohol consumption and craving during a 7-day period of exposure. The effects of 7 days of lacosamide (300mg) or placebo were evaluated in a human laboratory using an alcohol self-administration methodology. In this within-subjects crossover design, heavy drinkers (N=27) were randomized to the order of exposure (lacosamide or placebo) prior to completing two alcohol self-administration trials. Subjects received a priming drink of alcohol and had access to 8 alcoholic drinks over a 2-hour period. The investigators anticipated that subjects would consume less alcohol during an alcohol self-administration trial when receiving lacosamide compared to when they are receiving placebo. Significant lacosamide-induced reductions in the quantity of alcohol self-administered are considered to be an indication that this drug may have value as an AUD medication. This study may provide a rationale for phase II clinical studies testing lacosamide with a treatment-seeking AUD population. These results should also help to spur further pre-clinical investigation into the role play by CRMP-2 in regulating both alcohol consumption and alcohol seeking behaviors.

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
This is a double-blind, randomized, placebo-controlled, crossover design trial to test the effect of lacosamide on alcohol self-administration and craving following a priming dose of alcohol.This study is a within subjects design in which each subject receives both study drug (lacosamide) and placebo during participation.This is a double-blind, randomized, placebo-controlled, crossover design trial to test the effect of lacosamide on alcohol self-administration and craving following a priming dose of alcohol.This study is a within subjects design in which each subject receives both study drug (lacosamide) and placebo during participation.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
This study is double-blind. Medications are over-encapsulated.
Primary Purpose:
Treatment
Official Title:
Lacosamide Effects on Alcohol Self Administration and Craving in Heavy Drinkers
Actual Study Start Date :
Apr 15, 2018
Actual Primary Completion Date :
Aug 31, 2020
Actual Study Completion Date :
Aug 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lacosamide

Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.

Drug: Lacosamide
Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.
Other Names:
  • Vimpat
  • Placebo Comparator: Placebo oral capsule

    Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.

    Drug: Placebo oral capsule
    Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.

    Outcome Measures

    Primary Outcome Measures

    1. Alcohol Consumption in Alcohol Self-Administration Trials [2 hours]

      Alcohol consumption will be measured by using a graduated cylinder to determine the amount of alcohol given to the subject that was consumed. This outcome will be measured as standard drink units. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.

    Secondary Outcome Measures

    1. Verbal Fluency: Controlled Word Association (COWAT) [3 minutes]

      The Controlled Word Association (COWAT) is a verbal fluency test that measures the spontaneous production of words beginning with some designated letter. The participant is asked to name words beginning with a given letter, excluding proper nouns, for one minute and this procedure is repeated three times with a different letter each time. A different set of letters was used in each of the two alcohol self-administration trials: C-F-L and P-R-W. The examiner writes down the words provided by the participant on a piece of paper. This test is scored by counting the number of words generated by the subject for each letter, then adding the scores for each of the three letters to calculate a total test score. The lowest possible score is 0 and there is no upper limit to the score range. A higher score is indicative of better outcomes (I.e. better verbal fluency).

    2. Cognitive Function: Spatial Span Forward [10 minutes]

      The Wechsler Memory Scale (WMS-III) Spatial Span test will be used to assess subjects' working memory. Subjects will be shown a sequence of block tapping and asked to repeat back an increasing number of tapped blocks in the same order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).

    3. Cognitive Function: Spatial Span Backward [10 minutes]

      The Wechsler Memory Scale (WMS-III) Spatial Span test will be used to assess subjects' working memory. Subjects will be shown a sequence of block tapping and asked to repeat back an increasing number of tapped blocks in the opposite order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).

    4. Cognitive Function: Digit Span Forward [10 minutes]

      The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in the same order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).

    5. Cognitive Function: Digit Span Backward [10 minutes]

      The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in the opposite order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).

    6. Cognitive Function: Digit Span Sequencing [10 minutes]

      The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in ascending order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).

    7. Alcohol Craving: Obsessive-Compulsive Drinking Scale (OCDS) Pretrial [5 minutes]

      The Obsessive-Compulsive Drinking Scale (OCDS) is a quick and reliable 14-item self-rating instrument that provides a total score that measures some cognitive aspects of alcohol craving (obsessive and compulsive drinking). Each of the 14 items is scored from 0 to 4. The total score is calculated by adding the scores for each of the 14 items. The total score range is 0-56. Higher scores are indicative of more obsessive or compulsive drinking and lower scores are indicative of less obsessive or compulsive drinking.

    8. Alcohol Craving: Visual Analog Scale (VAS) Pretrial [1 minute]

      Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.

    9. Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 10 [1 minute]

      Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.

    10. Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 20 [1 minute]

      Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.

    11. Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 30 [1 minute]

      Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.

    12. Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 40 [1 minute]

      Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.

    13. Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 30 [1 minute]

      Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.

    14. Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 60 [1 minute]

      Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.

    15. Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 90 [1 minute]

      Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.

    16. Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 120 [1 minute]

      Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.

    17. Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 30 [1 minute]

      The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.

    18. Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 60 [1 minute]

      The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.

    19. Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 90 [1 minute]

      The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.

    20. Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 120 [1 minute]

      The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Subject Inclusion Criteria

    1. 21-55 years of age

    2. Can provide proof of age with state-issued or federal picture ID

    3. Exceeds safe weekly drinking limits (≥14 drinks for women or ≥21 drinks for men per week)

    4. Reports at least an average of one episode per week of binge drinking (>3 for women,

    4 for men) in the four weeks prior to baseline screening

    1. Meets DSM-5 criteria for mild alcohol use disorder or greater severity.

    2. Has a smartphone to complete some of the study assessments.

    Subject Exclusion Criteria

    1. Currently seeking treatment for alcohol problems

    2. Clinical Institute Withdrawal Assessment at >10

    3. DSM-5 diagnosis of current major depression, bipolar disorder, schizophrenia, bulimia/anorexia, dementia, or a substance use disorder other than alcohol, nicotine, marijuana or caffeine

    4. If female, pregnant, nursing, or have plans to become pregnant

    5. If female, does not agree to use an accepted form of birth control

    6. Is currently using medications for which alcohol is a contraindication

    7. Has a medical or mental health condition for which further alcohol exposure at the planned dose range would be contraindicated.

    8. Current risk of suicidality (MINI suicidality score greater than 8 (low risk) or Yes to the ideation question #4 of the C-SSRS)

    9. Has a history of myocardial infarction, congestive heart failure, has a risk for the development of heart block, or are taking medications that can decrease conduction through the atrial ventricular node.

    10. Has previous exposure to lacosamide

    11. Has received any form of counseling, self-help, pharmacotherapy, or other intervention to treat AUD in the past 90 days.

    12. Is unwilling to suspend use of multivitamins that contain riboflavin during study participation

    13. Has urine toxicology results positive for cocaine, opioids, amphetamines, buprenorphine, methadone, or methamphetamines

    14. Liver function values AST or ALT are twice the normal limit

    15. GFR <80 mL/min

    16. Unable to comfortably abstain from nicotine for a period of 8 hours.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boston University Psychiatry Research Center, Clinical Studies Unit Boston Massachusetts United States 02118

    Sponsors and Collaborators

    • Boston Medical Center
    • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    Investigators

    • Principal Investigator: Eric Devine, PhD, Assistant Professor

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Boston Medical Center
    ClinicalTrials.gov Identifier:
    NCT03271528
    Other Study ID Numbers:
    • H-36766
    • 1R21AA026389-01
    First Posted:
    Sep 5, 2017
    Last Update Posted:
    Jun 3, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Boston Medical Center
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 66 subjects were consented but 39 dropped out prior to randomization in the study (ineligible after screening or lost to follow-up). A total of 27 subjects were randomized.
    Arm/Group Title Lacosamide Then Placebo Placebo Then Lacosamide
    Arm/Group Description This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received 7 days of lacosamide before the first alcohol self-administration trial and 7 days of placebo before the second alcohol self-administration trial. This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received 7 days of placebo before the first alcohol self-administration trial and 7 days of lacosamide before the second alcohol self-administration trial.
    Period Title: Medication Dispense/Exposure Period 1
    STARTED 13 14
    COMPLETED 11 12
    NOT COMPLETED 2 2
    Period Title: Medication Dispense/Exposure Period 1
    STARTED 11 12
    COMPLETED 9 11
    NOT COMPLETED 2 1
    Period Title: Medication Dispense/Exposure Period 1
    STARTED 9 11
    COMPLETED 8 11
    NOT COMPLETED 1 0
    Period Title: Medication Dispense/Exposure Period 1
    STARTED 8 11
    COMPLETED 8 11
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Lacosamide Then Placebo Placebo Then Lacosamide Total
    Arm/Group Description This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received 7 days of lacosamide before the first alcohol self-administration trial and 7 days of placebo before the second alcohol self-administration trial. This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received 7 days of placebo before the first alcohol self-administration trial and 7 days of lacosamide before the second alcohol self-administration trial. Total of all reporting groups
    Overall Participants 7 9 16
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    7
    100%
    9
    100%
    16
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    34.5
    (9.4)
    37.8
    (8.2)
    36.4
    (9.2)
    Sex: Female, Male (Count of Participants)
    Female
    6
    85.7%
    8
    88.9%
    14
    87.5%
    Male
    1
    14.3%
    1
    11.1%
    2
    12.5%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    1
    14.3%
    1
    11.1%
    2
    12.5%
    Not Hispanic or Latino
    6
    85.7%
    8
    88.9%
    14
    87.5%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    3
    42.9%
    6
    66.7%
    9
    56.3%
    White
    3
    42.9%
    1
    11.1%
    4
    25%
    More than one race
    1
    14.3%
    1
    11.1%
    2
    12.5%
    Unknown or Not Reported
    0
    0%
    1
    11.1%
    1
    6.3%
    Region of Enrollment (Count of Participants)
    United States
    7
    100%
    9
    100%
    16
    100%

    Outcome Measures

    1. Primary Outcome
    Title Alcohol Consumption in Alcohol Self-Administration Trials
    Description Alcohol consumption will be measured by using a graduated cylinder to determine the amount of alcohol given to the subject that was consumed. This outcome will be measured as standard drink units. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.
    Time Frame 2 hours

    Outcome Measure Data

    Analysis Population Description
    66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
    Arm/Group Title Lacosamide Placebo Oral Capsule
    Arm/Group Description Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg. Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
    Measure Participants 16 16
    Mean (Standard Deviation) [Standard Drink Units (SDU)]
    3.02
    (3.00)
    2.35
    (2.31)
    2. Secondary Outcome
    Title Verbal Fluency: Controlled Word Association (COWAT)
    Description The Controlled Word Association (COWAT) is a verbal fluency test that measures the spontaneous production of words beginning with some designated letter. The participant is asked to name words beginning with a given letter, excluding proper nouns, for one minute and this procedure is repeated three times with a different letter each time. A different set of letters was used in each of the two alcohol self-administration trials: C-F-L and P-R-W. The examiner writes down the words provided by the participant on a piece of paper. This test is scored by counting the number of words generated by the subject for each letter, then adding the scores for each of the three letters to calculate a total test score. The lowest possible score is 0 and there is no upper limit to the score range. A higher score is indicative of better outcomes (I.e. better verbal fluency).
    Time Frame 3 minutes

    Outcome Measure Data

    Analysis Population Description
    66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
    Arm/Group Title Lacosamide Placebo Oral Capsule
    Arm/Group Description Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg. Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
    Measure Participants 16 16
    Mean (Standard Deviation) [score on a scale]
    38.19
    (8.26)
    42.25
    (9.75)
    3. Secondary Outcome
    Title Cognitive Function: Spatial Span Forward
    Description The Wechsler Memory Scale (WMS-III) Spatial Span test will be used to assess subjects' working memory. Subjects will be shown a sequence of block tapping and asked to repeat back an increasing number of tapped blocks in the same order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
    Time Frame 10 minutes

    Outcome Measure Data

    Analysis Population Description
    66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
    Arm/Group Title Lacosamide Placebo Oral Capsule
    Arm/Group Description Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg. Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
    Measure Participants 16 16
    Mean (Standard Deviation) [correct items]
    8.44
    (2.53)
    7.75
    (3.70)
    4. Secondary Outcome
    Title Cognitive Function: Spatial Span Backward
    Description The Wechsler Memory Scale (WMS-III) Spatial Span test will be used to assess subjects' working memory. Subjects will be shown a sequence of block tapping and asked to repeat back an increasing number of tapped blocks in the opposite order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
    Time Frame 10 minutes

    Outcome Measure Data

    Analysis Population Description
    66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
    Arm/Group Title Lacosamide Placebo Oral Capsule
    Arm/Group Description Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg. Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
    Measure Participants 16 16
    Mean (Standard Deviation) [score on a scale]
    7.19
    (2.49)
    7.62
    (3.14)
    5. Secondary Outcome
    Title Cognitive Function: Digit Span Forward
    Description The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in the same order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
    Time Frame 10 minutes

    Outcome Measure Data

    Analysis Population Description
    66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
    Arm/Group Title Lacosamide Placebo Oral Capsule
    Arm/Group Description Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg. Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
    Measure Participants 16 16
    Mean (Standard Deviation) [score on a scale]
    10.81
    (1.97)
    10.81
    (2.10)
    6. Secondary Outcome
    Title Cognitive Function: Digit Span Backward
    Description The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in the opposite order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
    Time Frame 10 minutes

    Outcome Measure Data

    Analysis Population Description
    66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
    Arm/Group Title Lacosamide Placebo Oral Capsule
    Arm/Group Description Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg. Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
    Measure Participants 16 16
    Mean (Standard Deviation) [score on a scale]
    8.06
    (1.48)
    7.62
    (2.16)
    7. Secondary Outcome
    Title Cognitive Function: Digit Span Sequencing
    Description The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in ascending order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
    Time Frame 10 minutes

    Outcome Measure Data

    Analysis Population Description
    66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
    Arm/Group Title Lacosamide Placebo Oral Capsule
    Arm/Group Description Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg. Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
    Measure Participants 16 16
    Mean (Standard Deviation) [score on a scale]
    8.12
    (2.33)
    7.62
    (2.36)
    8. Secondary Outcome
    Title Alcohol Craving: Obsessive-Compulsive Drinking Scale (OCDS) Pretrial
    Description The Obsessive-Compulsive Drinking Scale (OCDS) is a quick and reliable 14-item self-rating instrument that provides a total score that measures some cognitive aspects of alcohol craving (obsessive and compulsive drinking). Each of the 14 items is scored from 0 to 4. The total score is calculated by adding the scores for each of the 14 items. The total score range is 0-56. Higher scores are indicative of more obsessive or compulsive drinking and lower scores are indicative of less obsessive or compulsive drinking.
    Time Frame 5 minutes

    Outcome Measure Data

    Analysis Population Description
    66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
    Arm/Group Title Lacosamide Placebo Oral Capsule
    Arm/Group Description Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg. Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
    Measure Participants 16 16
    Mean (Standard Deviation) [scores on a scale]
    10.19
    (4.79)
    12.25
    (5.35)
    9. Secondary Outcome
    Title Alcohol Craving: Visual Analog Scale (VAS) Pretrial
    Description Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
    Time Frame 1 minute

    Outcome Measure Data

    Analysis Population Description
    66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
    Arm/Group Title Lacosamide Placebo Oral Capsule
    Arm/Group Description Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg. Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
    Measure Participants 16 16
    Mean (Standard Deviation) [scores on a scale]
    30.25
    (31.00)
    31.60
    (35.65)
    10. Secondary Outcome
    Title Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 10
    Description Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
    Time Frame 1 minute

    Outcome Measure Data

    Analysis Population Description
    66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
    Arm/Group Title Lacosamide Placebo Oral Capsule
    Arm/Group Description Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg. Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
    Measure Participants 16 16
    Mean (Standard Deviation) [scores on a scale]
    26.75
    (20.07)
    41.87
    (33.42)
    11. Secondary Outcome
    Title Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 20
    Description Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
    Time Frame 1 minute

    Outcome Measure Data

    Analysis Population Description
    66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
    Arm/Group Title Lacosamide Placebo Oral Capsule
    Arm/Group Description Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg. Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
    Measure Participants 16 16
    Mean (Standard Deviation) [scores on a scale]
    35.31
    (28.33)
    39.75
    (34.95)
    12. Secondary Outcome
    Title Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 30
    Description Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
    Time Frame 1 minute

    Outcome Measure Data

    Analysis Population Description
    66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
    Arm/Group Title Lacosamide Placebo Oral Capsule
    Arm/Group Description Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg. Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
    Measure Participants 16 16
    Mean (Standard Deviation) [score on a scale]
    35.19
    (28.85)
    37.81
    (36.50)
    13. Secondary Outcome
    Title Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 40
    Description Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
    Time Frame 1 minute

    Outcome Measure Data

    Analysis Population Description
    66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
    Arm/Group Title Lacosamide Placebo Oral Capsule
    Arm/Group Description Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg. Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
    Measure Participants 16 16
    Mean (Standard Deviation) [score on a scale]
    36.87
    (26.71)
    36.69
    (34.50)
    14. Secondary Outcome
    Title Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 30
    Description Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
    Time Frame 1 minute

    Outcome Measure Data

    Analysis Population Description
    66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
    Arm/Group Title Lacosamide Placebo Oral Capsule
    Arm/Group Description Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg. Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
    Measure Participants 16 16
    Mean (Standard Deviation) [score on a scale]
    28.00
    (19.73)
    31.87
    (30.66)
    15. Secondary Outcome
    Title Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 60
    Description Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
    Time Frame 1 minute

    Outcome Measure Data

    Analysis Population Description
    66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
    Arm/Group Title Lacosamide Placebo Oral Capsule
    Arm/Group Description Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg. Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
    Measure Participants 16 16
    Mean (Standard Deviation) [score on a scale]
    24.94
    (20.78)
    30.37
    (30.38)
    16. Secondary Outcome
    Title Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 90
    Description Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
    Time Frame 1 minute

    Outcome Measure Data

    Analysis Population Description
    66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
    Arm/Group Title Lacosamide Placebo Oral Capsule
    Arm/Group Description Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg. Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
    Measure Participants 16 16
    Mean (Standard Deviation) [score on a scale]
    21.62
    (21.60)
    27.81
    (29.52)
    17. Secondary Outcome
    Title Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 120
    Description Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
    Time Frame 1 minute

    Outcome Measure Data

    Analysis Population Description
    66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
    Arm/Group Title Lacosamide Placebo Oral Capsule
    Arm/Group Description Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg. Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
    Measure Participants 16 16
    Mean (Standard Deviation) [score on a scale]
    23.62
    (28.78)
    29.00
    (32.55)
    18. Secondary Outcome
    Title Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 30
    Description The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.
    Time Frame 1 minute

    Outcome Measure Data

    Analysis Population Description
    66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
    Arm/Group Title Lacosamide Placebo Oral Capsule
    Arm/Group Description Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg. Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
    Measure Participants 16 16
    Mean (Standard Deviation) [score on a scale]
    24.00
    (7.54)
    23.94
    (8.65)
    19. Secondary Outcome
    Title Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 60
    Description The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.
    Time Frame 1 minute

    Outcome Measure Data

    Analysis Population Description
    66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
    Arm/Group Title Lacosamide Placebo Oral Capsule
    Arm/Group Description Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg. Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
    Measure Participants 16 16
    Mean (Standard Deviation) [score on a scale]
    24.88
    (7.49)
    26.25
    (6.70)
    20. Secondary Outcome
    Title Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 90
    Description The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.
    Time Frame 1 minute

    Outcome Measure Data

    Analysis Population Description
    66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
    Arm/Group Title Lacosamide Placebo Oral Capsule
    Arm/Group Description Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg. Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
    Measure Participants 16 16
    Mean (Standard Deviation) [score on a scale]
    22.94
    (7.46)
    22.00
    (4.98)
    21. Secondary Outcome
    Title Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 120
    Description The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.
    Time Frame 1 minute

    Outcome Measure Data

    Analysis Population Description
    66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
    Arm/Group Title Lacosamide Placebo Oral Capsule
    Arm/Group Description Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg. Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
    Measure Participants 16 16
    Mean (Standard Deviation) [score on a scale]
    24.94
    (9.45)
    25.44
    (8.34)

    Adverse Events

    Time Frame Up to 44 days
    Adverse Event Reporting Description The primary risks of this study were risks related to taking study medication, loss of confidentiality, discomfort with study procedures, overconsumption of alcohol, and interference with efforts for recovery from alcohol use disorder. These risks were adequately minimized by study design and adherence to the study protocol.
    Arm/Group Title Lacosamide Placebo
    Arm/Group Description Subjects received 7 days of lacosamide before the alcohol self-administration trial. Subjects received 7 days of placebo before the alcohol self-administration trial.
    All Cause Mortality
    Lacosamide Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/16 (0%) 0/16 (0%)
    Serious Adverse Events
    Lacosamide Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/16 (0%) 0/16 (0%)
    Other (Not Including Serious) Adverse Events
    Lacosamide Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/16 (43.8%) 6/16 (37.5%)
    Gastrointestinal disorders
    Nausea 1/16 (6.3%) 0/16 (0%)
    Indigestion 1/16 (6.3%) 2/16 (12.5%)
    General disorders
    Drowsiness 1/16 (6.3%) 1/16 (6.3%)
    Dry mouth 1/16 (6.3%) 0/16 (0%)
    Unpleasant taste in mouth 0/16 (0%) 1/16 (6.3%)
    Mental foginess 0/16 (0%) 1/16 (6.3%)
    Renal and urinary disorders
    Bright yellow urine 2/16 (12.5%) 3/16 (18.8%)
    Skin and subcutaneous tissue disorders
    Mosquito bites 1/16 (6.3%) 0/16 (0%)

    Limitations/Caveats

    This study was terminated early at the discretion of the Principal Investigator due to COVID-19 restrictions on human subject research recruitment, leading to a smaller number of subjects analyzed than planned. At the time of termination, 19 subjects had completed the study compared to the target sample size of 28. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Eric Devine
    Organization Boston Medical Center
    Phone 617-638-7888
    Email eric.devine@bmc.org
    Responsible Party:
    Boston Medical Center
    ClinicalTrials.gov Identifier:
    NCT03271528
    Other Study ID Numbers:
    • H-36766
    • 1R21AA026389-01
    First Posted:
    Sep 5, 2017
    Last Update Posted:
    Jun 3, 2021
    Last Verified:
    May 1, 2021