Trial Outcomes & Findings for Lacosamide Effects on Alcohol Self Administration and Craving in Heavy Drinkers (NCT NCT03271528)
NCT ID: NCT03271528
Last Updated: 2021-06-03
Results Overview
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.
COMPLETED
PHASE1
66 participants
2 hours
2021-06-03
Participant Flow
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.
Participant milestones
| Measure |
Lacosamide Then Placebo
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.
|
Placebo Then Lacosamide
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.
|
|---|---|---|
|
Medication Dispense/Exposure Period 1
STARTED
|
13
|
14
|
|
Medication Dispense/Exposure Period 1
COMPLETED
|
11
|
12
|
|
Medication Dispense/Exposure Period 1
NOT COMPLETED
|
2
|
2
|
|
Alcohol Trial 1, Washout Period 1
STARTED
|
11
|
12
|
|
Alcohol Trial 1, Washout Period 1
COMPLETED
|
9
|
11
|
|
Alcohol Trial 1, Washout Period 1
NOT COMPLETED
|
2
|
1
|
|
Medication Dispense/Exposure Period 2
STARTED
|
9
|
11
|
|
Medication Dispense/Exposure Period 2
COMPLETED
|
8
|
11
|
|
Medication Dispense/Exposure Period 2
NOT COMPLETED
|
1
|
0
|
|
Alcohol Self-Administration Trial 2
STARTED
|
8
|
11
|
|
Alcohol Self-Administration Trial 2
COMPLETED
|
8
|
11
|
|
Alcohol Self-Administration Trial 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Lacosamide Then Placebo
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.
|
Placebo Then Lacosamide
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.
|
|---|---|---|
|
Medication Dispense/Exposure Period 1
Adverse Event
|
1
|
0
|
|
Medication Dispense/Exposure Period 1
Protocol Violation
|
1
|
0
|
|
Medication Dispense/Exposure Period 1
Lost to Follow-up
|
0
|
1
|
|
Medication Dispense/Exposure Period 1
Participation discontinued due to COVID-19 research pause
|
0
|
1
|
|
Alcohol Trial 1, Washout Period 1
Lost to Follow-up
|
1
|
1
|
|
Alcohol Trial 1, Washout Period 1
Failed urine drug screen at time of Alcohol Trial 1
|
1
|
0
|
|
Medication Dispense/Exposure Period 2
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Lacosamide Effects on Alcohol Self Administration and Craving in Heavy Drinkers
Baseline characteristics by cohort
| Measure |
Lacosamide Then Placebo
n=7 Participants
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.
|
Placebo Then Lacosamide
n=9 Participants
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
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
37.8 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
36.4 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hoursPopulation: 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.
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.
Outcome measures
| Measure |
Lacosamide
n=16 Participants
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.
|
Placebo Oral Capsule
n=16 Participants
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
|
|---|---|---|
|
Alcohol Consumption in Alcohol Self-Administration Trials
|
3.02 Standard Drink Units (SDU)
Standard Deviation 3.00
|
2.35 Standard Drink Units (SDU)
Standard Deviation 2.31
|
SECONDARY outcome
Timeframe: 3 minutesPopulation: 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.
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).
Outcome measures
| Measure |
Lacosamide
n=16 Participants
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.
|
Placebo Oral Capsule
n=16 Participants
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
|
|---|---|---|
|
Verbal Fluency: Controlled Word Association (COWAT)
|
38.19 score on a scale
Standard Deviation 8.26
|
42.25 score on a scale
Standard Deviation 9.75
|
SECONDARY outcome
Timeframe: 10 minutesPopulation: 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.
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).
Outcome measures
| Measure |
Lacosamide
n=16 Participants
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.
|
Placebo Oral Capsule
n=16 Participants
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
|
|---|---|---|
|
Cognitive Function: Spatial Span Forward
|
8.44 correct items
Standard Deviation 2.53
|
7.75 correct items
Standard Deviation 3.70
|
SECONDARY outcome
Timeframe: 10 minutesPopulation: 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.
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).
Outcome measures
| Measure |
Lacosamide
n=16 Participants
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.
|
Placebo Oral Capsule
n=16 Participants
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
|
|---|---|---|
|
Cognitive Function: Spatial Span Backward
|
7.19 score on a scale
Standard Deviation 2.49
|
7.62 score on a scale
Standard Deviation 3.14
|
SECONDARY outcome
Timeframe: 10 minutesPopulation: 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.
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).
Outcome measures
| Measure |
Lacosamide
n=16 Participants
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.
|
Placebo Oral Capsule
n=16 Participants
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
|
|---|---|---|
|
Cognitive Function: Digit Span Forward
|
10.81 score on a scale
Standard Deviation 1.97
|
10.81 score on a scale
Standard Deviation 2.10
|
SECONDARY outcome
Timeframe: 10 minutesPopulation: 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.
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).
Outcome measures
| Measure |
Lacosamide
n=16 Participants
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.
|
Placebo Oral Capsule
n=16 Participants
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
|
|---|---|---|
|
Cognitive Function: Digit Span Backward
|
8.06 score on a scale
Standard Deviation 1.48
|
7.62 score on a scale
Standard Deviation 2.16
|
SECONDARY outcome
Timeframe: 10 minutesPopulation: 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.
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).
Outcome measures
| Measure |
Lacosamide
n=16 Participants
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.
|
Placebo Oral Capsule
n=16 Participants
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
|
|---|---|---|
|
Cognitive Function: Digit Span Sequencing
|
8.12 score on a scale
Standard Deviation 2.33
|
7.62 score on a scale
Standard Deviation 2.36
|
SECONDARY outcome
Timeframe: 5 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Lacosamide
n=16 Participants
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.
|
Placebo Oral Capsule
n=16 Participants
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
|
|---|---|---|
|
Alcohol Craving: Obsessive-Compulsive Drinking Scale (OCDS) Pretrial
|
10.19 scores on a scale
Standard Deviation 4.79
|
12.25 scores on a scale
Standard Deviation 5.35
|
SECONDARY outcome
Timeframe: 1 minutePopulation: 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.
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.
Outcome measures
| Measure |
Lacosamide
n=16 Participants
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.
|
Placebo Oral Capsule
n=16 Participants
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
|
|---|---|---|
|
Alcohol Craving: Visual Analog Scale (VAS) Pretrial
|
30.25 scores on a scale
Standard Deviation 31.00
|
31.60 scores on a scale
Standard Deviation 35.65
|
SECONDARY outcome
Timeframe: 1 minutePopulation: 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.
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.
Outcome measures
| Measure |
Lacosamide
n=16 Participants
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.
|
Placebo Oral Capsule
n=16 Participants
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
|
|---|---|---|
|
Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 10
|
26.75 scores on a scale
Standard Deviation 20.07
|
41.87 scores on a scale
Standard Deviation 33.42
|
SECONDARY outcome
Timeframe: 1 minutePopulation: 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.
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.
Outcome measures
| Measure |
Lacosamide
n=16 Participants
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.
|
Placebo Oral Capsule
n=16 Participants
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
|
|---|---|---|
|
Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 20
|
35.31 scores on a scale
Standard Deviation 28.33
|
39.75 scores on a scale
Standard Deviation 34.95
|
SECONDARY outcome
Timeframe: 1 minutePopulation: 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.
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.
Outcome measures
| Measure |
Lacosamide
n=16 Participants
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.
|
Placebo Oral Capsule
n=16 Participants
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
|
|---|---|---|
|
Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 30
|
35.19 score on a scale
Standard Deviation 28.85
|
37.81 score on a scale
Standard Deviation 36.50
|
SECONDARY outcome
Timeframe: 1 minutePopulation: 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.
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.
Outcome measures
| Measure |
Lacosamide
n=16 Participants
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.
|
Placebo Oral Capsule
n=16 Participants
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
|
|---|---|---|
|
Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 40
|
36.87 score on a scale
Standard Deviation 26.71
|
36.69 score on a scale
Standard Deviation 34.50
|
SECONDARY outcome
Timeframe: 1 minutePopulation: 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.
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.
Outcome measures
| Measure |
Lacosamide
n=16 Participants
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.
|
Placebo Oral Capsule
n=16 Participants
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
|
|---|---|---|
|
Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 30
|
28.00 score on a scale
Standard Deviation 19.73
|
31.87 score on a scale
Standard Deviation 30.66
|
SECONDARY outcome
Timeframe: 1 minutePopulation: 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.
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.
Outcome measures
| Measure |
Lacosamide
n=16 Participants
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.
|
Placebo Oral Capsule
n=16 Participants
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
|
|---|---|---|
|
Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 60
|
24.94 score on a scale
Standard Deviation 20.78
|
30.37 score on a scale
Standard Deviation 30.38
|
SECONDARY outcome
Timeframe: 1 minutePopulation: 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.
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.
Outcome measures
| Measure |
Lacosamide
n=16 Participants
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.
|
Placebo Oral Capsule
n=16 Participants
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
|
|---|---|---|
|
Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 90
|
21.62 score on a scale
Standard Deviation 21.60
|
27.81 score on a scale
Standard Deviation 29.52
|
SECONDARY outcome
Timeframe: 1 minutePopulation: 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.
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.
Outcome measures
| Measure |
Lacosamide
n=16 Participants
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.
|
Placebo Oral Capsule
n=16 Participants
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
|
|---|---|---|
|
Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 120
|
23.62 score on a scale
Standard Deviation 28.78
|
29.00 score on a scale
Standard Deviation 32.55
|
SECONDARY outcome
Timeframe: 1 minutePopulation: 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.
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.
Outcome measures
| Measure |
Lacosamide
n=16 Participants
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.
|
Placebo Oral Capsule
n=16 Participants
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
|
|---|---|---|
|
Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 30
|
24.00 score on a scale
Standard Deviation 7.54
|
23.94 score on a scale
Standard Deviation 8.65
|
SECONDARY outcome
Timeframe: 1 minutePopulation: 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.
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.
Outcome measures
| Measure |
Lacosamide
n=16 Participants
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.
|
Placebo Oral Capsule
n=16 Participants
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
|
|---|---|---|
|
Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 60
|
24.88 score on a scale
Standard Deviation 7.49
|
26.25 score on a scale
Standard Deviation 6.70
|
SECONDARY outcome
Timeframe: 1 minutePopulation: 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.
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.
Outcome measures
| Measure |
Lacosamide
n=16 Participants
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.
|
Placebo Oral Capsule
n=16 Participants
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
|
|---|---|---|
|
Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 90
|
22.94 score on a scale
Standard Deviation 7.46
|
22.00 score on a scale
Standard Deviation 4.98
|
SECONDARY outcome
Timeframe: 1 minutePopulation: 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.
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.
Outcome measures
| Measure |
Lacosamide
n=16 Participants
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.
|
Placebo Oral Capsule
n=16 Participants
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
|
|---|---|---|
|
Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 120
|
24.94 score on a scale
Standard Deviation 9.45
|
25.44 score on a scale
Standard Deviation 8.34
|
Adverse Events
Lacosamide
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lacosamide
n=16 participants at risk
Subjects received 7 days of lacosamide before the alcohol self-administration trial.
|
Placebo
n=16 participants at risk
Subjects received 7 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Renal and urinary disorders
Bright yellow urine
|
12.5%
2/16 • Up to 44 days
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.
|
18.8%
3/16 • Up to 44 days
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.
|
|
General disorders
Drowsiness
|
6.2%
1/16 • Up to 44 days
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.
|
6.2%
1/16 • Up to 44 days
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.
|
|
General disorders
Dry mouth
|
6.2%
1/16 • Up to 44 days
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.
|
0.00%
0/16 • Up to 44 days
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.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Up to 44 days
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.
|
0.00%
0/16 • Up to 44 days
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.
|
|
Gastrointestinal disorders
Indigestion
|
6.2%
1/16 • Up to 44 days
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.
|
12.5%
2/16 • Up to 44 days
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.
|
|
Skin and subcutaneous tissue disorders
Mosquito bites
|
6.2%
1/16 • Up to 44 days
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.
|
0.00%
0/16 • Up to 44 days
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.
|
|
General disorders
Unpleasant taste in mouth
|
0.00%
0/16 • Up to 44 days
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.
|
6.2%
1/16 • Up to 44 days
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.
|
|
General disorders
Mental foginess
|
0.00%
0/16 • Up to 44 days
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.
|
6.2%
1/16 • Up to 44 days
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place