Trial Outcomes & Findings for Pilot Human Lab Study of Lacosamide in Alcohol Use Disorder (AUD) (NCT NCT03897348)
NCT ID: NCT03897348
Last Updated: 2022-06-28
Results Overview
Recruitment feasibility will be measured as the time (in months) required to recruit, screen and conduct the study procedures for a total of 4 participants.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
7 months
Results posted on
2022-06-28
Participant Flow
52 participants who were community volunteers were screened for eligibility between September 17, 2018 and April 17, 2019 at the San Francisco VA Medical Center.
4 of the 52 were randomized. Of the 48 not randomized, 5 declined to participate and 43 did not meet inclusion criteria.
Participant milestones
| Measure |
Crossover Sequence A: Placebo, Then Lacosamide 200 mg, Then Lacosamide 100 mg
Participants receive a single dose of Placebo in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 200 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Lacosamide 100 mg.
|
Crossover Sequence B: Lacosamide 200 mg, Then Lacosamide 100 mg, Then Placebo
Participants receive a single dose of Lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 100 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Placebo.
|
Crossover Sequence C: Lacosamide 200 mg, Then Placebo, Then Lacosamide 100 mg
Participants receive a single dose of Lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Placebo. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Lacosamide 100 mg
|
Crossover Sequence D: Lacosamide 100 mg, Then Lacosamide 200 mg, Then Placebo
Participants receives a single dose of Lacosamide 100 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 200 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Placebo.
|
|---|---|---|---|---|
|
ADP Session 1
STARTED
|
1
|
1
|
1
|
1
|
|
ADP Session 1
COMPLETED
|
1
|
1
|
1
|
1
|
|
ADP Session 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
ADP Session 2
STARTED
|
1
|
1
|
1
|
1
|
|
ADP Session 2
COMPLETED
|
1
|
1
|
1
|
1
|
|
ADP Session 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
ADP Session 3
STARTED
|
1
|
1
|
0
|
1
|
|
ADP Session 3
COMPLETED
|
1
|
1
|
0
|
1
|
|
ADP Session 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Human Lab Study of Lacosamide in Alcohol Use Disorder (AUD)
Baseline characteristics by cohort
| Measure |
Crossover Sequence A: Placebo, Then Lacosamide 200 mg, Then Lacosamide 100 mg
n=1 Participants
Participant received single dose of placebo in ADP Session 1. After a 1 week washout period, they then underwent ADP Session 2 in which they received a single dose of lacosamide 200 mg. After another 1 week washout period, they underwent ADP Session 3 in which they received a single dose of lacosamide 100 mg.
(2) 200 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.
(3) Placebo. A single dose is given at the beginning of 1 of 3 ADP sessions.
Lacosamide: Oral medication Placebo: Oral medication
|
Crossover Sequence B: Lacosamide 200 mg, Then Lacosamide 100 mg, Then Placebo
n=1 Participants
Participant received a single dose of lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they then underwent ADP Session 2 in which they received a single dose of lacosamide 100 mg. After another 1 week washout period, they underwent ADP Session 3 in which they received a single dose of placebo.
|
Crossover Sequence C: Lacosamide 200 mg, Then Placebo, Then Lacosamide 100 mg
n=1 Participants
Participant received a single dose of lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they then underwent ADP Session 2 in which they received a single dose of placebo. After another 1 week washout period, they underwent ADP Session 3 in which they received a single dose of lacosamide 100 mg.
|
Crossover Sequence D: Lacosamide 100 mg, Then Lacosamide 200 mg, Then Placebo
n=1 Participants
Participant received a single dose of lacosamide 100 mg in ADP Session 1. After a 1 week washout period, they then underwent ADP Session 2 in which they received a single dose of lacosamide 200 mg. After another 1 week washout period, they underwent ADP Session 3 in which they received a single dose of placebo.
|
Total
n=4 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 7 monthsRecruitment feasibility will be measured as the time (in months) required to recruit, screen and conduct the study procedures for a total of 4 participants.
Outcome measures
| Measure |
Total
n=4 Participants
Total of all reporting groups
|
Lacosamide 100 mg
100 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.
Lacosamide: Oral medication
|
Lacosamide 200 mg
200 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.
Lacosamide: Oral medication
|
|---|---|---|---|
|
Recruitment Feasibility (Time, in Months,) Required to Recruit, Screen and Conduct the Study Procedures
|
7.0 months
|
—
|
—
|
PRIMARY outcome
Timeframe: 6.5 weeksRetention feasibility will be measured by the proportion of participants completing the Alcohol Drinking Paradigm (ADP) Sessions 1, 2 and 3.
Outcome measures
| Measure |
Total
n=4 Participants
Total of all reporting groups
|
Lacosamide 100 mg
100 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.
Lacosamide: Oral medication
|
Lacosamide 200 mg
200 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.
Lacosamide: Oral medication
|
|---|---|---|---|
|
Retention Feasibility (Proportion of Participants Completing the Alcohol Drinking Paradigm (ADP) Sessions)
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 days (1 day each for ADP Session 1, 2, and 3)Tolerability will be measured by the number of participants with mild, moderate, and severe adverse events for each of the 3 drug interventions (100 mg lacosamide, 200 mg lacosamide and placebo).
Outcome measures
| Measure |
Total
n=4 Participants
Total of all reporting groups
|
Lacosamide 100 mg
n=3 Participants
100 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.
Lacosamide: Oral medication
|
Lacosamide 200 mg
n=4 Participants
200 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.
Lacosamide: Oral medication
|
|---|---|---|---|
|
Tolerability (Number of Participants With Mild, Moderate, or Severe Adverse Events)
mild adverse events
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Tolerability (Number of Participants With Mild, Moderate, or Severe Adverse Events)
moderate adverse events
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Tolerability (Number of Participants With Mild, Moderate, or Severe Adverse Events)
severe adverse events
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 days (1 day each for ADP Session 1, 2, and 3. Each ADP Session included 1 dose of the drug intervention, either Placebo, Lacosamide 100 mg, or Lacosamide 200 mg).Alcohol craving will be measured during Alcohol Drinking Paradigm (ADP) sessions 1, 2 and 3 using the total score of the Alcohol Urge Questionnaire (AUQ). The AUQ has 8 items. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7; items 2 and 7 are reverse scored). Higher scores reflect greater craving. Total score range is from a minimum of 8 to a maximum of 56. The AUQ is administered before study medication and at various times after study medication. The AUQ score reported here is the highest AUQ score following administration of study medication.
Outcome measures
| Measure |
Total
n=3 Participants
Total of all reporting groups
|
Lacosamide 100 mg
n=3 Participants
100 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.
Lacosamide: Oral medication
|
Lacosamide 200 mg
n=4 Participants
200 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.
Lacosamide: Oral medication
|
|---|---|---|---|
|
Alcohol Craving
|
34.7 score on a scale
Standard Deviation 19.1
|
36 score on a scale
Standard Deviation 16.4
|
37.8 score on a scale
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: 3 days (1 day each for ADP Session 1, 2, and 3. Each ADP Session included 1 dose of the drug intervention, either Placebo, Lacosamide 100 mg, or Lacosamide 200 mg).Alcohol consumption is measured during each of the Alcohol Drinking Paradigm (ADP) sessions, 1, 2 and 3. In each session participants received one of the 3 drug interventions, Placebo, Lacosamide 100 mg, or Lacosamide 200 mg. Consumption was measured using the number of alcoholic standard drinks consumed during the ADP sessions. A standard drink per NIAAA definition is 14 grams of pure alcohol.
Outcome measures
| Measure |
Total
n=3 Participants
Total of all reporting groups
|
Lacosamide 100 mg
n=3 Participants
100 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.
Lacosamide: Oral medication
|
Lacosamide 200 mg
n=4 Participants
200 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.
Lacosamide: Oral medication
|
|---|---|---|---|
|
Alcohol Consumption (Number of Standard Drinks Consumed)
|
3.44 standard drinks
Standard Deviation 2.41
|
2.84 standard drinks
Standard Deviation 2.00
|
4.46 standard drinks
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: 3 days (1 day each for ADP Session 1, 2, and 3. Each ADP Session included 1 dose of the drug intervention, either Placebo, Lacosamide 100 mg, or Lacosamide 200 mg).Subjective effects of alcohol consumption are measured during the Alcohol Drinking Paradigm (ADP) sessions 1, 2 and 3 using the Biphasic Alcohol Effects Scale (BAES), which has 2 subscales; the Stimulation Subscale range is 0 - 70, where 0 is the least and 70 is the greatest stimulation; the Sedation Subscale range is 0 - 70, where 0 is the least and 70 is the greatest sedation. The BAES was administered both before and at various timepoints after study medication administration in each of the ADP sessions. The BAES scores reported here are the peak Stimulation scores after medication administration and peak Sedation scores after medication administration for each of ADP sessions 1, 2 and 3.
Outcome measures
| Measure |
Total
n=3 Participants
Total of all reporting groups
|
Lacosamide 100 mg
n=3 Participants
100 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.
Lacosamide: Oral medication
|
Lacosamide 200 mg
n=4 Participants
200 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.
Lacosamide: Oral medication
|
|---|---|---|---|
|
Subjective Effects of Alcohol Consumption
Stimulation subscale
|
31.3 score on a scale
Standard Deviation 27.7
|
44.3 score on a scale
Standard Deviation 22.4
|
45.2 score on a scale
Standard Deviation 16.0
|
|
Subjective Effects of Alcohol Consumption
Sedative subscale
|
27.3 score on a scale
Standard Deviation 4.7
|
26.7 score on a scale
Standard Deviation 7.0
|
30.5 score on a scale
Standard Deviation 10.0
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Lacosamide 100 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Lacosamide 200 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=4 participants at risk
A matching capsule of placebo. A single dose is given at the beginning of 1 of the 3 ADP sessions.
Placebo: Oral medication
|
Lacosamide 100 mg
n=3 participants at risk
100 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.
Lacosamide: Oral medication
|
Lacosamide 200 mg
n=4 participants at risk
200 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.
Lacosamide: Oral medication
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
33.3%
1/3 • Number of events 1 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
25.0%
1/4 • Number of events 1 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
33.3%
1/3 • Number of events 1 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
25.0%
1/4 • Number of events 1 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
33.3%
1/3 • Number of events 1 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
25.0%
1/4 • Number of events 1 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
0.00%
0/3 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
25.0%
1/4 • Number of events 1 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
0.00%
0/3 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
0.00%
0/4 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
|
Eye disorders
Double Vision
|
0.00%
0/4 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
0.00%
0/3 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
25.0%
1/4 • Number of events 1 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
|
Nervous system disorders
Sensation of spinning
|
0.00%
0/4 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
33.3%
1/3 • Number of events 1 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
50.0%
2/4 • Number of events 2 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
|
General disorders
Sleepiness
|
25.0%
1/4 • Number of events 1 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
100.0%
3/3 • Number of events 3 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
75.0%
3/4 • Number of events 3 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
0.00%
0/3 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
0.00%
0/4 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
|
Nervous system disorders
Loss of coordination of muscle movements
|
0.00%
0/4 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
33.3%
1/3 • Number of events 1 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
0.00%
0/4 • Starting at baseline and ending at follow-up for a total of 5 weeks.
|
Additional Information
Steven L. Batki, MD
University of California, San Francisco/San Francisco VA Health Care System
Phone: 415-221-4810
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place