NCT03897348: ACGT

Pilot Human Lab Study of Lacosamide in Alcohol Use Disorder (AUD)

Completed Phase 2 Results posted Last updated 28 June 2022

What this trial tests

Phase 2 trial testing Placebo in Alcohol Use Disorder in 4 participants. Completed in 12 June 2019.

Timeline

17 September 2018

Primary endpoint
12 June 2019

12 June 2019

Quick facts

Lead sponsor	University of California, San Francisco
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	4
Start date	17 September 2018
Primary completion	12 June 2019
Estimated completion	12 June 2019
Sites	1 location across United States

Drugs / interventions tested

• Placebo
• Lacosamide 100 mg — full drug profile →
• Lacosamide 200 mg — full drug profile →

Conditions studied

• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →

Sponsor

University of California, San Francisco

Who can join

Adults 21 to 50, male only, with Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Recruitment Feasibility (Time, in Months,) Required to Recruit, Screen and Conduct the Study Procedures Primary · 7 months

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.

Group	Value	95% CI
Total	7.0

Retention Feasibility (Proportion of Participants Completing the Alcohol Drinking Paradigm (ADP) Sessions) Primary · 6.5 weeks

Retention feasibility will be measured by the proportion of participants completing the Alcohol Drinking Paradigm (ADP) Sessions 1, 2 and 3.

Group	Value	95% CI
Total	3

Tolerability (Number of Participants With Mild, Moderate, or Severe Adverse Events) Primary · 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).

mild adverse events

Group	Value	95% CI
Placebo	1
Lacosamide 100 mg	3
Lacosamide 200 mg	3

moderate adverse events

Group	Value	95% CI
Placebo	1
Lacosamide 100 mg	1
Lacosamide 200 mg	1

severe adverse events

Group	Value	95% CI
Placebo	0
Lacosamide 100 mg	0
Lacosamide 200 mg	1

Alcohol Craving Secondary · 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.

Group	Value	95% CI
Placebo	34.7	± 19.1
Lacosamide 100 mg	36	± 16.4
Lacosamide 200 mg	37.8	± 8.9

Alcohol Consumption (Number of Standard Drinks Consumed) Secondary · 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.

Group	Value	95% CI
Placebo	3.44	± 2.41
Lacosamide 100 mg	2.84	± 2.00
Lacosamide 200 mg	4.46	± 2.83

Subjective Effects of Alcohol Consumption Secondary · 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 administ

Stimulation subscale

Group	Value	95% CI
Placebo	31.3	± 27.7
Lacosamide 100 mg	44.3	± 22.4
Lacosamide 200 mg	45.2	± 16.0

Sedative subscale

Group	Value	95% CI
Placebo	27.3	± 4.7
Lacosamide 100 mg	26.7	± 7.0
Lacosamide 200 mg	30.5	± 10.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Starting at baseline and ending at follow-up for a total of 5 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/4 (0%)

Deaths: 0/4

Lacosamide 100 mg

Serious: 0/3 (0%)

Deaths: 0/3

Lacosamide 200 mg

Serious: 0/4 (0%)

Deaths: 0/4

Other adverse events (10 terms — click to expand)

Reaction	System	Placebo	Lacosamide 100 mg	Lacosamide 200 mg
Sleepiness	General disorders	—	—	—
Sensation of spinning	Nervous system disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Fatigue	General disorders	—	—	—
Double Vision	Eye disorders	—	—	—
Loss of coordination of muscle movements	Nervous system disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Tremor	Nervous system disorders	—	—	—

Data from ClinicalTrials.gov NCT03897348 adverse events section.

Sponsor's own description

The overall goal of the proposed project is to improve the treatment of individuals with AUD. The investigators will conduct the first pilot human laboratory study to assess the effects of two doses of lacosamide on alcohol drinking and craving. The investigators will assess its effects on reducing alcohol intake using a human laboratory method, the Yale Alcohol Drinking Paradigm (ADP). The investigators will also assess the feasibility of the Alcohol Drinking Paradigm (ADP) in order to position our research team to have the capacity to conduct future, larger, hypothesis-testing human laboratory-based experiments designed to test the efficacy of potential alcohol treatments.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.