Phase 1
Completed N=27
Lacosamide Effects on Alcohol Self Administration and Craving in Heavy Drinkers
Source: ClinicalTrials.gov NCT03271528 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Alcohol Consumption in Alcohol Self-Administration Trials — 3.02; 2.35 Standard Drink Units (SDU)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alcohol Consumption in Alcohol Self-Administration Trials |
3.02; 2.35 | — |
| SECONDARY Verbal Fluency: Controlled Word Association (COWAT) |
38.19; 42.25 | — |
| SECONDARY Cognitive Function: Spatial Span Forward |
8.44; 7.75 | — |
| SECONDARY Cognitive Function: Spatial Span Backward |
7.19; 7.62 | — |
| SECONDARY Cognitive Function: Digit Span Forward |
10.81; 10.81 | — |
| SECONDARY Cognitive Function: Digit Span Backward |
8.06; 7.62 | — |
| SECONDARY Cognitive Function: Digit Span Sequencing |
8.12; 7.62 | — |
| SECONDARY Alcohol Craving: Obsessive-Compulsive Drinking Scale (OCDS) Pretrial |
10.19; 12.25 | — |
| SECONDARY Alcohol Craving: Visual Analog Scale (VAS) Pretrial |
30.25; 31.60 | — |
| SECONDARY Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 10 |
26.75; 41.87 | — |
| SECONDARY Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 20 |
35.31; 39.75 | — |
| SECONDARY Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 30 |
35.19; 37.81 | — |
| SECONDARY Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 40 |
36.87; 36.69 | — |
| SECONDARY Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 30 |
28.00; 31.87 | — |
| SECONDARY Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 60 |
24.94; 30.37 | — |
| SECONDARY Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 90 |
21.62; 27.81 | — |
| SECONDARY Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 120 |
23.62; 29.00 | — |
| SECONDARY Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 30 |
24.00; 23.94 | — |
| SECONDARY Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 60 |
24.88; 26.25 | — |
| SECONDARY Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 90 |
22.94; 22.00 | — |
| SECONDARY Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 120 |
24.94; 25.44 | — |
Eligibility Criteria
Subject Inclusion Criteria
- 21-55 years of age
- Can provide proof of age with state-issued or federal picture ID
- Exceeds safe weekly drinking limits (≥14 drinks for women or ≥21 drinks for men per week)
- 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
- Meets DSM-5 criteria for mild alcohol use disorder or greater severity.
- Has a smartphone to complete some of the study assessments.
Subject Exclusion Criteria
- Currently seeking treatment for alcohol problems
- Clinical Institute Withdrawal Assessment at >10
- 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
- If female, pregnant, nursing, or have plans to become pregnant
- If female, does not agree to use an accepted form of birth control
- Is currently using medications for which alcohol is a contraindication
- Has a medical or mental health condition for which further alcohol exposure at the planned dose range would be contraindicated.
- Current risk of suicidality (MINI suicidality score greater than 8 (low risk) or Yes to the ideation question #4 of the C-SSRS)
- 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.
- Has previous exposure to lacosamide
- Has received any form of counseling, self-help, pharmacotherapy, or other intervention to treat AUD in the past 90 days.
- Is unwilling to suspend use of multivitamins that contain riboflavin during study participation
- Has urine toxicology results positive for cocaine, opioids, amphetamines, buprenorphine, methadone, or methamphetamines
- Liver function values AST or ALT are twice the normal limit
- GFR <80 mL/min
- Unable to comfortably abstain from nicotine for a period of 8 hours.
Data sourced from ClinicalTrials.gov (NCT03271528). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.