Lacosamide Effects on Alcohol Self Administration and Craving in Heavy Drinkers
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcoholic Intoxication; Alcohol Drinking
Intervention: Lacosamide; Placebo oral capsule
Intervention 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.
Intervention MeSH terms: Lacosamide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: This study is double-blind. Medications are over-encapsulated.
Enrollment: 66.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Lacosamide; Alcohol craving; Alcohol Urge Questionnaire; Obsessive-Compulsive Drinking Scale; Visual Analog Scale; Alcohol consumption; Alcohol use disorder

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.
    

Eligibility criteria:

        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

          5. Meets DSM-5 criteria for mild alcohol use disorder or greater severity.

          6. 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.