Pilot Human Lab Study of Lacosamide in Alcohol Use Disorder (AUD)
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: Placebo; Lacosamide 100 mg; Lacosamide 200 mg
Intervention description: Oral medication; Oral medication; Oral medication
Intervention MeSH terms: Lacosamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Double-blind, placebo-controlled
Enrollment: 4.0
Sex: Male
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: alcohol craving; human laboratory; lacosamide; non-treatment seeking

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men, ages 21-50;

          2. Able to read English and to complete study evaluations;

          3. Meet DSM-V criteria for current alcohol use disorder (AUD);

          4. Average weekly alcohol use of 25-70 standard drinks for men over the past 30 days;

          5. No more than 3 days/week of alcohol abstinence in the past 30 days, to maximize
             likelihood that participants will choose to drink during the laboratory sessions.

        Exclusion Criteria:

          1. Individuals who are seeking AUD treatment or have been in treatment within the past 6
             months;

          2. Current DSM-V non-alcohol use disorder other than tobacco or cannabis;

          3. Positive urine drug test results at more than one baseline appointment for opioids,
             cocaine, benzodiazepines or barbiturates;

          4. Regular use of psychoactive drugs including antipsychotics, anxiolytics and
             antidepressants during the 30 days prior to entry, as well as anticonvulsants, beta
             blockers, central nervous system stimulants or depressants, or other drugs that cause
             excessive sedation;

          5. Taking medications that may interact with lacosamide, e.g. medications that prolong
             the ECG PR interval, or medications with strong CYP3A4 and CYP2C9;

          6. Psychosis or any other serious mental illness as judged by SCID and study physician
             assessment;

          7. Medical conditions that in the judgment of the study physician contraindicate the
             consumption of alcohol;

          8. Medical conditions that in the judgment of the study physician contraindicate LAC (non
             contraindications listed in the FDA-approved Prescribing Information for LAC);

          9. Any other medical conditions that in the opinion of the study physician would make
             study participation hazardous;

         10. History of serious alcohol withdrawal (e.g. seizures, DTs, hospitalization) or a
             Clinical Institute Withdrawal Assessment Scale (CIWA-AD) score greater than or equal
             to 8;

         11. Participants who report disliking spirits will be excluded because 80 proof liquor
             will be provided during the alcohol self-administration periods;

         12. Participants who have taken any investigational drug within 4 weeks preceding study
             entry;

         13. Participants with first-degree atrioventricular block (AV block), PR interval
             lengthened beyond 0.20 seconds or greater.