Pilot Human Lab Study of Lacosamide in Alcohol Use Disorder (AUD) (ACGT)
Alcohol Use Disorder
About this trial
This is an interventional treatment trial for Alcohol Use Disorder focused on measuring alcohol craving, human laboratory, lacosamide, non-treatment seeking
Eligibility Criteria
Inclusion Criteria:
- Men, ages 21-50;
- Able to read English and to complete study evaluations;
- Meet DSM-V criteria for current alcohol use disorder (AUD);
- Average weekly alcohol use of 25-70 standard drinks for men over the past 30 days;
- 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:
- Individuals who are seeking AUD treatment or have been in treatment within the past 6 months;
- Current DSM-V non-alcohol use disorder other than tobacco or cannabis;
- Positive urine drug test results at more than one baseline appointment for opioids, cocaine, benzodiazepines or barbiturates;
- 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;
- Taking medications that may interact with lacosamide, e.g. medications that prolong the ECG PR interval, or medications with strong CYP3A4 and CYP2C9;
- Psychosis or any other serious mental illness as judged by SCID and study physician assessment;
- Medical conditions that in the judgment of the study physician contraindicate the consumption of alcohol;
- Medical conditions that in the judgment of the study physician contraindicate LAC (non contraindications listed in the FDA-approved Prescribing Information for LAC);
- Any other medical conditions that in the opinion of the study physician would make study participation hazardous;
- 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;
- Participants who report disliking spirits will be excluded because 80 proof liquor will be provided during the alcohol self-administration periods;
- Participants who have taken any investigational drug within 4 weeks preceding study entry;
- Participants with first-degree atrioventricular block (AV block), PR interval lengthened beyond 0.20 seconds or greater.
Sites / Locations
- San Francisco VA Health Care System
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Crossover Sequence A: Placebo, then Lacosamide 200 mg, then Lacosamide 100 mg
Crossover Sequence B: Lacosamide 200 mg, then Lacosamide 100 mg, then Placebo
Crossover Sequence C: Lacosamide 200 mg, then Placebo, then Lacosamide 100 mg
Crossover Sequence D: Lacosamide 100 mg, then Lacosamide 200 mg, then Placebo
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.
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.
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.
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.