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

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 2

Conditions: Alcohol Use Disorder

Treatments: Drug: Placebo; Drug: Lacosamide 200 mg; Drug: Lacosamide 100 mg

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03897348

17-22180

Details and patient eligibility

About

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.

Full description

Four heavy-drinking non-treatment seeking male community volunteers with a diagnosis of AUD will undergo 3 ADP sessions. In each of the 3 ADP sessions, they will receive one of the following 3 different interventions: either 100 mg of lacosamide, 200 mg of lacosamide or placebo.

The ADP session is a one day human laboratory session at the SFVA Medical Center. This human laboratory session involves the self-administration of alcoholic beverages by research participants under highly structured, observed conditions in order to evaluate the effects of the study drug interventions (either 100 mg lacosamide, 200 mg lacosamide, or placebo) on alcohol craving and alcohol consumption. The study follows a double-blind placebo-controlled crossover design in which each participant receives each of the 3 drug interventions in a randomly assigned sequence. There were 4 possible sequences representing the 4 arms of the study.

Enrollment: 4 patients

Sex: Male

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

4 participants in 4 patient groups

Crossover Sequence A: Placebo, then Lacosamide 200 mg, then Lacosamide 100 mg

Experimental group

Description:

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.

Treatment:

Drug: Lacosamide 100 mg

Drug: Lacosamide 200 mg

Drug: Placebo

Crossover Sequence B: Lacosamide 200 mg, then Lacosamide 100 mg, then Placebo

Experimental group

Description:

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.

Treatment:

Drug: Lacosamide 100 mg

Drug: Lacosamide 200 mg

Drug: Placebo

Crossover Sequence C: Lacosamide 200 mg, then Placebo, then Lacosamide 100 mg

Experimental group

Description:

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.

Treatment:

Drug: Lacosamide 100 mg

Drug: Lacosamide 200 mg

Drug: Placebo

Crossover Sequence D: Lacosamide 100 mg, then Lacosamide 200 mg, then Placebo

Experimental group

Description:

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.

Treatment:

Drug: Lacosamide 100 mg

Drug: Lacosamide 200 mg

Drug: Placebo