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

NCT03897348 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 17-22180
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder

Keywords

alcohol craving; human laboratory; lacosamide; non-treatment seeking

Outcome Measures

Primary Outcomes (3)

• Recruitment Feasibility (Time, in Months,) Required to Recruit, Screen and Conduct the Study Procedures

  Recruitment feasibility will be measured as the time (in months) required to recruit, screen and conduct the study procedures for a total of 4 participants.

  7 months

• Retention Feasibility (Proportion of Participants Completing the Alcohol Drinking Paradigm (ADP) Sessions)

  Retention feasibility will be measured by the proportion of participants completing the Alcohol Drinking Paradigm (ADP) Sessions 1, 2 and 3.

  6.5 weeks

• Tolerability (Number of Participants With Mild, Moderate, or Severe Adverse Events)

  Tolerability will be measured by the number of participants with mild, moderate, and severe adverse events for each of the 3 drug interventions (100 mg lacosamide, 200 mg lacosamide and placebo).

  3 days (1 day each for ADP Session 1, 2, and 3)

Secondary Outcomes (3)

• Alcohol Craving

  3 days (1 day each for ADP Session 1, 2, and 3. Each ADP Session included 1 dose of the drug intervention, either Placebo, Lacosamide 100 mg, or Lacosamide 200 mg).

• Alcohol Consumption (Number of Standard Drinks Consumed)

  3 days (1 day each for ADP Session 1, 2, and 3. Each ADP Session included 1 dose of the drug intervention, either Placebo, Lacosamide 100 mg, or Lacosamide 200 mg).

• Subjective Effects of Alcohol Consumption

  3 days (1 day each for ADP Session 1, 2, and 3. Each ADP Session included 1 dose of the drug intervention, either Placebo, Lacosamide 100 mg, or Lacosamide 200 mg).

Study Arms (4)

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

Interventions

Placebo DRUG

Oral medication

Also known as: Placebo capsule identical in appearance to Lacosamide 100 mg and 200 mg capsules.

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

Lacosamide 100 mg DRUG

Oral medication

Also known as: Lacosamide 100 mg capsule identical in appearance to Placebo and Lacosamide 200 mg capsule

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

Lacosamide 200 mg DRUG

Oral medication

Also known as: Lacosamide 200 mg capsule identical in appearance to Placebo and Lacosamide 100 mg capsules.

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

Eligibility Criteria

• Age: 21 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• San Francisco VA Health Care System: collaborator

Study Sites (1)

San Francisco VA Health Care System

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Lacosamide

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Limitations and Caveats

1 participant withdrew prior to ADP Session 3 and therefore did not receive the drug intervention of Lacosamide 100 mg.

Results Point of Contact

• Title: Steven L. Batki, MD
• Organization: University of California, San Francisco/San Francisco VA Health Care System

steven.batki@ucsf.edu

415-221-4810

Study Officials

• Steven L. Batki, MD

  UCSF/SFVAHCS/NCIRE

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, placebo-controlled
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: April 1, 2019
• Study Start: September 17, 2018
• Primary Completion: June 12, 2019
• Study Completion: June 12, 2019
• Last Updated: June 28, 2022
• Results First Posted: October 27, 2021

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)