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

NCT ID: NCT03897348

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-17
• Study Completion Date: 2019-06-12

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.

Detailed 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.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Oral medication

Lacosamide 100 mg

Intervention Type: DRUG

Oral medication

Lacosamide 200 mg

Intervention Type: DRUG

Oral medication

Crossover Sequence B: Lacosamide 200 mg, then Lacosamide 100 mg, then 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 Lacosamide 100 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Placebo.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Oral medication

Lacosamide 100 mg

Intervention Type: DRUG

Oral medication

Lacosamide 200 mg

Intervention Type: DRUG

Oral medication

Crossover Sequence C: Lacosamide 200 mg, then Placebo, then 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 Placebo. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Lacosamide 100 mg.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Oral medication

Lacosamide 100 mg

Intervention Type: DRUG

Oral medication

Lacosamide 200 mg

Intervention Type: DRUG

Oral medication

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

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.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Oral medication

Lacosamide 100 mg

Intervention Type: DRUG

Oral medication

Lacosamide 200 mg

Intervention Type: DRUG

Oral medication

Interventions

Placebo

Oral medication

Intervention Type: DRUG

Lacosamide 100 mg

Oral medication

Intervention Type: DRUG

Lacosamide 200 mg

Oral medication

Intervention Type: DRUG

Other Intervention Names

Placebo capsule identical in appearance to Lacosamide 100 mg and 200 mg capsules.; Lacosamide 100 mg capsule identical in appearance to Placebo and Lacosamide 200 mg capsule; Lacosamide 200 mg capsule identical in appearance to Placebo and Lacosamide 100 mg capsules.

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

San Francisco VA Health Care System

FED

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven L. Batki, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF/SFVAHCS/NCIRE

Locations

San Francisco VA Health Care System

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

17-22180

Identifier Type: -

Identifier Source: org_study_id