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

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ClinicalTrials.gov Identifier: NCT03897348
Recruitment Status : Completed
First Posted : April 1, 2019
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
San Francisco VA Health Care System
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Drug: Lacosamide Drug: Placebo Phase 2

Detailed Description:

4 heavy-drinking non-treatment seeking male community volunteers with a diagnosis of AUD will attend 3 ADP sessions and subsequently receive 3 different interventions, 100 mg of lacosamide, 200 mg of lacosamide and placebo.

The ADP sessions is a one day human laboratory session taking place 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 study intervention (100 mg lacosamide vs. 200 mg lacosadmide vs. placebo) on alcohol craving and alcohol consumption.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double-blind, placebo-controlled
Primary Purpose: Treatment
Official Title: A Pilot Placebo-controlled Human Laboratory Feasibility Study of Lacosamide Effects in Alcohol Use Disorder
Actual Study Start Date : April 5, 2018
Actual Primary Completion Date : June 12, 2019
Actual Study Completion Date : June 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol
Drug Information available for: Lacosamide

Arm Intervention/treatment
Experimental: Lacosamide 100 mg
100 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.
Drug: Lacosamide
Oral medication

Experimental: Lacosamide 200 mg
200 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.
Drug: Lacosamide
Oral medication

Placebo Comparator: Placebo
A matching capsule of placebo. A single dose is given at the beginning of 1 of the 3 ADP sessions.
Drug: Placebo
Oral medication




Primary Outcome Measures :
  1. Recruitment feasibility (time (in months) required to recruit, screen and conduct the study procedures) [ Time Frame: 18 months ]
    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.

  2. Retention feasibility (proportion of participants completing the Alcohol Drinking Paradigm (ADP) sessions) [ Time Frame: 18 months ]
    Retention feasibility will be measured by the proportion of participants completing the Alcohol Drinking Paradigm (ADP) sessions 1, 2 and 3.

  3. Tolerability feasibility (number and severity of adverse events) [ Time Frame: 18 months ]
    Tolerability feasibility will be measured by the number and severity of adverse events reported for participants for each of the 3 ADP sessions and each of the 3 medication conditions (100 mg lacosamide, 200 mg lacosamide and placebo).


Secondary Outcome Measures :
  1. Alcohol craving [ Time Frame: 3 weeks ]
    Alcohol craving will be measured during Alcohol Drinking Paradigm (ADP) sessions 1, 2 and 3 using the total score of the Obsessive Compulsive Drinking Scale (OCDS). OCDS total score range is 0 to 56.

  2. Alcohol consumption [ Time Frame: 3 weeks ]
    Alcohol consumption will be measured during Alcohol Drinking Paradigm (ADP) sessions 1, 2 and 3 using the number of alcoholic standard drinks consumed during the ADP sessions. Number of drinks consumed and total milliliters consumed will be measured.

  3. Subjective effects of alcohol consumption [ Time Frame: 3 weeks ]
    Subject effects of alcohol consumption will be measured during the Alcohol Drinking Paradigm (ADP) sessions 1, 2 and 3 using the 2 subscales of the Biphasic Alcohol Effects Scale (BAES). The stimulation subscale range is 0 - 70 and the sedation subscale range is 0 - 70.



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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897348


Locations
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United States, California
San Francisco VA Health Care System
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, San Francisco
San Francisco VA Health Care System
Investigators
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Principal Investigator: Steven L. Batki, MD UCSF/SFVAHCS/NCIRE

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03897348     History of Changes
Other Study ID Numbers: 17-22180
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of California, San Francisco:
alcohol craving
human laboratory
lacosamide
non-treatment seeking
Additional relevant MeSH terms:
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Disease
Alcoholism
Alcohol Drinking
Pathologic Processes
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Lacosamide
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action