- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03897348
Pilot Human Lab Study of Lacosamide in Alcohol Use Disorder (AUD) (ACGT)
A Pilot Placebo-controlled Human Laboratory Feasibility Study of Lacosamide Effects in Alcohol Use Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94121
- San Francisco VA Health Care System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Oral medication
Other Names:
Oral medication
Other Names:
Oral medication
Other Names:
|
Experimental: 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.
|
Oral medication
Other Names:
Oral medication
Other Names:
Oral medication
Other Names:
|
Experimental: 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.
|
Oral medication
Other Names:
Oral medication
Other Names:
Oral medication
Other Names:
|
Experimental: 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.
|
Oral medication
Other Names:
Oral medication
Other Names:
Oral medication
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment Feasibility (Time, in Months,) Required to Recruit, Screen and Conduct the Study Procedures
Time Frame: 7 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.
|
7 months
|
Retention Feasibility (Proportion of Participants Completing the Alcohol Drinking Paradigm (ADP) Sessions)
Time Frame: 6.5 weeks
|
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)
Time Frame: 3 days (1 day each for ADP Session 1, 2, and 3)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol Craving
Time Frame: 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 craving will be measured during Alcohol Drinking Paradigm (ADP) sessions 1, 2 and 3 using the total score of the Alcohol Urge Questionnaire (AUQ).
The AUQ has 8 items.
Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7; items 2 and 7 are reverse scored).
Higher scores reflect greater craving.
Total score range is from a minimum of 8 to a maximum of 56.
The AUQ is administered before study medication and at various times after study medication.
The AUQ score reported here is the highest AUQ score following administration of study medication.
|
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)
Time Frame: 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 is measured during each of the Alcohol Drinking Paradigm (ADP) sessions, 1, 2 and 3.
In each session participants received one of the 3 drug interventions, Placebo, Lacosamide 100 mg, or Lacosamide 200 mg.
Consumption was measured using the number of alcoholic standard drinks consumed during the ADP sessions.
A standard drink per NIAAA definition is 14 grams of pure alcohol.
|
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
Time Frame: 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 are measured during the Alcohol Drinking Paradigm (ADP) sessions 1, 2 and 3 using the Biphasic Alcohol Effects Scale (BAES), which has 2 subscales; the Stimulation Subscale range is 0 - 70, where 0 is the least and 70 is the greatest stimulation; the Sedation Subscale range is 0 - 70, where 0 is the least and 70 is the greatest sedation.
The BAES was administered both before and at various timepoints after study medication administration in each of the ADP sessions.
The BAES scores reported here are the peak Stimulation scores after medication administration and peak Sedation scores after medication administration for each of ADP sessions 1, 2 and 3.
|
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).
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Steven L. Batki, MD, UCSF/SFVAHCS/NCIRE
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Drinking Behavior
- Alcohol-Related Disorders
- Substance-Related Disorders
- Alcohol Drinking
- Alcoholism
- Molecular Mechanisms of Pharmacological Action
- Membrane Transport Modulators
- Anticonvulsants
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lacosamide
Other Study ID Numbers
- 17-22180
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Use Disorder
-
Washington State UniversityRecruitingNicotine Use Disorder | Alcohol Use Disorder (AUD)United States
-
University of North Carolina, Chapel HillCompletedAlcohol Use Disorder, Mild | Alcohol Use Disorder, ModerateUnited States
-
Université du Québec à Trois-RivièresCompletedAlcohol Use, Unspecified | Alcohol Use Disorder, MildCanada
-
Woebot HealthStanford UniversityCompletedSubstance Use Disorders | Alcohol Use Disorder (AUD)United States
-
Medical University of South CarolinaNational Institute on Alcohol Abuse and Alcoholism (NIAAA); National Institutes...RecruitingAlcohol Drinking | Substance Use | Alcohol Use Disorder | Drinking, Alcohol | Alcohol Use Disorder (AUD)United States
-
Kaiser PermanenteNORC at the University of Chicago; Agency for Healthcare Research and Quality... and other collaboratorsCompleted
-
Centre Hospitalier Universitaire de NīmesRecruiting
-
Central Institute of Mental Health, MannheimNot yet recruitingAlcohol Use Disorder (AUD)Germany
-
Massachusetts General HospitalMbarara University of Science and TechnologyCompletedAlcohol Use Disorder (AUD)Uganda
-
ITAB - Institute for Advanced Biomedical TechnologiesNot yet recruitingNeurobiological Effects of Transcranial Direct Current Stimulation Treatment in Alcohol Use DisorderAlcohol Dependence | Alcohol-Related Disorders | Substance Use Disorders | Drug Abuse | Mental Disorder | Alcohol Abuse | Alcohol Use Disorder (AUD)
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States