Lacosamide Effects on Alcohol Self Administration and Craving in Heavy Drinkers

NCT03271528 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: H-367661R21AA026389-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blind, randomized, placebo-controlled, crossover design trial tested the effect of lacosamide on alcohol self-administration and craving following a priming dose of alcohol. The specific objective of this study was to determine whether lacosamide, a novel anticonvulsant that is FDA-approved for treating partial seizures, has effects on alcohol craving and consumption.

Conditions

Alcohol Use Disorder

Keywords

Lacosamide; Alcohol craving; Alcohol Urge Questionnaire; Obsessive-Compulsive Drinking Scale; Visual Analog Scale; Alcohol consumption; Alcohol use disorder

Outcome Measures

Primary Outcomes (1)

• Alcohol Consumption in Alcohol Self-Administration Trials

  Alcohol consumption will be measured by using a graduated cylinder to determine the amount of alcohol given to the subject that was consumed. This outcome will be measured as standard drink units. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.

  2 hours

Secondary Outcomes (20)

• Verbal Fluency: Controlled Word Association (COWAT)

  3 minutes

• Cognitive Function: Spatial Span Forward

  10 minutes

• Cognitive Function: Spatial Span Backward

  10 minutes

• Cognitive Function: Digit Span Forward

  10 minutes

• Cognitive Function: Digit Span Backward

  10 minutes

Study Arms (2)

Lacosamide

EXPERIMENTAL

Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.

Drug: Lacosamide

Placebo oral capsule

PLACEBO COMPARATOR

Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.

Drug: Placebo oral capsule

Interventions

Lacosamide DRUG

Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.

Also known as: Vimpat

Lacosamide

Placebo oral capsule DRUG

Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.

Placebo oral capsule

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Can provide proof of age with state-issued or federal picture ID
• Exceeds safe weekly drinking limits (≥14 drinks for women or ≥21 drinks for men per week)
• Reports at least an average of one episode per week of binge drinking (\>3 for women, \>4 for men) in the four weeks prior to baseline screening
• Meets DSM-5 criteria for mild alcohol use disorder or greater severity.
• Has a smartphone to complete some of the study assessments.

You may not qualify if:

• Currently seeking treatment for alcohol problems
• Clinical Institute Withdrawal Assessment at \>10
• DSM-5 diagnosis of current major depression, bipolar disorder, schizophrenia, bulimia/anorexia, dementia, or a substance use disorder other than alcohol, nicotine, marijuana or caffeine
• If female, pregnant, nursing, or have plans to become pregnant
• If female, does not agree to use an accepted form of birth control
• Is currently using medications for which alcohol is a contraindication
• Has a medical or mental health condition for which further alcohol exposure at the planned dose range would be contraindicated.
• Current risk of suicidality (MINI suicidality score greater than 8 (low risk) or Yes to the ideation question #4 of the C-SSRS)
• Has a history of myocardial infarction, congestive heart failure, has a risk for the development of heart block, or are taking medications that can decrease conduction through the atrial ventricular node.
• Has previous exposure to lacosamide
• Has received any form of counseling, self-help, pharmacotherapy, or other intervention to treat AUD in the past 90 days.
• Is unwilling to suspend use of multivitamins that contain riboflavin during study participation
• Has urine toxicology results positive for cocaine, opioids, amphetamines, buprenorphine, methadone, or methamphetamines
• Liver function values AST or ALT are twice the normal limit
• GFR \<80 mL/min

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Boston University Psychiatry Research Center, Clinical Studies Unit

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Alcoholism; Alcohol Drinking

Interventions

Lacosamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This study was terminated early at the discretion of the Principal Investigator due to COVID-19 restrictions on human subject research recruitment, leading to a smaller number of subjects analyzed than planned. At the time of termination, 19 subjects had completed the study compared to the target sample size of 28. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.

Results Point of Contact

• Title: Dr. Eric Devine
• Organization: Boston Medical Center

eric.devine@bmc.org

617-638-7888

Study Officials

• Eric Devine, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is double-blind. Medications are over-encapsulated.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a double-blind, randomized, placebo-controlled, crossover design trial to test the effect of lacosamide on alcohol self-administration and craving following a priming dose of alcohol.This study is a within subjects design in which each subject receives both study drug (lacosamide) and placebo during participation.

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 5, 2017
• Study Start: April 15, 2018
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: June 3, 2021
• Results First Posted: June 3, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)