Lacosamide Effects on Alcohol Self Administration and Craving in Heavy Drinkers

• Status: Completed
• Trial end date: 2020-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Medical Center
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Ethanol; Lacosamide

Criteria

Subject Inclusion Criteria

1. 21-55 years of age

2. Can provide proof of age with state-issued or federal picture ID

3. Exceeds safe weekly drinking limits (≥14 drinks for women or ≥21 drinks for men per week)

4. 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

5. Meets DSM-5 criteria for mild alcohol use disorder or greater severity.

6. Has a smartphone to complete some of the study assessments.

Subject Exclusion Criteria

1. Currently seeking treatment for alcohol problems

2. Clinical Institute Withdrawal Assessment at >10

3. 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

4. If female, pregnant, nursing, or have plans to become pregnant

5. If female, does not agree to use an accepted form of birth control

6. Is currently using medications for which alcohol is a contraindication

7. Has a medical or mental health condition for which further alcohol exposure at the planned dose range would be contraindicated.

8. Current risk of suicidality (MINI suicidality score greater than 8 (low risk) or Yes to the ideation question #4 of the C-SSRS)

9. 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.

10. Has previous exposure to lacosamide

11. Has received any form of counseling, self-help, pharmacotherapy, or other intervention to treat AUD in the past 90 days.

12. Is unwilling to suspend use of multivitamins that contain riboflavin during study participation

13. Has urine toxicology results positive for cocaine, opioids, amphetamines, buprenorphine, methadone, or methamphetamines

14. Liver function values AST or ALT are twice the normal limit

15. GFR <80 mL/min

16. Unable to comfortably abstain from nicotine for a period of 8 hours.