Status:
COMPLETED
Lacosamide Effects on Alcohol Self Administration and Craving in Heavy Drinkers
Lead Sponsor:
Boston Medical Center
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
21-55 years
Phase:
PHASE1
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 speci...
Detailed Description
The present proposal was intended to answer the call for accelerating drug development by exploring the potential of a novel anticonvulsant, lacosamide, as a candidate medication for the treatment of ...
Eligibility Criteria
Inclusion
- Subject Inclusion Criteria
- 21-55 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.
- Subject Exclusion Criteria
- 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
- Unable to comfortably abstain from nicotine for a period of 8 hours.
Exclusion
Key Trial Info
Start Date :
April 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03271528
Start Date
April 15 2018
End Date
August 31 2020
Last Update
June 3 2021
Active Locations (1)
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1
Boston University Psychiatry Research Center, Clinical Studies Unit
Boston, Massachusetts, United States, 02118