CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 4 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Lacosamide 100 mg or 200 mg orally (dose assignment per study design; placebo control)AI-extracted
Key inclusion· 5
  • Men aged 21–50 years
  • Meet DSM-5 criteria for current alcohol use disorder
  • Average weekly alcohol use of 25–70 standard drinks over the past 30 days
  • No more than 3 days/week of alcohol abstinence in the past 30 days
Key exclusion· 11
  • Currently seeking AUD treatment or in treatment within the past 6 months
  • Current DSM-5 non-alcohol use disorder other than tobacco or cannabis
  • Positive urine drug test for opioids, cocaine, benzodiazepines, or barbiturates at more than one baseline appointment
  • Regular use of psychoactive drugs (antipsychotics, anxiolytics, antidepressants, anticonvulsants, beta blockers, CNS stimulants/depressants, or excessive sedating agents) in the 30 days prior to entry

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03897348
NCT03897348Phase 2Completed

A Pilot Placebo-controlled Human Laboratory Feasibility Study of Lacosamide Effects in Alcohol Use Disorder

University of California, San Francisco·interventional·Posted Apr 1, 2019·Updated Jun 28, 2022

In Brief

A Phase 2 clinical trial evaluating Placebo, Lacosamide 100 mg, and 1 other intervention for Alcohol Use Disorder. Completed, enrolled 4 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedApr 1, 2019
Enrollment StartSep 17, 2018
Primary CompletionJun 12, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.3 years ago

Interventions

Placebodrug

Oral medication

Lacosamide 100 mgdrug

Oral medication

Lacosamide 200 mgdrug

Oral medication