Pilot Human Lab Study of Lacosamide in Alcohol Use Disorder (AUD) (ACGT)
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|ClinicalTrials.gov Identifier: NCT03897348|
Recruitment Status : Completed
First Posted : April 1, 2019
Last Update Posted : August 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder||Drug: Lacosamide Drug: Placebo||Phase 2|
4 heavy-drinking non-treatment seeking male community volunteers with a diagnosis of AUD will attend 3 ADP sessions and subsequently receive 3 different interventions, 100 mg of lacosamide, 200 mg of lacosamide and placebo.
The ADP sessions is a one day human laboratory session taking place 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 study intervention (100 mg lacosamide vs. 200 mg lacosadmide vs. placebo) on alcohol craving and alcohol consumption.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Double-blind, placebo-controlled|
|Official Title:||A Pilot Placebo-controlled Human Laboratory Feasibility Study of Lacosamide Effects in Alcohol Use Disorder|
|Actual Study Start Date :||April 5, 2018|
|Actual Primary Completion Date :||June 12, 2019|
|Actual Study Completion Date :||June 12, 2019|
Experimental: Lacosamide 100 mg
100 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.
Experimental: Lacosamide 200 mg
200 mg capsule of lacosamide, an FDA-approved anticonvulsant. A single dose is given at the beginning of 1 of the 3 ADP sessions.
Placebo Comparator: Placebo
A matching capsule of placebo. A single dose is given at the beginning of 1 of the 3 ADP sessions.
- Recruitment feasibility (time (in months) required to recruit, screen and conduct the study procedures) [ Time Frame: 18 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.
- Retention feasibility (proportion of participants completing the Alcohol Drinking Paradigm (ADP) sessions) [ Time Frame: 18 months ]Retention feasibility will be measured by the proportion of participants completing the Alcohol Drinking Paradigm (ADP) sessions 1, 2 and 3.
- Tolerability feasibility (number and severity of adverse events) [ Time Frame: 18 months ]Tolerability feasibility will be measured by the number and severity of adverse events reported for participants for each of the 3 ADP sessions and each of the 3 medication conditions (100 mg lacosamide, 200 mg lacosamide and placebo).
- Alcohol craving [ Time Frame: 3 weeks ]Alcohol craving will be measured during Alcohol Drinking Paradigm (ADP) sessions 1, 2 and 3 using the total score of the Obsessive Compulsive Drinking Scale (OCDS). OCDS total score range is 0 to 56.
- Alcohol consumption [ Time Frame: 3 weeks ]Alcohol consumption will be measured during Alcohol Drinking Paradigm (ADP) sessions 1, 2 and 3 using the number of alcoholic standard drinks consumed during the ADP sessions. Number of drinks consumed and total milliliters consumed will be measured.
- Subjective effects of alcohol consumption [ Time Frame: 3 weeks ]Subject effects of alcohol consumption will be measured during the Alcohol Drinking Paradigm (ADP) sessions 1, 2 and 3 using the 2 subscales of the Biphasic Alcohol Effects Scale (BAES). The stimulation subscale range is 0 - 70 and the sedation subscale range is 0 - 70.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897348
|United States, California|
|San Francisco VA Health Care System|
|San Francisco, California, United States, 94121|
|Principal Investigator:||Steven L. Batki, MD||UCSF/SFVAHCS/NCIRE|