Lacosamide Effects on Alcohol Self Administration and Craving in Heavy Drinkers
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|ClinicalTrials.gov Identifier: NCT03271528|
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : August 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder||Drug: Lacosamide Drug: Placebo oral capsule||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||This is a double-blind, randomized, placebo-controlled, crossover design trial that will test the effect of lacosamide on alcohol self-administration and craving following a priming dose of alcohol.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||This study is double-blind. Medications are over-encapsulated.|
|Official Title:||Lacosamide Effects on Alcohol Self Administration and Craving in Heavy Drinkers|
|Actual Study Start Date :||April 15, 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||December 2019|
Lacosamide titration will be done to a target dose of 300mg. Participants will take 100 mg of lacosamide once on day 1, twice per day from day 2 until day 6, on day 7 the lacrosamide dose will increase to 150 mg twice daily, and on day 8 the participant will take one dose of 150 mg.
Other Name: vimpat
|Placebo Comparator: Placebo oral capsule||
Drug: Placebo oral capsule
Participants will take a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
- Alcohol Consumption [ Time Frame: 4 hours ]Alcohol consumption will be measured by using a graduated cylinder to determine the amount of alcohol given to the subject that was not consumed. This outcome will be measured as standard drink units. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.
- Alcohol Cravings [ Time Frame: 4 hours ]Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving and the other end meaning intense alcohol craving. The Participant marks a point on the line that matches their amount of alcohol craving.
- Alcohol Urge [ Time Frame: 4 hours ]The Alcohol Urge questionnaire (AUQ) is an 8 item measure of self-reported urges to drink in human laboratory studies that assesses the participant's urge for an alcoholic drink at the time the questionnaire is completed, Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly disagree) and participants select the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Lower scores are associated with less urge for an alcoholic drink.
- Verbal Fluency [ Time Frame: 21 days ]The Controlled Word Association (COWAT) is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter. The participant is asked to name words beginning with a letter, excluding proper nouns, for one minute and this procedure is repeated three times. The most commons letters used are FAS because of their frequency in the English language. The examiner writes down the words provided by the participant on a piece of paper. It usually takes 5-10 minutes. The more words, the subject generates, the better the fluency.
- Cognitive function [ Time Frame: 21 days ]The Wechsler Adult Intelligence Scale (WAIS-5) Spatial and Digit Span tests will be used to assess subjects' working memory. Subjects will be asked to repeat back an increasing number of digits. Higher scores are indicative of higher levels of working memory and lower scores are indicative of lesser working memory function.
- Alcohol craving at titration [ Time Frame: 7 days ]The Visual Analog Scale (VAS) will be used to assess alcohol craving during the medication titration period. The VAS is a 10 cm straight line with one end meaning no alcohol craving and the other end meaning intense alcohol craving. The Participant marks a point on the line that matches their amount of alcohol craving. The point is measured from baseline (mm) to yield a scale score between 0-100.
- Cognitive aspects of alcohol craving [ Time Frame: 7 days ]The Obsessive-Compulsive Drinking Scale (OCDS) is a quick and reliable 14 item self-rating instrument that provides a total and two subscale scores (obsessive and compulsive) that measure some cognitive aspects of alcohol "craving". Each item is scored from 0 to 4 with lower scores indicating less obsessive or compulsive drinking.
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): NCT03271528
|Contact: Eric Devine, PhDfirstname.lastname@example.org|
|United States, Massachusetts|
|Boston University Psychiatry Research Center, Clinical Studies Unit||Recruiting|
|Boston, Massachusetts, United States, 02118|
|Contact: Eric G Devine, Ph.D. 617-414-1990 email@example.com|
|Principal Investigator:||Eric Devine, PhD||Assistant Professor|