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Lacosamide Effects on Alcohol Self Administration and Craving in Heavy Drinkers
Phase 1 trial testing Lacosamide in Alcohol Use Disorder in 66 participants. Completed in 31 August 2020.
| Lead sponsor | Boston Medical Center |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 66 |
| Start date | 15 April 2018 |
| Primary completion | 31 August 2020 |
| Estimated completion | 31 August 2020 |
| Sites | 1 location across United States |
Boston Medical Center
Adults 21 to 55, any sex, with Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Alcohol consumption will be measured by using a graduated cylinder to determine the amount of alcohol given to the subject that was consumed. This outcome will be measured as standard drink units. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.
| Group | Value | 95% CI |
|---|---|---|
| Lacosamide | 3.02 | ± 3.00 |
| Placebo Oral Capsule | 2.35 | ± 2.31 |
The Controlled Word Association (COWAT) is a verbal fluency test that measures the spontaneous production of words beginning with some designated letter. The participant is asked to name words beginning with a given letter, excluding proper nouns, for one minute and this procedure is repeated three times with a different letter each time. A different set of letters was used in each of the two alcohol self-administration trials: C-F-L and P-R-W. The examiner writes down the words provided by the participant on a piece of paper. This test is scored by counting the number of words generated by th
| Group | Value | 95% CI |
|---|---|---|
| Lacosamide | 38.19 | ± 8.26 |
| Placebo Oral Capsule | 42.25 | ± 9.75 |
The Wechsler Memory Scale (WMS-III) Spatial Span test will be used to assess subjects' working memory. Subjects will be shown a sequence of block tapping and asked to repeat back an increasing number of tapped blocks in the same order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
| Group | Value | 95% CI |
|---|---|---|
| Lacosamide | 8.44 | ± 2.53 |
| Placebo Oral Capsule | 7.75 | ± 3.70 |
The Wechsler Memory Scale (WMS-III) Spatial Span test will be used to assess subjects' working memory. Subjects will be shown a sequence of block tapping and asked to repeat back an increasing number of tapped blocks in the opposite order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
| Group | Value | 95% CI |
|---|---|---|
| Lacosamide | 7.19 | ± 2.49 |
| Placebo Oral Capsule | 7.62 | ± 3.14 |
The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in the same order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
| Group | Value | 95% CI |
|---|---|---|
| Lacosamide | 10.81 | ± 1.97 |
| Placebo Oral Capsule | 10.81 | ± 2.10 |
The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in the opposite order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
| Group | Value | 95% CI |
|---|---|---|
| Lacosamide | 8.06 | ± 1.48 |
| Placebo Oral Capsule | 7.62 | ± 2.16 |
The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in ascending order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
| Group | Value | 95% CI |
|---|---|---|
| Lacosamide | 8.12 | ± 2.33 |
| Placebo Oral Capsule | 7.62 | ± 2.36 |
The Obsessive-Compulsive Drinking Scale (OCDS) is a quick and reliable 14-item self-rating instrument that provides a total score that measures some cognitive aspects of alcohol craving (obsessive and compulsive drinking). Each of the 14 items is scored from 0 to 4. The total score is calculated by adding the scores for each of the 14 items. The total score range is 0-56. Higher scores are indicative of more obsessive or compulsive drinking and lower scores are indicative of less obsessive or compulsive drinking.
| Group | Value | 95% CI |
|---|---|---|
| Lacosamide | 10.19 | ± 4.79 |
| Placebo Oral Capsule | 12.25 | ± 5.35 |
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
| Group | Value | 95% CI |
|---|---|---|
| Lacosamide | 30.25 | ± 31.00 |
| Placebo Oral Capsule | 31.60 | ± 35.65 |
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
| Group | Value | 95% CI |
|---|---|---|
| Lacosamide | 26.75 | ± 20.07 |
| Placebo Oral Capsule | 41.87 | ± 33.42 |
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
| Group | Value | 95% CI |
|---|---|---|
| Lacosamide | 35.31 | ± 28.33 |
| Placebo Oral Capsule | 39.75 | ± 34.95 |
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
| Group | Value | 95% CI |
|---|---|---|
| Lacosamide | 35.19 | ± 28.85 |
| Placebo Oral Capsule | 37.81 | ± 36.50 |
Time frame: Up to 44 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Lacosamide | Placebo |
|---|---|---|---|
| Bright yellow urine | Renal and urinary disorders | — | — |
| Indigestion | Gastrointestinal disorders | — | — |
| Drowsiness | General disorders | — | — |
| Dry mouth | General disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Mosquito bites | Skin and subcutaneous tissue disorders | — | — |
| Unpleasant taste in mouth | General disorders | — | — |
| Mental foginess | General disorders | — | — |
Data from ClinicalTrials.gov NCT03271528 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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