Trial Outcomes & Findings for Carisbamate as a Potential Treatment for Alcohol Dependence (NCT NCT02435381)

Last Updated: 2021-03-02

Results Overview

The Biphasic Alcohol Effects Scale (BAES) is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. The BAES consists of 14 items that are rated on a eleven-point scale. The Sedation and Stimulation subscales are calculated by summing the following items (for the 14-point scale): Stimulation: = BAES3 + BAES4 + BAES5 + BAES11 + BAES12 + BAES13 +BAES14/ Sedation: = BAES1 + BAES2 + BAES6 + BAES7 + BAES8 + BAES9 + BAES10. Individuals are instructed to rate the extent to which drinking alcohol has produced these feelings in you at the present time from 0 (not at all) to 10 (extremely). Higher scores on the Sedative Subscale represent extreme sedation (0 not at all sedated - 70 extremely sedated). Higher scores on the Stimulant Subscale represent extreme stimulation (0 not at all stimulated - 70 extremely stimulated). Scale scores are calculated as the sum of respective stimulant and sedative effects items.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

11 participants

Primary outcome timeframe

15, 30 and 60 minutes after consumption of placebo (1% alcohol by volume) and alcohol (0.8g/kg; 16% by volume) beverages, stimulant ratings

Results posted on

2021-03-02

Participant Flow

The study was a crossover design, double-blind, placebo controlled, 8 week clinical trail.

Participant milestones

Participant milestones
Measure	Placebo First, Then Carisbamate Participants received placebo from days 2- 4. Participants were discharged on day 4 and asked to return a week later to repeat the study under the alternate study drug condition (active carisbamate)	Carisbamate First, Then Placebo Participants received carisbamate from days 2- 4. Participants were discharged on day 4 and asked to return a week later to repeat the study under the alternate study drug condition (placebo)
Overall Study STARTED	5	6
Overall Study COMPLETED	3	5
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo First, Then Carisbamate Participants received placebo from days 2- 4. Participants were discharged on day 4 and asked to return a week later to repeat the study under the alternate study drug condition (active carisbamate)	Carisbamate First, Then Placebo Participants received carisbamate from days 2- 4. Participants were discharged on day 4 and asked to return a week later to repeat the study under the alternate study drug condition (placebo)
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

Carisbamate as a Potential Treatment for Alcohol Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo/Carisbamate n=8 Participants This within-subjects study included two treatment arms (placebo and carisbamate); 8 subjects completed both study arms. Participants received placebo on study days 2- 4. Participants were discharged on day 4 and asked to return a week later to repeat the study procedures under the alternate study drug condition (active carisbamate) Placebo: 0mg orally on days 2-4 Carisbamate: 600mg orally on days 2-4
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
U.S. Veteran	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15, 30 and 60 minutes after consumption of placebo (1% alcohol by volume) and alcohol (0.8g/kg; 16% by volume) beverages, stimulant ratings

Population: This within-subjects study included 2 treatment arms (placebo \& carisbamate), during both arms subjects completed study procedures twice, once after consuming placebo (1% alcohol by volume) and once after consuming alcohol (0.8g/kg; 16% by volume). The data here represent the means, following consumption of alcohol and placebo beverage, for the 8 subjects that completed both study arms.

Outcome measures

Outcome measures
Measure	Placebo + Alcohol Beverage n=8 Participants Participants will receive placebo from days 2- 4. Placebo: Placebo treatment only	Carisbamate + Alcohol Beverage n=8 Participants Participants will receive carisbamate 600mg qd from days 2- 4. Carisbamate: 600mg Orally on days 2-4	Placebo + Placebo Beverage n=8 Participants Participants will receive placebo from days 2- 4. Placebo: Placebo treatment only	Carisbamate + Placebo Beverage n=8 Participants Participants will receive carisbamate 600mg qd from days 2- 4. Carisbamate: 600mg Orally on days 2-4
Mean Biphasic Alcohol Effects Scale (BAES) Scores 'BAES Stimulant Subscale' +15 minutes after alcohol and placebo beverage consumption	27.5 score on a scale Standard Error 5.8	32.4 score on a scale Standard Error 4.1	23.0 score on a scale Standard Error 6.9	21.1 score on a scale Standard Error 5.2
Mean Biphasic Alcohol Effects Scale (BAES) Scores 'BAES Stimulant Subscale' +30 minutes after alcohol and placebo beverage consumption	34.4 score on a scale Standard Error 4.5	32.5 score on a scale Standard Error 4.1	26.0 score on a scale Standard Error 6.6	18.5 score on a scale Standard Error 4.8
Mean Biphasic Alcohol Effects Scale (BAES) Scores 'BAES Stimulant Subscale' +60 minutes after alcohol and placebo beverage consumption	24.8 score on a scale Standard Error 6.2	29.0 score on a scale Standard Error 7.2	20.6 score on a scale Standard Error 6.0	20.1 score on a scale Standard Error 5.1
Mean Biphasic Alcohol Effects Scale (BAES) Scores 'BAES Sedative Subscale' +15 minutes after alcohol and placebo beverage consumption	16.9 score on a scale Standard Error 4.9	16.8 score on a scale Standard Error 5.1	4.9 score on a scale Standard Error 2.6	11.8 score on a scale Standard Error 5.7
Mean Biphasic Alcohol Effects Scale (BAES) Scores 'BAES Sedative Subscale' +30 minutes after alcohol and placebo beverage consumption	20.0 score on a scale Standard Error 6.1	20.4 score on a scale Standard Error 6.5	7.6 score on a scale Standard Error 3.8	8.8 score on a scale Standard Error 5.3
Mean Biphasic Alcohol Effects Scale (BAES) Scores 'BAES Sedative Subscale' +60 minutes after alcohol and placebo beverage consumption	16.8 score on a scale Standard Error 5.9	20.1 score on a scale Standard Error 7.1	5.3 score on a scale Standard Error 3.0	9.5 score on a scale Standard Error 5.3

PRIMARY outcome

Timeframe: 15, 30 and 60 minutes after consumption of placebo (1% alcohol by volume) and alcohol (0.8g/kg; 16% by volume) beverages.

The Alcohol Urge Questionnaire (AUQ) consists of eight statements about the respondent's feelings and thoughts about drinking as they are completing the questionnaire (i.e., right now). Drinking refers to various types of alcohol, including beer, wine and liquor. The respondent is asked to respond to each statement about alcohol craving via a 7-item Likert scale ranging from "0-strongly disagree" to "6- strongly agree." Item scores were averaged and the total score also ranges from 0-6.

Outcome measures

Outcome measures
Measure	Placebo + Alcohol Beverage n=8 Participants Participants will receive placebo from days 2- 4. Placebo: Placebo treatment only	Carisbamate + Alcohol Beverage n=8 Participants Participants will receive carisbamate 600mg qd from days 2- 4. Carisbamate: 600mg Orally on days 2-4	Placebo + Placebo Beverage n=8 Participants Participants will receive placebo from days 2- 4. Placebo: Placebo treatment only	Carisbamate + Placebo Beverage n=8 Participants Participants will receive carisbamate 600mg qd from days 2- 4. Carisbamate: 600mg Orally on days 2-4
Mean Alcohol Urge Questionnaire (AUQ) Scores 'AUQ' +15 minutes after alcohol and placebo beverage consumption	3.3 score on a scale Standard Error 0.4	3.5 score on a scale Standard Error 0.5	3.1 score on a scale Standard Error 0.4	3.3 score on a scale Standard Error 0.5
Mean Alcohol Urge Questionnaire (AUQ) Scores 'AUQ' +30 minutes after alcohol and placebo beverage consumption	3.7 score on a scale Standard Error 0.4	3.9 score on a scale Standard Error 0.5	2.9 score on a scale Standard Error 0.5	3.4 score on a scale Standard Error 0.5
Mean Alcohol Urge Questionnaire (AUQ) Scores 'AUQ' +60 minutes after alcohol and placebo beverage consumption	2.8 score on a scale Standard Error 0.5	3.4 score on a scale Standard Error 0.6	3.1 score on a scale Standard Error 0.5	2.8 score on a scale Standard Error 0.5

PRIMARY outcome

Timeframe: 15, 30 and 60 minutes after consumption of placebo (1% alcohol by volume) and alcohol (0.8g/kg; 16% by volume) beverages.

The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Range between 10 and 50 points. Higher positive affect scores indicated a better outcome, while lower negative affect scores indicated a better outcome.

Outcome measures

Outcome measures
Measure	Placebo + Alcohol Beverage n=8 Participants Participants will receive placebo from days 2- 4. Placebo: Placebo treatment only	Carisbamate + Alcohol Beverage n=8 Participants Participants will receive carisbamate 600mg qd from days 2- 4. Carisbamate: 600mg Orally on days 2-4	Placebo + Placebo Beverage n=8 Participants Participants will receive placebo from days 2- 4. Placebo: Placebo treatment only	Carisbamate + Placebo Beverage n=8 Participants Participants will receive carisbamate 600mg qd from days 2- 4. Carisbamate: 600mg Orally on days 2-4
Mean Positive and Negative Affect Schedule (PANAS) Scores 'PANAS, Positive' +15 minutes after alcohol and placebo beverage consumption	28.1 score on a scale Standard Error 3.4	27.5 score on a scale Standard Error 3.0	27.5 score on a scale Standard Error 3.3	26.6 score on a scale Standard Error 3.4
Mean Positive and Negative Affect Schedule (PANAS) Scores 'PANAS, Positive' +30 minutes after alcohol and placebo beverage consumption	28.4 score on a scale Standard Error 3.2	29.3 score on a scale Standard Error 3.5	27.9 score on a scale Standard Error 2.8	26.6 score on a scale Standard Error 3.0
Mean Positive and Negative Affect Schedule (PANAS) Scores 'PANAS, Positive' +60 minutes after alcohol and placebo beverage consumption	29.0 score on a scale Standard Error 2.2	27.6 score on a scale Standard Error 2.9	29.3 score on a scale Standard Error 2.9	28.5 score on a scale Standard Error 2.8
Mean Positive and Negative Affect Schedule (PANAS) Scores 'PANAS, Negative' +15 minutes after alcohol and placebo beverage consumption	13.9 score on a scale Standard Error 2.0	13.0 score on a scale Standard Error 1.7	12.0 score on a scale Standard Error 1.2	13.6 score on a scale Standard Error 1.8
Mean Positive and Negative Affect Schedule (PANAS) Scores 'PANAS, Negative' +30 minutes after alcohol and placebo beverage consumption	13.3 score on a scale Standard Error 2.0	13.9 score on a scale Standard Error 1.6	13.0 score on a scale Standard Error 2.5	14.3 score on a scale Standard Error 1.8
Mean Positive and Negative Affect Schedule (PANAS) Scores 'PANAS, Negative' +60 minutes after alcohol and placebo beverage consumption	13.1 score on a scale Standard Error 2.5	14.1 score on a scale Standard Error 2.6	12.9 score on a scale Standard Error 2.2	15.8 score on a scale Standard Error 2.5

PRIMARY outcome

Timeframe: 15, 30 and 60 minutes after consumption of placebo (1% alcohol by volume) and alcohol (0.8g/kg; 16% by volume) beverages.

Self-reported subjective drug effects questionnaire evaluated whether a respondent was currently affected by doses of alcohol. Participants completed VAS at regular intervals after ingesting active alcohol (0.8g/kg; 16% by volume) or placebo (1% by volume as a mask). The questionnaire assessed the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", and "Want More". The "Feel Drug", "Feel High", "Like Drug", "Dislike Drug", and "Want More" subscales are reported.Each item is rated on a 100-point scale of 1 (not at all) to 100 (extremely). 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.

Outcome measures

Outcome measures
Measure	Placebo + Alcohol Beverage n=8 Participants Participants will receive placebo from days 2- 4. Placebo: Placebo treatment only	Carisbamate + Alcohol Beverage n=8 Participants Participants will receive carisbamate 600mg qd from days 2- 4. Carisbamate: 600mg Orally on days 2-4	Placebo + Placebo Beverage n=8 Participants Participants will receive placebo from days 2- 4. Placebo: Placebo treatment only	Carisbamate + Placebo Beverage n=8 Participants Participants will receive carisbamate 600mg qd from days 2- 4. Carisbamate: 600mg Orally on days 2-4
MEAN DRUG EFFECTS QUESTIONNAIRE (DEQ) SCORES 'FEEL' +15 minutes after alcohol and placebo beverage consumption	32.4 score on a scale Standard Error 12.3	53.2 score on a scale Standard Error 14.4	14.0 score on a scale Standard Error 12.3	23.6 score on a scale Standard Error 14.6
MEAN DRUG EFFECTS QUESTIONNAIRE (DEQ) SCORES 'FEEL' +30 minutes after alcohol and placebo beverage consumption	39.4 score on a scale Standard Error 11.6	53.5 score on a scale Standard Error 14.2	10.9 score on a scale Standard Error 9.3	16.8 score on a scale Standard Error 10.4
MEAN DRUG EFFECTS QUESTIONNAIRE (DEQ) SCORES 'FEEL' +60 minutes after alcohol and placebo beverage consumption	43.6 score on a scale Standard Error 12.8	42.6 score on a scale Standard Error 13.5	11.4 score on a scale Standard Error 10.1	16.5 score on a scale Standard Error 11.0
MEAN DRUG EFFECTS QUESTIONNAIRE (DEQ) SCORES 'LIKE' +15 minutes after alcohol and placebo beverage consumption	46.5 score on a scale Standard Error 13.5	54.0 score on a scale Standard Error 13.6	23.1 score on a scale Standard Error 10.2	33.4 score on a scale Standard Error 14.5
MEAN DRUG EFFECTS QUESTIONNAIRE (DEQ) SCORES 'LIKE' +30 minutes after alcohol and placebo beverage consumption	54.8 score on a scale Standard Error 13.2	47.8 score on a scale Standard Error 15.2	27.4 score on a scale Standard Error 13.4	17.6 score on a scale Standard Error 10.6
MEAN DRUG EFFECTS QUESTIONNAIRE (DEQ) SCORES 'LIKE' +60 minutes after alcohol and placebo beverage consumption	37.9 score on a scale Standard Error 13.1	33.8 score on a scale Standard Error 11.8	18.6 score on a scale Standard Error 11.0	24.4 score on a scale Standard Error 12.0
MEAN DRUG EFFECTS QUESTIONNAIRE (DEQ) SCORES 'DISLIKE' +15 minutes after alcohol and placebo beverage consumption	14.8 score on a scale Standard Error 8.9	22.8 score on a scale Standard Error 14.1	18.9 score on a scale Standard Error 12.3	24.1 score on a scale Standard Error 12.6
MEAN DRUG EFFECTS QUESTIONNAIRE (DEQ) SCORES 'DISLIKE' +30 minutes after alcohol and placebo beverage consumption	13.9 score on a scale Standard Error 7.6	21.9 score on a scale Standard Error 14.3	22.4 score on a scale Standard Error 14.1	15.6 score on a scale Standard Error 12.2
MEAN DRUG EFFECTS QUESTIONNAIRE (DEQ) SCORES 'DISLIKE' +60 minutes after alcohol and placebo beverage consumption	16.1 score on a scale Standard Error 12.1	18.0 score on a scale Standard Error 11.0	22.3 score on a scale Standard Error 14.1	35.3 score on a scale Standard Error 14.2
MEAN DRUG EFFECTS QUESTIONNAIRE (DEQ) SCORES 'HIGH' +15 minutes after alcohol and placebo beverage consumption	35.6 score on a scale Standard Error 10.9	53.8 score on a scale Standard Error 14.4	8.8 score on a scale Standard Error 6.7	31.6 score on a scale Standard Error 15.7
MEAN DRUG EFFECTS QUESTIONNAIRE (DEQ) SCORES 'HIGH' +30 minutes after alcohol and placebo beverage consumption	43.0 score on a scale Standard Error 10.6	52.1 score on a scale Standard Error 13.6	10.3 score on a scale Standard Error 8.6	13.8 score on a scale Standard Error 10.4
MEAN DRUG EFFECTS QUESTIONNAIRE (DEQ) SCORES 'HIGH' +60 minutes after alcohol and placebo beverage consumption	37.9 score on a scale Standard Error 13.5	46.9 score on a scale Standard Error 14.3	1.9 score on a scale Standard Error 1.3	10.1 score on a scale Standard Error 10.1
MEAN DRUG EFFECTS QUESTIONNAIRE (DEQ) SCORES 'WANT MORE' +15 minutes after alcohol and placebo beverage consumption	44.3 score on a scale Standard Error 14.3	50.5 score on a scale Standard Error 14.0	24.1 score on a scale Standard Error 12.3	28.9 score on a scale Standard Error 14.7
MEAN DRUG EFFECTS QUESTIONNAIRE (DEQ) SCORES 'WANT MORE' +30 minutes after alcohol and placebo beverage consumption	46.5 score on a scale Standard Error 14.5	56.3 score on a scale Standard Error 15.0	30.1 score on a scale Standard Error 12.4	23.4 score on a scale Standard Error 11.7
MEAN DRUG EFFECTS QUESTIONNAIRE (DEQ) SCORES 'WANT MORE' +60 minutes after alcohol and placebo beverage consumption	37.6 score on a scale Standard Error 12.6	50.0 score on a scale Standard Error 15.7	28.3 score on a scale Standard Error 11.9	15.4 score on a scale Standard Error 10.2

SECONDARY outcome

Timeframe: 15, 30 and 60 minutes after alcohol (0.8 mg/kg;16% by volume) consumption

Population: This within-subjects study included 2 treatment arms (placebo \& carisbamate), during both arms subjects completed study procedures twice, once after consuming placebo and once after consuming alcohol (0.8g/kg; 16% by volume). The data here represent the means, following consumption of alcohol only, for the 8 subjects that completed both study arms.

systolic and diastolic blood pressure will be monitored after consuming carisbamate and alcohol

Outcome measures

Outcome measures
Measure	Placebo + Alcohol Beverage n=8 Participants Participants will receive placebo from days 2- 4. Placebo: Placebo treatment only	Carisbamate + Alcohol Beverage n=8 Participants Participants will receive carisbamate 600mg qd from days 2- 4. Carisbamate: 600mg Orally on days 2-4	Placebo + Placebo Beverage Participants will receive placebo from days 2- 4. Placebo: Placebo treatment only	Carisbamate + Placebo Beverage Participants will receive carisbamate 600mg qd from days 2- 4. Carisbamate: 600mg Orally on days 2-4
Physiologic Effects of Carisbamate: Mean Systolic and Diastolic Blood Pressure 'Systolic BP' + 15 minutes after alcohol (0.8g/kg; 16% by volume) consumption	149.4 mm Hg Standard Error 7.1	140.1 mm Hg Standard Error 7.6	—	—
Physiologic Effects of Carisbamate: Mean Systolic and Diastolic Blood Pressure 'Systolic BP' + 30 minutes after alcohol (0.8g/kg; 16% by volume) consumption	145.0 mm Hg Standard Error 8.0	137.3 mm Hg Standard Error 5.8	—	—
Physiologic Effects of Carisbamate: Mean Systolic and Diastolic Blood Pressure 'Systolic BP' + 60 minutes after alcohol (0.8g/kg; 16% by volume) consumption	140.8 mm Hg Standard Error 10.5	134.0 mm Hg Standard Error 8.5	—	—
Physiologic Effects of Carisbamate: Mean Systolic and Diastolic Blood Pressure 'Diastolic BP' + 15 minutes after alcohol (0.8g/kg; 16% by volume) consumption	89.6 mm Hg Standard Error 4.4	87.4 mm Hg Standard Error 3.0	—	—
Physiologic Effects of Carisbamate: Mean Systolic and Diastolic Blood Pressure 'Diastolic BP' + 30 minutes after alcohol (0.8g/kg; 16% by volume) consumption	84.4 mm Hg Standard Error 4.2	84.3 mm Hg Standard Error 2.5	—	—
Physiologic Effects of Carisbamate: Mean Systolic and Diastolic Blood Pressure 'Diastolic BP' + 60 minutes after alcohol (0.8g/kg; 16% by volume) consumption	81.6 mm Hg Standard Error 3.9	79.6 mm Hg Standard Error 3.5	—	—

SECONDARY outcome

Timeframe: 15, 30 and 60 minutes after alcohol (0.8 mg/kg;16% by volume) consumption

Population: This within-subjects study included 2 treatment arms (placebo \& carisbamate), during both arms subjects completed study procedures twice, once after consuming placebo and once after consuming alcohol (0.8g/kg; 16% by volume). The data here represent the means, following consumption of alcohol only, for the 8 subjects that completed both study arms.

pulse will be monitored after consuming carisbamate and alcohol

Outcome measures

Outcome measures
Measure	Placebo + Alcohol Beverage n=8 Participants Participants will receive placebo from days 2- 4. Placebo: Placebo treatment only	Carisbamate + Alcohol Beverage n=8 Participants Participants will receive carisbamate 600mg qd from days 2- 4. Carisbamate: 600mg Orally on days 2-4	Placebo + Placebo Beverage Participants will receive placebo from days 2- 4. Placebo: Placebo treatment only	Carisbamate + Placebo Beverage Participants will receive carisbamate 600mg qd from days 2- 4. Carisbamate: 600mg Orally on days 2-4
Physiologic Effects of Carisbamate: Mean Heart Rate 'Pulse' + 15 minutes after alcohol (0.8g/kg; 16% by volume) consumption	81.8 beats per minute Standard Error 4.0	86.5 beats per minute Standard Error 5.3	—	—
Physiologic Effects of Carisbamate: Mean Heart Rate 'Pulse' + 30 minutes after alcohol (0.8g/kg; 16% by volume) consumption	83.3 beats per minute Standard Error 2.0	90.1 beats per minute Standard Error 4.8	—	—
Physiologic Effects of Carisbamate: Mean Heart Rate 'Pulse' + 60 minutes after alcohol (0.8g/kg; 16% by volume) consumption	81.8 beats per minute Standard Error 2.5	91.0 beats per minute Standard Error 5.5	—	—

Adverse Events

Placebo First, Then Carisbamate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Carisbamate First, Then Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christopher D. Verrico Ph.D.

Baylor College of Medicine

Phone: 713-791-1414

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator shall have the right to publish or otherwise publicly disclose information gained in the course of this Agreement. Investigator agrees to submit to Company copies of manuscripts, posters, slides, or abstracts that are intended for presentation or publication and that contain the results of the performance of this Agreement not less than 30 days before submission of manuscripts for publications or presentations of slides and posters, or 10 days prior to abstract submission.
Publication restrictions are in place

Restriction type: OTHER