Carisbamate as a Potential Treatment for Alcohol Dependence

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02435381
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arms: 2
• Duration (Months): 7.9
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effects of treatment with carisbamate compared to treatment with placebo, on alcohol-induced stimulant and subjective effects in non-treatment seeking alcohol-dependent human volunteers.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Dependence; Alcohol Abuse; Substance Abuse	Drug: Carisbamate; Drug: Placebo	Phase 1/Phase 2

Detailed Description

This within-subjects placebo-controlled experimental protocol will assess the effects of carisbamate (600mg qd) on the positive subjective effects of alcohol in non-treatment-seeking alcohol-dependent volunteers. Participants will receive study drug (carisbamate or placebo) from days 2- 4. On day 4, study drug will be followed by alcohol (0.8g/kg; 16% by volume) and a placebo beverage (1% by volume as a mask), both separated by 2 hours. Physiologic, subjective effects and BAL will be obtained after the alcohol challenges. Participants will be discharged on day 4 and asked to return a week later to repeat the study under the alternate study drug condition (active carisbamate vs. placebo).

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Carisbamate as a Potential Treatment for Alcohol Dependence
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Sep 30, 2013
• Actual Study Completion Date: Sep 30, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Participants will receive placebo from days 2- 4.	Drug: Placebo; Placebo treatment only; Other Names: Sugar Pill
Active Comparator: Carisbamate Participants will receive carisbamate 600mg qd from days 2- 4.	Drug: Carisbamate; 600mg Orally on days 2-4; Other Names: YKP 509

Outcome Measures

Primary Outcome Measures

1. Mean Biphasic Alcohol Effects Scale (BAES) Scores [15, 30 and 60 minutes after consumption of placebo (1% alcohol by volume) and alcohol (0.8g/kg; 16% by volume) beverages, stimulant ratings]

   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.

2. Mean Alcohol Urge Questionnaire (AUQ) Scores [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.

3. Mean Positive and Negative Affect Schedule (PANAS) Scores [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.

4. MEAN DRUG EFFECTS QUESTIONNAIRE (DEQ) SCORES [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.

Secondary Outcome Measures

1. Physiologic Effects of Carisbamate: Mean Systolic and Diastolic Blood Pressure [15, 30 and 60 minutes after alcohol (0.8 mg/kg;16% by volume) consumption]

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

2. Physiologic Effects of Carisbamate: Mean Heart Rate [15, 30 and 60 minutes after alcohol (0.8 mg/kg;16% by volume) consumption]

   pulse will be monitored after consuming carisbamate and alcohol

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Be an English-speaking volunteer who is not seeking treatment at the time of the study

2. Be between 18-55 years of age

3. Meet DSM-IV TR criteria for alcohol abuse; participants may or may not meet criteria for nicotine dependence. Nicotine dependence is allowed but not required because most alcohol users smoke cigarettes.

4. Have a self-reported history of using alcohol.

5. Have vital signs as follows: resting pulse must be < 90 bpm and the blood pressure must be < 150 mmHg systolic and < 90 mmHg diastolic.

6. Have hematology and chemistry laboratory tests that are within normal (+/- 10%) limits with the following exceptions:

• liver function tests (total bilirubin, ALT, AST, and alkaline phosphatase) < 3 x the upper limit of normal, and b) kidney function tests (creatinine and BUN) within normal limits

1. Have a baseline EKG that demonstrates clinically normal sinus rhythm, clinically normal conduction, and no clinically significant arrhythmias

2. Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician and the principal investigator.

Exclusion Criteria:

1. Meet DSM IV TR criteria for dependence on drugs other than alcohol or nicotine.

2. Have any history or evidence suggestive of seizure disorder or brain injury

3. Have any previous medically adverse reaction to alcohol, including loss of consciousness, chest pain, or epileptic seizure

4. Have neurological or psychiatric disorders, such as:

• psychosis, bipolar illness or major depression as assessed by SCID

• organic brain disease or dementia assessed by clinical interview

• history of any psychiatric disorder which would require ongoing treatment or which would make study compliance difficult

• history of suicide attempts within the past year and/or current suicidal ideation/plan

1. Have evidence of clinically significant heart disease or hypertension, as determined by the PI

2. Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease

3. Have symptomatic HIV or are taking antiretroviral medication

4. Be pregnant or nursing. Other females must either be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide). All females must provide negative pregnancy urine tests before study entry, upon hospital admission, and at the end of study participation

5. Have any other illness, condition, or use of psychotropic medications, which in the opinion of the PI and/or the admitting physician would preclude safe and/or successful completion of the study.

6. Currently seeking help for alcohol dependence.

7. Subjects with or prone to clinically significant alcohol withdrawal.

8. More than thirty days of abstinence from alcohol in the ninety days prior to enrollment.

9. A history of major alcohol-related medical complications requiring hospitalization (i.e. pancreatitis).

10. Contraindication(s) to take the study medication such as renal or hepatic impairment, nephrolithiasis, congenital metabolic disorders or history of seizures. Moderate-to-severe renal impairment defined as creatinine clearance less than 30 mL/min.

11. Use of inhibitors/substrates for renal cationic transporters, or medications contraindicated with ethanol.

12. A history of violence or aggression, assessed as part of the clinical interview at screening visit.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Michael E. DeBakey VA Medical Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• Baylor College of Medicine

Investigators

• Principal Investigator: Thomas F Newton, M.D, Baylor College of Medicine

Study Documents (Full-Text)

• Informed Consent Form - Jun 13, 2017

More Information

Publications

None provided.

• Responsible Party: Christopher Verrico, Assistant Professor, Psychiatry Research, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT02435381
• Other Study ID Numbers: H-30334
• First Posted: May 6, 2015
• Last Update Posted: Mar 2, 2021
• Last Verified: Feb 1, 2021

• Additional relevant MeSH terms: Alcoholism; Substance-Related Disorders

Study Results

Participant Flow

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

Arm/Group Title	Placebo First, Then Carisbamate	Carisbamate First, Then Placebo
Arm/Group Description	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)	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)
Period Title: Overall Study
STARTED	5	6
COMPLETED	3	5
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Placebo/Carisbamate
Arm/Group Description	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
Overall Participants	8
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	8 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	1 12.5%
Male	7 87.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	8 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 25%
White	6 75%
More than one race	0 0%
Unknown or Not Reported	0 0%
U.S. Veteran (Count of Participants)
Count of Participants [Participants]	6 75%

Outcome Measures

1. Primary Outcome

Title	Mean Biphasic Alcohol Effects Scale (BAES) Scores
Description	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.
Time Frame	15, 30 and 60 minutes after consumption of placebo (1% alcohol by volume) and alcohol (0.8g/kg; 16% by volume) beverages, stimulant ratings

Outcome Measure Data

Analysis Population Description

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.

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

2. Primary Outcome

Title	Mean Alcohol Urge Questionnaire (AUQ) Scores
Description	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.
Time Frame	15, 30 and 60 minutes after consumption of placebo (1% alcohol by volume) and alcohol (0.8g/kg; 16% by volume) beverages.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo + Alcohol Beverage	Carisbamate + Alcohol Beverage	Placebo + Placebo Beverage	Carisbamate + Placebo Beverage
Arm/Group Description	Participants will receive 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) Placebo: Placebo treatment only	Participants will receive carisbamate 600mg qd 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). Carisbamate: 600mg Orally on days 2-4	Participants will receive placebo from days 2- 4. Placebo: Placebo treatment only	Participants will receive carisbamate 600mg qd from days 2- 4. Carisbamate: 600mg Orally on days 2-4
Measure Participants	8	8	8	8
'AUQ' +15 minutes after alcohol and placebo beverage consumption	3.3 (0.4)	3.5 (0.5)	3.1 (0.4)	3.3 (0.5)
'AUQ' +30 minutes after alcohol and placebo beverage consumption	3.7 (0.4)	3.9 (0.5)	2.9 (0.5)	3.4 (0.5)
'AUQ' +60 minutes after alcohol and placebo beverage consumption	2.8 (0.5)	3.4 (0.6)	3.1 (0.5)	2.8 (0.5)

3. Primary Outcome

Title	Mean Positive and Negative Affect Schedule (PANAS) Scores
Description	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.
Time Frame	15, 30 and 60 minutes after consumption of placebo (1% alcohol by volume) and alcohol (0.8g/kg; 16% by volume) beverages.

Outcome Measure Data

Analysis Population Description

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.

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

4. Primary Outcome

Title	MEAN DRUG EFFECTS QUESTIONNAIRE (DEQ) SCORES
Description	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.
Time Frame	15, 30 and 60 minutes after consumption of placebo (1% alcohol by volume) and alcohol (0.8g/kg; 16% by volume) beverages.

Outcome Measure Data

Analysis Population Description

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.

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

5. Secondary Outcome

Title	Physiologic Effects of Carisbamate: Mean Systolic and Diastolic Blood Pressure
Description	systolic and diastolic blood pressure will be monitored after consuming carisbamate and alcohol
Time Frame	15, 30 and 60 minutes after alcohol (0.8 mg/kg;16% by volume) consumption

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Carisbamate
Arm/Group Description	Participants will receive 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) Placebo: Placebo treatment only	Participants will receive carisbamate 600mg qd 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). Carisbamate: 600mg Orally on days 2-4
Measure Participants	8	8
'Systolic BP' + 15 minutes after alcohol (0.8g/kg; 16% by volume) consumption	149.4 (7.1)	140.1 (7.6)
'Systolic BP' + 30 minutes after alcohol (0.8g/kg; 16% by volume) consumption	145.0 (8.0)	137.3 (5.8)
'Systolic BP' + 60 minutes after alcohol (0.8g/kg; 16% by volume) consumption	140.8 (10.5)	134.0 (8.5)
'Diastolic BP' + 15 minutes after alcohol (0.8g/kg; 16% by volume) consumption	89.6 (4.4)	87.4 (3.0)
'Diastolic BP' + 30 minutes after alcohol (0.8g/kg; 16% by volume) consumption	84.4 (4.2)	84.3 (2.5)
'Diastolic BP' + 60 minutes after alcohol (0.8g/kg; 16% by volume) consumption	81.6 (3.9)	79.6 (3.5)

6. Secondary Outcome

Title	Physiologic Effects of Carisbamate: Mean Heart Rate
Description	pulse will be monitored after consuming carisbamate and alcohol
Time Frame	15, 30 and 60 minutes after alcohol (0.8 mg/kg;16% by volume) consumption

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Carisbamate
Arm/Group Description	Participants will receive placebo from days 2- 4. Placebo: Placebo treatment only	Participants will receive carisbamate 600mg qd from days 2- 4. Carisbamate: 600mg Orally on days 2-4
Measure Participants	8	8
'Pulse' + 15 minutes after alcohol (0.8g/kg; 16% by volume) consumption	81.8 (4.0)	86.5 (5.3)
'Pulse' + 30 minutes after alcohol (0.8g/kg; 16% by volume) consumption	83.3 (2.0)	90.1 (4.8)
'Pulse' + 60 minutes after alcohol (0.8g/kg; 16% by volume) consumption	81.8 (2.5)	91.0 (5.5)

Adverse Events

Time Frame	Adverse event data was assessed over the 4 week active enrollment period on each condition (active carisbamate vs. placebo), up to 8 weeks following active enrollment.
Arm/Group Title	Placebo First, Then Carisbamate		Carisbamate First, Then Placebo
Arm/Group Description	Participants will receive placebo from days 2- 4. Placebo: Placebo treatment only		Participants will receive carisbamate 600mg qd from days 2- 4. Carisbamate: 600mg Orally on days 2-4
All Cause Mortality
	Placebo First, Then Carisbamate		Carisbamate First, Then Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)
Serious Adverse Events
	Placebo First, Then Carisbamate		Carisbamate First, Then Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Placebo First, Then Carisbamate		Carisbamate First, Then Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.