Alcohol DependencePhase 1/2NCT02435381

Carisbamate as a Potential Treatment for Alcohol Dependence

A Phase 1/2 study testing Carisbamate in people with Alcohol Dependence and Alcohol Abuse, run by Baylor College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Alcohol Dependence, Alcohol Abuse, Substance Abuse
What is being tested?: Carisbamate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 11 participants
Where: 1 siteUnited States
Study dates: Feb 2013to 30 Sep 2013
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Be an English-speaking volunteer who is not seeking treatment at the time of the study
Be between 18-55 years of age
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.
Have a self-reported history of using alcohol.
Have vital signs as follows: resting pulse must be < 90 bpm and the blood pressure must be < 150 mmHg systolic and < 90 mmHg diastolic.
Have hematology and chemistry laboratory tests that are within normal (+/- 10%) limits with the following exceptions:

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

Who cannot join

Meet DSM IV TR criteria for dependence on drugs other than alcohol or nicotine.
Have any history or evidence suggestive of seizure disorder or brain injury
Have any previous medically adverse reaction to alcohol, including loss of consciousness, chest pain, or epileptic seizure
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

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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
Have evidence of clinically significant heart disease or hypertension, as determined by the PI
Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease
Have symptomatic HIV or are taking antiretroviral medication
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
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.
Currently seeking help for alcohol dependence.
Subjects with or prone to clinically significant alcohol withdrawal.
More than thirty days of abstinence from alcohol in the ninety days prior to enrollment.
A history of major alcohol-related medical complications requiring hospitalization (i.e. pancreatitis).
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.
Use of inhibitors/substrates for renal cationic transporters, or medications contraindicated with ethanol.
A history of violence or aggression, assessed as part of the clinical interview at screening visit.

Trial locations and contacts

1 site in 1 country.

United States1 site

Michael E. DeBakey VA Medical Center
Houston, Texas, 77030

Other trials in United States

About this study

Read the 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).

Conditions: Alcohol Dependence, Alcohol Abuse, Substance Abuse
Being tested: Carisbamate, Placebo
Medical subject headings: Alcoholism, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CarisbamateDrug
Also called YKP 509
600mg Orally on days 2-4
PlaceboDrug
Also called Sugar Pill
Placebo treatment only

Study groups in NCT02435381
Study group	Role	What they receive
Placebo	Placebo comparator	Participants will receive placebo from days 2- 4. Receives: Drug: Placebo
Carisbamate	Active comparator	Participants will receive carisbamate 600mg qd from days 2- 4. Receives: Drug: Carisbamate

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Biphasic Alcohol Effects Scale (BAES) Scores
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.
Measured: 15, 30 and 60 minutes after consumption of placebo (1% alcohol by volume) and alcohol (0.8g/kg; 16% by volume) beverages, stimulant ratings
Mean Alcohol Urge Questionnaire (AUQ) Scores
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.
Measured: 15, 30 and 60 minutes after consumption of placebo (1% alcohol by volume) and alcohol (0.8g/kg; 16% by volume) beverages.
Mean Positive and Negative Affect Schedule (PANAS) Scores
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.
Measured: 15, 30 and 60 minutes after consumption of placebo (1% alcohol by volume) and alcohol (0.8g/kg; 16% by volume) beverages.
MEAN DRUG EFFECTS QUESTIONNAIRE (DEQ) SCORES
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.
Measured: 15, 30 and 60 minutes after consumption of placebo (1% alcohol by volume) and alcohol (0.8g/kg; 16% by volume) beverages.

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 201330 Sep 2013

First posted6 May 2015 (estimated)
Study startFeb 2013
Primary completion30 Sep 2013
Study completion30 Sep 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alcohol DependenceStudies of the same condition, open and under way.
More trials run by Baylor College of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02435381
Sponsor's protocol ID: H-30334
Status last verified: Feb 2021
First submitted: 7 Sep 2013
Last updated: 2 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder

All Alcohol Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Carisbamate as a Potential Treatment for Alcohol Dependence
ClinicalTrials.gov ID: NCT02435381
Acronym / sponsor ID: H-30334
Conditions: Alcohol Dependence, Alcohol Abuse, Substance Abuse
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Baylor College of MedicineUniversity, hospital or other
Study start: Feb 2013
Primary completion: 30 Sep 2013 (actual)
Study completion: 30 Sep 2013 (actual)
First posted: 6 May 2015 (estimated)
Results: Posted 2 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive placebo from days 2- 4.
Carisbamate	Active comparator	Drug: CarisbamateParticipants will receive carisbamate 600mg qd from days 2- 4.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Be an English-speaking volunteer who is not seeking treatment at the time of the study
Be between 18-55 years of age
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.
Have a self-reported history of using alcohol.
Have vital signs as follows: resting pulse must be < 90 bpm and the blood pressure must be < 150 mmHg systolic and < 90 mmHg diastolic.

Key exclusion criteria (20 listed)

Meet DSM IV TR criteria for dependence on drugs other than alcohol or nicotine.
Have any history or evidence suggestive of seizure disorder or brain injury
Have any previous medically adverse reaction to alcohol, including loss of consciousness, chest pain, or epileptic seizure
Have neurological or psychiatric disorders, such as:
Have evidence of clinically significant heart disease or hypertension, as determined by the PI

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CarisbamateAlso: YKP 509600mg Orally on days 2-4	Drug	Carisbamate
PlaceboAlso: Sugar PillPlacebo treatment only	Drug	Placebo

Primary outcome

Mean Biphasic Alcohol Effects Scale (BAES) Scores
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
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.
Mean Alcohol Urge Questionnaire (AUQ) Scores
Time frame: 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.
Mean Positive and Negative Affect Schedule (PANAS) Scores
Time frame: 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.
MEAN DRUG EFFECTS QUESTIONNAIRE (DEQ) SCORES
Time frame: 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.

2 secondary outcomes

Physiologic Effects of Carisbamate: Mean Systolic and Diastolic Blood Pressure
Time frame: 15, 30 and 60 minutes after alcohol (0.8 mg/kg;16% by volume) consumption
Physiologic Effects of Carisbamate: Mean Heart Rate
Time frame: 15, 30 and 60 minutes after alcohol (0.8 mg/kg;16% by volume) consumption

Results and safety

Results posted to the registry on 2 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo First, Then Carisbamate	5	3
Carisbamate First, Then Placebo	6	5

Primary outcome: Mean Biphasic Alcohol Effects Scale (BAES) Scores

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. Mean (Standard Error). Unit: score on a scale

Measure	Placebo + Alcohol Beverage n = 8	Carisbamate + Alcohol Beverage n = 8	Placebo + Placebo Beverage n = 8	Carisbamate + Placebo Beverage n = 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)

Population analysed: 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.

Primary outcome: Mean Alcohol Urge Questionnaire (AUQ) Scores

Time frame: 15, 30 and 60 minutes after consumption of placebo (1% alcohol by volume) and alcohol (0.8g/kg; 16% by volume) beverages.. Mean (Standard Error). Unit: score on a scale

Measure	Placebo + Alcohol Beverage n = 8	Carisbamate + Alcohol Beverage n = 8	Placebo + Placebo Beverage n = 8	Carisbamate + Placebo Beverage n = 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)

Primary outcome: Mean Positive and Negative Affect Schedule (PANAS) Scores

Time frame: 15, 30 and 60 minutes after consumption of placebo (1% alcohol by volume) and alcohol (0.8g/kg; 16% by volume) beverages.. Mean (Standard Error). Unit: score on a scale

Measure	Placebo + Alcohol Beverage n = 8	Carisbamate + Alcohol Beverage n = 8	Placebo + Placebo Beverage n = 8	Carisbamate + Placebo Beverage n = 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)

Primary outcome: MEAN DRUG EFFECTS QUESTIONNAIRE (DEQ) SCORES

Time frame: 15, 30 and 60 minutes after consumption of placebo (1% alcohol by volume) and alcohol (0.8g/kg; 16% by volume) beverages.. Mean (Standard Error). Unit: score on a scale

Measure	Placebo + Alcohol Beverage n = 8	Carisbamate + Alcohol Beverage n = 8	Placebo + Placebo Beverage n = 8	Carisbamate + Placebo Beverage n = 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)

2 secondary outcomes are reported in the full results.

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo First, Then Carisbamate	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Carisbamate First, Then Placebo	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas F Newton, M.D principal investigator

Baylor College of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Carisbamate in people with Alcohol Dependence and Alcohol Abuse, run by Baylor College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Biphasic Alcohol Effects Scale (BAES) Scores (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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02435381.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.