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Carisbamate as a Potential Treatment for Alcohol Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02435381
Recruitment Status : Unknown
Verified July 2017 by Thomas Newton, Baylor College of Medicine.
Recruitment status was:  Active, not recruiting
First Posted : May 6, 2015
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):
Thomas Newton, Baylor College of Medicine

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Single Group 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 : February 2013
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Participants will receive placebo from days 2- 4.
Drug: Placebo
Placebo treatment only
Other Name: Sugar Pill

Active Comparator: Carisbamate
Participants will receive carisbamate 600mg qd from days 2- 4.
Drug: Carisbamate
600mg Orally on days 2-4
Other Name: YKP 509




Primary Outcome Measures :
  1. Effects of carisbamate on the positive subjective effects of alcohol [ Time Frame: 2 hours post alcohol administration ]
    Subjective effects (after consuming carisbamate and alcohol) will be assessed using a 10-item visual analog scale (VAS).


Secondary Outcome Measures :
  1. physiologic effects of carisbamate [ Time Frame: 2 hours post alcohol administration ]
    systolic and diastolic blood pressure will be monitored after consuming carisbamate and alcohol

  2. physiologic effects of carisbamate [ Time Frame: 2 hours post alcohol administration ]
    pulse will be monitored after consuming carisbamate and alcohol

  3. physiologic effects of carisbamate [ Time Frame: 2 hours post alcohol administration ]
    ECG will be monitored after consuming carisbamate and alcohol



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  7. Have a baseline EKG that demonstrates clinically normal sinus rhythm, clinically normal conduction, and no clinically significant arrhythmias
  8. 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
  5. Have evidence of clinically significant heart disease or hypertension, as determined by the PI
  6. Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease
  7. Have symptomatic HIV or are taking antiretroviral medication
  8. 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
  9. 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.
  10. Currently seeking help for alcohol dependence.
  11. Subjects with or prone to clinically significant alcohol withdrawal.
  12. More than thirty days of abstinence from alcohol in the ninety days prior to enrollment.
  13. A history of major alcohol-related medical complications requiring hospitalization (i.e. pancreatitis).
  14. 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.
  15. Use of inhibitors/substrates for renal cationic transporters, or medications contraindicated with ethanol.
  16. A history of violence or aggression, assessed as part of the clinical interview at screening visit.

Information from the National Library of Medicine

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): NCT02435381


Locations
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United States, Texas
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Thomas F Newton, M.D Baylor College of Medicine
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Responsible Party: Thomas Newton, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02435381    
Other Study ID Numbers: H-30334
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders