This trial is active, not recruiting.

Conditions alcohol dependence, alcohol abuse, substance abuse
Treatments carisbamate, placebo
Phase phase 1/phase 2
Sponsor Baylor College of Medicine
Start date February 2013
End date December 2016
Trial size 26 participants
Trial identifier NCT02435381, H-30334


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
(Placebo Comparator)
Participants will receive placebo from days 2- 4.
placebo Sugar Pill
Placebo treatment only
(Active Comparator)
Participants will receive carisbamate 600mg qd from days 2- 4.
carisbamate YKP 509
600mg Orally on days 2-4

Primary Outcomes

Effects of carisbamate on the positive subjective effects of alcohol
time frame: 2 hours post alcohol administration

Secondary Outcomes

physiologic effects of carisbamate
time frame: 2 hours post alcohol administration
physiologic effects of carisbamate
time frame: 2 hours post alcohol administration
physiologic effects of carisbamate
time frame: 2 hours post alcohol administration

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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.

Additional Information

Official title Carisbamate as a Potential Treatment for Alcohol Dependence
Principal investigator Thomas F Newton, M.D
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).
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Baylor College of Medicine.