Carisbamate as a Potential Treatment for Alcohol Dependence

NCT02435381 | Completed Phase 1 Results DMC

• 1 other identifier: H-30334
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Dependence; Alcohol Abuse; Substance Abuse

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

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

• Physiologic Effects of Carisbamate: Mean Heart Rate

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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants will receive placebo from days 2- 4.

Drug: Placebo

Carisbamate

ACTIVE COMPARATOR

Participants will receive carisbamate 600mg qd from days 2- 4.

Drug: Carisbamate

Interventions

Carisbamate DRUG

600mg Orally on days 2-4

Also known as: YKP 509

Carisbamate

Placebo DRUG

Placebo treatment only

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Alcoholism; Substance-Related Disorders

Interventions

S-2-O-carbamoyl-1-o-chlorophenyl-ethanol; Sugars

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Christopher D. Verrico Ph.D.
• Organization: Baylor College of Medicine

Cverrico@bcm.edu

713-791-1414

Study Officials

• Thomas F Newton, M.D

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Psychiatry Research

Study Record Dates

• First Submitted: September 7, 2013
• First Posted: May 6, 2015
• Study Start: February 1, 2013
• Primary Completion: September 30, 2013
• Study Completion: September 30, 2013
• Last Updated: March 2, 2021
• Results First Posted: March 2, 2021

Record last verified: 2021-02

Locations

US (1)