NCT02435381

Carisbamate as a Potential Treatment for Alcohol Dependence

Completed Phase 1/Phase 2 Results posted Last updated 10 February 2021

What this trial tests

Phase 1/Phase 2 trial testing Carisbamate in Alcohol Dependence in 11 participants. Completed in 30 September 2013.

Timeline

1 February 2013

Primary endpoint
30 September 2013

30 September 2013

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	other
Enrollment	11
Start date	1 February 2013
Primary completion	30 September 2013
Estimated completion	30 September 2013
Sites	1 location across United States

Drugs / interventions tested

• Carisbamate — full drug profile →
• Placebo

Conditions studied

• Alcohol Dependence — all drugs for Alcohol Dependence →
• Alcohol Abuse — all drugs for Alcohol Abuse →
• Substance Abuse — all drugs for Substance Abuse →

Sponsor

Baylor College of Medicine

Who can join

Adults 18 to 55, any sex, with Alcohol Dependence or Alcohol Abuse. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 + BAE
• 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"
• 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"

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.