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Completed

NCT Number: NCT01342341

Placebo-Controlled Cross Over Trial of Chlorzoxazone Intake

The overall goals of this study are to (1) expand knowledge about interactions of chlorzoxazone with alcohol by assessing the effects of chlorzoxazone compared to placebo in moderate and heavy social alcohol users and (2) to compare the effects of chlorzoxazone on visual cue induced alcohol craving to placebo in moderate to heavy social alcohol users.

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Key information

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ernest Gallo Clinic and Research Center

Emeryville, California, 94608, United States

About this study

The investigators propose a 45-day, double-blind, placebo-controlled crossover study in light to moderate and heavy alcohol users.

The specific aims are to:

  • Determine if chlorzoxazone alters daily alcohol consumption by comparing the mean drinks consumed per day during chlorzoxazone administration compared with the mean drinks per day consumed during placebo administration.
  • To determine if polymorphisms in genes encoding for neurotransmitters or receptors involved in alcohol reward, abuse, dependence, craving, or relapse may predict the level of response to chlorzoxazone's effects on alcohol consumption or craving.
  • To investigate any change in alcohol craving during a cue induced craving task where participants view and respond to a number of images.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

Healthy adults who are social drinkers 21 - 50 years of age.

  • Moderate to heavy social drinkers (women=10-25 drinks/week, men=14-30 drinks/week).
  • If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device [IUD], or hormonal birth control).
  • Able and willing to provide written informed consent.
  • Able to understand and follow the instructions of the investigator, and understand all rating scales.

Exclusion criteria

  • Use of cocaine, amphetamines, hallucinogens, "ecstasy", opiates, sedatives, pain pills, sleeping pills, or other psychoactive drugs more than twice a week.
  • A history of complicated alcohol or other drug withdrawal syndrome(s), e.g. delirium tremens or seizures.
  • Current physiological dependence on any psychoactive drug (except nicotine or caffeine) including alcohol, as determined by MD or NP assessment.
  • Current enrollment in an alcohol or other drug treatment program, or current legal problems relating to alcohol or other drug use, including awaiting trial or supervision by a parole or probation officer.
  • Currently trying to quit using alcohol and/or "recreational" drugs.
  • Clinically significant medical or psychiatric illness as determined by screening blood tests, medical history, and physical exam performed or reviewed by the study MD or NP.
  • Bilirubin more than 2 times the normal upper limit.
  • AST (SGOT), ALT (SGPT), or alkaline phosphatase more than 2 ½ times the normal upper limit.
  • Symptoms of liver disease, as assessed by MD or NP assessment (jaundice, Hx of hepatitis, itchy skin, etc.).
  • A current pregnancy, or a woman of child-bearing potential not currently using an adequate means of contraception.
  • BAC level greater than 0.05% at the beginning of Screening Visit, Visit 1 or Visit 4.
  • Neurological dysfunction or psychiatric disorder severe enough to interfere with assessment of outcome measures as defined above.
  • Known allergy to chlorzoxazone.
  • Has received an investigational drug within 30 days prior to Study Visit 2 (after screening visit).
  • Subjects who are unable to read or speak English.
  • Those who, in the opinion of the investigator, are considered unable to adhere to scheduled appointments, are unlikely to comply with the study protocol, or who are unsuitable for any other reason.

Treatment and study plan

Parafon Forte

Drug

Drug: Parafon Forte administered at study visit

Other: Placebo administered at study visit

Other names: Chlorzoxazone

Primary outcomes

  1. Alcohol Consumption in Drinks/Week.

    Time frame: 45 days

    Each subject will record how many drinks/week they are consuming while on the study drug and placebo during the 45-day study. The primary outcome of this study is to determine the effect of chlorzoxazone on alcohol consumption. Reduction in alcohol consumption is measured utilizing behavioral inventories, electronic diaries, urine, and ethyl glucuronide.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 27, 2011
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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