Placebo-Controlled Cross Over Trial of Chlorzoxazone Intake

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01342341
First received: April 19, 2011
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Alcohol Abuse
Drug: Parafon Forte
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Placebo-Controlled Cross Over Trial of Chlorzoxazone Intake

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Alcohol Consumption in Drinks/Week. [ Time Frame: 45 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: April 2011
Study Completion Date: December 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Parafon Forte first, then Placebo
Experimental: Forty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive either 250 or 500 mg of chlorzoxazone BID (500 or 1000 mg/day) x 7 days followed by 500 or 1000 mg of chlorzoxazone BID (1000 or 2000 mg/day) x 7 days (1st intervention; 14 days), followed by a washout (7 days), and then followed by placebo (2nd intervention; 14 days).
Drug: Parafon Forte

Drug: Parafon Forte administered at study visit

Other: Placebo administered at study visit

Other Name: Chlorzoxazone
Placebo Comparator: Placebo first, then Parafon Forte
Experimental: Forty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive placebo (1st intervention; 14days) followed by a washout (7 days), and then followed by either 250 or 500 mg of chlorzoxazone BID (500 or 1000 mg/day) x 7 days followed by 500 or 1000 mg of chlorzoxazone BID (1000 or 2000 mg/day) x 7 days (2nd intervention; 14 days).
Drug: Parafon Forte

Drug: Parafon Forte administered at study visit

Other: Placebo administered at study visit

Other Name: Chlorzoxazone

Detailed Description:

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:

  1. 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.
  2. 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.
  3. To investigate any change in alcohol craving during a cue induced craving task where participants view and respond to a number of images.
  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

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

Exclusion Criteria:

  1. Use of cocaine, amphetamines, hallucinogens, "ecstasy", opiates, sedatives, pain pills, sleeping pills, or other psychoactive drugs more than twice a week.
  2. A history of complicated alcohol or other drug withdrawal syndrome(s), e.g. delirium tremens or seizures.
  3. Current physiological dependence on any psychoactive drug (except nicotine or caffeine) including alcohol, as determined by MD or NP assessment.
  4. 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.
  5. Currently trying to quit using alcohol and/or "recreational" drugs.
  6. 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.
  7. Bilirubin more than 2 times the normal upper limit.
  8. AST (SGOT), ALT (SGPT), or alkaline phosphatase more than 2 ½ times the normal upper limit.
  9. Symptoms of liver disease, as assessed by MD or NP assessment (jaundice, Hx of hepatitis, itchy skin, etc.).
  10. A current pregnancy, or a woman of child-bearing potential not currently using an adequate means of contraception.
  11. BAC level greater than 0.05% at the beginning of Screening Visit, Visit 1 or Visit 4.
  12. Neurological dysfunction or psychiatric disorder severe enough to interfere with assessment of outcome measures as defined above.
  13. Known allergy to chlorzoxazone.
  14. Has received an investigational drug within 30 days prior to Study Visit 2 (after screening visit).
  15. Subjects who are unable to read or speak English.
  16. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342341

Locations
United States, California
Ernest Gallo Clinic and Research Center
Emeryville, California, United States, 94608
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Howard Fields, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01342341     History of Changes
Other Study ID Numbers: Chlorzoxazone
Study First Received: April 19, 2011
Results First Received: April 22, 2014
Last Updated: May 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Chlorzoxazone
Muscle Relaxants, Central
Physiological Effects of Drugs
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014