Placebo-Controlled Cross Over Trial of Chlorzoxazone Intake

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01342341
First received: April 19, 2011
Last updated: December 28, 2012
Last verified: December 2012
  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:
  • Reduction in alcohol consumption is measured utilizing behavioral inventories, electronic diaries, urine, and ethyl glucuronide. [ 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.


Secondary Outcome Measures:
  • Reduction in alcohol craving is measured utilizing a visual alcohol craving task, behavioral inventories, and obtaining salivary cortisol. [ Time Frame: 45 days ] [ Designated as safety issue: No ]
    Investigate whether chlorzoxazone attenuates visual cue induced alcohol craving.


Estimated Enrollment: 48
Study Start Date: April 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Parafon Forte

Experimental: Twenty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive 250 mg of chlorzoxazone BID (500 mg/day) x 7 days followed by 500 mg of chlorzoxazone BID (1000 mg/day) x 7 days.

Twenty moderate to heavy social alcohol users as described above will receive 500 mg chlorzoxazone BID (1000 mg/day) x 7 days followed by 750 mg chlorzoxazone BID (1500 mg per day) x 7 days.

Drug: Parafon Forte

Drug: Parafon Forte administered at study visit

Other: Placebo administered at study visit

Other Name: Chlorzoxazone
Placebo Comparator: Placebo

Group B Experimental: Forty moderate to heavy social alcohol users as described above will receive placebo x 14 days.

NOTE: This is a cross-over design and subjects will participate in both arms.

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
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
Last Updated: December 28, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related 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 April 14, 2014