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Placebo-Controlled Cross Over Trial of Chlorzoxazone Intake

Primary Purpose

Alcohol Abuse

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Parafon Forte
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Abuse

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ernest Gallo Clinic and Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Parafon Forte first, then Placebo

Placebo first, then Parafon Forte

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Alcohol Consumption in Drinks/Week.
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.

Secondary Outcome Measures

Full Information

First Posted
April 19, 2011
Last Updated
November 18, 2020
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01342341
Brief Title
Placebo-Controlled Cross Over Trial of Chlorzoxazone Intake
Official Title
Placebo-Controlled Cross Over Trial of Chlorzoxazone Intake
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parafon Forte first, then Placebo
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo first, then Parafon Forte
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Parafon Forte
Other Intervention Name(s)
Chlorzoxazone
Intervention Description
Drug: Parafon Forte administered at study visit Other: Placebo administered at study visit
Primary Outcome Measure Information:
Title
Alcohol Consumption in Drinks/Week.
Description
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.
Time Frame
45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Fields, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ernest Gallo Clinic and Research Center
City
Emeryville
State/Province
California
ZIP/Postal Code
94608
Country
United States

12. IPD Sharing Statement

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Placebo-Controlled Cross Over Trial of Chlorzoxazone Intake

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