Placebo-Controlled Cross Over Trial of Chlorzoxazone Intake

NCT01342341 | Completed Phase 4 Results DMC

• 1 other identifier: Chlorzoxazone
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Abuse

Outcome Measures

Primary Outcomes (1)

• 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.

  45 days

Study Arms (2)

Parafon Forte first, then Placebo

EXPERIMENTAL

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

Placebo first, then Parafon Forte

PLACEBO COMPARATOR

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

Interventions

Parafon Forte DRUG

Drug: Parafon Forte administered at study visit Other: Placebo administered at study visit

Also known as: Chlorzoxazone

Parafon Forte first, then Placebo; Placebo first, then Parafon Forte

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Ernest Gallo Clinic and Research Center

Emeryville, California, 94608, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Chlorzoxazone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzoxazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Jennifer Mitchell, Clinical Project Director
• Organization: Ernest Gallo Clinic and Research Center

jmitchell@gallo.ucsf.edu

510-985-3921

Study Officials

• Howard Fields, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2011
• First Posted: April 27, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 20, 2020
• Results First Posted: June 26, 2014

Record last verified: 2020-11

Locations

US (1)