Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
Results First Received: April 22, 2014  
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
Condition: Alcohol Abuse
Intervention: Drug: Parafon Forte

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Parafon Forte: Drug: Parafon Forte administered at study visit

Other: Placebo administered at study visit

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.

Parafon Forte: Drug: Parafon Forte administered at study visit

Other: Placebo administered at study visit


Participant Flow:   Overall Study
    Parafon Forte   Placebo
STARTED   24   24 
COMPLETED   20   20 
NOT COMPLETED   4   4 
Lost to Follow-up                4                4 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Parafon Forte: Drug: Parafon Forte administered at study visit

Other: Placebo administered at study visit

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.

Parafon Forte: Drug: Parafon Forte administered at study visit

Other: Placebo administered at study visit

Total Total of all reporting groups

Baseline Measures
   Parafon Forte   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   40 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   20   20   40 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   10   10   20 
Male   10   10   20 


  Outcome Measures

1.  Primary:   Alcohol Consumption in Drinks/Week.   [ Time Frame: 45 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Jennifer Mitchell, Clinical Project Director
Organization: Ernest Gallo Clinic and Research Center
phone: 510-985-3921
e-mail: jmitchell@gallo.ucsf.edu



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