Open-Label Disulfiram for Methamphetamine Dependence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00731133
First received: August 6, 2008
Last updated: January 20, 2012
Last verified: January 2012
Results First Received: November 2, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Methamphetamine Dependence
Intervention: Drug: Disulfiram

  Participant Flow
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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
Disulfiram Disulfiram at 250 mg daily

Participant Flow:   Overall Study
    Disulfiram  
STARTED     15  
COMPLETED     5  
NOT COMPLETED     10  
Withdrawal by Subject                 10  



  Baseline Characteristics
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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
Disulfiram Disulfiram at 250 mg daily

Baseline Measures
    Disulfiram  
Number of Participants  
[units: participants]
  15  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     15  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  35.93  ± 9.29  
Gender  
[units: participants]
 
Female     5  
Male     10  
Region of Enrollment  
[units: participants]
 
United States     15  



  Outcome Measures
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1.  Primary:   Side Effects Checklist   [ Time Frame: Weekly for six weeks ]

2.  Secondary:   Proportion of Amphetamine-positive Urine Samples   [ Time Frame: thrice weekly for 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Large dropout so few participants had data throughout the trial. No control group so cannot determine whether side effects were related to disulfiram or an artifact of participation.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Alison Oliveto
Organization: UAMS
phone: 501-526-8441
e-mail: olivetoalison@uams.edu


No publications provided


Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00731133     History of Changes
Other Study ID Numbers: 5-P50-DA018197-105242, 5-P50-DA018197, DPMCDA
Study First Received: August 6, 2008
Results First Received: November 2, 2011
Last Updated: January 20, 2012
Health Authority: United States: Food and Drug Administration