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Open-Label Disulfiram for Methamphetamine Dependence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00731133
First Posted: August 8, 2008
Last Update Posted: February 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Arkansas
Results First Submitted: November 2, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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
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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 
Overall Participants Analyzed 
[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



Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00731133     History of Changes
Other Study ID Numbers: 5-P50-DA018197-105242
5P50DA018197 ( U.S. NIH Grant/Contract )
DPMCDA
First Submitted: August 6, 2008
First Posted: August 8, 2008
Results First Submitted: November 2, 2011
Results First Posted: February 27, 2012
Last Update Posted: February 27, 2012