Open-Label Disulfiram for Methamphetamine Dependence

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. Identifier: NCT00731133
Recruitment Status : Completed
First Posted : August 8, 2008
Results First Posted : February 27, 2012
Last Update Posted : February 27, 2012
Information provided by (Responsible Party):
University of Arkansas

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

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
Disulfiram Disulfiram at 250 mg daily

Participant Flow:   Overall Study
Withdrawal by Subject                10 

  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
Disulfiram Disulfiram at 250 mg daily

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   15 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 35.93  (9.29) 
[Units: Participants]
Female   5 
Male   10 
Region of Enrollment 
[Units: Participants]
United States   15 

  Outcome Measures

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

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

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

Responsible Party: University of Arkansas Identifier: NCT00731133     History of Changes
Other Study ID Numbers: 5-P50-DA018197-105242
5P50DA018197 ( U.S. NIH Grant/Contract )
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