Modafinil for Methamphetamine Dependence

This study has been terminated.
(Terminated due to lack of funding.)
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00859573
First received: March 10, 2009
Last updated: June 17, 2011
Last verified: June 2011
Results First Received: April 15, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Methamphetamine Dependence
Interventions: Drug: Modafinil
Drug: Placebo

  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
A total of 20 participants were recruited into the study between 5/26/2009 and 3/30/2010. However, only 9 participants entered the study with 11 dropping out during the consent or intake process. They were recruited from newspaper advertisements and word-of-mouth advertising and who meet the following criteria.

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
Modafinil Modafinil 400mg orally once daily
Placebo Two placebo tablets orally once daily

Participant Flow:   Overall Study
    Modafinil     Placebo  
STARTED     6     3  
COMPLETED     1     1  
NOT COMPLETED     5     2  
Withdrawal by Subject                 4                 1  
Physician Decision                 1                 1  



  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
Modafinil Modafinil 400mg orally once daily
Placebo Two placebo tablets orally once daily
Total Total of all reporting groups

Baseline Measures
    Modafinil     Placebo     Total  
Number of Participants  
[units: participants]
  6     3     9  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     6     3     9  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  29.25  ± 2.87     35.88  ± 12.15     32.56  ± 9.19  
Gender  
[units: participants]
     
Female     3     1     4  
Male     3     2     5  
Region of Enrollment  
[units: participants]
     
United States     6     3     9  



  Outcome Measures

1.  Primary:   Mean Treatment Effectiveness Scores   [ Time Frame: thrice weekly from week 3 through week 8 ]

2.  Primary:   Withdrawal Symptoms   [ Time Frame: thrice weekly ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Pre-attentional Neurophysiological Measures   [ Time Frame: week 0, week 2, week 10 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Attentional Neurophysiological Measures   [ Time Frame: week 0, 2, 10 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Vital Signs   [ Time Frame: thrice weekly ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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
Early termination leading to small numbers of subjects analyzed. Small number of completers leading to small numbers of subjects analyzed.


  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: Michael J. Mancino, M.D.
Organization: University of Arkansas for Medical Sciences
phone: 501-526-8442
e-mail: mjmancino@uams.edu


No publications provided


Responsible Party: Michael Mancino, MD/Assistant Professor, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier: NCT00859573     History of Changes
Other Study ID Numbers: P50 DA018197-104386, P50 DA018197, DPMCDA
Study First Received: March 10, 2009
Results First Received: April 15, 2011
Last Updated: June 17, 2011
Health Authority: United States: Food and Drug Administration