Modafinil 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: NCT00859573
Recruitment Status : Terminated (Terminated due to lack of funding.)
First Posted : March 11, 2009
Results First Posted : July 15, 2011
Last Update Posted : November 21, 2017
Information provided by (Responsible Party):
University of Arkansas

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Methamphetamine Dependence
Interventions: Drug: Modafinil
Drug: Placebo

  Participant Flow

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
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 
Withdrawal by Subject                4                1 
Physician Decision                1                1 

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

Baseline Measures
   Modafinil   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   3   9 
[Units: Participants]
Count of Participants
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      6 100.0%      3 100.0%      9 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
[Units: Years]
Mean (Standard Deviation)
 29.25  (2.87)   35.88  (12.15)   32.56  (9.19) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      3  50.0%      1  33.3%      4  44.4% 
Male      3  50.0%      2  66.7%      5  55.6% 
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 ]

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

  More Information

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

Responsible Party: University of Arkansas Identifier: NCT00859573     History of Changes
Other Study ID Numbers: P50 DA018197-104386
First Submitted: March 10, 2009
First Posted: March 11, 2009
Results First Submitted: April 15, 2011
Results First Posted: July 15, 2011
Last Update Posted: November 21, 2017