Modafinil for Methamphetamine Dependence
This study has been terminated.
(Terminated due to lack of funding.)
Sponsor:
University of Arkansas
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00859573
First received: March 10, 2009
Last updated: June 17, 2011
Last verified: June 2011
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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
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
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
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
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. |
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
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 |