Safety and Tolerability of Modafinil for Methamphetamine Dependence

This study has been completed.

Study NCT00569374 Information provided by University of Arkansas

First Received on December 5, 2007. Last Updated on September 30, 2010 History of Changes

Results First Received: November 6, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Methamphetamine Dependence
Intervention:	Drug: Modafinil

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
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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
Modafinil	All participants were started on Modafinil titrated to 400mg in this open label trial.

Participant Flow: Overall Study

	Modafinil
STARTED	8
COMPLETED	4
NOT COMPLETED	4
Withdrawal by Subject	4

Baseline Characteristics

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Reporting Groups

	Description
Modafinil	All participants were started on Modafinil titrated to 400mg in this open label trial.

Baseline Measures

	Modafinil
Number of Participants [units: participants]	8
Age [units: participants]
<=18 years	0
Between 18 and 65 years	8
>=65 years	0
Age [units: years] Mean ± Standard Deviation	45.3 ± 7.2
Gender [units: participants]
Female	4
Male	4
Region of Enrollment [units: participants]
United States	8

Outcome Measures

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1. Primary:

Heart Rate [ Time Frame: Thrice weekly for 7 weeks ]

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2. Primary:

Systolic Blood Pressure [ Time Frame: Thrice weekly for 7 weeks ]

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3. Primary:

Diastolic Blood Pressure [ Time Frame: Thrice weekly for 7 weeks ]

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4. Primary:

"Modafinil Side Effects Checklist" [ Time Frame: Weekly for 7 weeks ]

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5. Primary:

Anxiety as Measured by the Hamilton Anxiety Scale [ Time Frame: Thrice weekly for 7 weeks ]

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6. Primary:

Depression as Measured by the Hamilton Depression Scale [ Time Frame: Thrice weekly for 7 weeks ]

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7. Secondary:

Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire. [ Time Frame: Thrice weekly for the first three weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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
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Results Point of Contact:

Name/Title: Dr. Alison Oliveto
Organization: University of Arkansas for Medical Sciences Center for Addiction Research
phone: 501-526-8441
e-mail: olivetoalison@uams.edu

No publications provided

Responsible Party:	Carole Hamon, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier:	NCT00569374 History of Changes
Other Study ID Numbers:	Protocol / IRB # 79045
Study First Received:	December 5, 2007
Results First Received:	November 6, 2009
Last Updated:	September 30, 2010
Health Authority:	United States: Food and Drug Administration