Safety and Tolerability of Modafinil for Methamphetmaine Dependence

This study has been completed.

First Received: December 5, 2007 Last Updated: December 3, 2008 History of Changes

Sponsor:	University of Arkansas
Collaborator:	NIDA Baylor Medications Development Center
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00569374

Purpose

This 7 week, open-label pilot clinical trial will examine the safety and tolerability of modafinil up to 400mg/day as a potential treatment to reduce methamphetamine use in methamphetamine-dependent volunteers.

Condition	Intervention	Phase
Methamphetamine Dependence	Drug: Modafinil	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Safety and Tolerability of Modafinil for Methamphetamine Dependence

Resource links provided by NLM:

MedlinePlus related topics: Methamphetamine

Drug Information available for: Modafinil

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

Safety and tolerability of modafinil in methamphetamine-dependent persons [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Treatment retention and illicit drug use [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	8
Study Start Date:	September 2007
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Intervention Details:

subjects attend clinic for the first week in order to receive meds; oral, 200mg/day doses for three days for initiation doses; increased to oral 400mg/day for the remainder of the trial (weeks 2-6); washout period during week 7

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

18-65 years old
not currently enrolled in a treatment program
subjects must have a history of methamphetamine use with recent use confirmed by a positive urine toxicology screen for amphetamines during themonth prior to study entry
subjects must meet DSM-IV criteria for amphetamine dependence as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV (SCID)
women of childbearing age must have a negative pregnancy test to enroll in this study, agree to monthly pregnancy testing, and agree to use appropriate forms of birth control for the duration of the study

Exclusion Criteria:

current diagnosis of alcohol, opiate, or sedative physical dependence
ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder)
history of schizophrenia, or bipolar type I disorder
present or recent use of over-the-counter or prescription psychoative drug or drug(s) that would be expected to have major interaction with drug to be tested
medical contraindication to receiving study medications (e.g., allergy to modafinil, treatment with cyclosporine, clomipramine, or desipramine)
Current suicidality or psychosis
liver function tests (i.e., liver enzymes) greater than three times normal levels
pregnancy or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569374

Locations

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205

Sponsors and Collaborators

University of Arkansas

NIDA Baylor Medications Development Center

Investigators

Principal Investigator:

Dr. Janette McGaugh, MD

University of Arkansas

More Information

No publications provided

Responsible Party:	University of Arkansas for Medical Sciences ( Carole Hamon )
Study ID Numbers:	Protocol / IRB # 79045
Study First Received:	December 5, 2007
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00569374 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Stimulants
Protective Agents

Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Modafinil

ClinicalTrials.gov processed this record on November 25, 2009