Modafinil for Methamphetamine Dependence - Full Text View

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) University of Arkansas
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00859573

Purpose

Fifty methamphetamine dependent treatment-seeking volunteers will be enrolled in this 10 week, double bind, placebo controlled, randomized clinical trial to receive either modafinil or placebo. Eligible subjects will reside at the Recovery Centers of Arkansas residential facility to achieve initial abstinence and be inducted onto study medication during wks 1-2. Then during wks 3-10, subjects participate on an outpatient basis, receiving weekly psychotherapy while continuing to receive study medications. Urine samples will be collected thrice weekly and self reports weekly to assess methamphetamine use. It is hoped that the results of this study will contribute to our understanding of which types of agents may be good candidates for further development as potential treatment agents for this disorder.

Condition	Intervention	Phase
Methamphetamine Dependence	Drug: Modafinil Drug: Placebo	Phase II

MedlinePlus related topics: Methamphetamine Urine and Urination

Drug Information available for: Methamphetamine hydrochloride Modafinil Amphetamine Methamphetamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Efficacy of Modafinil in Recently-Abstinent Methamphetamine-Dependent Volunteers

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

urine toxicology screens [ Time Frame: thrice weekly ] [ Designated as safety issue: No ]
withdrawal symptoms [ Time Frame: thrice weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

pre-attentional neurophysiological measures [ Time Frame: week 0, week 2, week 10 ] [ Designated as safety issue: No ]
attentional neurophysiological measures [ Time Frame: week 0, 2, 10 ] [ Designated as safety issue: No ]
vital signs [ Time Frame: thrice weekly ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	March 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1. Modafinil: Active Comparator	Drug: Modafinil 400 mg/day
2: Placebo: Placebo Comparator Placebo	Drug: Placebo inactive substance

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18-65 years old. For the neurophysiological measures portion of the study subjects will be included if they are between the ages of 20-65 because the P50 potential is not fully developed in children and adolescents (Rasco 2000).

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 the month 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 psychoactive 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: NCT00859573

Contacts

Contact: Mahadev Prasad

501-526-7969

prasadmahadev@uams.edu

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

University of Arkansas

Investigators

Principal Investigator:

Michael Mancino, MD

University of Arkansas

More Information

No publications provided

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

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Methamphetamine
Dopamine
Adrenergic Agents
Central Nervous System Stimulants

Dopamine Agents
Amphetamine
Peripheral Nervous System Agents
Neuroprotective Agents
Modafinil

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Sympathomimetics
Physiological Effects of Drugs
Central Nervous System Stimulants
Protective Agents

Neuroprotective Agents
Modafinil
Pharmacologic Actions
Methamphetamine
Autonomic Agents
Therapeutic Uses
Amphetamine
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 06, 2009