Effects of Modafinil in Methamphetamine Dependence - Full Text View

Sponsor:	Medical University of South Carolina
Information provided by:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00751023

Purpose

Methamphetamine dependence is a serious public health problem with no pharmacologic treatments currently available. Relapse rates are high in this population. Exposure to cues previously associated with methamphetamine use may induce profound craving in abstinent individuals. Chronic methamphetamine abuse is associated with selective cognitive deficits that may undermine successful participation in psychosocial treatments. Medications which improve cognitive deficits in methamphetamine-dependent individuals may improve abstinence rates, especially in the critical early period of recovery. Modafinil is an atypical stimulant medication with evidence to support its use in treating cocaine dependence and attention deficit/hyperactivity disorder. The proposed studies are designed to evaluate modafinil as a potential treatment for methamphetamine dependence and its cognitive sequelae.

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

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
Official Title:	Effects of Modafinil in Methamphetamine Dependence

Resource links provided by NLM:

MedlinePlus related topics: Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Modafinil Amphetamine Methamphetamine

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:

Percentage of methamphetamine-positive urine drug screens [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Score on the California Verbal Learning Test [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Score on the Symbol Digit Modalities Test [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Score on the Paced Auditory Serial Addition Test [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Score on the Wisconsin Card Sort Test [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Score on the Grooved Pegboard Test [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Score on the Shipley Institute of Living Scale [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Score on the Beck Depression Inventory [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
Effects on cue-induced craving for methamphetamine [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	February 2009
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Modafinil 400 mg daily	Drug: Modafinil 400 mg daily for four weeks Other Name: Provigil
Placebo Comparator: 2 Placebo	Drug: Placebo Placebo 2 tablets daily for 4 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
Subjects must meet DSM-IV criteria for methamphetamine dependence within the past six months. Subjects may meet criteria for abuse, but not dependence on any other substance with the exception of nicotine. Because of the high comorbidity of methamphetamine and nicotine dependence, excluding nicotine dependence would seriously compromise the feasibility of recruitment. Nicotine use immediately prior to the cue reactivity testing session will be controlled.
Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) for 24 hours prior to the cue reactivity testing sessions.
Subjects must consent to random assignment to the modafinil vs. placebo conditions.

Exclusion Criteria:

Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease as these conditions may affect heart rate or skin conductance measurement.
Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may impact cue reactivity.
Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) for 24 hours prior the cue procedures.
Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or methamphetamine as appropriate) within the past 60 days.
Subjects currently taking B-blockers, anti-arrhythmic agents, psychostimulants or any other agents known to interfere with heart rate and skin conductance monitoring.
Known or suspected hypersensitivity to modafinil.
Individuals taking medications that could adversely interact with study medications.
Subjects with a history of epilepsy or seizure disorder.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751023

Locations

United States, South Carolina
Behavioral Health Services of Pickens County
Pickens, South Carolina, United States, 29671

Sponsors and Collaborators

Medical University of South Carolina

Investigators

Principal Investigator:

Bryan K Tolliver, MD, PhD

Medical University of South Carolina

More Information

No publications provided

Responsible Party:	Bryan K. Tolliver, M.D., Ph.D., MUSC Department of Psychiatry, Division of Clinical Neuroscience
ClinicalTrials.gov Identifier:	NCT00751023 History of Changes
Other Study ID Numbers:	HR#18440
Study First Received:	September 10, 2008
Last Updated:	August 4, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:

Methamphetamine
Modafinil
Addiction
Craving
Cognitive

Additional relevant MeSH terms:

Methamphetamine
Amphetamine
Modafinil
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on February 09, 2012