Effects of Modafinil in Methamphetamine Dependence
This study has been completed.
Information provided by:
Medical University of South Carolina
First received: September 10, 2008
Last updated: August 4, 2011
Last verified: November 2009
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Effects of Modafinil in Methamphetamine Dependence
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:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2010 (Final data collection date for primary outcome measure)
Modafinil 400 mg daily
400 mg daily for four weeks
Other Name: Provigil
Placebo Comparator: 2
Placebo 2 tablets daily for 4 weeks
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751023
|Behavioral Health Services of Pickens County
|Pickens, South Carolina, United States, 29671 |
Medical University of South Carolina
||Bryan K Tolliver, MD, PhD
||Medical University of South Carolina
No publications provided
||Bryan K. Tolliver, M.D., Ph.D., MUSC Department of Psychiatry, Division of Clinical Neuroscience
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 10, 2008
||August 4, 2011
||United States: Food and Drug Administration
Keywords provided by Medical University of South Carolina:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Peripheral Nervous System Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors