Effects of Modafinil in Methamphetamine Dependence
This study has been completed.
Sponsor:
Medical University of South Carolina
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00751023
First received: September 10, 2008
Last updated: August 4, 2011
Last verified: November 2009
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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 4 |
| 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
Amphetamine
Methamphetamine
Modafinil
Armodafinil
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 May 22, 2013