Effects of Modafinil in Methamphetamine Dependence

Condition(s) targeted: Methamphetamine Dependence

Intervention: Modafinil (Drug); Placebo (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Medical University of South Carolina

Official(s) and/or principal investigator(s):
Bryan K Tolliver, MD, PhD

Overall contact:
Bryan K Tolliver, MD, PhD, Phone: (843) 792-4869, Email: tollive@musc.edu

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.

Official title: Effects of Modafinil in Methamphetamine Dependence

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Percentage of methamphetamine-positive urine drug screens

Secondary outcome:

Score on the California Verbal Learning Test

Score on the Symbol Digit Modalities Test

Score on the Paced Auditory Serial Addition Test

Score on the Wisconsin Card Sort Test

Score on the Grooved Pegboard Test

Score on the Shipley Institute of Living Scale

Score on the Beck Depression Inventory

Effects on cue-induced craving for methamphetamine

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.

2. 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.

3. Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) for 24 hours prior to the cue reactivity testing sessions.

4. Subjects must consent to random assignment to the modafinil vs. placebo conditions.

Exclusion Criteria:

1. Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.

2. 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.

3. Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may impact cue reactivity.

4. 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.

5. Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or methamphetamine as appropriate) within the past 60 days.

6. Subjects currently taking B-blockers, anti-arrhythmic agents, psychostimulants or any other agents known to interfere with heart rate and skin conductance monitoring.

7. Known or suspected hypersensitivity to modafinil.

8. Individuals taking medications that could adversely interact with study medications.

9. Subjects with a history of epilepsy or seizure disorder.

Bryan K Tolliver, MD, PhD, Phone: (843) 792-4869, Email: tollive@musc.edu

Starting date: February 2009
Last updated: February 12, 2009