Safety and Tolerability of Modafinil for Methamphetamine Dependence

University of Arkansas

Status and phase

Completed

Phase 2

Conditions

Methamphetamine Dependence

Treatments

Drug: Modafinil

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00569374

Protocol / IRB # 79045

Details and patient eligibility

About

This 7 week, open-label pilot clinical trial will examine the safety and tolerability of modafinil up to 400mg/day as a potential treatment to reduce methamphetamine use in methamphetamine-dependent volunteers.

Enrollment

8 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

18-65 years old
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