Methamphetamine Addiction Clinical Trial
Official title:
A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence
Patients treated for methamphetamine dependence have high rates of relapse, and no
pharmacotherapy has yet been demonstrated to be efficacious. Modafinil (d,
l-2-[(diphenylmethyl) sulfinyl] acetamide) is a novel wake- and vigilance- promoting agent
that is chemically and pharmacologically dissimilar to CNS stimulants such as the
amphetamines, methylphenidate, and pemoline. It is well tolerated and has low abuse
liability compared to CNS stimulants. Modafinil is FDA approved for a variety of sleep
disorders, may relieve methamphetamine withdrawal symptoms, improves cognitive function, has
been shown to reduce cocaine use in dependent users, and is safe when co-administered with
intravenous methamphetamine. We will conduct a pilot, open-label clinical trial of modafinil
to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence.
Specific Aims:
1. Determine the safety of modafinil in the treatment of methamphetamine dependence.
2. Determine the efficacy of modafinil in the treatment of methamphetamine dependence.
3. Assess the effect of modafinil on cognitive function in methamphetamine users.
4. Assess the effect of modafinil on methamphetamine withdrawal symptoms.
5. Compare the validity of a cellular telephone-based reporting system for assessing
medication regimen adherence to conventional electronic medication monitoring.
Hypotheses:
1. Modafinil will be as safe and well tolerated as placebo in a comparison group from
another study.
2. Subjects given modafinil will use less methamphetamine than subjects given placebo.
3. Subjects given modafinil with demonstrate improvements in cognitive function when
compared to subjects given placebo.
4. Subjects given modafinil will have reduced withdrawal symptoms when compared to
subjects given placebo.
5. Adherence will be recorded more accurately by cellular telephone than by conventional
electronic medication monitoring.
n/a
Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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