Clinical trial NCT00538655: A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence
Official title: A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Methamphetamine Addiction
Keywords: amphetamine
methamphetamine
addition
treatment study
drug use
modafinil
Lead sponsor: California Pacific Medical Center Research Institute
Sponsor class: OTHER
First posted: 2007-10-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 50 years
* Patient is agreeable to conditions of study and signs consent form
* Fluency in English

Contact site for additional information.

Primary outcomes:
measure: MA (-) urine samples
timeFrame: multiple
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: CPMC - St. Luke's Hospital ~ 7th Floor/ Addiction Pharmacology Research Lab
state: California
Study officials:
affiliation: California Pacific Medical Center
name: Gantt Galloway, Pharm D.
role: PRINCIPAL_INVESTIGATOR
References: