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A Dose Ranging Study of Modafinil for Methamphetamine Dependence

NCT00630097 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2011-06-22

No results posted yet for this study

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. 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 coadministered with intravenous methamphetamine. We will conduct a randomized dose ranging clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence.

Conditions

  • Substance Dependence
  • Amphetamine Dependence

Interventions

DRUG

modafinil

Modafinil, 100mg, 400mg, or 600 mg tablets QD for 4 weeks.

Sponsors & Collaborators

  • California Pacific Medical Center Research Institute

    lead OTHER

Principal Investigators

  • Gantt Galloway, PharmD · California Pacific Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00630097 on ClinicalTrials.gov