A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence

May 30, 2013 updated by: Gantt Galloway, PharmD, California Pacific Medical Center Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • CPMC - St. Luke's Hospital ~ 7th Floor/ Addiction Pharmacology Research Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: modafinil
Drug: modafinil
400mg vs. 200mg (PO) daily
Other Names:
  • Provigil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MA (-) urine samples
Time Frame: multiple
multiple

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Pacific Medical Center Research Institute

Investigators

  • Principal Investigator: Gantt Galloway, Pharm D., California Pacific Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

October 2, 2007

First Submitted That Met QC Criteria

October 2, 2007

First Posted (Estimate)

October 3, 2007

Study Record Updates

Last Update Posted (Estimate)

June 3, 2013

Last Update Submitted That Met QC Criteria

May 30, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27.004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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