Phase 2, Multi-Center Trial of Modafinil for Methamphetamine Dependence

February 23, 2017 updated by: National Institute on Drug Abuse (NIDA)

Phase2, Double-blind, Placebo-controlled Trial of Modafinil for the Treatment of Methamphetamine Dependence

The purpose of this study will be to examine the safety and efficacy of modafinil in increasing number of methamphetamine non-use weeks in subjects with methamphetamine dependence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To evaluate the efficacy and safety of modafinil in reducing methamphetamine use in subjects with methamphetamine dependence. It is hypothesized that modafinil, compared to placebo, will be associated with an increase in the number of methamphetamine non-use weeks over time as measured by quantitative urine analysis for methamphetamine.

Study Type

Interventional

Enrollment (Actual)

210

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 Diego, California, United States, 92105
        • South Bay Treatment Center
      • Tarzana, California, United States, 91356
        • Matrix Institute on Addictions
      • Torrance, California, United States, 90502
        • Torrance Site
    • Colorado
      • Denver, Colorado, United States, 80220
        • University of Colorado Health Sciences Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • John A. Burns School of Medicine
    • Iowa
      • Des Moines, Iowa, United States, 50316
        • Powell Chemical Dependency Center
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • START Research and Treatment
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • Salt Lake City VA Medical Center

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be between the ages of 18 and 65
  • Methamphetamine dependent as defined by DSM-IV criteria
  • Must be in good general heath with a history of methamphetamine use at screening
  • Must be able to provide written informed consent
  • If female and of child bearing potential, must agree to use birth control.

Exclusion Criteria:

  • Please contact site for more 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
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Modafinil
Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks
Drug: Modafinil
200 mg or 400 mg /daily
Placebo Comparator: Placebo
Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks
Drug: Placebo
Placebo / daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abstinence (Week 1 - 12)
Time Frame: Weeks 1 - 12
Number of participant who abstained from methamphetamine from weeks 1 through 12
Weeks 1 - 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of Craving
Time Frame: 21 days
Number of subjects with 21 or more consecutive days of abstinence
21 days

Collaborators and Investigators

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

Sponsor

National Institute on Drug Abuse (NIDA)

Collaborators

VA Office of Research and Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

August 23, 2007

First Submitted That Met QC Criteria

August 23, 2007

First Posted (Estimate)

August 24, 2007

Study Record Updates

Last Update Posted (Actual)

April 7, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-CSP-1026-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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