Trial of Modafinil for Methamphetamine Dependence

April 29, 2007 updated by: The University of New South Wales

Randomised Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence

The study aims to evaluate the safety and efficacy of modafinil (200 mg/day) over 10 weeks plus a tailored cognitive behavioural therapy program in the treatment of methamphetamine dependence.

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

Modafinil is a novel wake promoting agent approved in Australia for the treatment of narcolepsy. Preliminary studies have suggested that modafinil may have value in the treatment of psychostimulant dependence through positive effects on mood, sleep patterns, concentration, fatigue and drug craving. It appears to be well tolerated with a low abuse potential. Sixty dependent methamphetamine users will be allocated to 2 equal groups. The experimental group will receive modafinil 200 mg/day for 10 weeks and a tailored cognitive behavioural therapy program. The control group will receive placebo under equivalent conditions. Primary outcome will be a between group comparison of methamphetamine negative urine samples over the 10 week study period. Adverse events, side effects, compliance, retention and self reported health, psychosocial and drug use will also be compared between the study groups.

Study Type

Interventional

Enrollment (Anticipated)

87

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

    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Kirketon Road Centre
      • Darlinghurst, New South Wales, Australia, 2010
        • Alcohol and Drug Services, St Vincent's Hospital

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) amphetamine dependence diagnosis
  • Amphetamine positive urine sample at intake
  • Regular current amphetamine use (2-3 days per week)
  • Aged 18 years or older

Exclusion Criteria:

  • Pregnant or nursing females
  • Hazardous concurrent uncontrolled physical or mental illness

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: SINGLE_GROUP
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 10 weeks
10 weeks
Urinalysis results negative for methamphetamine over 10 weeks
Time Frame: 10 weeks
10 weeks
Compliance
Time Frame: 10 weeks
10 weeks
Retention
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Self reported drug use
Time Frame: 10 weeks
10 weeks
Health outcomes
Time Frame: 10 weeks
10 weeks
Psychosocial outcomes
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Richard P Mattick, PhD, University of New South Wales

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.

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

July 1, 2006

Study Completion (ANTICIPATED)

September 1, 2007

Study Registration Dates

First Submitted

July 21, 2005

First Submitted That Met QC Criteria

July 21, 2005

First Posted (ESTIMATE)

July 22, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

May 1, 2007

Last Update Submitted That Met QC Criteria

April 29, 2007

Last Verified

July 1, 2006

More Information

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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