Trial of Modafinil for Methamphetamine Dependence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Amphetamine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Modafinil

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Richard P Mattick, PhD

Role: PRINCIPAL_INVESTIGATOR

University of New South Wales

Locations

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Alcohol and Drug Services, St Vincent's Hospital

Darlinghurst, New South Wales, Australia

Site Status

Kirketon Road Centre

Darlinghurst, New South Wales, Australia

Site Status

Countries

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Australia

References

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Shearer J, Shanahan M, Darke S, Rodgers C, van Beek I, McKetin R, Mattick RP. A cost-effectiveness analysis of modafinil therapy for psychostimulant dependence. Drug Alcohol Rev. 2010 May;29(3):235-42. doi: 10.1111/j.1465-3362.2009.00148.x.

Reference Type DERIVED

PMID: 20565514 (View on PubMed)

Shearer J, Darke S, Rodgers C, Slade T, van Beek I, Lewis J, Brady D, McKetin R, Mattick RP, Wodak A. A double-blind, placebo-controlled trial of modafinil (200 mg/day) for methamphetamine dependence. Addiction. 2009 Feb;104(2):224-33. doi: 10.1111/j.1360-0443.2008.02437.x.

Reference Type DERIVED

PMID: 19149817 (View on PubMed)

Other Identifiers

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HREC05025

Identifier Type: -

Identifier Source: org_study_id