Trial of Modafinil for Methamphetamine Dependence - Full Text View

Sponsors and Collaborators:	The University of New South Wales Australian Government Department of Health and Ageing Kirketon Road Centre, Sydney Hospital St Vincent's Hospital, Sydney
Information provided by:	The University of New South Wales
ClinicalTrials.gov Identifier:	NCT00123370

Purpose

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.

Condition	Intervention	Phase
Amphetamine Dependence	Drug: Modafinil	Phase II

MedlinePlus related topics: Methamphetamine

Drug Information available for: Modafinil Amphetamine Amphetamine sulfate Methamphetamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Randomised Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence

Further study details as provided by The University of New South Wales:

Primary Outcome Measures:

Urinalysis results negative for methamphetamine over 10 weeks [ Time Frame: 10 weeks ]
Adverse events [ Time Frame: 10 weeks ]
Compliance [ Time Frame: 10 weeks ]
Retention [ Time Frame: 10 weeks ]

Secondary Outcome Measures:

Self reported drug use [ Time Frame: 10 weeks ]
Health outcomes [ Time Frame: 10 weeks ]
Psychosocial outcomes [ Time Frame: 10 weeks ]

Estimated Enrollment:	87
Study Start Date:	July 2006
Estimated Study Completion Date:	September 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123370

Locations

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

Sponsors and Collaborators

The University of New South Wales

Australian Government Department of Health and Ageing

Kirketon Road Centre, Sydney Hospital

St Vincent's Hospital, Sydney

Investigators

Principal Investigator:

Richard P Mattick, PhD

University of New South Wales

More Information

Study ID Numbers:	HREC05025
Study First Received:	July 21, 2005
Last Updated:	April 29, 2007
ClinicalTrials.gov Identifier:	NCT00123370
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The University of New South Wales:

Modafinil
Amphetamine Dependence
Randomised placebo-controlled trial

Study placed in the following topic categories:

Methamphetamine
Dopamine
Mental Disorders
Amphetamine-Related Disorders

Substance-Related Disorders
Disorders of Environmental Origin
Amphetamine
Modafinil

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Sympathomimetics
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants

Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009