Trial of Modafinil for Methamphetamine Dependence

Randomised Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00123370

Enrollment

Registered

2005-07-22

Start date

2006-07-31

Completion date

2007-09-30

Last updated

2007-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amphetamine Dependence

Keywords

Modafinil, Amphetamine Dependence, Randomised placebo-controlled trial

Brief summary

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

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.

Interventions

DRUGModafinil

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Urinalysis results negative for methamphetamine over 10 weeks	10 weeks
Adverse events	10 weeks
Compliance	10 weeks
Retention	10 weeks

Secondary

Measure	Time frame
Health outcomes	10 weeks
Psychosocial outcomes	10 weeks
Self reported drug use	10 weeks

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026