Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00123383

Enrollment

Registered

2005-07-22

Start date

2005-07-31

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

Cocaine Dependence

Keywords

Modafinil, Cocaine 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 cocaine 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 liability. Thirty dependent cocaine users will be randomised 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 cocaine negative urine samples collected over the 10 week study period. Adverse events, side effects, compliance, retention, self reported health, psychosocial and drug use outcomes will also be compared between the 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

* DSM-IV cocaine dependence diagnosis * Cocaine positive urine sample at intake * Regular current cocaine use (2-3 days per week) * Aged 18 years or older

Exclusion criteria

* Pregnant or nursing females * Concurrent uncontrolled physical or mental illness

Design outcomes

Primary

Measure	Time frame
Urinalysis negative for cocaine 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