NCT00123383

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

May 1, 2007

Status Verified

July 1, 2006

First QC Date

July 21, 2005

Last Update Submit

April 29, 2007

Conditions

Cocaine Dependence

Keywords

ModafinilCocaine DependenceRandomised placebo-controlled trial

Outcome Measures

Primary Outcomes (4)

  • Urinalysis negative for cocaine over 10 weeks

    10 weeks

  • Adverse events

    10 weeks

  • Compliance

    10 weeks

  • Retention

    10 weeks

Secondary Outcomes (3)

  • Self reported drug use

    10 weeks

  • Health outcomes

    10 weeks

  • Psychosocial outcomes

    10 weeks

Interventions

ModafinilDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alcohol & Drug Services, St Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

Kirketon Road Centre, Sydney Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

Related Publications (1)

  • 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.

    PMID: 20565514DERIVED

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Richard P Mattick, PhD

    University of New South Wales

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2005

First Posted

July 22, 2005

Study Start

July 1, 2005

Study Completion

September 1, 2007

Last Updated

May 1, 2007

Record last verified: 2006-07

Locations

AU(2)