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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00123383




Registration number
NCT00123383
Ethics application status
Date submitted
21/07/2005
Date registered
22/07/2005
Date last updated
1/05/2007

Titles & IDs
Public title
Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence
Scientific title
Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence
Secondary ID [1] 0 0
HREC05023
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cocaine Dependence 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Urinalysis negative for cocaine over 10 weeks
Timepoint [1] 0 0
10 weeks
Primary outcome [2] 0 0
Adverse events
Timepoint [2] 0 0
10 weeks
Primary outcome [3] 0 0
Compliance
Timepoint [3] 0 0
10 weeks
Primary outcome [4] 0 0
Retention
Timepoint [4] 0 0
10 weeks
Secondary outcome [1] 0 0
Self reported drug use
Timepoint [1] 0 0
10 weeks
Secondary outcome [2] 0 0
Health outcomes
Timepoint [2] 0 0
10 weeks
Secondary outcome [3] 0 0
Psychosocial outcomes
Timepoint [3] 0 0
10 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or nursing females
* Concurrent uncontrolled physical or mental illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2007
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Alcohol & Drug Services, St Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Kirketon Road Centre, Sydney Hospital - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Australian Government Department of Health and Ageing
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Kirketon Road Centre, Sydney Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
St Vincent's Hospital, Sydney
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00123383
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Richard P Mattick, PhD
Address 0 0
University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00123383