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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00123370




Registration number
NCT00123370
Ethics application status
Date submitted
21/07/2005
Date registered
22/07/2005
Date last updated
1/05/2007

Titles & IDs
Public title
Trial of Modafinil for Methamphetamine Dependence
Scientific title
Randomised Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence
Secondary ID [1] 0 0
HREC05025
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Modafinil

Treatment: Drugs: Modafinil
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Urinalysis results negative for methamphetamine 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
- 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
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

- Hazardous 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 status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2007
Actual
Sample size
Target
87
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Alcohol and Drug Services, St Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Kirketon Road Centre - 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
Other
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 methamphetamine
dependence.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00123370
Trial related presentations / publications
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/ct2/show/NCT00123370