The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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/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/show/NCT00123370