Amphetamine DependencePhase 2NCT00123370
Trial of Modafinil for Methamphetamine Dependence
A Phase 2 study testing Modafinil in people with Amphetamine Dependence, run by The University of New South Wales at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amphetamine Dependence
- What is being tested?
- Modafinil
- How many people
- 87 participants
- Where
- 2 sitesAustralia
- Study dates
- Jul 2006to Sep 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or nursing females
- Hazardous concurrent uncontrolled physical or mental illness
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Alcohol and Drug Services, St Vincent's Hospital
Darlinghurst, New South Wales, 2010
Kirketon Road Centre
Darlinghurst, New South Wales, 2010
About this study
Official title: Randomised Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence
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.
Read the 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 potential. Sixty dependent methamphetamine users will be allocated 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 methamphetamine negative urine samples over the 10 week study period. Adverse events, side effects, compliance, retention and self reported health, psychosocial and drug use will also be compared between the study groups.
- Conditions
- Amphetamine Dependence
- Being tested
- Modafinil
- Keywords
- Modafinil, Amphetamine Dependence, Randomised placebo-controlled trial
- Medical subject headings
- Amphetamine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinalysis results negative for methamphetamine over 10 weeks
Measured: 10 weeks
Adverse events
Measured: 10 weeks
Compliance
Measured: 10 weeks
Retention
Measured: 10 weeks
Secondary outcomes (3)
Self reported drug use
Measured: 10 weeks
Health outcomes
Measured: 10 weeks
Psychosocial outcomes
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startJul 2006
- Study completionSep 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Amphetamine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- Australian Government Department of Health and Ageing, Kirketon Road Centre, Sydney Hospital, St Vincent's Hospital, Sydney
- Investigators
- Richard P Mattick, PhD, Principal investigator, University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123370
- Sponsor's protocol ID
- HREC05025
- Status last verified
- Jul 2006
- First submitted
- 21 Jul 2005
- Last updated
- 1 May 2007
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 20565514Shearer J, Darke S, Rodgers C, Slade T, van Beek I, Lewis J, Brady D, McKetin R, Mattick RP, Wodak A. A double-blind, placebo-controlled trial of modafinil (200 mg/day) for methamphetamine dependence. Addiction. 2009 Feb;104(2):224-33. doi: 10.1111/j.1360-0443.2008.02437.x.
PubMed 19149817
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence
- ClinicalTrials.gov ID
- NCT00123370
- Acronym / sponsor ID
- HREC05025
- Conditions
- Amphetamine Dependence
- Keywords
- Modafinil, Amphetamine Dependence, Randomised placebo-controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Collaborators
- Australian Government Department of Health and Ageing, Kirketon Road Centre, Sydney Hospital, St Vincent's Hospital, Sydney
- Study start
- Jul 2006
- Study completion
- Sep 2007 (estimated)
- First posted
- 22 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 potential. Sixty dependent methamphetamine users will be allocated 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 methamphetamine negative urine samples over the 10 week study period. Adverse events, side effects, compliance, retention and self reported health, psychosocial and drug use will also be compared between the study groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant or nursing females
- Hazardous concurrent uncontrolled physical or mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modafinil | Drug | – |
Primary outcome
Urinalysis results negative for methamphetamine over 10 weeks
Time frame: 10 weeks
Adverse events
Time frame: 10 weeks
Compliance
Time frame: 10 weeks
Retention
Time frame: 10 weeks
3 secondary outcomes
Self reported drug use
Time frame: 10 weeks
Health outcomes
Time frame: 10 weeks
Psychosocial outcomes
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2007.
- Derived from this study: PubMed 20565514Shearer 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.
- Derived from this study: PubMed 19149817Shearer J, Darke S, Rodgers C, Slade T, van Beek I, Lewis J, Brady D, McKetin R, Mattick RP, Wodak A. A double-blind, placebo-controlled trial of modafinil (200 mg/day) for methamphetamine dependence. Addiction. 2009 Feb;104(2):224-33. doi: 10.1111/j.1360-0443.2008.02437.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard P Mattick, PhD principal investigator
University of New South Wales
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Modafinil in people with Amphetamine Dependence, run by The University of New South Wales at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinalysis results negative for methamphetamine over 10 weeks (time frame: 10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00123370, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2007.