Methamphetamine AddictionPhase 2NCT00538655
A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence
A Phase 2 study testing modafinil in people with Methamphetamine Addiction, run by California Pacific Medical Center Research Institute at 1 site in United States.
Trial summary
Patients treated for methamphetamine dependence have high rates of relapse, and no pharmacotherapy has yet been demonstrated to be efficacious. Modafinil (d, l-2-[(diphenylmethyl) sulfinyl] acetamide) is a novel wake- and vigilance- promoting agent that is chemically and pharmacologically dissimilar to CNS stimulants… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Methamphetamine Addiction
- What is being tested?
- modafinil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jun 2011
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 50 years
- Patient is agreeable to conditions of study and signs consent form
- Fluency in English
- Contact site for additional information.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
CPMC - St. Luke's Hospital ~ 7th Floor/ Addiction Pharmacology Research Lab
San Francisco, California, 94110
About this study
Patients treated for methamphetamine dependence have high rates of relapse, and no pharmacotherapy has yet been demonstrated to be efficacious. Modafinil (d, l-2-[(diphenylmethyl) sulfinyl] acetamide) is a novel wake- and vigilance- promoting agent that is chemically and pharmacologically dissimilar to CNS stimulants such as the amphetamines, methylphenidate, and pemoline. It is well tolerated and has low abuse liability compared to CNS stimulants. Modafinil is FDA approved for a variety of sleep disorders, may relieve methamphetamine withdrawal symptoms, improves cognitive function, has been shown to reduce cocaine use in dependent users, and is safe when co-administered with intravenous methamphetamine. We will conduct a pilot, open-label clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence.
Specific Aims:
Read more
- Determine the safety of modafinil in the treatment of methamphetamine dependence.
- Determine the efficacy of modafinil in the treatment of methamphetamine dependence.
- Assess the effect of modafinil on cognitive function in methamphetamine users.
- Assess the effect of modafinil on methamphetamine withdrawal symptoms.
- Compare the validity of a cellular telephone-based reporting system for assessing medication regimen adherence to conventional electronic medication monitoring.
Hypotheses:
- Modafinil will be as safe and well tolerated as placebo in a comparison group from another study.
- Subjects given modafinil will use less methamphetamine than subjects given placebo.
- Subjects given modafinil with demonstrate improvements in cognitive function when compared to subjects given placebo.
- Subjects given modafinil will have reduced withdrawal symptoms when compared to subjects given placebo.
- Adherence will be recorded more accurately by cellular telephone than by conventional electronic medication monitoring.
- Conditions
- Methamphetamine Addiction
- Being tested
- modafinil
- Keywords
- amphetamine, methamphetamine, addition, treatment study, drug use, modafinil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modafinilDrug
Also called Provigil
400mg vs. 200mg (PO) daily
| Study group | Role | What they receive |
|---|---|---|
| modafinil | Experimental | Not described Receives: Drug: modafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
MA (-) urine samples
Measured: multiple
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2007 (estimated)
- Study startJan 2008
- Primary completionJan 2009
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine AddictionStudies 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
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Pacific Medical Center Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gantt Galloway, PharmD, California Pacific Medical Center Research Institute
- Investigators
- Gantt Galloway, Pharm D., Principal investigator, California Pacific Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538655
- Sponsor's protocol ID
- 27.004
- Status last verified
- May 2013
- First submitted
- 2 Oct 2007
- Last updated
- 3 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence
- ClinicalTrials.gov ID
- NCT00538655
- Acronym / sponsor ID
- 27.004
- Conditions
- Methamphetamine Addiction
- Keywords
- amphetamine, methamphetamine, addition, treatment study, drug use, modafinil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- California Pacific Medical Center Research InstituteUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 3 Oct 2007 (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.
Patients treated for methamphetamine dependence have high rates of relapse, and no pharmacotherapy has yet been demonstrated to be efficacious. Modafinil (d, l-2-[(diphenylmethyl) sulfinyl] acetamide) is a novel wake- and vigilance- promoting agent that is chemically and pharmacologically dissimilar to CNS stimulants such as the amphetamines, methylphenidate, and pemoline. It is well tolerated and has low abuse liability compared to CNS stimulants. Modafinil is FDA approved for a variety of sleep disorders, may relieve methamphetamine withdrawal symptoms, improves cognitive function, has been shown to reduce cocaine use in dependent users, and is safe when co-administered with intravenous methamphetamine. We will conduct a pilot, open-label clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence.
Specific Aims:
- Determine the safety of modafinil in the treatment of methamphetamine dependence.
- Determine the efficacy of modafinil in the treatment of methamphetamine dependence.
- Assess the effect of modafinil on cognitive function in methamphetamine users.
- Assess the effect of modafinil on methamphetamine withdrawal symptoms.
- Compare the validity of a cellular telephone-based reporting system for assessing medication regimen adherence to conventional electronic medication monitoring.
Hypotheses:
- Modafinil will be as safe and well tolerated as placebo in a comparison group from another study.
- Subjects given modafinil will use less methamphetamine than subjects given placebo.
- Subjects given modafinil with demonstrate improvements in cognitive function when compared to subjects given placebo.
- Subjects given modafinil will have reduced withdrawal symptoms when compared to subjects given placebo.
- Adherence will be recorded more accurately by cellular telephone than by conventional electronic medication monitoring.
Study design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| modafinil | Experimental | Drug: modafinil |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 50 years
- Patient is agreeable to conditions of study and signs consent form
- Fluency in English
- Contact site for additional information.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| modafinilAlso: Provigil400mg vs. 200mg (PO) daily | Drug | modafinil |
Primary outcome
MA (-) urine samples
Time frame: multiple
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2013.
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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.
Gantt Galloway, Pharm D. principal investigator
California Pacific Medical Center
1 site 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 Methamphetamine Addiction, run by California Pacific Medical Center Research Institute at 1 site in United States.
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 0 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: finished, as of the sponsor's last update on 3 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MA (-) urine samples (time frame: multiple). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2013.