Methamphetamine Dependence5INCT01919437
Comparison of Methamphetamine-Dependent and Healthy Volunteers Using a Web-Enabled Cognitive Neuropsychological Evaluation System
A study testing Web-Enabled Cognitive Neuropsychological Evaluation System in people with Methamphetamine Dependence, run by California Pacific Medical Center Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to develop the technology infrastructure for a mobile Web-based cognitive and neuropsychological assessment of substance abusers, and to perform a pilot trial using neurocognitive tasks designed to demonstrate that our system is statistically comparable to current clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Methamphetamine Dependence
- What is being tested?
- Web-Enabled Cognitive Neuropsychological Evaluation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Oct 2013
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, aged 18 to 55.
- Ability to give informed consent.
Who cannot join
- Unwilling or unable to access the web over a cell phone or living in an area with no cell phone service.
- Any medical, psychiatric, or other condition that, in the opinion of the investigator, would preclude safe, consistent, or useful participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
CPMC Addiction & Pharmacology Research Laboratory
San Francisco, California, 94107
About this study
The purpose of this study is to develop the technology infrastructure for a mobile Web-based cognitive and neuropsychological assessment of substance abusers, and to perform a pilot trial using neurocognitive tasks designed to demonstrate that our system is statistically comparable to current clinical practice.
The primary hypotheses are that results collected using a web-based data collection platform will be comparable (but not necessarily equivalent) to data collected under controlled laboratory conditions, that methamphetamine (MA) dependent participants will have worsened neurocognitive performance compared to healthy volunteers, and the platform will be acceptable to participants.
- Conditions
- Methamphetamine Dependence
- Being tested
- Web-Enabled Cognitive Neuropsychological Evaluation System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Enabled Cognitive Neuropsychological Evaluation SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Web-Enabled Cognitive Neuropsychological Evaluation System | Experimental | Not described Receives: Device: Web-Enabled Cognitive Neuropsychological Evaluation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of neurocognitive task results
Results collected using a web-based data collection platform will be comparable (but not necessarily equivalent) to data collected under controlled laboratory conditions.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startApr 2012
- Primary completionOct 2012
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Pacific Medical Center Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Creare, Inc.
- Responsible party
- Principal investigator, John Mendelson, MD, California Pacific Medical Center Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919437
- Sponsor's protocol ID
- 2011.118-2
- Acronym
- 5I
- Status last verified
- Aug 2013
- First submitted
- 29 May 2013
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Methamphetamine-Dependent and Healthy Volunteers Using a Web-Enabled Cognitive Neuropsychological Evaluation System
- ClinicalTrials.gov ID
- NCT01919437
- Acronym / sponsor ID
- 5I / 2011.118-2
- Conditions
- Methamphetamine Dependence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- California Pacific Medical Center Research InstituteUniversity, hospital or other
- Collaborators
- Creare, Inc.
- Study start
- Apr 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2013 (estimated)
- First posted
- 9 Aug 2013 (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 purpose of this study is to develop the technology infrastructure for a mobile Web-based cognitive and neuropsychological assessment of substance abusers, and to perform a pilot trial using neurocognitive tasks designed to demonstrate that our system is statistically comparable to current clinical practice.
The primary hypotheses are that results collected using a web-based data collection platform will be comparable (but not necessarily equivalent) to data collected under controlled laboratory conditions, that methamphetamine (MA) dependent participants will have worsened neurocognitive performance compared to healthy volunteers, and the platform will be acceptable to participants.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Web-Enabled Cognitive Neuropsychological Evaluation System | Experimental | Device: Web-Enabled Cognitive Neuropsychological Evaluation System |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male or female, aged 18 to 55.
- Ability to give informed consent.
Key exclusion criteria (2 listed)
- Unwilling or unable to access the web over a cell phone or living in an area with no cell phone service.
- Any medical, psychiatric, or other condition that, in the opinion of the investigator, would preclude safe, consistent, or useful participation in the study.
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 |
|---|---|---|
| Web-Enabled Cognitive Neuropsychological Evaluation System | Device | Web-Enabled Cognitive Neuropsychological Evaluation System |
Primary outcome
Comparison of neurocognitive task results
Time frame: 2 weeks
Results collected using a web-based data collection platform will be comparable (but not necessarily equivalent) to data collected under controlled laboratory conditions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Enabled Cognitive Neuropsychological Evaluation System in people with Methamphetamine Dependence, 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 2 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 9 Aug 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.
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?
Comparison of neurocognitive task results (time frame: 2 weeks). 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 9 Aug 2013.