Nasal CongestionNCT00829634
Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation
A study testing l-methamphetamine and d-methamphetamine in people with Nasal Congestion, run by California Pacific Medical Center Research Institute at 1 site in United States.
Trial summary
The intent of this study is to see if the rate that the body breaks down l-methamphetamine (l-MA) could be used as an accurate estimate for the rate that the body breaks down d-methamphetamine (d-MA). l-MA is sold over the counter as a nasal decongestant where as d-MA is the commonly abused form of methamphetamine. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Congestion
- What is being tested?
- l-methamphetamine and d-methamphetamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Sep 2009
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Males and Females Between the Ages of 18 and 50
- Must have some experience with methamphetamine
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
CPMC Addiction & Pharmacology Research Laboratory (APRL)
San Francisco, California, 94110
About this study
The intent of this study is to see if the rate that the body breaks down l-methamphetamine (l-MA) could be used as an accurate estimate for the rate that the body breaks down d-methamphetamine (d-MA). l-MA is sold over the counter as a nasal decongestant where as d-MA is the commonly abused form of methamphetamine.
Read the detailed description
Subjects will screen at St. Luke's Hospital in San Francisco to determine their eligibility.
Once enrolled the study will take two weeks. During the first week subjects attend daily, hour-long outpatient visits at San Francisco General Hospital. At these visits subjects will receive an oral dose of l-methamphetamine, have their vitals read, answer questionnaires and receive a blood draw.
During the second week of the study subjects are admitted to San Francisco General Hospital for a week long inpatient stay. During this stay the subject continues to receive l-methamphetamine but also receives three doses of d-methamphetamine on three separate days. In addition the subject receives blood draws, has their urine collected, and answers questionnaires.
- Conditions
- Nasal Congestion
- Being tested
- l-methamphetamine, d-methamphetamine
- Keywords
- methamphetamine, inpatient, d-MA, l-MA, APRL, San Francisco, metabolism, Metabolism of methamphetamine
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
l-methamphetamineDrug
Also called l-MA
5mg of l-methamphetamine per day throughout the 2 week study
d-methamphetamineDrug
Also called d-MA
15mg on Study Day 9, 30mg on Study Day 11, 45mg on Study Day 13
| Study group | Role | What they receive |
|---|---|---|
| l-methamphetamine | Other | Not described Receives: Drug: l-methamphetamine; Drug: d-methamphetamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum samples
Measured: Predose and Multiple Timepoints Post Doses
Urine Samples
Measured: 24 Hour Inpatient Collection
Secondary outcomes (1)
Questionnaries
Measured: Predose and Multiple Timepoints Post Doses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startOct 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal CongestionStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Pacific Medical Center Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco General Hospital, University of California, San Francisco, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, John Mendelson, MD, California Pacific Medical Center Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829634
- Sponsor's protocol ID
- 27.092
- Status last verified
- May 2013
- First submitted
- 23 Jan 2009
- Last updated
- 31 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation
- ClinicalTrials.gov ID
- NCT00829634
- Acronym / sponsor ID
- 27.092
- Conditions
- Nasal Congestion
- Keywords
- methamphetamine, inpatient, d-MA, l-MA, APRL, San Francisco, metabolism, Metabolism of methamphetamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- California Pacific Medical Center Research InstituteUniversity, hospital or other
- Collaborators
- San Francisco General Hospital, University of California, San Francisco, National Institutes of Health (NIH)
- Study start
- Oct 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 27 Jan 2009 (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 intent of this study is to see if the rate that the body breaks down l-methamphetamine (l-MA) could be used as an accurate estimate for the rate that the body breaks down d-methamphetamine (d-MA). l-MA is sold over the counter as a nasal decongestant where as d-MA is the commonly abused form of methamphetamine.
Detailed description
Subjects will screen at St. Luke's Hospital in San Francisco to determine their eligibility.
Once enrolled the study will take two weeks. During the first week subjects attend daily, hour-long outpatient visits at San Francisco General Hospital. At these visits subjects will receive an oral dose of l-methamphetamine, have their vitals read, answer questionnaires and receive a blood draw.
During the second week of the study subjects are admitted to San Francisco General Hospital for a week long inpatient stay. During this stay the subject continues to receive l-methamphetamine but also receives three doses of d-methamphetamine on three separate days. In addition the subject receives blood draws, has their urine collected, and answers questionnaires.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| l-methamphetamine | Other | Drug: l-methamphetamine, Drug: d-methamphetamine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Males and Females Between the Ages of 18 and 50
- Must have some experience with methamphetamine
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 |
|---|---|---|
| l-methamphetamineAlso: l-MA5mg of l-methamphetamine per day throughout the 2 week study | Drug | l-methamphetamine |
| d-methamphetamineAlso: d-MA15mg on Study Day 9, 30mg on Study Day 11, 45mg on Study Day 13 | Drug | l-methamphetamine |
Primary outcome
Serum samples
Time frame: Predose and Multiple Timepoints Post Doses
Urine Samples
Time frame: 24 Hour Inpatient Collection
1 secondary outcome
Questionnaries
Time frame: Predose and Multiple Timepoints Post Doses
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 31 May 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 l-methamphetamine and d-methamphetamine in people with Nasal Congestion, 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 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 31 May 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?
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?
Serum samples (time frame: Predose and Multiple Timepoints Post Doses). The study lists 2 primary outcomes in all. 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 31 May 2013.