Methamphetamine DisordersPROJECT RESINNCT07464873
Reliability, Validity, and Acceptability of a Novel Visual Scale for Estimating Daily Methamphetamine Use Among People Who Use Methamphetamine
An observational study of Methamphetamine Disorders, run by Phillip Coffin, MD, MIA at 1 site in United States.
Trial summary
PROJECT RESIN: This study is examining the reliability, validity, and acceptability of a novel visual scale for estimating daily methamphetamine use among people who use methamphetamine. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Methamphetamine Disorders
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2026to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adults 20-40 years old who use methamphetamine and have scalp hair.
Who may be able to join
- Age 20-40 inclusive
- English speaking
- Self-reports using methamphetamine at least once in the past 7 days (attempts will be made to enroll participants with varied frequencies of methamphetamine use)
- At least 1cm of untreated occipital scalp hair
- Hair is brown or black
- Willing to provide a hair sample
Who cannot join
- Participant, in the opinion of the investigators, would be unable to complete study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
SFDPH Center on Substance Use and Health
San Francisco, California, 94102
Phillip Coffin, MD, MIA, 628-217-6282, Phillip.coffin@sfdph.org
About this study
PROJECT RESIN: This study is examining the reliability, validity, and acceptability of a novel visual scale for estimating daily methamphetamine use among people who use methamphetamine.
Read the detailed description
Methamphetamine is a widely used psychostimulant associated with substantial cardiovascular and neuropsychiatric morbidity. The toxic effects of methamphetamine are dose-dependent, but clinical trials of interventions for methamphetamine use disorder often rely on urine drug screening as a primary outcome. Urine drug screening provides qualitative results and can remain positive for 5-7 days after using methamphetamine, thus limiting its use in trials that seek to measure use reduction and not only abstinence as a treatment outcome.
Existing methods of measuring the frequency and amount of methamphetamine use include timeline follow-back (TLFB), which provides only days of use without any assessment of amount used each day, and hair sampling analysis, which may be able to demonstrate within-subject reduction in use over time but is impacted by numerous variables (including age, sex hormones, presence of hair, willingness to provide hair, hair color, and exposure to secondhand methamphetamine smoke) that limit its widespread use and inter-person reliability.
To address this gap in methods for measuring reductions in methamphetamine use, we developed a novel visual scale that uses measured quantities of a methamphetamine analog (crystallized phenethylamine hydrochloride) encased in transparent polyester resin blocks, similar to food intake visual scales that use three-dimensional models of food portions. The purpose of this study is to assess the reliability, validity, and acceptability of the methamphetamine analogue visual scale (MAVS) among people who use methamphetamine (PWUM) with the hope of using the scale in future trials of pharmacotherapies for methamphetamine use disorder.
- Conditions
- Methamphetamine Disorders
- Keywords
- methamphetamine, timeline, follow, back, timeline follow-back, resin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Resin Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability - Timeline Follow-back
The methamphetamine analog visual scale (MAVS) will be administered with the timeline follow-back (TLFB) at V0 and V1, which are 7-14 days apart. Each TLFB will assess 30 days prior to the date of assessment. The reliability outcome will compare within-subject reliability of meth use on overlapping days of TLFB using MAVS.
Measured: Conducted at enrollment (V0) and follow-up (V1) to record meth use 30 days from those dates. The data will be collected as amount per day for 30 days.
Validity - Hair Sample
To assess validity, we will compare the hair sampling analysis and self-reported meth use via the MAVS/TLFB. Methamphetamine levels are determined by liquid chromatography tandem mass spectrometry (LC/MS/MS) using a Micromass Quattro Ultima and Shimadzu HPLC system equipped with a Phenomenex Synergi Polar-RP column (4.6 x 150 mm, 4 μm particle size), a mobile phase system consisting of acetonitrile:water:trifluoro acetic acid (20:80:0.05), and mass spectrometric detection with positive ionization by electrospray ionization and mass scanning by multiple reaction monitoring ([M+H]+ transitions of 150/119 (Q1/Q3) m/z for methamphetamine and 159/125 m/z for deuterated methamphetamine). The standard curve range of methamphetamine by LC/MS/MS analysis is 0.00800 nanograms (ng)/mg (lower limit) to 3.20 ng/mg of hair.
Measured: Hair sample will be collected at the enrollment visit
Validity - Weighted Surrogate Assessment
Participants will work with the researchers to measure out a quantity of a non-psychoactive drug surrogate onto a physical milligram scale until the participant reports that the quantity matches their daily use. The min value of this scale is 0 and there is no max value. The actual score does not represent a better or worse outcome, rather we are comparing it to the reported value. To avoid potential use triggers associated with this procedure, it will be performed in a professional and clinical fashion, with the phenethylamine kept in laboratory glassware and handled with gloves and tweezers. This will be compared to the reported value to assess validity. This will be conducted at V0 and V1.
Measured: At enrollment visit (V0) and at follow-up visit (V1). The data will be collected as amount per day for the most recent day of use.
Acceptability Questionnaire
A questionnaire will be administered to assess the acceptability of the MAVS among people who use methamphetamine. This will be performed V1 and will consist of several 5-point Likert scale questions on the MAVS' ease of use, relevance to use patterns, and whether seeing the drug surrogate triggers a desire to use. A higher value on the scale measures higher acceptability.
Measured: Follow-up visit (V1). The questionnaire will cover the time frame of the study, which will be 7-14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine DisordersStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phillip Coffin, MD, MIA
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Phillip Coffin, MD, MIA, San Francisco Department of Public Health
- Investigators
- Phillip Coffin, Principal investigator, San Francisco Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464873
- Sponsor's protocol ID
- 26-45903
- Acronym
- PROJECT RESIN
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability, Validity, and Acceptability of a Novel Visual Scale for Estimating Daily Methamphetamine Use Among People Who Use Methamphetamine
- ClinicalTrials.gov ID
- NCT07464873
- Acronym / sponsor ID
- PROJECT RESIN / 26-45903
- Conditions
- Methamphetamine Disorders
- Keywords
- methamphetamine, timeline, follow, back, timeline follow-back, resin
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Phillip Coffin, MD, MIAOther government
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 11 Mar 2026 (actual)
- 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.
PROJECT RESIN: This study is examining the reliability, validity, and acceptability of a novel visual scale for estimating daily methamphetamine use among people who use methamphetamine.
Detailed description
Methamphetamine is a widely used psychostimulant associated with substantial cardiovascular and neuropsychiatric morbidity. The toxic effects of methamphetamine are dose-dependent, but clinical trials of interventions for methamphetamine use disorder often rely on urine drug screening as a primary outcome. Urine drug screening provides qualitative results and can remain positive for 5-7 days after using methamphetamine, thus limiting its use in trials that seek to measure use reduction and not only abstinence as a treatment outcome.
Existing methods of measuring the frequency and amount of methamphetamine use include timeline follow-back (TLFB), which provides only days of use without any assessment of amount used each day, and hair sampling analysis, which may be able to demonstrate within-subject reduction in use over time but is impacted by numerous variables (including age, sex hormones, presence of hair, willingness to provide hair, hair color, and exposure to secondhand methamphetamine smoke) that limit its widespread use and inter-person reliability.
To address this gap in methods for measuring reductions in methamphetamine use, we developed a novel visual scale that uses measured quantities of a methamphetamine analog (crystallized phenethylamine hydrochloride) encased in transparent polyester resin blocks, similar to food intake visual scales that use three-dimensional models of food portions. The purpose of this study is to assess the reliability, validity, and acceptability of the methamphetamine analogue visual scale (MAVS) among people who use methamphetamine (PWUM) with the hope of using the scale in future trials of pharmacotherapies for methamphetamine use disorder.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resin Cohort | – | – |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adults 20-40 years old who use methamphetamine and have scalp hair.
Key inclusion criteria (6 listed)
- Age 20-40 inclusive
- English speaking
- Self-reports using methamphetamine at least once in the past 7 days (attempts will be made to enroll participants with varied frequencies of methamphetamine use)
- At least 1cm of untreated occipital scalp hair
- Hair is brown or black
Key exclusion criteria (1 listed)
- Participant, in the opinion of the investigators, would be unable to complete study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reliability - Timeline Follow-back
Time frame: Conducted at enrollment (V0) and follow-up (V1) to record meth use 30 days from those dates. The data will be collected as amount per day for 30 days.
The methamphetamine analog visual scale (MAVS) will be administered with the timeline follow-back (TLFB) at V0 and V1, which are 7-14 days apart. Each TLFB will assess 30 days prior to the date of assessment. The reliability outcome will compare within-subject reliability of meth use on overlapping days of TLFB using MAVS.
Validity - Hair Sample
Time frame: Hair sample will be collected at the enrollment visit
To assess validity, we will compare the hair sampling analysis and self-reported meth use via the MAVS/TLFB. Methamphetamine levels are determined by liquid chromatography tandem mass spectrometry (LC/MS/MS) using a Micromass Quattro Ultima and Shimadzu HPLC system equipped with a Phenomenex Synergi Polar-RP column (4.6 x 150 mm, 4 μm particle size), a mobile phase system consisting of acetonitrile:water:trifluoro acetic acid (20:80:0.05), and mass spectrometric detection with positive ionization by electrospray ionization and mass scanning by multiple reaction monitoring ([M+H]+ transitions of 150/119 (Q1/Q3) m/z for methamphetamine and 159/125 m/z for deuterated methamphetamine). The standard curve range of methamphetamine by LC/MS/MS analysis is 0.00800 nanograms (ng)/mg (lower limit) to 3.20 ng/mg of hair.
Validity - Weighted Surrogate Assessment
Time frame: At enrollment visit (V0) and at follow-up visit (V1). The data will be collected as amount per day for the most recent day of use.
Participants will work with the researchers to measure out a quantity of a non-psychoactive drug surrogate onto a physical milligram scale until the participant reports that the quantity matches their daily use. The min value of this scale is 0 and there is no max value. The actual score does not represent a better or worse outcome, rather we are comparing it to the reported value. To avoid potential use triggers associated with this procedure, it will be performed in a professional and clinical fashion, with the phenethylamine kept in laboratory glassware and handled with gloves and tweezers. This will be compared to the reported value to assess validity. This will be conducted at V0 and V1.
Acceptability Questionnaire
Time frame: Follow-up visit (V1). The questionnaire will cover the time frame of the study, which will be 7-14 days.
A questionnaire will be administered to assess the acceptability of the MAVS among people who use methamphetamine. This will be performed V1 and will consist of several 5-point Likert scale questions on the MAVS' ease of use, relevance to use patterns, and whether seeing the drug surrogate triggers a desire to use. A higher value on the scale measures higher acceptability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Phillip Coffin principal investigator
San Francisco Department of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Methamphetamine Disorders, run by Phillip Coffin, MD, MIA 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 6 inclusion and 1 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: opening soon, as of the sponsor's last update on 11 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phillip Coffin, MD, MIA (628-217-6282, Phillip.coffin@sfdph.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability - Timeline Follow-back (time frame: Conducted at enrollment (V0) and follow-up (V1) to record meth use 30 days from those dates. The data will be collected as amount per day for 30 days.). 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?
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 11 Mar 2026.