Reliability, Validity, and Acceptability of a Novel Visual Scale for Estimating Daily Methamphetamine Use Among People Who Use Methamphetamine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Methamphetamine Disorders. Basic parameters: 20 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- 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.]
- Validity - Hair Sample [Time frame: Hair sample will be collected at the enrollment visit]
- 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.]
- Acceptability Questionnaire [Time frame: Follow-up visit (V1). The questionnaire will cover the time frame of the study, which will be 7-14 days.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Participant, in the opinion of the investigators, would be unable to complete study procedures
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- SFDPH Center on Substance Use and Health — San Francisco
Identifiers
NCT: NCT07464873 · 26-45903