Reliability, Validity, and Acceptability of a Novel Visual Scale for Estimating Daily Methamphetamine Use Among People Who Use Methamphetamine
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Methamphetamine Disorders. Базовые параметры: 20 лет — 40 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Reliability - Timeline Follow-back [Срок оценки: 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 [Срок оценки: Hair sample will be collected at the enrollment visit]
- Validity - Weighted Surrogate Assessment [Срок оценки: 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 [Срок оценки: Follow-up visit (V1). The questionnaire will cover the time frame of the study, which will be 7-14 days.]
Критерии участия
Критерии включения
- 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
Критерии исключения
- Participant, in the opinion of the investigators, would be unable to complete study procedures
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
США · 1 центр
- SFDPH Center on Substance Use and Health — San Francisco
Идентификаторы
NCT: NCT07464873 · 26-45903