Neuroimaging of Adolescent Cannabis Use Treatment
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
- В протоколе указаны: Contingency Management, Elastic Net Regression.
- Кому может быть актуально
- Состояния в реестре: Cannabis Use, Cannabis Dependence, Cannabis Use Disorder, Cannabis Abuse. Базовые параметры: 14 лет — 17 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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Официальное название
Neuroimaging of Instrumental Learning Networks in Adolescent Cannabis Use Treatment
Обзор
This study is testing whether brain activity related to learning can help predict how well teens respond to a treatment program designed to reduce cannabis use. Teens ages 14-17 will complete a brain scan and then take part in 10 weekly virtual sessions where they report cannabis use and complete drug tests at home. Participants can earn prizes for staying cannabis-free.
Подробное описание
This is a 13-week clinical trial to examine whether success during contingency management treatment for cannabis use is associated with baseline functioning of instrumental learning neuro-circuitries. The investigators propose to recruit N=80 youths ages 14-17 with varying levels of cannabis use. Following phone prescreening, participants will undergo informed consent/assent and eligibility assessment with an in-person visit. Participants who are eligible will undergo a functional magnetic resonance imaging (fMRI) scan where participants will perform an instrumental learning task during a second in-person visit. At this visit, participants and participants' guardians or most recent caregiver will be provided with ten urine drug screens. A tutorial will be provided by study staff on how to administer and read urine drug screens. After the fMRI scan, participants will undergo ten weekly virtual contingency management sessions administered via HIPAA-compliant telehealth software (e.g., Microsoft Teams). At each contingency management (CM) session, participants will be asked to provide a urine sample, and participants' guardians will be asked to administer the urine drug screen based on this sample. At each contingency management session, the timeline followback will be used to assess which days since the last session participants used cannabis at all. Finally, at each contingency management session, participants will answer brief questionnaires regarding participants' current cannabis cravings and cannabis withdrawal symptoms. For the first two sessions, participants will be able to spin a virtual wheel to win prizes (either positive affirmations or amazon gift cards in varying amounts from $5-$100) for producing a urine drug screen and answering the questions. For sessions 3-10, participants will spin the virtual wheel to win prizes after producing a urine drug screen that is negative for cannabinoids and reporting that they have not used cannabis since the last session. After the ten weekly contingency management sessions, participants will return for an in-person visit where participants will answer questions regarding their cannabis use disorder symptoms during the contingency management treatment and readiness to change. The investigators' specific aims are to identify associations between baseline Cannabis Use Disorder (CUD) symptom levels and neural activity during instrumental learning in cannabis-using adolescents (Aim 1) and Identify associations between neural activity during instrumental learning and reductions in cannabis use frequency during contingency management (Aim 2).
Вмешательства
- Поведенческое Contingency Management
Contingency management is an evidence-based behavioral intervention used to treat substance use disorders, including cannabis use disorder (CUD). Contingency management operates on the principles of instrumental learning, where positive reinforcement is used to encourage desired behaviors, such as abstinence from cannabis. First, specific target behaviors are identified for reinforcement. In CUD, this is often abstinence from cannabis use, verified through regular urine drug screens and self-rep - Устройство Elastic Net Regression
We will apply an elastic net regression model to the neuroimaging data to estimate CUDIT score based on neuroimaging data.
Первичные конечные точки
- Cannabis use frequency [Срок оценки: Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)]
- Cannabis Use Disorder Identification Test (CUDIT) Score [Срок оценки: Baseline]
Вторичные конечные точки (4)
- Total quantity of cannabis use [Срок оценки: Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)]
- Cannabis withdrawal [Срок оценки: Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)]
- Cannabis expectancy [Срок оценки: Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)]
- Proportion of negative cannabis urine drug screen [Срок оценки: Screening, Baseline, once weekly at each CM visit, and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)]
Критерии участия
Критерии включения
- 14-17 year old youth
- Guardian 18 years or older
- Youth is MRI-eligible: No metal implants, prosthetics, orthodontic devices, transdermal medication patches, piercings and/or hair or eyelash extensions that cannot easily be removed, metallic ink tattoos on the neck or face, or claustrophobia, and are not pregnant
- Youth must endorse having used cannabis at least once per week over the past month OR youth must have been diagnosed with cannabis use disorder within the past three months
Критерии исключения
- Youth has a history of Fetal Alcohol Spectrum Disorder, intellectual disorders, pervasive development disorder or autism spectrum disorder, psychotic disorders, history of neurological problems (epilepsy, traumatic brain injury, brain tumor, cerebrovascular disease) by parent/guardian report
- Youth or caretaker who is monolingual non-English speaker
- Youth who is currently experiencing active psychosis symptoms or suicidal/homicidal ideation or who has been hospitalized within the past 6 months for psychosis or suicidality/homicidality
- Youth who is currently undergoing contingency management treatment for cannabis use disorder
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Indiana University School of Medicine — Indianapolis
Идентификаторы
NCT: NCT07340554 · 27183 · K23DA063832