Меню
Идёт набор NCT06395389

A Brief Intervention for Cannabis Use

Без фазы С лечением Cannabis Use Disorder

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: Health Education (HealthEdu), Bloom.
Кому может быть актуально
Состояния в реестре: Cannabis Use Disorder. Базовые параметры: 18 лет — 25 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Development of a Novel Cannabis Brief Intervention for Frequently-Using Emerging Adults: Pilot Randomized Trial

Обзор

The purpose of this study is to compare two brief interventions targeting potentially problematic cannabis use in emerging adults (ages 18-25). Brief interventions are two 40-50 minute sessions separated by 1 week. Eligible emerging adults will complete a detailed cannabis assessment (biological and self-report), followed by one of the two brief interventions, and four follow-up assessments: one immediately after the second session and at 1-, 3-, and 6-months post-intervention. Assignment to the brief intervention is random. Salivary samples will be collected at baseline, post-intervention, and all follow-ups, for a total of 5 samples, to be tested for tetrahydrocannabinol (THC) and cannabidiol (CBD).

Подробное описание

Cannabis is the most widely used federally illicit substance among emerging adults (age 18-25) in the U.S., and frequent cannabis use is associated with myriad long-term health, social, and academic/occupational consequences. Despite this, rates of perceived risk of daily/regular cannabis use have steadily declined over the past two decades, and this is associated with increased frequency of use, a risk for for Cannabis Use Disorder (CUD). Brief interventions (BIs) are among the most frequently used approaches for addressing problematic or potentially problematic substance use in non-treatment-seeking adolescents and young adults. Although several cannabis brief interventions have been developed and tested to date, meta-analyses indicate that the efficacy of these interventions for emerging adults is mixed and the quality of studies is low, suggesting that novel approaches and rigorous methodology are necessary to improve efficacy. The current study will evaluate the feasibility, acceptability, and preliminary efficacy of a novel cannabis BI for emerging adults who frequently use cannabis.

Вмешательства

  • Поведенческое Health Education (HealthEdu)
    The Health Education condition is a 2-session brief intervention with each session lasting 40-50 minutes and separated by about 1 week (5-10 days). The first session focuses on providing in-depth information on good sleep hygiene and habits to improve sleep and information on positive eating habits, nutrition, and physical activity/functional exercise. The second session focuses on providing information about stress and social connection.
  • Поведенческое Bloom
    Bloom is a 2-session brief intervention with each session lasting 40-50 minutes and separated by about 1 week (5-10 days). The first session encourages participants to ask themselves what is important to them. This discussion emphasizes identifying values and ways to live in line with their values, as well as why they use cannabis and providing personalized feedback related to their reasons for use. The second session asks participants to reflect on information from session one and consider what

Первичные конечные точки

  • Timeline Followback (TLFB) [Срок оценки: Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up]
Вторичные конечные точки (3)
  • Marijuana Assessment of Problems Inventory (MAPI) [Срок оценки: Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up]
  • Mini International Neuropsychiatric Interview (MINI) Cannabis Use Disorder Module [Срок оценки: Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up]
  • Oral Fluid Biospecimen Assay [Срок оценки: Baseline, 2-week follow-up, 1-month follow-up, 3-month follow-up, 6-month follow-up]

Критерии участия

Критерии включения

  • Ages 18-25
  • Self-Report report cannabis use on at least 20 days of the past 30 days
  • Submit a positive urine cannabinoid test

Критерии исключения

  • Currently engaged in substance use treatment for any type of substance use or currently treatment seeking
  • History of substance use treatment for any type of substance
  • Severe alcohol use disorder or indication of any substance use disorder requiring a higher level of care (AUDIT score ≥14 or DUDIT score ≥2 for women, ≥6 for men)
  • Significant or acutely unstable medical or psychiatric problems (i.e., psychosis, mania) that would contraindicate research procedures, interfere with safety, compromise data integrity, or preclude consistent study participation (Screening psychosis score =7)
  • Significant risk of suicide or homicide
  • Currently pregnant or breastfeeding

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT06395389 · Pro00133931 · K23DA058077

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗