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Идёт набор NCT05957848

Guanfacine Extended-release for Adolescents With Cannabis Use

Фаза II 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: Guanfacine Extended Release Oral Tablet, Residential withdrawal, Engagement with alcohol and other drug services, Placebo.
Кому может быть актуально
Состояния в реестре: Cannabis Use Disorder. Базовые параметры: 12 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
Австралия
Следующий шаг
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Официальное название

Guanfacine Extended-release Randomised Controlled Trial for Adolescents With Cannabis usE (GRACE)

Обзор

A randomized controlled trial to assess the efficacy of extended-release guanfacine to reduce cannabis use frequency in young people with cannabis use disorder following a period of monitored abstinence.

Вмешательства

  • Препарат Guanfacine Extended Release Oral Tablet
    Target dose 4 mg daily
  • Поведенческое Residential withdrawal
    4-14 days in residential withdrawal treatment
  • Поведенческое Engagement with alcohol and other drug services
    Ongoing engagement with a youth drug and alcohol service for counselling or other support for the duration of the study
  • Препарат Placebo
    Placebo capsule taken daily

Первичные конечные точки

  • Efficacy - change from baseline in cannabis use frequency following monitored abstinence [Срок оценки: Baseline and weekly in the 4 week outpatient phase immediately following discharge from residential withdrawal]
Вторичные конечные точки (12)
  • Change from baseline in cannabis use frequency following monitored abstinence (categorical) [Срок оценки: Baseline and weekly in the 4 weeks immediately following discharge from residential withdrawal]
  • Cannabis exposure [Срок оценки: Approximately weekly between Baseline (week 0) and the end of treatment visit (week C7), approximately 12 weeks from baseline]
  • Change from baseline in cannabis use disorder symptoms [Срок оценки: Baseline and end of Maintenance phase (4 weeks post discharge from residential withdrawal)]
  • Cannabis withdrawal symptoms during residential withdrawal admission [Срок оценки: Daily during residential treatment for 4 to 14 days]
  • Sleep quality (subjective) during residential withdrawal admission [Срок оценки: Daily during residential treatment for 4 to 14 days]
  • Cannabis craving during residential withdrawal admission [Срок оценки: Daily during residential treatment for 4 to 14 days]
  • Sleep quality (objective) during residential withdrawal admission [Срок оценки: Daily during residential treatment for 4 to 14 days]
  • Food intake during residential withdrawal admission [Срок оценки: Daily during residential treatment for 4 to 14 days]
  • Treatment engagement (residential) [Срок оценки: Baseline to end of treatment]
  • Treatment engagement (outpatient) [Срок оценки: Baseline to end of treatment]
  • Change from baseline in daily functioning - social and occupational [Срок оценки: Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)]
  • Change from baseline in daily functioning - multidimensional [Срок оценки: Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)]

Критерии участия

Критерии включения

  • 12-25 years of age (inclusive) at consent;
  • Seeking treatment for cannabis use;
  • DSM-5 Cannabis Use Disorder, mild, moderate or severe;
  • Self-reported cannabis use on average at least 5 days/week during the 28 days prior to screening with a THC positive urine drug screen on the day of screening; and
  • Able to provide informed consent (both adequate IQ and English fluency; <18-year-olds will provide consent themselves in addition to parent/guardian consent).

Критерии исключения

  • DSM-5 substance use disorder (moderate or severe) except cannabis or nicotine;
  • Any unstable medical, psychiatric or neurological condition or medical contraindicating study participation;
  • Diagnosis of a psychotic or bipolar illness;
  • Acute suicidality as assessed by clinician;
  • Prescribed antipsychotics, benzodiazepines or other sedative medications, or other medications for the treatment of ADHD. If prescribed antidepressants, the participant must have been on a stable dose for more than 2 weeks at screening;
  • A history of heart disease or cardiac risk factors (e.g. arrhythmias);
  • Abnormal liver or thyroid function as indicated by clinically-significant findings on blood tests;
  • Pregnancy, breast feeding or, if sexually active and able to become pregnant, no effective contraception.
  • Intention to enter residential rehabilitation after treatment in the YSAS residential withdrawal facility.

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Австралия · 1 центр
  • Orygen — Parkville

Идентификаторы

NCT: NCT05957848 · 22389

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗