Changes in Cognition and Psychiatric Disorder Symptoms During Cannabis Abstinence Using a Novel Discordant Twin Design
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.
- Кому может быть актуально
- Состояния в реестре: Cannabis. Базовые параметры: 31 лет — 47 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
This study will test whether 42 days of cannabis abstinence, compared to continued cannabis use, is associated with improvements in cognition and psychiatric disorder symptoms. Identical twins, who are concordant on cannabis use, will be experimentally-manipulated to be discordant for 42 days. Each twin, within a twin pair, will be randomly assigned to either the contingency management condition, incentive-based protocol to promote cannabis abstinence, or control condition, no changes in cannabis use requested.
Подробное описание
The proposed project is a randomized controlled trial to compare cognition and psychiatric disorder symptoms between monozygotic (MZ) twin pairs, who are concordant on frequency of cannabis use. Each twin, within the twin pair, will be randomly assigned to either contingency management (CM), monetary incentives provided to reinforce cannabis abstinence, or control, no changes in cannabis use required or reinforced. Participants in the CM condition will receive an increasing schedule of payments at each visit reinforcing continued cannabis abstinence. All participants will receive increases in the payment schedule for attendance of each subsequent assessment. Participants will be assessed on measures of cognition including attention, memory, and processing speed as well as anxiety, depression, and ADHD symptoms. In addition, at each visit participants will complete a qualitative and quantitative drug test. The qualitative drug test will be used to determine if new cannabis use has occurred since the last visit, and will determine if the participant receives payment for abstinence. The investigators will also use previously collected genotype for each participant.
The first aim of this study is to characterize cognitive recovery, across all potential cognitive domains, using an experimental manipulation to achieve discordance between MZ twins on cannabis use. The hypothesis for the first aim is that the abstinent group will have greater improvements in memory and processing speed compared to controls. However, there will not be any group differences between the abstinent group and the control group on attention, language, and executive function performance. The second aim of the proposed project is to characterize psychiatric disorder symptoms by comparing psychiatric disorder symptom changes among the cannabis abstaining twin to their cannabis using co-twin across 42 days. The abstinent group will endorse more psychiatric symptoms during the withdrawal period (up to 14 days) but will endorse fewer psychiatric symptoms at day 28 and 42 compared to the control group. The third aim (exploratory) of the proposed project is to examine how genetic risk for psychiatric disorders interacts with environment (i.e., cannabis abstinence versus continued use) to influence cognitive functioning. The hypothesis for aim 3 is that anxiety, depression, and ADHD polygenic scores will be more strongly associated with cognitive outcomes in the control group compared to the abstinent group.
Вмешательства
- Поведенческое Contingency management
Participants will be paid to abstain from cannabis use.
Первичные конечные точки
- Change in attention performance [Срок оценки: Change from baseline to day 42]
- Change in episodic memory [Срок оценки: Change from baseline to day 42]
- Change in working memory [Срок оценки: Change from baseline to day 42]
- Change in receptive vocabulary [Срок оценки: Change from baseline to day 42]
- Change in reading decoding [Срок оценки: Change from baseline to day 42]
- Change in immediate memory/verbal learning [Срок оценки: Change from baseline to day 4]
- Change in pattern comparison processing speed [Срок оценки: Change from baseline to day 42]
- Change in oral symbol digit test processing speed [Срок оценки: Change from baseline to day 42]
- Change in attention and executive function [Срок оценки: Change from baseline to day 42]
Вторичные конечные точки (3)
- Change in anxiety symptoms [Срок оценки: Change from baseline to day 42]
- Change in depressive symptoms [Срок оценки: Change from baseline to day 42]
- Change in attention deficit/hyperactivity disorder symptoms [Срок оценки: Change from baseline to day 42]
Критерии участия
Критерии включения
- Monozygotic (MZ) twin pair, in which both twins are willing to participate
- MZ twin pair must be concordant in their frequency of cannabis use (+/- 2 days)
- Cannabis use at least 1x per week on most weeks
- Cannabis use in the past 7 days at the baseline visit
- Positive qualitative urine toxicology at baseline for THC
- Located within the state of Colorado
Критерии исключения
1\) Discordance in the twin pairs on a significant, adverse experience, like traumatic brain injury.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Фундаментальное исследование
Центры проведения
США · 1 центр
- Jessica M Ross — Aurora
Идентификаторы
NCT: NCT05160688 · 21-4899