Changes in Cognition and Psychiatric Disorder Symptoms During Cannabis Abstinence Using a Novel Discordant Twin Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Change in working memory
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 31 Years 至 47 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •1) Discordance in the twin pairs on a significant, adverse experience, like traumatic brain injury.
研究组 & 干预措施
No intervention
Participants in this condition will be monitored and will not receive any compensation for cannabis abstinence.
Contingency management
Contingency management (CM) is an incentive-based intervention providing patients with tangible rewards as reinforcement for positive behaviors like abstinence from drug use. Incentives are provided with each urine sample that is drug-free and are increased with each subsequent drug-free urine sample. Participants in the CM condition will receive increasing payments for abstinence: $30 on day 3, $45 on day 5, $60 on day 7, $75 on day 14, $90 on day 21, $105 on day 28, and $120 on day 42. Participants in both conditions also receive increasing payment for visit attendance: $10 on day 1, $15 on day 3, $20 on day 5, $25 on day 7, $30 on day 14, $35 on day 21, $45 on day 28, and $55 on day 42. At the end of the baseline visit, participants in the CM condition will sign a behavioral contract with study staff that clearly outlines expectations as well as the payment schedule.
干预措施: Contingency management (Behavioral)
结局指标
主要结局
Change in working memory
时间窗: Change from baseline to day 42
List Sorting Working Memory Test on NIH Toolbox: Total items correct across all trials
Change in attention and executive function
时间窗: Change from baseline to day 42
Dimensional Change Card Sort Test on NIH Toolbox: Composite score of accuracy and correct answers
Change in attention performance
时间窗: Change from baseline to day 42
Flanker Inhibitory Control and Attention Test on NIH Toolbox: Composite score of accuracy and reaction time
Change in receptive vocabulary
时间窗: Change from baseline to day 42
Picture Vocabulary Test on NIH Toolbox: Computer adaptive testing
Change in oral symbol digit test processing speed
时间窗: Change from baseline to day 42
Oral Symbol Digit Test on NIH Toolbox: Total number of correctly identified symbols
Change in pattern comparison processing speed
时间窗: Change from baseline to day 42
Pattern Comparison Processing Speed Test: Total number of correct responses
Change in episodic memory
时间窗: Change from baseline to day 42
Picture Sequence Memory Test on NIH Toolbox: Cumulative number of correct adjacent pairs
Change in reading decoding
时间窗: Change from baseline to day 42
Oral Reading Recognition Test: Number of letters and words read correctly
Change in immediate memory/verbal learning
时间窗: Change from baseline to day 4
Auditory Verbal Learning Test on NIH Toolbox: Total number of words recalled
次要结局
- Change in depressive symptoms(Change from baseline to day 42)
- Change in anxiety symptoms(Change from baseline to day 42)
- Change in attention deficit/hyperactivity disorder symptoms(Change from baseline to day 42)
