Impact of Reduced Cannabis Use on Functional Outcomes (R33 Phase)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Mental Health Symptoms
研究概览
简要总结
Nearly 20 million Americans report use of cannabis in the past month, and heavy cannabis use has increased by nearly 60% in the U.S. since 2007. Heavy cannabis use is associated with lower educational attainment, reduced physical activity, increased rates of addiction and unemployment, and neuropsychological deficits. Studies suggest that cannabis use is also associated with increased mental health symptoms, drugged driving, and traffic accidents. While there is evidence that sustained abstinence can lead to improvements in the functional outcomes of former users, the degree to which reductions alone (i.e., not sustained abstinence) in cannabis use might be associated with positive changes in functional outcomes is unknown. This is a critical gap in the literature, as many interventions for cannabis and other drugs are associated with decreases in frequency and quantity of use, but fail to achieve an effect on overall abstinence rates. The objective of the present research is to use ecological momentary assessment (EMA), a real-time, naturalistic data collection method, to prospectively study the impact of reduced cannabis use on functional outcomes in heavy cannabis users. Contingency management (CM) will be used to promote reductions in frequency and quantity of cannabis use. CM is an intensive behavioral therapy that is highly effective at producing short-term reductions in illicit drug use. We have recently developed a novel approach that leverages mobile technology and recent developments in cannabis testing. We have pilot-tested this approach with heavy cannabis users and found that it is an acceptable and feasible method. The present research will use this technology in conjunction with EMA methods to study the impact of reduced cannabis use on key functional outcomes. Our central hypothesis is that reductions in frequency and quantity of cannabis use will lead to positive changes in cannabis users' mental health, self-efficacy, physical activity, working memory, health-related quality of life, and driving behavior. The rationale for this research is that it will provide the first and only real-time data concerning the potential impact of reductions in cannabis use on functional outcomes. As such, the findings from the present research will directly inform ongoing efforts to include reductions in illicit drug use as a valid, clinically-meaningful outcome measure in clinical trials of pharmacotherapies for the treatment of substance use disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Report 40 or more days of cannabis use (other than ingested cannabis, i.e., edibles) in past 90 days
- •Can speak and write fluent conversational English
- •Are between 18 and 80 years of age
- •Are willing to attempt to reduce frequency of cannabis use
- •Complete at least 10 of the 14 nightly diaries during the ad lib phase of the study procedures.
排除标准
- •Are expected to have an unstable medication regimen during the study
- •Are currently receiving non-study treatment for cannabis use disorder
- •Are pregnant or become pregnant
- •Meet criteria for a serious mental illness (e.g., bipolar disorder, schizophrenia)
- •Meet criteria for a substance use disorder other than nicotine or cannabis use disorders
- •Are currently imprisoned or in psychiatric hospitalization or become imprisoned or in psychiatric hospitalization
- •Report imminent risk for suicide or homicide
- •Meet criteria for bio-verified sustained abstinence (i.e., all of their saliva tests are negative during the 6-week experimental phase of the study)
结局指标
主要结局
Change in Mental Health Symptoms
时间窗: Baseline and post-treatment (approximately eight weeks)
Mental health symptoms will be measured by the 90-item Symptom Checklist (SCL-90). This measure has a scoring range of 0 to 360, with lower scores indicating lower distress related to mental health.
Change in Self-reported Self-efficacy
时间窗: Baseline and post-treatment (approximately eight weeks)
Self-efficacy will be measured by the Marijuana Reduction Strategies Self-Efficacy Scale. This measure has a scoring range of 0 to 84, with higher scores indicating increased self-efficacy.
Change in Physical Activity as Measured by the Leisure-Time Physical Activity Questionnaire
时间窗: Baseline and post-treatment (approximately eight weeks)
Physical activity will be measured using the Leisure-Time Physical Activity Questionnaire. Scores range from 0 to 99, with higher scores indicating increased physical activity.
Change in Physical Activity as Measured by the International Physical Activity Questionnaire
时间窗: Time Frame: Baseline and post-treatment (approximately eight weeks)
Physical activity will be measured using a continuous score on the International Physical Activity Questionnaire. The score is calculated by multiplying metabolic equivalents times minutes per day times days per week; scores range from 0 to 13,440. Higher scores indicate increased physical activity.
次要结局
- Change in Health-related Quality of Life, WHOQOL-BREF(Baseline and post-treatment (approximately eight weeks))
- Change in Visual Working Memory(Baseline and post-treatment (approximately eight weeks))
- Change in Auditory Working Memory(Baseline and post-treatment (approximately eight weeks))
- Change in Impulsivity as Measured by Delay Discounting (i.e., Iowa Gambling Task)(Baseline and post-treatment (approximately eight weeks))
- Change in Impulsivity as Measured by the Balloon Analogue Risk Task(Baseline and post-treatment (approximately eight weeks))
- Change in Impulsivity as Measured by Self-report(Baseline and post-treatment (approximately eight weeks))
- Change in Number of Days of Drugged Driving(Baseline and post-treatment (approximately eight weeks))