Comparative Effects of Exercise and Treatment-as-usual on Abstinence, Craving, and the Endocannabinoid System in Substance Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Withdrawal Checklist: Change in physical and psychological withdrawal symptoms over the course of the intervention
研究概览
简要总结
The research study compares the substance abuse treatment outcomes (e.g., craving, withdrawal symptoms, rates of use, abstinence) of standard intensive outpatient care, with or without an added 6-wk aerobic exercise component. In addition, certain biomarkers associated with both exercise and substance use (e.g., endocannabinoids and cortisol) will be assessed. In a rolling admissions format over the course of a year, approximately 36 treatment-seeking substance users who are currently receiving Intensive Outpatient Treatment through a local Alcohol or Other Drug Abuse agency will be randomized to either receive 6 weeks aerobic exercise training in addition to standard care or standard care with 6 weekly laboratory visits to complete questionnaires (18 per group).
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
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intact cognitive status and ability to provide informed consent
- •ability to read and write in English sufficient to provide consent and complete study questionnaires
- •current diagnosis of a single or of multiple substance use disorders
- •currently enrolled in an Intensive Outpatient Treatment substance use program
- •desire to quit and to seek treatment for substance use
- •currently sedentary, not participating in any formal/structured exercise program
排除标准
- •a history or present diagnosis of severe depression, psychotic, or bipolar disorder
- •presence of cardiac disease or any other medical condition that would make engaging in exercise unsafe
- •Undergoing methadone treatment
- •chronic conditions such as cancer, diabetes, kidney disease, or autoimmune disorders
- •women who are pregnant or planning to become pregnant
结局指标
主要结局
Withdrawal Checklist: Change in physical and psychological withdrawal symptoms over the course of the intervention
时间窗: up to 6 weeks
withdrawal symptoms will be assessed using the Withdrawal Checklist which asks participants to rate the severity of a variety physical and psychological symptoms over the past 48 hours. The total score on the Withdrawal Checklist will be used to provide an overall measured of withdrawal.
次要结局
- change in cortisol concentrations(measured before and after sessions (via saliva swab) during the first, third, and sixth weeks of the 6-week intervention)
- change in endocannabinoid concentrations(measured before and after sessions (via single venipuncture)during the first, third, and sixth weeks of the 6-week intervention)