Alcohol Use Disorder and Cannabis: Testing Novel Harm Reduction Strategies
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change in Drinks per Drinking Day
研究概览
简要总结
This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum CBD and broad spectrum CBD, compared to a placebo control (PC), to reduce drinking in participants with alcohol use disorder. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.
详细描述
To better understand the effects of hemp-derived CBD with and without a small amount of THC, we propose a Phase II randomized clinical trial (RCT) to examine the safety, tolerability, and clinical effects of Full Spectrum CBD (fsCBD, contains less than 0.3% THC) vs. Broad Spectrum CBD (bsCBD, does not contain THC), vs. a matching placebo in a population of AUD subjects.
This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of fsCBD and bsCBD, compared to a placebo control, to reduce drinking in participants with moderate alcohol use disorder according to the DSM-V. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks. The current study will test the hypothesis that a moderate dose of CBD leads to a reduction in alcohol consumption, alcohol craving, peripheral markers of inflammation, and anxiety. It is further hypothesized that CBD will lead to increased sleep duration and quality among individuals with AUD who want to quit or reduce their drinking. The study will also determine whether the small amount of THC found in full spectrum hemp-derived CBD products produces any negative effects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be ≥21 years old.
- •Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria for current Alcohol Use Disorder (AUD) of at least moderate severity (i.e., 4 or more DSM-V symptoms).
- •Expresses desire to reduce or quit drinking.
- •If male, reports drinking, on average, at least 15 standard alcoholic drinks per week prior to screening; if female, reports drinking, on average, at least 10 standard drinks per week prior to screening.
- •Able to attend in-person visits at the study site.
- •Participants reporting current nicotine use in any form will be included.
排除标准
- •Self-reported DSM-V diagnosis of any other substance use disorder.
- •Self-report illicit/recreational use of cocaine, methamphetamines, amphetamines, MDMA, opioids, or benzodiazepines in the last 30 days.
- •Daily cannabis use.
- •Uses CBD products for medical reasons.
- •Self-reports or indicates having a serious DSM-V psychiatric disorder, including panic disorder, obsessive/compulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, cluster B personality disorders (borderline, antisocial, histrionic, narcissistic), eating disorders, or any other psychotic mental disorder.
- •Endorsing item 2 on the C-SSRS measure of suicide risk.
- •Currently taking any of the following medications:
- •Those known to have a major interaction with Epidiolex.
- •Acute treatment with any antiepileptic medications.
- •Medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, and/or topiramate).
- •Self-reported history of severe alcohol withdrawal (e.g., seizure, delirium tremens).
- •Clinically significant medical problems in the last six months, such as cardiovascular, renal, gastrointestinal, or endocrine problems, that would impair participation or limit medication ingestion.
- •Current or past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, hepatocellular disease, or peptic ulcer.
- •Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
- •Current charges pending for a violent crime (not including DUI-related offenses).
- •Lack of a stable living situation.
- •Lack of access to internet.
研究组 & 干预措施
Full-Spectrum Cannabidiol
210mg/day of full-spectrum cannabidiol, containing less than 0.3% THC.
干预措施: Cannabidiol (Drug)
Broad-Spectrum Cannabidiol
210mg/day of full-spectrum cannabidiol, containing 0.0% THC.
干预措施: Cannabidiol (Drug)
Placebo
210mg/day of hemp seed oil with no cannabinoids present.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Drinks per Drinking Day
时间窗: 0-12 weeks
The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.
Change in Alcohol Use Disorder
时间窗: 0-12 weeks
The AUDIT consists of ten questions that cover such domains as alcohol consumption, drinking behavior, adverse psychological reactions, and alcohol-related problems.
Change in Alcohol Craving
时间窗: 0-12 Weeks
The Penn Alcohol Craving Scale (PACS) will be used to assess changes in alcohol craving.
次要结局
- Change in Cue-reactivity(0-12 weeks)
- Change in Anxiety(0-12 weeks)
- Change in Pain Levels(0-12 weeks)
- Change in Sleep Disturbance(0-12 weeks)
- Change in Impaired Control Scale (ICS)(0-12 Weeks)