Investigating the Effects of Palmitoylethanolamide (PEA) on Stress, Craving and Pain in Opioid Use Disorder
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- stress-induced opioid craving visual analog scale (VAS)
研究概览
简要总结
Opioid use disorder (OUD) represents one of the most severe public health crises, with more than 2 million individuals affected in the United States. Existing treatments do not target and restore several key alterations triggering opioid craving and relapse, including increased response to stress, mood disturbances and greater sensitivity to pain, which are caused by prolonged exposure to opioids. This double-blind, randomized, placebo-controlled study will investigate the effects that palmitoylethanolamide (PEA), an endogenous molecule part of the endocannabinoid system available as a dietary supplement, exerts on these alterations and their underlying mechanisms, with the goal of identifying a novel therapeutic approach to reduce craving and prevent relapse in patients with OUD.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65
- •DSM-5 diagnosis of OUD
- •English speaking
- •Receiving either buprenorphine or methadone for treatment of opioid use disorder for at least 3 consecutive months prior to enrollment
- •Receiving a stable dose of buprenorphine or methadone for the duration of the study
- •Agreeable to abstaining from using any cannabis or CBD products two weeks prior to enrollment in the study, and for the duration of the trial
- •For women of childbearing potential: agreeable to use one of the following:
- •hormonal methods, such as birth control pills, patches, injections, vaginal rings, or implants
- •barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
- •intrauterine device (IUD)
- •abstinence (no sex)
排除标准
- •DSM-5 diagnosis of moderate-to-severe cannabis use disorder, alcohol use disorder, and/or psychostimulant use disorder [medical record review and health history form]
- •Active, recurrent substance use within the last 3 months that will interfere with study participation and completion of study procedures [medical record review and health history form]
- •History of psychotic, bipolar and schizoaffective disorders [medical record review and health history form]
- •Lifetime psychiatric hospitalization or suicide attempt, as assessed by the health history form
- •Recent history (within 2 years) of major depressive disorder [health history form and clinical interview]
- •Currently pregnant or breastfeeding (female only) [pregnancy test/ self-reported]
- •History of autoimmune or chronic inflammatory diseases [health history form] Current use of medications known to alter inflammatory and immune response [health history form] Raynaud's disease [health history form]
- •Hepatic liver enzymes greater than 3x upper normal limit
- •Vital signs: HR ≤60 or ≥100, SBP ≤90 or ≥160, DBP ≤50 or ≥100, RR < 12 or > 20
- •Recent history of clinically significant medical conditions including, but not limited to, malignancy (and treatment for malignancy), HIV, immunological, endocrine (including uncontrolled diabetes or thyroid disease), renal, GI, or hematological abnormalities that are uncontrolled* [health history form and medical record review]
研究组 & 干预措施
PEA 600 mg
PEA capsules (600 mg twice a day) will be administered for 21 days
干预措施: Palmitoylethanolamide (Drug)
Placebo
Placebo capsules (600 mg twice a day) will be administered for 21 days
干预措施: Placebo (Other)
结局指标
主要结局
stress-induced opioid craving visual analog scale (VAS)
时间窗: day 21
decrease from baseline in experimentally-provoked stress-induced craving ratings as measured via the visual analog scale (0= no craving to 100= extremely strong craving). Lower scores indicate reduced craving
次要结局
未报告次要终点
研究者
Primavera A. Spagnolo, MD, PhD
Assistant Professor/Research Scientist
Brigham and Women's Hospital