Cannabidiol Pharmacotherapy for Comorbid Opioid Addiction and Chronic Pain
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Agitation Calmness Evaluation Scale (ACES)
研究概览
简要总结
The overarching goal of this study is to evaluate the potential of Cannabidiol (CBD) as an adjunctive treatment for comorbid opioid use disorder (OUD) and chronic pain. This is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of CBD on measures of pain and opioid craving in outpatients with OUD receiving methadone or buprenorphine.
详细描述
An initial safety pilot phase will recruit six participants: three receiving treatment with methadone and three receiving treatment with buprenorphine. If the results of the pilot study support the safety of CBD administration in this clinical sample, the general study will recruit participants with comorbid OUD and chronic pain, with half the subjects receiving methadone and half receiving buprenorphine. Both sub-studies will enroll participants who do not currently require an inpatient hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged between 18 and 70 years old.
- •Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment.
- •Having chronic pain, uniformly operationalized as grade II (high-intensity) non- cancer pain for ≥ 6 months
- •Capable of providing informed consent in English.
- •Compliant in opioid maintenance treatment and on a stable dose for four weeks or longer.
- •Not meeting DSM-5 criteria for substance use disorders other than OUD or tobacco use disorder within the last 12 months.
- •No current medical problems deemed contraindicated for participation by principal investigator.
- •For women, not pregnant as determined by pregnancy screening; not breast-feeding; using acceptable birth control methods. Acceptable contraception for women includes oral contraceptives, contraceptive depot injections, contraceptive subdermal implants, intrauterine devices, or surgical contraception methods. Acceptable contraception for men includes condoms or surgical contraception methods.
排除标准
- •Other current major psychiatric disorders deemed clinically unstable by the principal investigator, such as severe depression and/or active suicidal ideation.
- •Having experienced major psychosocial stressors recently (≤ 6 weeks before enrollment), at the discretion of the principal investigator.
- •Methadone dose under 60mg or over 100mg
- •Buprenorphine over 24mg.
- •Having received inpatient psychiatric treatment recently (≤ 60 days before enrollment).
- •Candidates receiving products containing either THC or CBD will be excluded.
- •Current use regular use other prescription opioids, gabapentinoids (pregabalin, gabapentin), antidepressants (SSRIs, SNRIs, TCAs), benzodiazepines, platelet inhibitors (e.g., clopidogrel, apixaban, ticagrelor), or NSAIDs.
- •Current weight of less of 60 kg.
- •Allergy to sesame seed oil, which is an ingredient of the CBD formulation used.
- •Serious medical or neurological illness or treatment for a medical disorder that could interfere with study participation as determined by principal investigator.
- •Participants who have elevation of liver enzymes (ALT and/or AST) 2x above the normal limit or higher.
研究组 & 干预措施
CBD 400mg
CBD 400mg
干预措施: CBD Day 1 (Drug)
CBD 800mg
CBD 800mg
干预措施: CBD Day 2 (Drug)
CBD 1200mg
CBD 1200mg
干预措施: CBD Day 3 (Drug)
结局指标
主要结局
Agitation Calmness Evaluation Scale (ACES)
时间窗: Baseline (30 minutes before the administration of CBD), hourly for 4 hours after the administration of methadone (administered +210 minutes after CBD) and 3 hours after the administration of buprenorphine (administered +210 minutes after CBD)
The ACES consists of a single item that rates overall agitation and sedation of the participant at the time of evaluation, where 1 indicates marked agitation; 2: moderate agitation; 3: mild agitation; 4: normal behavior; 5: mild calmness; 6: moderate calmness; 7: marked calmness; 8: deep sleep; and 9: unarousable. Clinically significant sedation was a priori defined as an ACES score of 7 (marked calmness) or higher at any point during the session. A score was averaged across all time intervals.
Mini Mental Status Examination (MMSE)
时间窗: Baseline (30 minutes before the administration of CBD), hourly for 4 hours after the administration of methadone (administered +210 after CBD) and 3 hours after the administration of buprenorphine (administered +210 minutes after CBD)
The MMSE is a 30-point scale ranging from 0 to 30 that measures five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. Each scale is summed to compute a total score. The MMSE is used extensively in clinical and research settings to measure cognitive impairment. A score of 24 or higher is generally considered within the normal range, while lower scores suggest potential cognitive impairment. Scores are often interpreted as follows: 25-30 = normal cognition, 21-24 = mild impairment, 10-20 = moderate impairment, and below 10 = severe impairment.
Systematic Assessment of Side Effects (SAFTEE)
时间窗: baseline and 4.5 hours after the administration of CBD
The SAFTEE is a multi-symptom checklist that has been used successfully in our previous studies to assess and monitor any adverse events and possible side effects of study medications. It includes information regarding the severity of any presenting symptoms (0= none, 1= mild, 2= moderate, and 3= severe), as well as the course of action taken by the study staff in response. The SAFTEE was administered before the administration of CBD at baseline, (timepoint -30 minutes) and 4.5 hours after the administration of CBD (timepoint +240 minutes) during each test session. Data presented here is the number of participants that reported symptoms on SAFTEE.
次要结局
- Quantitative Sensory Testing (QST)- Threshold and Tolerance(baseline, 2 hours and 4 hours after the administration of CBD.)
- Change in Quantitative Sensory Testing (QST) Conditioned Pain Modulation (CPM)(Baseline (-30 minutes), 2 hours (+120 minutes), and 4 hours (+240 minutes) after the administration of CBD.)
- Quantitative Sensory Testing (QST) Temporal Summation of Pain (TSP)(Baseline, 2 hours and 4 hours after the administration of CBD.)
研究者
Joao De Aquino
Principal Investigator
Yale University