Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid Dose in Patients With Chronic Non-Cancer Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 6
- 主要终点
- Mean Difference in Prescription Monitoring Program verified opioid dose at baseline and week 24
研究概览
简要总结
This study will use a randomized controlled design to test whether medical marijuana use by adults on high-dose chronic opioid therapy (COT) for chronic non-cancer pain is associated with reduced opioid dose and improved pain intensity and interference when added to a 24-week behavioral intervention (POTS).
详细描述
This trial is a randomized, six-month study of cannabis (CB) on opioid use that will: (1) evaluate whether adults with chronic, non-cancer pain on COT assigned to CB, compared with those assigned to a waitlist control condition (WL), have greater reduction in opioid dose and/or pain intensity and interference, (2) assess whether participants assigned to CB, compared with those assigned to WL, have improved quality of life, depression, and anxiety; and reduced self-reported opioid dose, (3) evaluate whether those assigned to CB develop symptoms of CUD and have a reduced number of OUD symptoms over the 24-week intervention, as well as at the 12-month time point.
Participants will be randomly assigned to either an active CB arm (n = 60), or to a waitlist control arm (WL) (n = 60). Participants will be assessed at baseline, every 4 weeks for 6 months, and at a 12-month follow-up for opioid use, development of CUD, development or resolution of OUD, and neurocognitive performance. Urine collected will be assessed with quantitative assays.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18-75, inclusive.
- •Endorsing > 6 months of chronic, non-cancer pain.
- •On stable prescription opioid doses of 25 MME or greater for >90 days, verified by the Prescription Monitoring Program.
- •Either no prior use or current light cannabis use (weekly or less in the past 12 months).
- •Plans to use medical cannabis for pain to control pain and/or reduce opioid dose.
- •Competent and willing to provide written informed consent in English.
- •Potential participants of childbearing potential must not be pregnant at enrollment. They will be asked to self-report pregnancy status and the start date of their most recent menstrual period and agree to use effective contraception: abstinence; hormonal contraception; intra-uterine device, sterilization; or double barrier contraception, during the study.
排除标准
- •Current cannabis use (including inhaled or ingested CBD products) of greater than weekly on average in the past 12 months, assessed via self-report (no more than 10 times in the past 90 days).
- •Current cannabis use disorder; current moderate to severe substance use disorder for any substance by structured interview, EXCEPT nicotine and opioids (OUD).
- •Current uncontrolled major medical illness, such as cancer, symptomatic hypothyroidism/hyperthyroidism or severe respiratory compromise.
- •Use of non-prescribed opioids, by self-report.
- •Dose change or initiation of medications with significant analgesic effects (e.g., tricyclic antidepressants, SSRIs, gabapentin, NSAIDs) in the past 4 weeks.
- •Concomitant medications will be discussed at each study visit, and any medications that may interact with cannabinoids (e.g., warfarin) will be discussed with a study clinician prior to enrollment or continued participation.
- •Actively suicidal and/or suicide attempt or psychiatric hospitalization in past year, or current suicidal ideation with specific plan or intent.
- •History of intellectual disability (e.g., Down's syndrome) or other severe developmental disorder or IQ <
- •Current diagnosis of delirium, dementia, amnestic, or other cognitive disorder; current diagnosis of bipolar II disorder; lifetime diagnosis of bipolar I disorder, schizophrenia spectrum, or other psychotic disorder.
- •Surgery within the past month or planned during the next 6 months.
- •Pregnant or trying to get pregnant or breastfeeding.
- •In the opinion of the investigator or study physicians, not able to complete study procedures or safely participate in this study.
研究组 & 干预措施
Medical Marijuana + Prescription Opioid Taper Support (POTS) behavioral treatment
This group can begin using medical marijuana immediately and will participate in the POTS treatment groups.
干预措施: Medical Marijuana (Drug)
结局指标
主要结局
Mean Difference in Prescription Monitoring Program verified opioid dose at baseline and week 24
时间窗: Week 24
Median opioid dose verified by the Prescription Monitoring Program, in morphine milligram equivalents (MME) per day, over monthly interval preceding study visit.
Mean Difference in Pain, Enjoyment, General Activity (PEG) Scale Summed Score over post-baseline to week 24 interval
时间窗: Every post-baseline day until week 24
The Pain, Enjoyment, General Activity (PEG) scale will assess pain intensity and interference. The scale ranges from 0-30, with a higher score indicating greater pain intensity and interference. Collected daily by a self-reported online survey.
次要结局
- Mean Difference in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form Summed Score at weeks 4, 8, 12, 16, 20, 24(Week 4, week 8, week 12, week 16, week 20, week 24)
- Mean Difference in PROMIS-29 Depression Subscale Summed Score at weeks 4, 8, 12, 16, 20, 24(Week 4, week 8, week 12, week 16, week 20, week 24)
- Mean Difference in PROMIS-29 Anxiety Subscale Summed Score at weeks 4, 8, 12, 16, 20, 24(Week 4, week 8, week 12, week 16, week 20, week 24)
- Mean Difference in Opioid Use Disorder Symptoms at weeks 4, 8, 12, 16, 20, 24(Week 4, week 8, week 12, week 16, week 20, week 24)
- Mean Difference in Cannabis Use Disorder Symptoms at weeks 12 and 24(Week 12, Week 24)
- Mean Difference in Self-Reported Opioid Dose over post-baseline to week 24 interval(Every post-baseline day until week 24)
研究者
Jodi Gilman
Associate Professor
Massachusetts General Hospital