A Randomized Controlled Clinical Trial of Dronabinol (Marinol) vs Placebo as Add-on Therapy For Patients on Opioids for Chronic Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Single-Dose Phase
研究概览
简要总结
The purpose of this research study is to determine if Marinol alleviates pain in patients with chronic pain who are currently taking opioids.
The study begins with a 2-hour initial visit followed by three 8-hour appointments at Brigham and Women's Hospital. At each 8-hour visit, patients receive a dose of medication and complete surveys relating to pain.
During the first visit a brief examination and a few surveys about pain, quality of life, and medical history are given. The study doctor then determines if the participant continues to qualify for the study.
If qualified for the study, patients receive a daily diary to record pain levels and pain medications; this will take about 5 minutes each day. After completion of the diary, patients begin the 8-hour visits.
Patients visit the Pain Trials Center three times to receive study medication. After taking the study medication, participants remain in the clinic for 8 hours to complete hourly surveys about pain and pain relief.
Subsequent to these visits, patients may enter a 1-month extension where Marinol is taken at home, and pain levels are recorded in a diary. Participants can change the dose of study drug to better control pain and side effects, after speaking with study staff. The study then concludes with a final 30-minute visit to summarize the participant's experience in the clinical trial.
详细描述
During the informed consent process subjects will be informed that Marinol (Dronabinol) is generally not used for chronic pain and there will be no provision for extended treatment with Dronabinol.
The study comprises two phases, the blinded single-dose phase and the open-label multi-dose phase. There are five visits in all; one baseline visit, three treatment visits in the single-dose phase, and then a final end-of-study visit after the multi-dose phase is over.
Subjects will be initially screened by telephone, and if eligible will present for a baseline visit. This visit will verify enrollment criteria, and will include a history and physical exam, urine pregnancy test if indicated, and baseline assessments. Subjects who meet full enrollment criteria will be randomly allocated to one of the treatment sequences of the single-dose phase.
Single-Dose Phase
The treatment sequence will be a randomized 3-treatment, 3-period crossover trial. Each subject will receive each treatment in a sequence randomly allocated by the Investigational Drug Services Department at Brigham and Women's Hospital. These visits will be scheduled a minimum of 3 days apart, and subjects will be instructed to reschedule if their pain is less than 4/10 on the morning of their visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic somatic nociceptive pain syndromes*, with a minimum pain score on average of 4/10
- •Stable doses of opioid analgesics per investigator judgment
- •Negative urine pregnancy test in all females with reproductive capacity
- •Patients agree to use adequate birth control measures during the study
- •(*including but not limited to, musculoskeletal pain, neck pain, low back pain, pain due to osteoarthritis, fibromyalgia, failed back surgery syndrome etc.)
排除标准
- •Current substance abuse by self-report.
- •Chronic pain due to cancer
- •Any marijuana use within three months by self-report
- •Active litigation, compensation, or disability issues
- •Significant baseline nausea, vomiting, sedation, or other symptoms that may compromise the collection of study-related data
- •Patients on a baseline opioid regimen that requires opioid dosing more frequently than every 8 hours
- •Unstable psychiatric disorders per investigator judgment
- •Baseline Beck depression inventory indicating moderate or greater depression, or active suicidality
- •Baseline anxiety inventory indicating moderate or greater anxiety
- •Patient feels unable to defer morning opioid dose until arrival in the study center
- •Patients using Duragesic patch
- •Patients receiving opioids via an implanted intrathecal pump
结局指标
主要结局
Single-Dose Phase
Multi-Dose Phase
- Change in pain score from baseline
- Total pain relief (TOTPAR) at 8 hours
次要结局
- Single-Dose Phase
- - SPID for pain bothersomeness at 8 hours
- - Side effects scale
- - Sleep scale
- - Sum of pain intensity differences at 8 hours
- - Pain and pain relief at all prespecified time points
- - Addiction Research Center Inventory scale of abuse liability
- - Patient global assessment at 8 hours
- - Changes in mood
- - Evoked pain at all prespecified timepoints
- - SPID for evoked pain at 8 hours
- - Drop outs due to need for rescue analgesia during the 8 hour study phase
- - Least squares mean change in pain score by ANCOVA.
- - Plasma levels of THC vs. effect of study drug
- Multi-Dose Phase
- - Time-weighted average of weekly pain assessments collected during study visits and by telephone
- - Patient global assessment
- - Adverse events
- - Quality of life (SF-36) compared to baseline on aggregate score and subscales.
研究者
Sanjeet Narang
Instructor in Anesthesia, Harvard Medical School
Brigham and Women's Hospital