A Randomized Controlled Trial of Dronabinol and Vaporized Cannabis in Chronic Low Back Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Numerical Pain Intensity
研究概览
简要总结
This study will involve treating low back pain associated with nerve injury with oral delta-9-tetrahydrocannabinol (Δ9-THC) or whole plant cannabis for eight weeks. Research subjects will consume either oral Δ9-THC (dronabinol), vaporized 3.7% Δ9-THC/5.6% CBD, or placebo. An analysis will then be determined to assess the risk--benefit ratio of dronabinol and vaporized 3.7% Δ9-THC/5.6% CBD .
详细描述
The present study is designed to assess whether treatment with vaporized cannabis or dronabinol (oral Δ9-THC) reduces spontaneous and evoked pain more than placebo, and whether there are any differences between the two active treatments in terms of interference with activities of daily living. This study also aims to examine the effects of vaporized whole plant cannabis and dronabinol on mood, neuropsychological function, and psychomimetic side-effects (high, stoned, etc.) compared to placebo and to each other. In addition, we plan to examine the acute effects (after receiving stable treatment for 4 weeks) of vaporized cannabis and dronabinol compared to placebo and each other on driving skills.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than
- •Presence of chronic low back pain (CLBP) defined as the response to two questions 1) How long has back pain been an ongoing problem for you? 2) How often has low back pain been an ongoing problem for you over the past 6 months? A response of greater than 3 months to question 1 and a response of "at least half the days in the past 6 months" to question 2 will define CLBP according to the NIH Task Force on Research Standards for Chronic Low Back Pain.
- •The numerical pain intensity must be greater than 3/10 each day during the one-week observation period.
- •To avoid confounding by concurrent medications, participants will have had a stable analgesic regimen that they will continue throughout the study To obviate residual neuropsychological effects from cannabis exposure, participants will be abstinent from this herbal medicine for 7 days prior to study entry.
排除标准
- •Presence of another painful condition of greater severity than the neuropathic pain condition which is being studied.
- •History of traumatic brain injury. Clinically significant or unstable medical condition. Individuals with significant cardiovascular, hepatic or renal disease, uncontrolled hypertension, and chronic pulmonary disease (eg, asthma, COPD), will be excluded. If warranted clinically, subjects will undergo laboratory evaluation (blood chemistry, electrocardiogram, urinalysis, toxicology screening for confirmation. Females of childbearing potential will undergo pregnancy testing.
- •A positive result on toxicity screening will exclude individuals from participation. A urine drug test that screens for 5 categories of drugs: marijuana (Δ9-THC), cocaine, amphetamines/methamphetamines, opiates, benzodiazepines and phencyclidine (PCP) will be employed. A positive result for opioids and/or THC will not be exclusionary if the patient is receiving a prescription for an opioid and/or THC.
- •Allergy to sesame oil, lactose, or gelatin Vascular disease, especially Raynauld's syndrome, systolic blood pressure > 170 mm, diastolic blood pressure > 100 mm Recent injuries to the upper extremity Cognitive impairment, such as Dementia or Alzheimer's Disease Substance Abuse History: The Substance Abuse Module of the Diagnostic Interview Schedule for the Diagnostic and Statistical Manual (DSM)-IV will be administered to exclude individuals with current substance use disorders.
- •Pregnancy as ascertained by a mandatory commercial pregnancy test Past history of suicide attempt. Cannabis can exacerbate pre-existing schizophrenia, and has been linked to an increase in the risk of suicide in such patients. In patients with bipolar disorder, cannabis use has been associated with worsening of manic and psychotic symptoms. Such findings suggest that cannabis is contraindicated in individuals with serious mental health issues, a line of reasoning that will be observed in the present study by excluding patients in the bipolar/schizoaffective/schizophrenic spectrum.
- •Suicidality. Exposure to cannabis does not lead to depression but it may be associated with suicidal thoughts and attempts. Therefore, the Beck Depression Inventory (BDI)-II will be used to measure suicidal ideation.
研究组 & 干预措施
Placebos
The present study is designed to evaluate whether or not a medium dose of cannabis (3.7% delta-9-THC/5.6% CBD) can maintain an analgesic response over an eight week period compared to placebo.
干预措施: Placebos (Drug)
Dronabinol
A direct comparison of cannabis and dronabinol has not been performed in a clinical population. The present study will fill this void by performing a randomized, controlled 8 week trial comparing the effectiveness of oral versus vaporized cannabis in patients with neuropathic low back pain.
干预措施: dronabinol (Drug)
Vaporized Cannabis 3.7% THC/5.6% CBD
The eight week outpatient study will compare the efficacy and side effect profile of cannabis (3.7%THC/5.6%CBD) and dronabinol. We will also perform a human laboratory experiment evaluating driving using the same study medications that subjects received during their 8 week outpatient treatment.
干预措施: Vaporized Cannabis 3.7% THC/5.6% CBD (Drug)
结局指标
主要结局
Numerical Pain Intensity
时间窗: 8 weeks
The primary outcome is self-reported daily average numerical pain intensity during the past 24 hours. The numerical pain intensity is an 11-point pain intensity numerical rating scale (PI-NRS), where 0 equals no pain and 10 equals worst possible pain. The time frame includes baseline and weeks 1, 3, 5, 7, 8. Baseline is the pain tensity reported at the first day in the daily diary, before the first dose. The follow-up pain intensities (weeks 1, 3, 5, 7, 8) are the daily diary average pain intensities since the previously reported timepoint.
次要结局
- Neuropathic Pain Scale(8 weeks)
- Hopkins Verbal Learning Test(8 weeks)
- Repeated Measures Recommended Minimal Dataset (NIH Task Force on Chronic Low Back Pain)(8 weeks)
- Wechsler Adult Intelligence Scale-III Digit Symbol Test(8 weeks)
- Beck Depression Inventory II(8 weeks)
- Cold Pressor Test - Pain Sensitivity(8 weeks)
- Grooved Pegboard Test - Dominant Hand(8 weeks)
- Locally Developed Psychoactive Effect Scale - Good Drug Effect(6 hours)
- Marijuana Subscale (M-scale) of the Addiction Research Center Inventory(8 weeks)
- Profile of Mood States(8 weeks)
- Cannabis Withdrawal Scale - Withdrawal Intensity(Week 8 and Week 10)
- Driving Simulation (Lane Tracking)(270 minutes)
- Driving Simulation (Car Following)(270 minutes)
- Locally Developed Psychoactive Effect Scale - High(6 hours)
- Cannabis Withdrawal Scale - Negative Impact of Withdrawal(Week 8, Week 10)
- Cold Pressor Test - Pain Tolerance(8 weeks)
研究者
Thomas D. Marcotte, PhD
Professor
University of California, San Diego