Dronabinol for Pain and Inflammation in Adults Living With Sickle Cell Disease
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Feasibility will be defined by ability to mask patients and investigators to treatment assignment and adherence
研究概览
简要总结
This study is designed to address the feasibility of a randomized, double masked, cross-over study of dronabinol as a palliative agent in the treatment of pain, inflammation, and other complications of sickle cell disease (SCD).
详细描述
The Primary Hypothesis is that such a study will be feasible as defined by subject adherence to study medication and study procedures and avoidance of other cannabinoid containing substances during the trial period as well as by ability to mask subjects and investigators to treatment assignment
Secondary hypotheses are:
Dronabinol will:
Reduce patient-reported pain interference Reduce patient-reported pain scores and change patient-reported pain quality. Reduce use of opioid pain medications. Improve patient-reported stiffness, nausea and vomiting, sleep, mood, anxiety, and social functioning.
Reduce markers of inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
double blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Age ≥18 years, able to understand and sign the informed consent form
- •Clinical diagnosis of SCD (HbSS, HbSC, HbSβ+; Thal, HbSβ0Thal, HbS variants)
- •Baseline score of 60 or lower on the ASCQ-Me 7-day pain interference domain
- •Willing to abstain from marijuana, medical and illicit, during study weeks 1 through
- •For patients currently receiving hydroxyurea and/or L-glutamine, on a stable dose(s) for at least 3 months
- •For patients currently on a chronic red blood cell transfusion program, on such a program for at least 3 months
排除标准
- •Known intolerance to dronabinol, sesame oil, or marijuana
- •Patients with a diagnosis or medical history of any psychiatric disorder with psychosis
- •Presence of any concomitant medical condition, or use of concomitant medication, that, in the Investigator's opinion, may place the subject at increased risk of side effects of dronabinol.
- •Pregnant or nursing women
- •If a woman capable of becoming pregnant, unwilling to use a medically accepted form of birth control for the duration of study participation. Accepted forms include oral contraception or vaginal ring, medroxyprogesterone, contraceptive implants, intrauterine device, or patch, surgical sterilization, total abstinence. We have not included a similar restriction for men as the current FDA approval includes no such restriction.
研究组 & 干预措施
Dronabinol, Then Placebo
Participants will take 2.5 mg of Dronabinol for 2 weeks, 1 week washout and then take 2 weeks of placebo (microcrystalline cellulos). Subjects will take up to 8 capsules daily of the treatment daily during each phase.
干预措施: Dronabinol 2.5 MG (Drug)
Dronabinol, Then Placebo
Participants will take 2.5 mg of Dronabinol for 2 weeks, 1 week washout and then take 2 weeks of placebo (microcrystalline cellulos). Subjects will take up to 8 capsules daily of the treatment daily during each phase.
干预措施: Microcrystalline cellulose (Drug)
Placebo, Then Dronabinol
Participants will take placebo (microcrystalline cellulos) for 2 weeks, 1 week washout and then take 2.5 mg of Dronabinol for 2 weeks. Subjects will take up to 8 capsules daily of the treatment daily during each phase.
干预措施: Dronabinol 2.5 MG (Drug)
Placebo, Then Dronabinol
Participants will take placebo (microcrystalline cellulos) for 2 weeks, 1 week washout and then take 2.5 mg of Dronabinol for 2 weeks. Subjects will take up to 8 capsules daily of the treatment daily during each phase.
干预措施: Microcrystalline cellulose (Drug)
结局指标
主要结局
Feasibility will be defined by ability to mask patients and investigators to treatment assignment and adherence
时间窗: 1 year
Feasibility will be defined by ability to mask patients and investigators to treatment assignment and adherence which will be defined in 3 ways.
Adherence
时间窗: 1 year
Adherence to study drug will be assessed with weekly pill counts and urine toxicology.
Avoidance
时间窗: 7 weeks
Avoidance of other cannabinoid containing substances will also be defined using urine toxicology once at the end of each treatment period and once at the end of the wash out period.
Adherence to other study proceedures
时间窗: 7 weeks
Adherence to other study procedures will be defined as percent of visits attended, percent of urine and serum studies collected and percent of patient reported outcomes and daily pain severity and pain unpleasentness journals returned.
次要结局
- Patient Pain Severity(end of 2nd week)
- PROMIS (Patient Reported Outcomes Measurement Information System) Nociceptive Pain Severity(end of 2nd week)
- Adult Sickle Cell Quality (ASCQ)-Me short form measure of social functioning impact(end of 2nd week)
- Serum pro-inflammatory cytokines(end of 2nd week)
- Patient reported 7-day pain interference(7 days)
- PROMIS Neuropathic Pain Severity(end of 2nd week)
- PROMIS Gastrointestinal Nausea short form measure(end of 2nd week)
- PROMIS short form for emotional distress anxiety 8a.(end of 2nd week)
- Adult Sickle Cell Quality (ASCQ)-Me short form measures of emotional impact(end of 2nd week)
- Adult Sickle Cell Quality (ASCQ)-Me short form measure of sleep impact(end of 2nd week)
- Serum measure of Substance P(end of 2nd week)
- Adult Sickle Cell Quality (ASCQ)-Me short form measure of stiffness impact(end of 2nd week)
- Markers of Inflammation Concentration of white blood cell count differential(end of 2nd week)
- Markers of Inflammation serum tryptase(end of 2nd week)
- Markers of Inflammation C reactive protein(end of 2nd week)
- Patient Pain Unpleasantness(end of 2nd week)
- Opioid Utilization(end of 2nd week)