NCT00381199已完成不适用

Nabilone Versus Amitriptyline in Improving Quality of Sleep in Patients With Fibromyalgia

McGill University Health Centre/Research Institute of the McGill University Health Centre1 个研究点分布在 1 个国家目标入组 32 人开始时间: 2006年4月1日最近更新: 2007年5月21日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 32
试验地点: 1
主要终点: Quality of sleep assessed using the Leeds Sleep Evaluation Questionnaire and the Insomnia Severity Index

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Most chronic pain patients with insomnia are currently not well-managed using existing medications. If found to safely improve sleep with chronic pain patients, nabilone could be added to the treatment options available in the management of fibromyalgia and associated symptoms.

The principle hypothesis of this study is that nabilone at a dose of 0.5-1mg is as efficacious as amitriptyline at a dose of 10-20mg, in improving sleep quality in patients with fibromyalgia.

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

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

•Patients aged ≥18 years;
•A diagnosis of fibromyalgia according to the American College of Rheumatology classification criteria (Wolfe F, Smythe HA, et al 1990);
•Suffering from self-reported disturbed sleep;
•Negative urine screen for cannabinoids;
•Women of childbearing potential must agree to use adequate contraception during study and for 3 months after study;
•Ability to attend research centre every second week for approximately seven to nine weeks and be able to be contacted by telephone during the study period;
•Stable drug regimen for 1 month prior to randomization;
•Normal liver (AST <3x normal) and renal function (serum creatinine <133µmol/L);
•Haematocrit >38%;
•Negative serum bHCG;
•Proficient in English or French;
•Willing and able to give written informed consent;
•Ability to follow study protocol (cognitive and situational).

排除标准

•Patients currently using cannabis or cannabinoid or tricyclic antidepressants (TCA) and who are unable to undergo a 2 week washout period before entering the study;
•Pain due to cancer;
•Unstable cardiac disease such as cardiac arrhythmias, cardiac failure, ischaemic heart disease and/or hypertension on clinical history and examination;
•History of psychotic disorder or schizophrenia;
•Known hypersensitivity to cannabinoids, amitriptyline, or related tricyclic antidepressants;
•Currently taking or unable to stop taking monoamine oxidase inhibitors (a two-week washout period is necessary for subjects taking MAOIs);
•History of seizures/epilepsy;
•Diagnosis of glaucoma;
•Urinary retention;
•Pregnancy and/or breast-feeding;
•Participation in other clinical trial in the 30 days prior to randomization;
•A recent manic episode (within the past year);
•Current suicidal ideation or history of suicide attempts

结局指标

主要结局

Quality of sleep assessed using the Leeds Sleep Evaluation Questionnaire and the Insomnia Severity Index

时间窗: Day 1, 15, 29 and 43 and given to the patient to complete every second day while taking the study medication

次要结局

Pain Intensity using the VAS (visual analogue scale)(Days 1, 15, 29 and 43)
Pain Quality using the McGill Pain Questionnaire(Days 1, 15, 29 and 43)
Mood using the Profile of Mood States (POMS) Questionnaire(Days 1, 15, 29 and 43)
Quality of Life using the Fibromyalgia Impact Questionnaire (FIQ)(Days 1, 15, 29 and 43)

研究者

发起方

McGill University Health Centre/Research Institute of the McGill University Health Centre

申办方类型

Other

研究点 (1)

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