INTERVENTIONALCOMPLETEDNCT00381199

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

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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2007-05-21

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: NA
Enrollment: 32 (ACTUAL)
Start date: 2006-04
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Design: RANDOMIZED · CROSSOVER · TREATMENT
Locations: 1
Results record: Not present in registry snapshot

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

No governed compound link was found.

Medicines

No exact medicine-name link was found.

Interventions

What was registered

DRUG

Amitriptyline Hydrochloride

DRUG

Nabilone

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: Not reported
Healthy volunteers: Not accepted

Inclusion criteria

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).

Exclusion criteria

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

primary outcomes

primary measures

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

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

secondary outcomes

secondary measures

Pain Intensity using the VAS (visual analogue scale)

Time frame: Days 1, 15, 29 and 43

Pain Quality using the McGill Pain Questionnaire

Time frame: Days 1, 15, 29 and 43

Mood using the Profile of Mood States (POMS) Questionnaire

Time frame: Days 1, 15, 29 and 43

Quality of Life using the Fibromyalgia Impact Questionnaire (FIQ)

Time frame: Days 1, 15, 29 and 43

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: daff2cac-4f59-4d2d-9e07-19e0fada4c74
Retrieved: 11/09/2026, 14:54:54
SHA-256: 767927e984d07e0a4397b651906ea347198607d433c71d1fa5b78cf7482b9685