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

Primary Purpose

Fibromyalgia, Sleep Initiation and Maintenance Disorders

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Amitriptyline Hydrochloride

Nabilone

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, cannabinoid, chronic pain, sleep, insomnia, diffuse widespread pain, antidepressant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

McGill University Health Centre, Pain Centre

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain Intensity using the VAS (visual analogue scale)

Pain Quality using the McGill Pain Questionnaire

Mood using the Profile of Mood States (POMS) Questionnaire

Quality of Life using the Fibromyalgia Impact Questionnaire (FIQ)

Full Information

NCT ID

NCT00381199

First Posted

September 25, 2006

Last Updated

May 16, 2007

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT00381199

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2007

Overall Recruitment Status

Completed

Study Start Date

April 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia, Sleep Initiation and Maintenance Disorders

Keywords

fibromyalgia, cannabinoid, chronic pain, sleep, insomnia, diffuse widespread pain, antidepressant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Amitriptyline Hydrochloride

Intervention Type

Drug

Intervention Name(s)

Nabilone

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Pain Intensity using the VAS (visual analogue scale)

Time Frame

Days 1, 15, 29 and 43

Title

Pain Quality using the McGill Pain Questionnaire

Time Frame

Days 1, 15, 29 and 43

Title

Mood using the Profile of Mood States (POMS) Questionnaire

Time Frame

Days 1, 15, 29 and 43

Title

Quality of Life using the Fibromyalgia Impact Questionnaire (FIQ)

Time Frame

Days 1, 15, 29 and 43

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark A Ware

Organizational Affiliation

McGill University Health Centre, Pain Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

McGill University Health Centre, Pain Centre

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

12. IPD Sharing Statement

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

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