FibromyalgiaNCT00381199
Nabilone Versus Amitriptyline in Improving Quality of Sleep in Patients With Fibromyalgia
A study testing Amitriptyline Hydrochloride and Nabilone in people with Fibromyalgia and Sleep Initiation and Maintenance Disorders, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Sleep Initiation and Maintenance Disorders
- What is being tested?
- Amitriptyline Hydrochloride and Nabilone
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2006to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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);
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill University Health Centre, Pain Centre
Montreal, Quebec, H3G 1A4
About this study
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.
- Being tested
- Amitriptyline Hydrochloride, Nabilone
- Keywords
- fibromyalgia, cannabinoid, chronic pain, sleep, insomnia, diffuse widespread pain, antidepressant
- Medical subject headings
- Fibromyalgia, Sleep Initiation and Maintenance Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amitriptyline HydrochlorideDrug
NabiloneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of sleep assessed using the Leeds Sleep Evaluation Questionnaire and the Insomnia Severity Index
Measured: Day 1, 15, 29 and 43 and given to the patient to complete every second day while taking the study medication
Secondary outcomes (4)
Pain Intensity using the VAS (visual analogue scale)
Measured: Days 1, 15, 29 and 43
Pain Quality using the McGill Pain Questionnaire
Measured: Days 1, 15, 29 and 43
Mood using the Profile of Mood States (POMS) Questionnaire
Measured: Days 1, 15, 29 and 43
Quality of Life using the Fibromyalgia Impact Questionnaire (FIQ)
Measured: Days 1, 15, 29 and 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study startApr 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Investigators
- Mark A Ware, Principal investigator, McGill University Health Centre, Pain Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381199
- Sponsor's protocol ID
- GEN#05-017
- Status last verified
- May 2007
- First submitted
- 25 Sep 2006
- Last updated
- 21 May 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nabilone Versus Amitriptyline in Improving Quality of Sleep in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT00381199
- Acronym / sponsor ID
- GEN#05-017
- Keywords
- fibromyalgia, cannabinoid, chronic pain, sleep, insomnia, diffuse widespread pain, antidepressant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Apr 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 27 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amitriptyline Hydrochloride | Drug | – |
| Nabilone | Drug | – |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A Ware principal investigator
McGill University Health Centre, Pain Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amitriptyline Hydrochloride and Nabilone in people with Fibromyalgia and Sleep Initiation and Maintenance Disorders, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2007.