---
title: Nabilone Versus Amitriptyline in Improving Quality of Sleep in Patients With Fibromyalgia
nct_id: NCT00381199
overall_status: COMPLETED
phase: NA
sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
study_type: INTERVENTIONAL
primary_condition: Fibromyalgia
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00381199.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00381199"
ct_last_update_post_date: 2007-05-21
last_seen_at: "2026-05-12T06:36:52.713Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Nabilone Versus Amitriptyline in Improving Quality of Sleep in Patients With Fibromyalgia

**NCT ID:** [NCT00381199](https://clinicaltrials.gov/study/NCT00381199)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 32
- **Lead Sponsor:** McGill University Health Centre/Research Institute of the McGill University Health Centre
- **Conditions:** Fibromyalgia, Sleep Initiation and Maintenance Disorders
- **Start Date:** 2006-04
- **Completion Date:** 2007-03
- **CT.gov Last Update:** 2007-05-21

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Interventions

- **Amitriptyline Hydrochloride** (DRUG)
- **Nabilone** (DRUG)

## Primary Outcomes

- **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

- **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)_

## Locations (1)

- McGill University Health Centre, Pain Centre, Montreal, Quebec, Canada

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.mcgill university health centre, pain centre|montreal|quebec|canada` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT00381199*  
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