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Cannabinoid
Nabilone for Insomnia Due to Chronic Pain
Phase 2
Waitlist Available
Led By Colin M. Shapiro, MBBCh, PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient not currently being prescribed opiates for pain management
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will study whether nabilone, a medication approved to prevent vomiting in chemotherapy patients, can help improve sleep in patients with pain and insomnia.
Who is the study for?
This trial is for individuals with chronic, non-cancer pain and insomnia who are not currently using opiates. They should have stable vital signs and no significant medical issues at screening. People can't join if they're sensitive to cannabinoids, taking certain CNS depressants or antidepressants, have active heart/respiratory diseases, severe mental disorders, liver disease affecting drug clearance, or a history of substance abuse.Check my eligibility
What is being tested?
The study is testing Nabilone's effectiveness in improving sleep quality for patients suffering from insomnia due to chronic pain. Nabilone is usually used to prevent vomiting during chemotherapy but may help with sleep based on its properties.See study design
What are the potential side effects?
Nabilone could potentially cause drowsiness, dry mouth, dizziness, euphoria (feeling 'high'), confusion or disorientation. Since it affects the central nervous system (CNS), it might also intensify the effects of other CNS depressants.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not taking opiates for pain management.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The primary analysis variable will be the change in the mean of the sleep efficiency as measured by overnight polysomnography.
Secondary outcome measures
• The key secondary efficacy variable will be the change in the total sleep time with nabilone treatment as compared to placebo
Find a Location
Who is running the clinical trial?
Bausch Health Americas, Inc.Industry Sponsor
262 Previous Clinical Trials
82,012 Total Patients Enrolled
University Health Network, TorontoLead Sponsor
1,472 Previous Clinical Trials
484,977 Total Patients Enrolled
5 Trials studying Pain
2,496 Patients Enrolled for Pain
Colin M. Shapiro, MBBCh, PhDPrincipal InvestigatorUniversity Health Network, Toronto
2 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver condition might affect how my body handles certain medications.I have a history of insomnia and long-term non-cancer pain.I am currently taking medications that affect my mood or sleep.I have heart or lung problems.I have an untreated sleep disorder, not insomnia, confirmed by a sleep study.I am not pregnant, nursing, or planning to become pregnant during the study.I am not taking opiates for pain management.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this therapy been federally sanctioned?
"While there is some evidence to support the safety of this treatment, it received a score of 2 because Phase 2 trials have yet to demonstrate efficacy."
Answered by AI
Can new patients still sign up for this trial?
"This particular clinical trial is not actively recruiting, as stated on clinicaltrials.gov. This study was first posted December 1st, 2005 and edited October 4th, 2006. There are 606 other trials that patients can participate in at this time."
Answered by AI
Does this research project restrict eligibility to those over 40 years old?
"Eligibility for this study requires that potential participants must between the ages of 18 to 65, as specified in the inclusion criteria."
Answered by AI
Who would be an eligible candidate for this clinical trial?
"Eligible patients for this study must be aged 18-65, have a history of insomnia, and currently experience chronic pain that is not being managed with opiates. In addition, all subjects must have normal vital signs and no other significant clinical findings."
Answered by AI
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