BridgeMD
Tests treatment safety and results for Back Pain
Official title Safety and Efficacy of Oral Cannabis in Chronic Spine Pain
ClinicalTrials.gov ID: NCT05052541
What this study is testing
What is THC/CBD?
THC/CBD is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for back pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The overall objectives of this study are to investigate the efficacy of extended cannabis treatment to reduce patient exposure to prescription opioids through its use 1) as a non-opioid analgesic treatment, and 2) as a therapy for reducing high-dose opioid use in patients with chronic spine pain.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 84
You may be able to join if
- Some inclusion/
You likely can't join if
- are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.
- Inclusion Criteria:
- Self-reported chronic (≥3 months' duration), non-radicular spine pain
- Exclusion Criteria:
- Unwilling/unable to refrain from cannabis use (medical or recreational) for 14 days prior to Baseline Visit and throughout the study (other than...
- Co-morbid cancer-related pain condition
See the full eligibility criteria
- Some inclusion/
- are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.
- Inclusion Criteria:
- Self-reported chronic (≥3 months' duration), non-radicular spine pain
- Exclusion Criteria:
- Unwilling/unable to refrain from cannabis use (medical or recreational) for 14 days prior to Baseline Visit and throughout the study (other than study drug). This includes whole plant inhalation, edibles, extracts, and...
- Co-morbid cancer-related pain condition
- Neuropathic Pain
- A co-morbid pain condition that is of greater severity than the patient's spine pain
- Spine or other major surgery within the 3 months prior to enrollment
- Planned surgery or procedural intervention during the study period
- Allergy or adverse reaction to cannabis
- Current or historical substance use disorder
- Current or historical alcohol use disorder
- Current or prior cannabis abuse/dependence
- Positive result for use of amphetamine/methamphetamine, barbiturates, benzodiazepines, cocaine, phencyclidine (PCP), ecstasy (MDMA), as detected on urine screen
- Current use of valproate, clobazam, clopidogrel, warfarin, barbiturates, benzodiazepines
- Prior adverse reaction to cannabis exposure (paranoia, anxiety, etc.)
- History or diagnosis of schizophrenia, bipolar or a psychotic disorder
- History of any mental health illness that in the opinion of the Investigator would compromise the safety of the participant
- Current or historical severe depression
- Current suicidal ideation
- Diagnosed cognitive impairment (e.g. Alzheimer's Disease, traumatic brain injury)
- Uncontrolled hypertension (\>139/89)
- Abnormal values on CBC (complete blood count) or CMP (comprehensive metabolic panel) laboratory analysis that are deemed clinically significant by study physician
- Known hepatic disease or dysfunction, or identification of such on screening laboratory studies
- Known cardiovascular disease
- Abnormal result on electrocardiogram (ECG) that is deemed clinically significant by study MD
- Cognitive disability that interferes with ability to provide consent or understand study procedure
- History of seizure disorder
- Any medical condition for which immunosuppressive therapy is required.
- Inability to refrain from using tobacco for at least 4 hours
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data
- Pending legal action or workers compensation
- Pregnant females or females intending to become pregnant during the study period
- Unwilling to use one of the accepted forms of contraception during the study period and for at least 60 days after completion of the study (females of childbearing potential and males with sexual partners of...
- Lactating females
- Analgesia Arm Exclusion Criteria:
- Unwilling/unable to discontinue current opioid use for 14 days prior to Baseline study visit and throughout the study
- Reduction Arm Exclusion Criteria:
- Not interested in reducing or discontinuing use of prescribed opioids for chronic pain
- Unwilling to allow the study team to communicate with the participant's opioid prescribing provider
- \ Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 84 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.