Sciatica study: Active Cannabis
Official title Brain Mechanisms Supporting Cannabis-induced Pain Relief
ClinicalTrials.gov ID: NCT04982965
What this study is testing
What is Active Cannabis?
This is an investigational inhaled medicine being studied to see if it helps with chronic low back pain. It is designed to be vaporized and inhaled so the active ingredients enter the body through the lungs.
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
- This study is testing whether inhaled cannabis can change brain activity and reduce pain in people with chronic low back pain.
- Who it's for
- You may be able to join if you have chronic low back pain that has not been fully relieved by other treatments.
- What's involved
- You will breathe in cannabis vapor at the clinic. The study will measure your brain activity and pain levels before and after. You may also fill out pain questionnaires.
- Time commitment
- The study lasts a few weeks and includes several clinic visits for breathing sessions and brain scans.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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 65. Healthy volunteers may be eligible.
You may be able to join if
- Between 21-65 years old
- Currently 30 days cannabis free
- Lower back pain for three months or more
- Are not taking opioids
- If female and of a child bearing potential age, are not pregnant or nursing mothers
You likely can't join if
- Active pulmonary disease
- Allergy or past adverse effects or negative past experiences from cannabis
- Positive urine drug test for THC, barbiturates, opioids, oxycodone, or methadone
- Any significant illness, including cardiovascular disease, diabetes, renal and liver disease.
- Any current or history of an immunocompromising disease or condition (such as lupus, psoriasis, multiple sclerosis, etc.)
- Any current or history of neurologic conditions, including Parkinson disease, dementia, cognitive impairment, history of seizure disorder, and...
See the full eligibility criteria
- Between 21-65 years old
- Currently 30 days cannabis free
- Lower back pain for three months or more
- Are not taking opioids
- If female and of a child bearing potential age, are not pregnant or nursing mothers
- Do not have mental or neurological conditions inhibiting sensory/motor functions
- Do not have a lifetime history of dependence on cannabis
- Do not have a lifetime history of DSM-IV schizophrenia, bipolar disorder, panic disorder, or psychosis
- Prior THC-containing cannabis experience within the past two years
- Agrees not to use cannabis outside of the study during participation in the study
- Agrees not to use opioids or barbiturates during participation in the study
- Agrees not to drive a motor vehicle within 4 hours following last use of inhaled cannabis during participation in the study
- Active pulmonary disease
- Allergy or past adverse effects or negative past experiences from cannabis
- Positive urine drug test for THC, barbiturates, opioids, oxycodone, or methadone
- Any significant illness, including cardiovascular disease, diabetes, renal and liver disease.
- Any current or history of an immunocompromising disease or condition (such as lupus, psoriasis, multiple sclerosis, etc.)
- Any current or history of neurologic conditions, including Parkinson disease, dementia, cognitive impairment, history of seizure disorder, and history of traumatic brain injury/head injury
- Any current major psychiatric illness, such as bipolar disorder, major depression, psychosis, substance use disorder, or schizophrenia
- Any current or history of suicidal ideation or attempt
- Overt sensitivity to thermal stimulation
- Resting blood pressure \> 140/90
- Resting heart rate \> 100 beats/minute
- Prisoner
- Institutionalized
- Claustrophobia
- MRI contraindications
- Participation in any new (within 2 weeks prior or any time after enrollment) pain management procedures during the study period
- Known history of vasovagal fainting, syncope, or severe adverse reactions associated with blood draws or needle procedures
The study team makes the final eligibility decision.
Where it is enrolling
- La Jolla, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at La Jolla, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.