Brain Mechanisms Supporting Cannabis-induced Pain Relief

Cannabis and Pain

The American Academy of Pain Medicine has labeled pain as a "silent epidemic" due to its staggering costs to society (over $500 billion/year) and widespread prevalence (affects over 100 million Americans). Thus, it is imperative to test and validate cost-effective pain therapies. To this extent, cannabis is characterized as one of the most promising therapies to treat a wide spectrum of pain conditions. However, the clinical applicability of cannabis-based pain therapies has been limited due to lacking mechanistic characterization in human-focused studies. Of critical importance, the neural mechanisms supporting cannabis induced pain relief remain unknown. The primary objective of the proposed pilot study is to identify the brain mechanisms supporting the direct alleviation of acutely evoked pain through vaporized cannabis.

2021-05-07

2027-01-15

2027-03-15

Recruiting

Early phase I

100

Inclusion Criteria: * are between 21-65 years old * Volunteers with no previous medical history (e.g., cardiac or pulmonary disease); * are not currently using any type of cannabis * have had a previous history with cannabis * currently 30 days cannabis free * are not taking opioids * if female and of a child bearing potential age, are not pregnant or nursing mothers; * do not lack sensory/motor deficits that preclude participation in pain-inducing procedures * do not have a lifetime history of dependence on cannabis * do not have a lifetime history of DSM-IV schizophrenia, bipolar disorder, generalized anxiety or panic disorder, or previous psychosis with or intolerance to cannabinoids * 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 Exclusion Criteria: * Current or past history of cannabis, alcohol or opioid abuse * 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 prior to study session 1 * Pregnancy * Breastfeeding * Prisoner * Known cognitive impairment * Institutionalized * Claustrorphobia * MRI contraindications

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Participants and outcome assessor will not be made aware if they are receiving active or placebo marijuana.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-01-08