Brain Mechanisms Supporting Cannabis-induced Pain Relief

NCT04982965 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: Cannabis and Pain
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (1)

• Cerebral blood flow

  changes in CBF during rest, cannabis state, and pain

  At the first baseline testing session (session 1) and at the intervention session (session 2). All data will be collected within 2 weeks of signing consent.

Secondary Outcomes (1)

• Visual Analog Scale Pain ratings

  At the first baseline testing session (session 1) and at the intervention session (session 2). All data will be collected within 2 weeks of signing consent.

Study Arms (2)

Active THC

EXPERIMENTAL

Participants will be administered 400mg of vaporized cannabis (5.1%) before pain testing and fMRI.

Drug: Active Cannabis

Placebo THC

PLACEBO COMPARATOR

Participants will be administered 400mg of vaporized cannabis (\<.1%) before pain testing and fMRI.

Drug: Placebo Cannabis

Interventions

Active Cannabis DRUG

400 mg of vaporized and inhaled active cannabis (5.1%)

Active THC

Placebo Cannabis DRUG

400 mg of vaporized and inhaled placebo cannabis (\<.1%)

Also known as: Non-Active cannabis

Placebo THC

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (2)

Altman Clinical and Translational Research Institute

La Jolla, California, 92093, United States

RECRUITING

University of California, San Diego

San Diego, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessor will not be made aware if they are receiving active or placebo marijuana.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 29, 2021
• Study Start: May 7, 2021
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: January 8, 2024

Record last verified: 2024-01

Locations

US (2)