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Brain Mechanisms Supporting Cannabis-induced Pain Relief

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ClinicalTrials.gov Identifier: NCT04982965
Recruitment Status : Not yet recruiting
First Posted : July 29, 2021
Last Update Posted : July 29, 2021
Sponsor:
Information provided by (Responsible Party):
Fadel Zeidan, University of California, San Diego

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)(Institute of Medicine (US) Committee on Advancing Pain Research, 2011; Summers B, 2005). 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 (Andreae et al., 2015; Baker, Pryce, Giovannoni, & Thompson, 2003; Bostwick, 2014; Haroutounian et al., 2016; Shohet, Khlebtovsky, Roizen, Roditi, & Djaldetti, 2017). 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.


Condition or disease Intervention/treatment Phase
Healthy and Chronic Pain Patients Drug: Active Cannabis Drug: Placebo Cannabis Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants and outcome assessor will not be made aware if they are receiving active or placebo marijuana.
Primary Purpose: Basic Science
Official Title: Brain Mechanisms Supporting Cannabis-induced Pain Relief
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: Active THC
Participants will be administered 400mg of vaporized cannabis (5.1%) before pain testing and fMRI.
Drug: Active Cannabis
400 mg of vaporized and inhaled active cannabis (5.1%)

Placebo Comparator: Placebo THC
Participants will be administered 400mg of vaporized cannabis (<.1%) before pain testing and fMRI.
Drug: Placebo Cannabis
400 mg of vaporized and inhaled placebo cannabis (<.1%)
Other Name: Non-Active cannabis




Primary Outcome Measures :
  1. Cerebral blood flow [ Time Frame: 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. ]
    changes in CBF during rest, cannabis state, and pain


Secondary Outcome Measures :
  1. Visual Analog Scale Pain ratings [ Time Frame: 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. ]
    Pain ratings will be assessed in response to the noxious heat stimulation. Pain intensity and unpleasantness ratings will be assessed with a visual analog scale (VAS). The minimum rating ("0") is designated as "no pain" whereas the maximum ("10") is labeled as "most intense imaginable" or "most unpleasant imaginable." Higher numbers correspond to higher pain.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Responsible Party: Fadel Zeidan, Associate Professor of Anesthesiology, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04982965    
Other Study ID Numbers: Cannabis and Pain
First Posted: July 29, 2021    Key Record Dates
Last Update Posted: July 29, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations