RECRUITING

PAIN: A Project Assessing the Impact of a Novel Cannabinoid Product

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is a clinical trial of a high-cannabidiol (CBD) sublingual product compared to placebo for 9 weeks in patients with chronic pain conditions. The study will assess the impact of CBD on chronic pain symptoms, conventional medication use, clinical state, quality of life, cognition, and biomarkers.

Official Title

PAIN: A Project Assessing the Impact of a Novel Cannabinoid Product

Quick Facts

Study Start:2024-06-27
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03984565

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject has provided informed consent
  2. * Subject is 21 or older
  3. * Subject is fluent in English
  4. * Subject endorses a chronic pain condition including, but not limited to, chronic pain due to injury, musculoskeletal pain, arthritis (including osteoarthritis and rheumatoid arthritis), fibromyalgia, bursitis, endometriosis, etc.
  1. * Non-fluent English speakers
  2. * Estimated IQ \< 75
  3. * A history of head injury or loss of consciousness greater than 5 minutes
  4. * Currently uses CBD products regularly
  5. * Female subjects will be excluded if they have a positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding
  6. * Presence of a serious or unstable medical illness, including liver, kidney, or cardiovascular disease (hyper/hypotension, cardiac disorders), or neurological disorder (including seizure disorder)
  7. * Neuropathic pain or cancer-related pain
  8. * Disclosure of a genetic polymorphism affecting CYP2C9 function

Contacts and Locations

Study Contact

Staci Gruber, Ph.D.
CONTACT
617-855-2762
gruber@mclean.harvard.edu
Rosie Smith, M.S.
CONTACT
617-855-3338
cbdstudy@mclean.harvard.edu

Principal Investigator

Staci Gruber, Ph.D.
PRINCIPAL_INVESTIGATOR
Mclean Hospital

Study Locations (Sites)

McLean Hospital
Belmont, Massachusetts, 02478
United States

Collaborators and Investigators

Sponsor: Staci Gruber, Ph.D.

  • Staci Gruber, Ph.D., PRINCIPAL_INVESTIGATOR, Mclean Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-27
Study Completion Date2026-09

Study Record Updates

Study Start Date2024-06-27
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • Cannabidiol
  • Medical Cannabis
  • Industrial Hemp

Additional Relevant MeSH Terms

  • Chronic Pain