RECRUITING

Reducing Pain and Opioid Use With CBD

Conditions

Opioid Use Disorder Opioids Pain Cannabidiol CBD Cannabis

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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 is a double-blind, placebo-controlled, parallel group study designed to assess the tolerability and efficacy of fsCBD and bsCBD, compared to a placebo control, to reduce opioid use, anxiety, and pain and improve sleep and cognitive function. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.

Official Title

Reducing Pain and Opioid Use With CBD

Quick Facts

Study Start:2022-03-08

Study Completion:2027-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05299944

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Self-reported desire or intent to use cannabidiol to reduce pain and/or opioid use 2. Must be 18 years of age or older.	1. Self-reported recreational drug use (other than opioids) in the past 30 days or failed urine screen for cocaine, benzodiazepines (if not prescribed), MDMA, sedatives, or methamphetamine; 2. Self-reported current moderate/severe alcohol use, or severe opioid use disorder on the DSM V (unless patient is medically stable and approved by personal physician as well as the Medical Director for the study); 3. Actively seeking or in treatment for or history of any substance use disorder, other than opioid use disorder; 4. Currently being treated for or diagnosed with a moderate, severe, or unstable medical illness (e.g., renal disease, liver disease, cardiovascular disease). If the person has had a recent operation, they must be cleared for study participation by their surgeon or primary care doctor. Study inclusion/exclusion will be evaluated by our medical director when there are questions about applying criteria; 5. Currently taking any of the following medications: 1. Those known to have a major interaction with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, and/or teriflunomide) 2. Acute treatment with any antiepileptic medications (e.g. clobazam, sodium valproate) 6. Report being treated for bipolar disorder, schizophrenia, dissociative disorders, eating disorders, or any other psychotic or organic mental disorder in the last year. 7. Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control. 8. Endorsing item 2 on the C-SSRS measure of suicide risk. 9. Currently using CBD for medical reasons.

Inclusion Criteria

Exclusion Criteria

1. Self-reported desire or intent to use cannabidiol to reduce pain and/or opioid use
2. Must be 18 years of age or older.

1. Self-reported recreational drug use (other than opioids) in the past 30 days or failed urine screen for cocaine, benzodiazepines (if not prescribed), MDMA, sedatives, or methamphetamine;
2. Self-reported current moderate/severe alcohol use, or severe opioid use disorder on the DSM V (unless patient is medically stable and approved by personal physician as well as the Medical Director for the study);
3. Actively seeking or in treatment for or history of any substance use disorder, other than opioid use disorder;
4. Currently being treated for or diagnosed with a moderate, severe, or unstable medical illness (e.g., renal disease, liver disease, cardiovascular disease). If the person has had a recent operation, they must be cleared for study participation by their surgeon or primary care doctor. Study inclusion/exclusion will be evaluated by our medical director when there are questions about applying criteria;
5. Currently taking any of the following medications:
1. Those known to have a major interaction with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, and/or teriflunomide)
2. Acute treatment with any antiepileptic medications (e.g. clobazam, sodium valproate)
6. Report being treated for bipolar disorder, schizophrenia, dissociative disorders, eating disorders, or any other psychotic or organic mental disorder in the last year.
7. Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
8. Endorsing item 2 on the C-SSRS measure of suicide risk.
9. Currently using CBD for medical reasons.

Contacts and Locations

Study Contact

Raeghan Mueller

CONTACT

302.724.2208

raeghan.mueller@cuanschutz.edu

Study Locations (Sites)

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, 80045

United States

University of Colorado Denver

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

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 Date2022-03-08

Study Completion Date2027-02-28

Study Record Updates

Study Start Date2022-03-08

Study Completion Date2027-02-28

Terms related to this study

Keywords Provided by Researchers

Opioids
Pain
Cannabidiol
CBD
Cannabis

Additional Relevant MeSH Terms

Opioid Use Disorder