Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC)

NCT ID: NCT03215940

Last Updated: 2025-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2024-12-01

Brief Summary

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This is a study comparing the effects of Delta-9-Tetrahydrocannabinol (THC) versus Cannabidiol (CBD) versus a placebo on chronic non-cancer pain.

Detailed Description

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The overall aim of this study is to examine the effects of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) on chronic pain symptoms, specifically we will examine the effects of different doses of THC/CBD on symptoms of chronic pain and life functioning. Participants will include individuals with chronic pain, who will be randomized into one of three intervention conditions: high THC/low CBD, low THC/high CBD, or placebo. In addition to receiving THC/CBD/placebo, participants also will complete symptom assessments of chronic pain data (intensity, quality, interference/disability) throughout the study. These measures will be gathered prior to and following the fifth doses (dosing will occur once per day for five days) of CBD/THC or placebo. A secondary objective will be to examine the association between clinical and neurocognitive variables and use of CBD/THC, including the potential side effects of THC/CBD. Other secondary objectives include the use of magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS), acquired before and after final administration with CBD/THC or placebo to examine differences in brain metabolism, brain connectivity, and brain structure. Imaging analyses will focus on regional brain changes before and after administration of THC/CBD/placebo.

Conditions

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Chronic Pain, Widespread

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Delta-9-Tetrahydrocannabinol's (Delta-9-THC) effects on pain

This arm will be testing the analgesic effects of orally dosed Delta-9-Tetrahydrocannabinol on subjects with chronic non-cancer pain.

Group Type ACTIVE_COMPARATOR

Delta-9-Tetrahydrocannabinol

Intervention Type DRUG

An oral dose of Delta-9-Tetrahydrocannabinol (THC) will be given once a day for five day with pain ratings taken before and after each dose every day.

Cannabidiol's (CBD) effects on pain

This arm will be testing the analgesic effects of orally dosed Cannabidiol on subjects with chronic non-cancer pain.

Group Type ACTIVE_COMPARATOR

Cannabidiol

Intervention Type DRUG

An oral dose of Cannabidiol (CBD) will be given once a day for five day with pain ratings taken before and after each dose every day.

Placebo

This Placebo arm will act as the control as standard of care medications will be continued through the study. This arm will allow us to compare the analgesic effects of the other two arms with the standard of care treatments for chronic non-cancer pain.

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

An oral placebo will be given once a day for five day with pain ratings taken before and after each dose every day.

Interventions

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Delta-9-Tetrahydrocannabinol

An oral dose of Delta-9-Tetrahydrocannabinol (THC) will be given once a day for five day with pain ratings taken before and after each dose every day.

Intervention Type DRUG

Cannabidiol

An oral dose of Cannabidiol (CBD) will be given once a day for five day with pain ratings taken before and after each dose every day.

Intervention Type DRUG

Placebos

An oral placebo will be given once a day for five day with pain ratings taken before and after each dose every day.

Intervention Type DRUG

Other Intervention Names

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THC Delta-9-THC CBD placebo

Eligibility Criteria

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Inclusion Criteria

1. Age between 18-50 yrs.
2. History of cannabis use.
3. Chronic musculoskeletal and joint pain for at least 3 months or longer.
4. Participants must live within a 60 mile radius of Salt Lake City, Utah to be eligible.

Exclusion Criteria

1. Current or past neurological illness.
2. Substance abuse or dependence within the prior 60 days.
3. Contraindication to brain MRI.
4. Type I and type II diabetes.
5. Unstable medical conditions.
6. Consumption of more than 2 drinks of alcohol per night.
7. Current pregnancy or planning to become pregnant or breastfeeding
8. History of seizures or head trauma
9. Active or history of major mental illness
10. LFT results 3 times greater than the upper limit of normal at screening.
11. Participants may be excluded if the PI feels they do not meet safety criteria.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Deborah Yurgelun-Todd

Director of the Brain Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deborah Yurgelun-Todd, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah Brain Institute

Locations

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University Of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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IRB_00103451

Identifier Type: -

Identifier Source: org_study_id

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