Opioid Use DisorderPhase 2NCT05299944
Reducing Pain and Opioid Use With CBD
A Phase 2 study testing Cannabidiol in people with Opioid Use Disorder, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Cannabidiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Mar 2022to 19 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported desire or intent to use cannabidiol to reduce pain and/or opioid use
- Must be 18 years of age or older.
Who cannot join
- 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;
- 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);
- Actively seeking or in treatment for or history of any substance use disorder, other than opioid use disorder;
- 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;
- Currently taking any of the following medications:
- Those known to have a major interaction with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, and/or teriflunomide)
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- Acute treatment with any antiepileptic medications (e.g. clobazam, sodium valproate)
- Report being treated for bipolar disorder, schizophrenia, dissociative disorders, eating disorders, or any other psychotic or organic mental disorder in the last year.
- Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
- Endorsing item 2 on the C-SSRS measure of suicide risk.
- Currently using CBD for medical reasons.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, 80045
University of Colorado Denver
Aurora, Colorado, 80045
About this study
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.
Read the detailed description
To better understand the effects of hemp-derived CBD with and without a small amount of THC, the investigators propose a Phase II randomized clinical trial (RCT) to examine the safety, tolerability, and clinical effects of Full Spectrum CBD (fsCBD, contains less than 0.3% THC) vs. Broad Spectrum CBD (bsCBD, does not contain THC), vs. a matching placebo in a population of opioid users.
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.
Study visits will take place both in-person and via Zoom/online. Study participants will attend four in-person visits at the University of Colorado Anschutz at Week 0 (Baseline Medical Director Screen and Medication Dispense), Week 6, and Week 12. Research staff will meet with participants over Zoom during their Week 1 visit and will be contacted weekly during the 12-week study period. Following the Week 1 Zoom visit, participants will have the option to receive the survey link via email for Weeks 2-5 and 7-11 in lieu of meeting with a research team member over Zoom to allow more flexibility in time to complete the study surveys (participants can complete surveys at their convenience within a 3-business day period). In Week 16, approximately 4 weeks after the end of dosing, a final follow-up Zoom interview will occur.
- Conditions
- Opioid Use Disorder
- Being tested
- Cannabidiol, Placebo
- Keywords
- Opioids, Pain, Cannabidiol, CBD, Cannabis
- Medical subject headings
- Opioid-Related Disorders, Pain, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called CBD
The current study will directly test the hypothesis that a moderate dose of CBD leads to a reduction in opioid consumption, opioid craving, pain, peripheral markers of inflammation, and anxiety, as well as changes in sleep, AEA, and cognition.
PlaceboDrug
Placebo arm
| Study group | Role | What they receive |
|---|---|---|
| Full-spectrum Cannabidiol | Active comparator | 210mg/day of full-spectrum cannabidiol, containing less than 0.3%THC. Receives: Drug: Cannabidiol |
| Broad-spectrum Cannabidiol | Active comparator | 210mg/day of broad-spectrum cannabidiol, containing 0%THC. Receives: Drug: Cannabidiol |
| Hemp Seed Oil Placebo | Placebo comparator | 210mg/day of hemp-seed oil with no cannabinoids present. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in pain medication use
The Time Line Follow Back is a calendar-assisted measure that can be used to assess pain medication use. The investigators will use this measure to create the pain medication use variable. For opioids users, changes in opioid use will be assessed. For non-opioid users, non-opioid pain medication will be assessed.
Measured: 0-12 Weeks
Reduction in THC use
The Timeline Follow-back will be used to quantify and frequency of THC use.
Measured: 0-12 Weeks
Reduction in pain
-The PROMIS Numeric Rating Scale v1.0 - Pain Intensity - 1a will be used to measure pain intensity with a one question item over the past 7 days. Higher scores indicate more pain. The PROMIS Short Form v1.1 - Pain Interference - 6b rates pain on a scale from 1 (not at all) to 5 (very much), as it refers to the degree to which pain limits or interferes with subjects' physical, mental, and social activities. Higher scores indicate greater pain interference.
Measured: 0-12 Weeks
Secondary outcomes (7)
Change in opioid craving
The Opioid Craving Scale will be used to assess changes in craving over time. This scale has three questions assessed using a 10-pt likert scale. Higher scores (0-30) indicate greater opioid craving.
Measured: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Change in inflammation
Differences in inflammatory markers (e.g. IL-6) will be assessed over time as a moderating factor.
Measured: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Change in Anandamide (AEA)
Differences in AEA will be assessed over time as a moderating factor.
Measured: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Change in quality of life
Changes in subjective quality of life will be assessed using the PROMIS Global-10 Short Form). Scores range from 10-50, with higher scores indicating poorer quality of life.
Measured: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Change in self-reported cognitive function
Changes in self-reported cognitive function will be assessed using the FACT-Cog. There are 37 questions on a 5-pt likert scale with higher scores indicating poorer cognition.
Measured: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Reduction in anxiety
The Depression Anxiety Stress Scale measures the severity of anxiety symptoms. Possible scores range from 0 to 41 with higher scores indicating a worse outcome/more severe symptoms of anxiety.
Measured: 0-12 Weeks
Reduction in sleep disturbance / fatigue
- The PROMIS Short Form v1.0 - Sleep Disturbance - 4A measure the severity of sleep disturbances. Possible scores range from 0 to 4 with lower scores indicating a worse outcome/more severe symptoms of sleep disturbance/fatigue.
- The PROMIS Short Form v1.0 - Fatigue - 4a measures subject fatigue over the past 7 days on a 4 point scale, with higher scores indicating more fatigue.
Measured: 0-12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start8 Mar 2022
- Primary completion29 Jul 2025
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299944
- Sponsor's protocol ID
- 21-5122
- Status last verified
- Dec 2025
- First submitted
- 22 Feb 2022
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Pain and Opioid Use With CBD
- ClinicalTrials.gov ID
- NCT05299944
- Acronym / sponsor ID
- 21-5122
- Conditions
- Opioid Use Disorder
- Keywords
- Opioids, Pain, Cannabidiol, CBD, Cannabis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To better understand the effects of hemp-derived CBD with and without a small amount of THC, the investigators propose a Phase II randomized clinical trial (RCT) to examine the safety, tolerability, and clinical effects of Full Spectrum CBD (fsCBD, contains less than 0.3% THC) vs. Broad Spectrum CBD (bsCBD, does not contain THC), vs. a matching placebo in a population of opioid users.
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.
Study visits will take place both in-person and via Zoom/online. Study participants will attend four in-person visits at the University of Colorado Anschutz at Week 0 (Baseline Medical Director Screen and Medication Dispense), Week 6, and Week 12. Research staff will meet with participants over Zoom during their Week 1 visit and will be contacted weekly during the 12-week study period. Following the Week 1 Zoom visit, participants will have the option to receive the survey link via email for Weeks 2-5 and 7-11 in lieu of meeting with a research team member over Zoom to allow more flexibility in time to complete the study surveys (participants can complete surveys at their convenience within a 3-business day period). In Week 16, approximately 4 weeks after the end of dosing, a final follow-up Zoom interview will occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full-spectrum Cannabidiol | Active comparator | Drug: Cannabidiol210mg/day of full-spectrum cannabidiol, containing less than 0.3%THC. |
| Broad-spectrum Cannabidiol | Active comparator | Drug: Cannabidiol210mg/day of broad-spectrum cannabidiol, containing 0%THC. |
| Hemp Seed Oil Placebo | Placebo comparator | Drug: Placebo210mg/day of hemp-seed oil with no cannabinoids present. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Self-reported desire or intent to use cannabidiol to reduce pain and/or opioid use
- Must be 18 years of age or older.
Key exclusion criteria (11 listed)
- 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;
- 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);
- Actively seeking or in treatment for or history of any substance use disorder, other than opioid use disorder;
- 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;
- Currently taking any of the following medications:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabidiolAlso: CBDThe current study will directly test the hypothesis that a moderate dose of CBD leads to a reduction in opioid consumption, opioid craving, pain, peripheral markers of inflammation, and anxiety, as well as changes in sleep, AEA, and cognition. | Drug | Broad-spectrum Cannabidiol, Full-spectrum Cannabidiol |
| PlaceboPlacebo arm | Drug | Hemp Seed Oil Placebo |
Primary outcome
Reduction in pain medication use
Time frame: 0-12 Weeks
The Time Line Follow Back is a calendar-assisted measure that can be used to assess pain medication use. The investigators will use this measure to create the pain medication use variable. For opioids users, changes in opioid use will be assessed. For non-opioid users, non-opioid pain medication will be assessed.
Reduction in THC use
Time frame: 0-12 Weeks
The Timeline Follow-back will be used to quantify and frequency of THC use.
Reduction in pain
Time frame: 0-12 Weeks
-The PROMIS Numeric Rating Scale v1.0 - Pain Intensity - 1a will be used to measure pain intensity with a one question item over the past 7 days. Higher scores indicate more pain. The PROMIS Short Form v1.1 - Pain Interference - 6b rates pain on a scale from 1 (not at all) to 5 (very much), as it refers to the degree to which pain limits or interferes with subjects' physical, mental, and social activities. Higher scores indicate greater pain interference.
7 secondary outcomes
Change in opioid craving
Time frame: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Change in inflammation
Time frame: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Change in Anandamide (AEA)
Time frame: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Change in quality of life
Time frame: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Change in self-reported cognitive function
Time frame: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Reduction in anxiety
Time frame: 0-12 Weeks
Reduction in sleep disturbance / fatigue
Time frame: 0-12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol in people with Opioid Use Disorder, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in pain medication use (time frame: 0-12 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.