Chronic PainNCT06283862
MIVetsCan: Can-Coach Trial (Phase 2)
A study testing Educational Session in people with Chronic Pain, run by University of Michigan at 1 site in United States.
Trial summary
The goal of the MIVetsCan Can-Coach Trial is to test four coaching sessions to help Veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Educational Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2024to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- United States Veteran
- Experiencing chronic pain (pain lasting 3 or more months)
- Moderate to severe chronic pain
- Are planning or currently using cannabidiol (CBD) or cannabis products for pain management
- Able to read and speak English sufficiently to allow for informed consent and active participation in the educational intervention sessions
- Willingness to attend all study visits (conducted virtually)
- Willingness to fill out periodic assessments via smartphone to assess symptom status and cannabis use (protocol has more details)
Who cannot join
- Inability to provide informed consent (e.g., cognitive impairment, unable to sufficiently communicate in English)
- Participant states participant is pregnant
- Planning to move out of a state with legal recreational marijuana use during course of study;
- Current diagnosis or past history of a psychotic disorder (schizophrenia spectrum, except substance/medication -induced or due to another condition)
- Current diagnosis or past history of bipolar disorder
- Unable to attend study visits
- Risk for imminent harm - Suicidal ideation or wish to die as assessed with the Positive and Negative Suicide Ideation (PANSI) questionnaire and further risk assessment by study team members
- Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48105
Catherine Klida, 734-998-8010, CRKlida@umich.edu
Kevin Boehnke
About this study
Official title: MIVetsCan: Cannabis Coaching for Veteran Pain Management Trial (Phase 2)
The goal of the MIVetsCan Can-Coach Trial is to test four coaching sessions to help Veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms.
Read the detailed description
All study interactions will be done virtually.
- Conditions
- Chronic Pain
- Being tested
- Educational Session
- Keywords
- Veteran, Cannabis, Cannabidiol
- Medical subject headings
- Chronic Pain, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational SessionBehavioural
The initial session will last about 45 to 60 minutes. The subsequent 3 sessions are anticipated to take about 20-30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Education | Experimental | Education sessions starting ~ week 4 of trial Receives: Behavioral: Educational Session |
| Waitlist Control - delayed education | Other | Education sessions starting ~ week 12 of trial Receives: Behavioral: Educational Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Global Impression of Change (PGIC) score
Measured: Up to 14 weeks
Secondary outcomes (6)
Self-report of pain (intensity or severity) from a numerical rating scale of 0-10
Self report of pain from a numerical rating scale of 0-10 over 7 day epochs where a higher number score indicates more pain
Measured: Up to 14 weeks
Anxiety as measured by the score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile version 2.1
Measured: Up to 14 weeks
Pain interference trends as measured by the score on the PROMIS-29 Profile version 2.1
Measured: Up to 14 weeks
Sleep disturbance as measured by the score on the PROMIS-29 Profile version 2.1
Measured: Up to 14 weeks
Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Positive ideation
Measured: Up to 14 weeks
Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Negative ideation
Measured: Up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start4 Apr 2024
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to immediately receive 4 sessions of tailored guidance or to receive it after 12 weeks, as a waitlist control condition.
- Masking
- None (open label)
- Enrolment
- 468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan, State of, Licensing and Regulatory Affairs
- Responsible party
- Principal investigator, Kevin Boehnke, University of Michigan
- Investigators
- Kevin Boehnke, PhD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283862
- Sponsor's protocol ID
- HUM00231159b
- Other IDs
- VMR2022-03
- Status last verified
- May 2026
- First submitted
- 21 Feb 2024
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIVetsCan: Cannabis Coaching for Veteran Pain Management Trial (Phase 2)
- ClinicalTrials.gov ID
- NCT06283862
- Acronym / sponsor ID
- HUM00231159b
- Conditions
- Chronic Pain
- Keywords
- Veteran, Cannabis, Cannabidiol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 468 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Michigan, State of, Licensing and Regulatory Affairs
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 28 Feb 2024 (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.
The goal of the MIVetsCan Can-Coach Trial is to test four coaching sessions to help Veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms.
Detailed description
All study interactions will be done virtually.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to immediately receive 4 sessions of tailored guidance or to receive it after 12 weeks, as a waitlist control condition.
| Arm | Type | Receives |
|---|---|---|
| Immediate Education | Experimental | Behavioral: Educational SessionEducation sessions starting ~ week 4 of trial |
| Waitlist Control - delayed education | Other | Behavioral: Educational SessionEducation sessions starting ~ week 12 of trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- United States Veteran
- Experiencing chronic pain (pain lasting 3 or more months)
- Moderate to severe chronic pain
- Are planning or currently using cannabidiol (CBD) or cannabis products for pain management
- Able to read and speak English sufficiently to allow for informed consent and active participation in the educational intervention sessions
Key exclusion criteria (8 listed)
- Inability to provide informed consent (e.g., cognitive impairment, unable to sufficiently communicate in English)
- Participant states participant is pregnant
- Planning to move out of a state with legal recreational marijuana use during course of study;
- Current diagnosis or past history of a psychotic disorder (schizophrenia spectrum, except substance/medication -induced or due to another condition)
- Current diagnosis or past history of bipolar disorder
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 |
|---|---|---|
| Educational SessionThe initial session will last about 45 to 60 minutes. The subsequent 3 sessions are anticipated to take about 20-30 minutes. | Behavioural | Immediate Education, Waitlist Control - delayed education |
Primary outcome
Patient Global Impression of Change (PGIC) score
Time frame: Up to 14 weeks
6 secondary outcomes
Self-report of pain (intensity or severity) from a numerical rating scale of 0-10
Time frame: Up to 14 weeks
Anxiety as measured by the score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile version 2.1
Time frame: Up to 14 weeks
Pain interference trends as measured by the score on the PROMIS-29 Profile version 2.1
Time frame: Up to 14 weeks
Sleep disturbance as measured by the score on the PROMIS-29 Profile version 2.1
Time frame: Up to 14 weeks
Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Positive ideation
Time frame: Up to 14 weeks
Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Negative ideation
Time frame: Up to 14 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Kevin Boehnke, PhD study chair
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Session in people with Chronic Pain, run by University of Michigan at 1 site 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Klida (734-998-8010, crklida@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Global Impression of Change (PGIC) score (time frame: Up to 14 weeks). 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 1 Jun 2026.