Chronic PainNCT06320470
MIVetsCan: Can-Coach Trial (Phase 1)
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 pilot and modify a trial of 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
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2023to 11 Dec 2023
- Phase
- Interventional
- 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
- United States Veteran
- Experiencing chronic pain (pain lasting 3 or more months)
- Worst pain of ≥3 out of 10 using a 0-10 Numeric Rating Scale (NRS)
- 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
- 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 eminent 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.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: MIVetsCan: Cannabis Coaching for Veteran Pain Management Trial (Phase 1)
The goal of the MIVetsCan Can-Coach Trial is to pilot and modify a trial of 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 and recruitment data is exploratory.
- Conditions
- Chronic Pain
- Being tested
- Educational Session
- Keywords
- Veteran, Cannabis
- 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 |
|---|---|---|
| Education | Experimental | Prior to the educational sessions, study participants will be given access to educational materials (e.g., handouts, videos) that provide an overview of information regarding cannabis products, effects, and pain. These materials will be developed with insight from the study team and the Community Advisory Board.
Educational content will include known side effects of cannabis (e.g., common effects like dizziness or sedation, rare side effects like hallucinations or vomiting) as well as specific risks associated with administration routes, such as respiratory harm from smoking or unregulated vaporized concentrate products, and the delayed onset of edible products. Sessions will help the participants appropriately select products for use. 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
Patient's Global Impression of Change (PGIC) scale will be used. This is a 7 point scale ranging from 1 (very much worse) to 7 (very much better).
Measured: Week 14
Secondary outcomes (2)
Average satisfaction level of the cannabis coaching overall assessed from a single survey question on satisfaction.
Self-report during the end of treatment survey, from not at all satisfied (1), somewhat satisfied (2), satisfied (3), very satisfied (4), completely satisfied (5).
Measured: Following intervention, up to approximately Week 14
Average helpfulness level of the cannabis coaching assessed from a single survey question on cannabis coaching.
Measured from self-report during the end of treatment survey, from not at all helpful (1), somewhat helpful (2), helpful (3), very helpful (4), completely helpful (5).
Measured: Following intervention, up to approximately Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start7 Aug 2023
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
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
- NCT06320470
- Sponsor's protocol ID
- HUM00231159a
- Other IDs
- VMR2022-03
- Status last verified
- May 2026
- First submitted
- 21 Feb 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boehnke KF, Bowyer G, McAfee J, Smith T, Klida C, Kurtz V, Litinas E, Purohit P, Arewasikporn A, Horowitz D, Thomas L, Eckersley J, Railing M, Williams DA, Clauw DJ, Kidwell KM, Bohnert ASB, Bergmans RS. Feasibility pilot of a novel coaching intervention to optimize cannabis use for chronic pain management among Veterans. J Cannabis Res. 2025 Jan 25;7(1):7. doi: 10.1186/s42238-025-00265-z.
PubMed 39856785
Study at a glance
From the registry record, last updated by the sponsor on 29 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 1)
- ClinicalTrials.gov ID
- NCT06320470
- Acronym / sponsor ID
- HUM00231159a
- Conditions
- Chronic Pain
- Keywords
- Veteran, Cannabis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Michigan, State of, Licensing and Regulatory Affairs
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 20 Mar 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 pilot and modify a trial of 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 and recruitment data is exploratory.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Behavioral: Educational SessionPrior to the educational sessions, study participants will be given access to educational materials (e.g., handouts, videos) that provide an overview of information regarding cannabis products, effects, and pain. These materials will be developed with insight from the study team and the Community Advisory Board. Educational content will include known side effects of cannabis (e.g., common effects like dizziness or sedation, rare side effects like hallucinations or vomiting) as well as specific risks associated with administration routes, such as respiratory harm from smoking or unregulated vaporized concentrate products, and the delayed onset of edible products. Sessions will help the participants appropriately select products for use. |
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)
- Worst pain of ≥3 out of 10 using a 0-10 Numeric Rating Scale (NRS)
- 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 (7 listed)
- Inability to provide informed consent (e.g., cognitive impairment, unable to sufficiently communicate in English)
- Participant states participant is pregnant
- 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
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 | Education |
Primary outcome
Patient Global Impression of Change (PGIC) score
Time frame: Week 14
Patient's Global Impression of Change (PGIC) scale will be used. This is a 7 point scale ranging from 1 (very much worse) to 7 (very much better).
2 secondary outcomes
Average satisfaction level of the cannabis coaching overall assessed from a single survey question on satisfaction.
Time frame: Following intervention, up to approximately Week 14
Average helpfulness level of the cannabis coaching assessed from a single survey question on cannabis coaching.
Time frame: Following intervention, up to approximately Week 14
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 29 Jun 2026.
- Derived from this study: PubMed 39856785Boehnke KF, Bowyer G, McAfee J, Smith T, Klida C, Kurtz V, Litinas E, Purohit P, Arewasikporn A, Horowitz D, Thomas L, Eckersley J, Railing M, Williams DA, Clauw DJ, Kidwell KM, Bohnert ASB, Bergmans RS. Feasibility pilot of a novel coaching intervention to optimize cannabis use for chronic pain management among Veterans. J Cannabis Res. 2025 Jan 25;7(1):7. doi: 10.1186/s42238-025-00265-z.
- 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. This study is not recruiting at the moment.
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 7 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 29 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?
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?
Patient Global Impression of Change (PGIC) score (time frame: Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06320470, which also lists 1 linked publication.
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 29 Jun 2026.