Chronic Pain
Conditions
Keywords
Veteran, Cannabis, Cannabidiol
Brief 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.
Detailed description
All study interactions will be done virtually.
Interventions
BEHAVIORALEducational Session
The initial session will last about 45 to 60 minutes. The subsequent 3 sessions are anticipated to take about 20-30 minutes.
Sponsors
University of Michigan
Michigan, State of, Licensing and Regulatory Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient Global Impression of Change (PGIC) score | Up to 14 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-report of pain (intensity or severity) from a numerical rating scale of 0-10 | Up to 14 weeks | Self report of pain from a numerical rating scale of 0-10 over 7 day epochs where a higher number score indicates more pain |
| Anxiety as measured by the score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile version 2.1 | Up to 14 weeks | — |
| Pain interference trends as measured by the score on the PROMIS-29 Profile version 2.1 | Up to 14 weeks | — |
| Sleep disturbance as measured by the score on the PROMIS-29 Profile version 2.1 | Up to 14 weeks | — |
| Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Positive ideation | Up to 14 weeks | — |
| Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Negative ideation | Up to 14 weeks | — |
Countries
United States
Contacts
CONTACTVivian Kurtz
STUDY_CHAIRKevin Boehnke, PhD
University of Michigan
Outcome results
None listed