Clinical trial NCT06283862: MIVetsCan: Can-Coach Trial (Phase 2)
Official title: MIVetsCan: Cannabis Coaching for Veteran Pain Management Trial (Phase 2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: Veteran
Cannabis
Cannabidiol
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Michigan, State of, Licensing and Regulatory Affairs
First posted: 2024-02-28
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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
* 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

Primary outcomes:
measure: Patient Global Impression of Change (PGIC) score
timeFrame: Up to 14 weeks
Secondary outcomes:
measure: Self-report of pain (intensity or severity) from a numerical rating scale of 0-10
timeFrame: Up to 14 weeks
measure: Anxiety as measured by the score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile version 2.1
timeFrame: Up to 14 weeks
measure: Pain interference trends as measured by the score on the PROMIS-29 Profile version 2.1
timeFrame: Up to 14 weeks
measure: Sleep disturbance as measured by the score on the PROMIS-29 Profile version 2.1
timeFrame: Up to 14 weeks
measure: Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Positive ideation
timeFrame: Up to 14 weeks
measure: Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Negative ideation
timeFrame: Up to 14 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Kevin Boehnke, PhD
role: STUDY_CHAIR
References: