MIVetsCan: Can-Coach Trial (Phase 2)

Not Applicable

Recruiting

• Conditions: Chronic Pain
• Interventions: Behavioral: Educational Session

• Registration Number: NCT06283862
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-28
• Study Start: 2024-04-04
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 468

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Education	Educational Session	Education sessions starting \~ week 4 of trial
Waitlist Control - delayed education	Educational Session	Education sessions starting \~ week 12 of trial

Primary Outcome Measures

Name	Time	Method
Patient Global Impression of Change (PGIC) score	Up to 14 weeks

Secondary Outcome Measures

Name	Time	Method
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
Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Positive ideation	Up to 14 weeks
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) - Negative ideation	Up to 14 weeks

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States