MIVetsCan: Can-Coach Trial (Phase 2)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Educational Session

Detailed Description

All study interactions will be done virtually.

• Study Type: Interventional
• Enrollment (Estimated): 468
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine Klida; Phone Number: 734-998-8010; Email: CRKlida@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Recruiting
      • University of Michigan
      • Principal Investigator: Kevin Boehnke
      • Contact: Catherine Klida; Phone Number: 734-998-8010; Email: CRKlida@umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Education; Education sessions starting ~ week 4 of trial	Behavioral: Educational Session; The initial session will last about 45 to 60 minutes. The subsequent 3 sessions are anticipated to take about 20-30 minutes.
Other: Waitlist Control - delayed education; Education sessions starting ~ week 12 of trial	Behavioral: Educational Session; The initial session will last about 45 to 60 minutes. The subsequent 3 sessions are anticipated to take about 20-30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient Global Impression of Change (PGIC) score	Up to 14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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) - Positive ideation		Up to 14 weeks
Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Negative ideation		Up to 14 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Michigan, State of, Licensing and Regulatory Affairs
• Investigators: Study Chair: Kevin Boehnke, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2024
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Veteran; Cannabis; Cannabidiol
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Marijuana Abuse
• Other Study ID Numbers: HUM00231159b; VMR2022-03 (Other Identifier: Michigan, State of, Licensing and Regulatory Affairs)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No