MIVetsCan: Can-Coach Trial (Phase 2)

NCT06283862 | Recruiting

• 2 other identifiers: HUM00231159bVMR2022-03
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Veteran; Cannabis; Cannabidiol

Outcome Measures

Primary Outcomes (1)

• Patient Global Impression of Change (PGIC) score

  Up to 14 weeks

Secondary Outcomes (6)

• Self-report of pain (intensity or severity) from a numerical rating scale of 0-10

  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

Study Arms (2)

Immediate Education

EXPERIMENTAL

Education sessions starting \~ week 4 of trial

Behavioral: Educational Session

Waitlist Control - delayed education

OTHER

Education sessions starting \~ week 12 of trial

Behavioral: Educational Session

Interventions

Educational Session BEHAVIORAL

The initial session will last about 45 to 60 minutes. The subsequent 3 sessions are anticipated to take about 20-30 minutes.

Immediate Education; Waitlist Control - delayed education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Michigan, State of, Licensing and Regulatory Affairs: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48105, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Marijuana Abuse

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Kevin Boehnke, PhD

  University of Michigan

  STUDY CHAIR

Central Study Contacts

Vivian Kurtz

CONTACT

734-998-7156; vkurtz@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Anesthesiology

Model Details: Participants will be randomized to immediately receive 4 sessions of tailored guidance or to receive it after 12 weeks, as a waitlist control condition.

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: April 4, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)