MIVetsCan: Can-Coach Trial (Phase 1)

MIVetsCan: Cannabis Coaching for Veteran Pain Management Trial (Phase 1)

The goal of the MIVetsCan Can-Coach Trial is to pilot and modify a trial of 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: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Educational Session

Detailed Description

All study interactions will be done virtually and recruitment data is exploratory.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • The University of Michigan

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)
• Worst pain of ≥3 out of 10 using a 0-10 Numeric Rating Scale (NRS)
• 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 eminent 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Education; Prior to the educational sessions, study participants will be given access to educational materials (e.g., handouts, videos) that provide an overview of information regarding cannabis products, effects, and pain. These materials will be developed with insight from the study team and the Community Advisory Board. Educational content will include known side effects of cannabis (e.g., common effects like dizziness or sedation, rare side effects like hallucinations or vomiting) as well as specific risks associated with administration routes, such as respiratory harm from smoking or unregulated vaporized concentrate products, and the delayed onset of edible products. Sessions will help the participants appropriately select products for use.

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	Measure Description	Time Frame
Patient Global Impression of Change (PGIC) score	Patient's Global Impression of Change (PGIC) scale will be used. This is a 7 point scale ranging from 1 (very much worse) to 7 (very much better).	Week 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average satisfaction level of the cannabis coaching overall assessed from a single survey question on satisfaction.	Self-report during the end of treatment survey, from not at all satisfied (1), somewhat satisfied (2), satisfied (3), very satisfied (4), completely satisfied (5).	Following intervention, up to approximately Week 14
Average helpfulness level of the cannabis coaching assessed from a single survey question on cannabis coaching.	Measured from self-report during the end of treatment survey, from not at all helpful (1), somewhat helpful (2), helpful (3), very helpful (4), completely helpful (5).	Following intervention, up to approximately Week 14

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): August 7, 2023
• Primary Completion (Actual): December 11, 2023
• Study Completion (Actual): December 11, 2023

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Veteran; Cannabis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: HUM00231159a; 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