MIVetsCan: Can-Coach Trial (Phase 1)

NCT06320470 | Completed

• 2 other identifiers: HUM00231159aVMR2022-03
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain

Keywords

Veteran; Cannabis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Average satisfaction level of the cannabis coaching overall assessed from a single survey question on satisfaction.

  Following intervention, up to approximately Week 14

• Average helpfulness level of the cannabis coaching assessed from a single survey question on cannabis coaching.

  Following intervention, up to approximately Week 14

Study Arms (1)

Education

EXPERIMENTAL

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

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.

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)
• 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)

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
• 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

Sponsors & Collaborators

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

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Boehnke KF, Bowyer G, McAfee J, Smith T, Klida C, Kurtz V, Litinas E, Purohit P, Arewasikporn A, Horowitz D, Thomas L, Eckersley J, Railing M, Williams DA, Clauw DJ, Kidwell KM, Bohnert ASB, Bergmans RS. Feasibility pilot of a novel coaching intervention to optimize cannabis use for chronic pain management among Veterans. J Cannabis Res. 2025 Jan 25;7(1):7. doi: 10.1186/s42238-025-00265-z.

  PMID: 39856785 DERIVED

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

Study Design

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

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 20, 2024
• Study Start: August 7, 2023
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)