MIVetsCan: Can-Coach Trial (Phase 1)

NCT ID: NCT06320470

Last Updated: 2024-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-07

Study Completion Date

2023-12-11

Brief Summary

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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.

Detailed Description

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

Conditions

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Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Educational Session

Intervention Type BEHAVIORAL

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

Interventions

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Educational Session

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michigan, State of, Licensing and Regulatory Affairs

UNKNOWN

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Kevin Boehnke

Research Assistant Professor, Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kevin Boehnke, PhD

Role: STUDY_CHAIR

University of Michigan

Locations

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The University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39856785 (View on PubMed)

Other Identifiers

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VMR2022-03

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HUM00231159a

Identifier Type: -

Identifier Source: org_study_id

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