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NCT Number: NCT06283862

MIVetsCan: Can-Coach 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.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location status: Recruiting

Location contact

Catherine Klida

CONTACT

[email protected]

734-998-8010

Kevin Boehnke

PRINCIPAL_INVESTIGATOR

About this study

All study interactions will be done virtually.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Patient Global Impression of Change (PGIC) score

    Time frame: Up to 14 weeks

Secondary outcomes

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

    Time frame: Up to 14 weeks

    Self report of pain from a numerical rating scale of 0-10 over 7 day epochs where a higher number score indicates more pain

  2. Anxiety as measured by the score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile version 2.1

    Time frame: Up to 14 weeks

  3. Pain interference trends as measured by the score on the PROMIS-29 Profile version 2.1

    Time frame: Up to 14 weeks

  4. Sleep disturbance as measured by the score on the PROMIS-29 Profile version 2.1

    Time frame: Up to 14 weeks

  5. Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Positive ideation

    Time frame: Up to 14 weeks

  6. Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Negative ideation

    Time frame: Up to 14 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Klida

CONTACT

[email protected]

734-998-8010

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Michigan, State of, Licensing and Regulatory Affairs

Registry information

Official study title

MIVetsCan: Cannabis Coaching for Veteran Pain Management Trial (Phase 2)

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 28, 2024
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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