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Clinical Trials/NCT06283862
NCT06283862RecruitingNot Applicable

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

University of Michigan1 site in 1 country468 target enrollmentStarted: April 4, 2024Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
468
Locations
1
Primary Endpoint
Patient Global Impression of Change (PGIC) score
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Detailed Description

All study interactions will be done virtually.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Immediate Education

Experimental

Education sessions starting ~ week 4 of trial

Intervention: Educational Session (Behavioral)

Waitlist Control - delayed education

Other

Education sessions starting ~ week 12 of trial

Intervention: Educational Session (Behavioral)

Outcomes

Primary Outcomes

Patient Global Impression of Change (PGIC) score

Time Frame: Up to 14 weeks

Secondary Outcomes

  • Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Positive ideation(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)
  • Self-report of pain (intensity or severity) from a numerical rating scale of 0-10(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) - Negative ideation(Up to 14 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kevin Boehnke

Assistant Professor, Anesthesiology

University of Michigan

Study Sites (1)

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