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Recruiting NCT06283862

MIVetsCan: Can-Coach Trial (Phase 2)

No phase Interventional Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Educational Session.
Who it may be relevant to
Registry conditions: Chronic Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Patient Global Impression of Change (PGIC) score [Time frame: Up to 14 weeks]
Secondary outcome measures (6)
  • Self-report of pain (intensity or severity) from a numerical rating scale of 0-10 [Time frame: Up to 14 weeks]
  • 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]
  • Pain interference trends as measured by the score on the PROMIS-29 Profile version 2.1 [Time frame: Up to 14 weeks]
  • Sleep disturbance as measured by the score on the PROMIS-29 Profile version 2.1 [Time frame: Up to 14 weeks]
  • Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Positive ideation [Time frame: Up to 14 weeks]
  • Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Negative ideation [Time frame: Up to 14 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Michigan — Ann Arbor

Identifiers

NCT: NCT06283862 · HUM00231159b · VMR2022-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗