MIVetsCan: Can-Coach Trial (Phase 2)

University of Michigan

Status: Enrolling

Conditions: Chronic Pain

Treatments: Behavioral: Educational Session

Study type: Interventional

Funder types: Other

Identifiers

NCT06283862

VMR2022-03 (Other Identifier)

HUM00231159b

Details and patient eligibility

About

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.

Full description

All study interactions will be done virtually.

Enrollment: 468 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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468 participants in 2 patient groups

Immediate Education

Experimental group

Description:

Education sessions starting \~ week 4 of trial

Treatment:

Behavioral: Educational Session

Waitlist Control - delayed education

Other group

Description:

Education sessions starting \~ week 12 of trial

Treatment:

Behavioral: Educational Session