MIVetsCan: Can-Coach Trial (Phase 2)

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06283862
• Other study ID #: HUM00231159b
• Secondary ID: VMR2022-03
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2024
• Est. completion date: February 2027

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: Vivian Kurtz
• Phone: 734-998-7156
• Email: vkurtz[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

All study interactions will be done virtually.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 468
• Est. completion date: February 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Michigan, State of, Licensing and Regulatory Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Global Impression of Change (PGIC) score		Up to 14 weeks
Secondary	Self-report of pain (intensity or severity) from a numerical rating scale of 0-10	Self report of pain from a numerical rating scale of 0-10 over 7 day epochs where a higher number score indicates more pain	Up to 14 weeks
Secondary	Anxiety as measured by the score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile version 2.1		Up to 14 weeks
Secondary	Pain interference trends as measured by the score on the PROMIS-29 Profile version 2.1		Up to 14 weeks
Secondary	Sleep disturbance as measured by the score on the PROMIS-29 Profile version 2.1		Up to 14 weeks
Secondary	Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Positive ideation		Up to 14 weeks
Secondary	Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Negative ideation		Up to 14 weeks