MIVetsCan: Can-Coach Trial (Phase 1)

Chronic Pain Clinical Trial

Official title:

MIVetsCan: Cannabis Coaching for Veteran Pain Management Trial (Phase 1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06320470
• Other study ID #: HUM00231159a
• Secondary ID: VMR2022-03
• Status: Completed
• Phase: N/A
• Start date: August 7, 2023
• Est. completion date: December 11, 2023

Study information

• Verified date: March 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the MIVetsCan Can-Coach Trial is to pilot and modify a trial of 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 and recruitment data is exploratory.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 11, 2023
• Est. primary completion date: December 11, 2023
• 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)
• Worst pain of =3 out of 10 using a 0-10 Numeric Rating Scale (NRS)
• 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 eminent 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	The 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	Patient's Global Impression of Change (PGIC) scale will be used. This is a 7 point scale ranging from 1 (very much worse) to 7 (very much better).	Week 14
Secondary	Average satisfaction level of the cannabis coaching overall assessed from a single survey question on satisfaction.	Self-report during the end of treatment survey, from not at all satisfied (1), somewhat satisfied (2), satisfied (3), very satisfied (4), completely satisfied (5).	Following intervention, up to approximately Week 14
Secondary	Average helpfulness level of the cannabis coaching assessed from a single survey question on cannabis coaching.	Measured from self-report during the end of treatment survey, from not at all helpful (1), somewhat helpful (2), helpful (3), very helpful (4), completely helpful (5).	Following intervention, up to approximately Week 14