MIVetsCan: Can-Coach Trial (Phase 1)

N/ACompletedNCT06320470

University of Michigan22 enrolled

Overview

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.

All study interactions will be done virtually and recruitment data is exploratory.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Chronic Pain

Interventions

Educational SessionBEHAVIORAL

The initial session will last about 45 to 60 minutes. The subsequent 3 sessions are anticipated to take about 20-30 minutes.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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).

Time frame: Week 14

Secondary Outcomes

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).

Time frame: Following intervention, up to approximately Week 14

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).

Time frame: Following intervention, up to approximately Week 14

Data from ClinicalTrials.gov

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