Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
468 participants
INTERVENTIONAL
2024-04-04
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Immediate Education
Education sessions starting \~ week 4 of trial
Educational Session
The initial session will last about 45 to 60 minutes. The subsequent 3 sessions are anticipated to take about 20-30 minutes.
Waitlist Control - delayed education
Education sessions starting \~ week 12 of trial
Educational Session
The initial session will last about 45 to 60 minutes. The subsequent 3 sessions are anticipated to take about 20-30 minutes.
Interventions
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Educational Session
The initial session will last about 45 to 60 minutes. The subsequent 3 sessions are anticipated to take about 20-30 minutes.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Michigan, State of, Licensing and Regulatory Affairs
UNKNOWN
University of Michigan
OTHER
Responsible Party
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Kevin Boehnke
Research Assistant Professor, Anesthesiology
Principal Investigators
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Kevin Boehnke, PhD
Role: STUDY_CHAIR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VMR2022-03
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HUM00231159b
Identifier Type: -
Identifier Source: org_study_id
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