A Phase 2 interventional study of Placebo and Cannabidiol in Pain, Chronic, sponsored by Kevin Boehnke. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Kevin Boehnke · Phase 2, Interventional, and Treatment
This research is studying the effects of cannabidiol (CBD), an active component from cannabis (a.k.a. marijuana), on Veterans' chronic pain. The purpose of this study is to better understand if CBD can improve pain symptoms in Veterans with chronic pain.
Eligible participants will be randomly assigned to receive either placebo medication (not active) or CBD during the study period.
The study hypotheses:
- CBD would improve overall pain symptoms compared to placebo
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's planned enrollment of 468 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Kevin Boehnke is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Placebo
Drug: Cannabidiol
Participant will take placebo days 1-28 during study treatment. Given the pragmatic design, participants will be instructed to take the study drug whenever participants wish, with suggested starting dosing of 0.2 milliliter (mL) in the morning and 0.2mL in the evening (up to 1.2mL per day).
Participant will take Epidiolex days 1-28 during study treatment. Given the pragmatic design, participants will be instructed to take the study drug whenever participants wish, with suggested starting dosing of 0.2 milliliter (mL) in the morning and 0.2mL in the evening (up to 1.2mL per day).
Also known as: Epidiolex
Global impression of change (PGIC) between groups at end of treatment (Day 28)
This is a 1-item survey that measures patient perceptions of intervention success. This survey is scored from 1 to 7, where lower scores indicate a better outcome.
Time frame: Day 28
Chronic pain severity between groups in the study period (Days 1 - 28)
Aggregated worst pain intensity (0-10 numerical rating scale) between groups during 7-day epochs from day 1 through day 28. Higher scores indicate worse pain.
Time frame: Days 1-28
Change in pain interference based on the pain interference 4a short form items from the Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1
There are 4-items on this survey that participants will complete regarding pain interference from not at all (1) - very much (5). Scores range from 4-20 with a higher score meaning more interference.
Time frame: baseline (day 1), day 28
Anxiety based on the Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1
There are 4-items on this survey that participants will complete regarding anxiety from never (1) - always (5). Scores range from 4-20 with a higher score meaning more anxiety.
Time frame: Days 1-28
Sleep disturbance based on the Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1
This is a 4-item patient-reported scale indicating sleep quality. Scores range 4 to 20 with a higher score correspond to higher levels of sleep disturbance.
Time frame: Days 1-28
Change in suicidal ideation based on the Negative Suicide Ideation questionnaire (PANSI)
The 8-items of vulnerability to suicidality participants will complete with answers from none of the time (1)-most of the time (5). Scores range from 8-40 with a lower score having fewer suicidal ideations.
Time frame: Baseline (day 1), 28
Change in suicidal ideation based on Positive and Negative Suicide Ideation (PANSI) Inventory
This is a 14-item subjectively completed inventory that consisted of 2 subscales: the PANSI-negative suicide ideation (NSI) subscale composed of 8 items and the positive ideation (PI) subscale consisting of 6 items. The possible total scores on the PANSI-NSI and PANSI-PI subscales range from 8 to 40 and 6 to 30, respectively. Higher scores on the PANSI-NSI and lower scores on the PANSI-PI reflect greater risk for suicidal behavior.
Time frame: Baseline (day 1), 28
Safety assessed by the number of adverse events that are possibly, probably, or definitely related to the study drug between groups
Number of participants having the event, severity, expectedness, and relatedness to the study treatment. The study will utilize the Common Terminology Criteria for Adverse Events v.5.0.
Time frame: Days 1-28
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Kevin Boehnke