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| ID | Type | Description | Link |
|---|---|---|---|
| VMR2022-03 | Other Identifier | Michigan, State of, Licensing and Regulatory Affairs |
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| Name | Class |
|---|---|
| Michigan, State of, Licensing and Regulatory Affairs | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
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| Cannabidiol | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine Klida | Contact | 734-998-8010 | crklida@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kevin Boehnke, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38951902 | Derived | Bergmans RS, Wegryn-Jones R, Klida C, Kurtz V, Thomas L, Williams DA, Clauw DJ, Kidwell KM, Bohnert ASB, Boehnke KF. Protocol for a pragmatic trial of Cannabidiol (CBD) to improve chronic pain symptoms among United States Veterans. BMC Complement Med Ther. 2024 Jun 29;24(1):250. doi: 10.1186/s12906-024-04558-3. |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Cannabidiol | Drug | 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). |
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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. |
| 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. | 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. | 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. | 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. | 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. | Days 1-28 |