Cannabidiol
Liquid taken orally
Epidiolex · CBDLoading study record…
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This research study is investigating use of a single dose of cannabidiol (CBD) to help manage anticipatory anxiety in participants with advanced breast cancer poised to undergo computed tomography (CT) or positron emission tomography (PET) to assess tumor burden. The name of the study drug(s) are: \- Cannabidiol (CBD)
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-08-19
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
This is a randomized, double-blind, placebo-controlled Phase II trial of a single dose of CBD for acute anticipatory anxiety in patients with advanced breast cancer undergoing computed tomography (CT) or positron emission tomography (PET) to assess tumor burden. The research study investigates use of CBD to manage anxiety prior to an oncologic imaging scan. CBD is a component of the cannabis sativa (marijuana) plant and of hemp. Studies of CBD have led to its approval by the Food and Drug Administration for certain childhood seizure disorders. Researchers have also been studying the use of CBD to manage anxiety and pain. This study is designed to learn if the drug can help reduce anxiety and can safely be given to participants with advanced breast cancer who are scheduled for a CT or PET scan. * After screening procedures confirm participation in the research study, participants will be "randomized" into one of two study groups: one group will receive CBD, the other group will receive a placebo of flavored corn syrup. * Randomization means that participants are put into a group by chance. Neither the participant nor the research team will choose participant group assignment. * Participants will have a 66% chance of receiving a single dose of CBD. * Participants will have a 33% chance of receiving a single dose of placebo. * On the day of treatment, participants will complete questionnaires before and after receiving a single dose of CBD or placebo then undergo computed tomography (CT) scan or positron emission tomography (PET). Participants will be contacted by phone approximately a week later and interviewed about study drug consumption and the CT/PET scan experience. This study is supported by funding from the Hans and Mavis Lopater Foundation. Approximately 50 people are anticipated to take part in this study. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved CBD to manage anxiety but it has been approved for use in children with some seizure disorders.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Liquid taken orally
Epidiolex · CBDLiquid taken orally
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Afraid is a negative mood subscale on the VAMS. Each subscale involves a 0 (neutral face or lack of endorsement) to 100 mm (mood face of extreme endorsement) a horizontal line with each pole having an associated mood descriptor. A raw score is a measure of distance from the neutral face (0 mm) to where the participant marks their mood to be in the moment. A linear transformation of a raw score is converted to a T-score and calculated to have a mean of 50 and an SD of 10. The manual provides a T-score conversion table based on sex and age bracket (18-54 years and 55-94 years). A 20T-score (+/-) difference in either direction between a pre- and posttest scores is interpreted as a reliable change in mood, and those differing by more than 30T-score (+/-) is interpreted as both a reliable and a clinically significant relevant threshold for change in mood. A change score for a given mood was calculated based on using T-scores of post-drug administration minus the pre-drug.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidiol | 25 | -19.1 | 15.4 |
| Placebo | 25 | -15.0 | 10.9 |
Eligibility
primary outcomes
Time frame: 1 day of the drug administration pre-dose (T2) and 3 +/- 1 hour after drug administration (T3) up to 1 day
Afraid is a negative mood subscale on the VAMS. Each subscale involves a 0 (neutral face or lack of endorsement) to 100 mm (mood face of extreme endorsement) a horizontal line with each pole having an associated mood descriptor. A raw score is a measure of distance from the neutral face (0 mm) to where the participant marks their mood to be in the moment. A linear transformation of a raw score is converted to a T-score and calculated to have a mean of 50 and an SD of 10. The manual provides a T-score conversion table based on sex and age bracket (18-54 years and 55-94 years). A 20T-score (+/-) difference in either direction between a pre- and posttest scores is interpreted as a reliable change in mood, and those differing by more than 30T-score (+/-) is interpreted as both a reliable and a clinically significant relevant threshold for change in mood. A change score for a given mood was calculated based on using T-scores of post-drug administration minus the pre-drug.
secondary outcomes
Time frame: 1 day of the drug administration pre-dose (T2) and 3 +/- 1 hour after drug administration (T3) up to 1 weeks post ingestion
Measured using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) and a qualitative assessment, patient-reported side effects and acceptability of taking oral CBD (versus placebo) for managing anticipatory anxiety.
Time frame: Baseline through 3 +/- 1 hour after drug administration (T3) up to 1 day
Confused, Sad, Angry, Tired, Tense are negative moods and Energetic and Happy are positive moods on VAMS. Each subscale involves a 0 (neutral face) to 100 mm (mood face) a horizontal line with each pole having an associated mood descriptor. A raw score is a measure of distance from the neutral face (0 mm) to where the participant marks their mood to be in the moment. A linear transformation of a raw score is converted to a T-score and calculated to have a mean of 50 and SD of 10. The manual provides a T-score conversion table based on sex and age bracket (18-54 years and 55-94 years). A 20T-score (+/-) difference in either direction between a pre- and posttest scores is interpreted as a reliable change in mood, and those differing by more than 30T-score (+/-) is interpreted as both a reliable and a clinically significant relevant threshold for change in mood. A change score for a given mood was calculated based on using T-scores of post-drug administration minus the pre-drug.
Time frame: Baseline through 3 +/- 1 hour after drug administration (T3) up to 1 week
Nausea and vomiting were measured using two items. Scale scores were calculated by averaging items within scales and transforming average scores linearly. All of the scales range in score from 0 to 100. A high score for a symptom scale or item represents a high level of symptomatology or problems.
Time frame: Baseline , 1 day of the drug administration pre-dose
pain intensity scale is scored from 0 to 10 (with 10 representing "worst possible" pain).
Publications
No exact PMID-linked public article is currently readable locally.
Measured using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) and a qualitative assessment, patient-reported side effects and acceptability of taking oral CBD (versus placebo) for managing anticipatory anxiety.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidiol | 25 | 2 | - |
| Placebo | 25 | 0 | - |
Confused, Sad, Angry, Tired, Tense are negative moods and Energetic and Happy are positive moods on VAMS. Each subscale involves a 0 (neutral face) to 100 mm (mood face) a horizontal line with each pole having an associated mood descriptor. A raw score is a measure of distance from the neutral face (0 mm) to where the participant marks their mood to be in the moment. A linear transformation of a raw score is converted to a T-score and calculated to have a mean of 50 and SD of 10. The manual provides a T-score conversion table based on sex and age bracket (18-54 years and 55-94 years). A 20T-score (+/-) difference in either direction between a pre- and posttest scores is interpreted as a reliable change in mood, and those differing by more than 30T-score (+/-) is interpreted as both a reliable and a clinically significant relevant threshold for change in mood. A change score for a given mood was calculated based on using T-scores of post-drug administration minus the pre-drug.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidiol | 25 | 0.9 | 6.7 |
| Placebo | 25 | -0.1 | 4.9 |
| Cannabidiol | 25 | -5.8 | 11.2 |
| Placebo | 25 | -8.9 | 11.4 |
| Cannabidiol | 25 | -3.6 | 8.8 |
| Placebo | 25 | -6.1 | 10.5 |
| Cannabidiol | 25 | -1.8 | 8.7 |
| Placebo | 25 | -2.1 | 13.6 |
| Cannabidiol | 25 | -2.0 | 9.8 |
| Placebo | 25 | -3.6 | 10.1 |
| Cannabidiol | 25 | 3.3 | 8.7 |
| Placebo | 25 | 2.6 | 9.3 |
| Cannabidiol | 25 | -11.6 | 12.6 |
| Placebo | 25 | -10.4 | 8.8 |
Nausea and vomiting were measured using two items. Scale scores were calculated by averaging items within scales and transforming average scores linearly. All of the scales range in score from 0 to 100. A high score for a symptom scale or item represents a high level of symptomatology or problems.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidiol | 25 | 6.0 | 8.2 |
| Placebo | 25 | 6.7 | 13.6 |
| Cannabidiol | 25 | 7.3 | 15.3 |
| Placebo | 25 | 1.3 | 4.6 |
pain intensity scale is scored from 0 to 10 (with 10 representing "worst possible" pain).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidiol | 25 | -0.88 | 1.45 |
| Placebo | 25 | -0.88 | 1.33 |
501 screened. 310 excluded: 76 on clinical drug trial, 64 not responding, 37 declined,133 excluded for other reasons. Of 191 meeting eligibility, 54 without scheduled scan, 40 had scan too soon, 27 denied anxiety, \& 3 excluded for other reasons. 67 scheduled for consent: 3 lost interest, 3 denied anxiety, \& 1 did not attend. 60 patients consented, but 10 were not randomized, because they didn't meet eligibility criteria. 50 total participants were eligible, consented and randomized.
| Milestone | Cannabidiol | Placebo |
|---|---|---|
| STARTED | 25 | 25 |
| COMPLETED | 25 | 25 |
| NOT COMPLETED | 0 | 0 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Pain | General disorders | Cannabidiol: 1 / 25 · Placebo: 0 / 25 |
| Nausea | General disorders | Cannabidiol: 1 / 25 · Placebo: 0 / 25 |