Trial Outcomes & Findings for The Effect of Cannabidiol in Learning and Memory of Adults (NCT NCT06074172)
NCT ID: NCT06074172
Last Updated: 2025-03-24
Results Overview
Sum of Trials = Trial A1 + Trial A2 + Trial A3 + Trial A4 + Trial A5; Trial A1/A2/A3/A4/A5 are in reference to each trial in which list A is recalled during memory encoding. The score range for Sum of Trials is 0 to 75. A higher score is indicative of greater performance on the memory test and a lower score is indicative of lower performance on the memory test. Participants were instructed to listen to a list of 15 words (List A) read to them. Subjects were asked recall List A during five different trials (A1, A2, A3, A4, A5), with the words repeated to them after each trial. Participants were scored for the number of correctly repeated words for each trial.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
Each trial is 45 seconds for encoding and recall
Results posted on
2025-03-24
Participant Flow
Participant milestones
| Measure |
Placebo (Visit 1 Drug Administration)
246mg Placebo, oral, single-dose (visit 1 drug administration)
Placebo in Oral Dose Form: Placebo press pills provided by Steve Goods CBD (Longmont, Colorado). Placebo pills were tested by the chemistry lab at CSU Pueblo and by Botanacar in Denver, CO. Both laboratories determined placebo pills to be pure with no heavy metals, bacteria, and pesticides detected.
|
Cannabidiol (Visit 1 Drug Administration)
246mg Cannabidiol, oral single-dose (visit 1 drug administration)
Cannabidiol in Oral Dose Form: Cannabidiol press pills provided by Steve Goods CBD (Longmont, Colorado). CBD pills were tested by the chemistry lab at CSU Pueblo and by Botanacor in Denver, CO. Both laboratories determined CBD pills to be 99.98% pure with no THC, heavy metals, bacteria, and pesticides detected.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
30
|
|
Overall Study
COMPLETED
|
21
|
23
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Cannabidiol in Learning and Memory of Adults
Baseline characteristics by cohort
| Measure |
Placebo First, Then Cannabidiol
n=16 Participants
246mg Placebo, oral, single-dose (visit 1 or visit 2 drug administration)
Placebo in Oral Dose Form: Placebo press pills provided by Steve Goods CBD (Longmont, Colorado). Placebo pills were tested by the chemistry lab at CSU Pueblo and by Botanacar in Denver, CO. Both laboratories determined placebo pills to be pure with no heavy metals, bacteria, and pesticides detected.
|
Cannabidiol First, Then Placebo
n=19 Participants
246mg Cannabidiol, oral single-dose (visit 1 or visit 2 drug administration)
Cannabidiol in Oral Dose Form: Cannabidiol press pills provided by Steve Goods CBD (Longmont, Colorado). CBD pills were tested by the chemistry lab at CSU Pueblo and by Botanacor in Denver, CO. Both laboratories determined CBD pills to be 99.98% pure with no THC, heavy metals, bacteria, and pesticides detected.
|
Total
n=35 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27 years
n=5 Participants
|
33 years
n=7 Participants
|
30 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
19 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
History of CBD Use, categorical
Non-user
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
History of CBD Use, categorical
User
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Urine THC Result, categorical
THC -
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Urine THC Result, categorical
THC +
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
History of Nicotine Use, categorical
Non-user
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
History of Nicotine Use, categorical
User
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Each trial is 45 seconds for encoding and recallPopulation: The data reported is for 35 adult healthy human subjects who came in for visits 1 and 2 and were randomized to a treatment group (CBD or placebo). Since the 35 subjects came in twice, each of them received both interventions (CBD and placebo).
Sum of Trials = Trial A1 + Trial A2 + Trial A3 + Trial A4 + Trial A5; Trial A1/A2/A3/A4/A5 are in reference to each trial in which list A is recalled during memory encoding. The score range for Sum of Trials is 0 to 75. A higher score is indicative of greater performance on the memory test and a lower score is indicative of lower performance on the memory test. Participants were instructed to listen to a list of 15 words (List A) read to them. Subjects were asked recall List A during five different trials (A1, A2, A3, A4, A5), with the words repeated to them after each trial. Participants were scored for the number of correctly repeated words for each trial.
Outcome measures
| Measure |
Placebo (Administered During Visits 1 or 2)
n=35 Participants
246mg Placebo, oral, single-dose (visit 1 drug administration)
Placebo in Oral Dose Form: Placebo press pills provided by Steve Goods CBD (Longmont, Colorado). Placebo pills were tested by the chemistry lab at CSU Pueblo and by Botanacar in Denver, CO. Both laboratories determined placebo pills to be pure with no heavy metals, bacteria, and pesticides detected.
|
Cannabidiol (Administered During Visits 1 or 2)
n=35 Participants
246mg Cannabidiol, oral single-dose (visit 1 drug administration)
Cannabidiol in Oral Dose Form: Cannabidiol press pills provided by Steve Goods CBD (Longmont, Colorado). CBD pills were tested by the chemistry lab at CSU Pueblo and by Botanacor in Denver, CO. Both laboratories determined CBD pills to be 99.98% pure with no THC, heavy metals, bacteria, and pesticides detected.
|
|---|---|---|
|
Sum of Trials (I-V)
|
49.09 score on a scale
Standard Error 1.85
|
47.17 score on a scale
Standard Error 1.85
|
PRIMARY outcome
Timeframe: Each trial is 45 seconds for encoding and recallPopulation: Adult healthy human subjects
PI Ratio = Trial B1/A1. Proactive interference is the tendency for previously learned information to affect to hinder learning of new information. A higher proactive interference ratio indicates protective effects on memory i.e. protection from interference during learning. A lower proactive interference is indicative of negative effects on memory caused from interference. Trial A1 is in reference to list A recall during the first trial. Trial B1 is in reference to list B recall. Highest score for each trial is 15 with a point awarded for each correctly recalled word from List A (15 words) and List B (15 words).
Outcome measures
| Measure |
Placebo (Administered During Visits 1 or 2)
n=35 Participants
246mg Placebo, oral, single-dose (visit 1 drug administration)
Placebo in Oral Dose Form: Placebo press pills provided by Steve Goods CBD (Longmont, Colorado). Placebo pills were tested by the chemistry lab at CSU Pueblo and by Botanacar in Denver, CO. Both laboratories determined placebo pills to be pure with no heavy metals, bacteria, and pesticides detected.
|
Cannabidiol (Administered During Visits 1 or 2)
n=35 Participants
246mg Cannabidiol, oral single-dose (visit 1 drug administration)
Cannabidiol in Oral Dose Form: Cannabidiol press pills provided by Steve Goods CBD (Longmont, Colorado). CBD pills were tested by the chemistry lab at CSU Pueblo and by Botanacor in Denver, CO. Both laboratories determined CBD pills to be 99.98% pure with no THC, heavy metals, bacteria, and pesticides detected.
|
|---|---|---|
|
Proactive Interference Ratio (PI Ratio)
|
1.04 ratio
Standard Error 0.08
|
1.21 ratio
Standard Error 0.08
|
PRIMARY outcome
Timeframe: Each trial is 45 seconds for encoding and recallPopulation: Adult healthy human subjects
RI Ratio = Trial A6/A5. Retroactive interference is the tendency for newly learned information to hinder the memory of previously learned information. A higher retroactive interference ratio indicates protection from interference during learning. A lower retroactive interference ratio is indicative of negative effects on memory caused from interference. Trial A6 is referring to delayed recall of list A; Trial A5 is referring to the fifth trial of list A recall. Highest score for each trial is 15 with a point awarded for each word correctly recalled from List A (15 words).
Outcome measures
| Measure |
Placebo (Administered During Visits 1 or 2)
n=35 Participants
246mg Placebo, oral, single-dose (visit 1 drug administration)
Placebo in Oral Dose Form: Placebo press pills provided by Steve Goods CBD (Longmont, Colorado). Placebo pills were tested by the chemistry lab at CSU Pueblo and by Botanacar in Denver, CO. Both laboratories determined placebo pills to be pure with no heavy metals, bacteria, and pesticides detected.
|
Cannabidiol (Administered During Visits 1 or 2)
n=35 Participants
246mg Cannabidiol, oral single-dose (visit 1 drug administration)
Cannabidiol in Oral Dose Form: Cannabidiol press pills provided by Steve Goods CBD (Longmont, Colorado). CBD pills were tested by the chemistry lab at CSU Pueblo and by Botanacor in Denver, CO. Both laboratories determined CBD pills to be 99.98% pure with no THC, heavy metals, bacteria, and pesticides detected.
|
|---|---|---|
|
Retroactive Interference Ratio (RI Ratio)
|
0.87 ratio
Standard Error 0.03
|
0.83 ratio
Standard Error 0.03
|
PRIMARY outcome
Timeframe: Each recall takes about 5 min for encoding and recallPopulation: Adult healthy human subjects
Total Prose Recall = Immediate Recall + Delayed Recall; Recall of a prose story was done immediately then after a delay; Highest score for prose recall test is 25 with a point awarded for each item correctly recalled in the story (25 total items). A higher recall score is indicative of better memory.
Outcome measures
| Measure |
Placebo (Administered During Visits 1 or 2)
n=35 Participants
246mg Placebo, oral, single-dose (visit 1 drug administration)
Placebo in Oral Dose Form: Placebo press pills provided by Steve Goods CBD (Longmont, Colorado). Placebo pills were tested by the chemistry lab at CSU Pueblo and by Botanacar in Denver, CO. Both laboratories determined placebo pills to be pure with no heavy metals, bacteria, and pesticides detected.
|
Cannabidiol (Administered During Visits 1 or 2)
n=35 Participants
246mg Cannabidiol, oral single-dose (visit 1 drug administration)
Cannabidiol in Oral Dose Form: Cannabidiol press pills provided by Steve Goods CBD (Longmont, Colorado). CBD pills were tested by the chemistry lab at CSU Pueblo and by Botanacor in Denver, CO. Both laboratories determined CBD pills to be 99.98% pure with no THC, heavy metals, bacteria, and pesticides detected.
|
|---|---|---|
|
Total Prose Recall
|
27.49 Score on a scale
Standard Error 1.46
|
25.49 Score on a scale
Standard Error 1.46
|
PRIMARY outcome
Timeframe: 10 minutes total for encoding and recallPopulation: Adult healthy human population
Assessment of basal cognitive function; The range for Montreal Cognitive Assessment (MOCA) scores is 0 to 30. A higher recall score is indicative of better performance on the memory test. A lower recall score is indicative of worse performance on the memory test.
Outcome measures
| Measure |
Placebo (Administered During Visits 1 or 2)
n=35 Participants
246mg Placebo, oral, single-dose (visit 1 drug administration)
Placebo in Oral Dose Form: Placebo press pills provided by Steve Goods CBD (Longmont, Colorado). Placebo pills were tested by the chemistry lab at CSU Pueblo and by Botanacar in Denver, CO. Both laboratories determined placebo pills to be pure with no heavy metals, bacteria, and pesticides detected.
|
Cannabidiol (Administered During Visits 1 or 2)
n=35 Participants
246mg Cannabidiol, oral single-dose (visit 1 drug administration)
Cannabidiol in Oral Dose Form: Cannabidiol press pills provided by Steve Goods CBD (Longmont, Colorado). CBD pills were tested by the chemistry lab at CSU Pueblo and by Botanacor in Denver, CO. Both laboratories determined CBD pills to be 99.98% pure with no THC, heavy metals, bacteria, and pesticides detected.
|
|---|---|---|
|
Montreal Cognitive Assessment Score
|
26.31 Score on a scale
Standard Error 0.46
|
26.63 Score on a scale
Standard Error 0.46
|
Adverse Events
Placebo (Administered During Visits 1 or 2)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cannabidiol (Administered During Visits 1 or 2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo (Administered During Visits 1 or 2)
n=35 participants at risk
246mg Placebo, oral, single-dose (visit 1 drug administration)
Placebo in Oral Dose Form: Placebo press pills provided by Steve Goods CBD (Longmont, Colorado). Placebo pills were tested by the chemistry lab at CSU Pueblo and by Botanacar in Denver, CO. Both laboratories determined placebo pills to be pure with no heavy metals, bacteria, and pesticides detected.
|
Cannabidiol (Administered During Visits 1 or 2)
n=35 participants at risk
246mg Cannabidiol, oral single-dose (visit 1 drug administration)
Cannabidiol in Oral Dose Form: Cannabidiol press pills provided by Steve Goods CBD (Longmont, Colorado). CBD pills were tested by the chemistry lab at CSU Pueblo and by Botanacor in Denver, CO. Both laboratories determined CBD pills to be 99.98% pure with no THC, heavy metals, bacteria, and pesticides detected.
|
|---|---|---|
|
Nervous system disorders
Drowsiness
|
0.00%
0/35 • Adverse event data were collected as subjects completed exit surveys at the end of visit 2. Completion of the exit survey took about 15-20 minutes. Assessment administrators also followed up with study participants up until the completion of the study to confirm whether any adverse events occurred or resolved. Study participants confirmed that all adverse events were resolved. Adverse event data was collected at the end of visit 2.
An adverse event (AE) is an untoward medical occurrence in a patient who was administered an investigational product. A serious adverse event is an AE which also fulfills the following criteria: 1. Results in death 2. Is life-threatening 3. Requires in-patient hospitalization 4. Results in persistent or significant disability/incapacity 5. Cause congenital anomaly/birth defect 6. Important medical event that requires intervention to prevent permanent impairment or damage
|
11.4%
4/35 • Number of events 4 • Adverse event data were collected as subjects completed exit surveys at the end of visit 2. Completion of the exit survey took about 15-20 minutes. Assessment administrators also followed up with study participants up until the completion of the study to confirm whether any adverse events occurred or resolved. Study participants confirmed that all adverse events were resolved. Adverse event data was collected at the end of visit 2.
An adverse event (AE) is an untoward medical occurrence in a patient who was administered an investigational product. A serious adverse event is an AE which also fulfills the following criteria: 1. Results in death 2. Is life-threatening 3. Requires in-patient hospitalization 4. Results in persistent or significant disability/incapacity 5. Cause congenital anomaly/birth defect 6. Important medical event that requires intervention to prevent permanent impairment or damage
|
|
Gastrointestinal disorders
Hunger
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected as subjects completed exit surveys at the end of visit 2. Completion of the exit survey took about 15-20 minutes. Assessment administrators also followed up with study participants up until the completion of the study to confirm whether any adverse events occurred or resolved. Study participants confirmed that all adverse events were resolved. Adverse event data was collected at the end of visit 2.
An adverse event (AE) is an untoward medical occurrence in a patient who was administered an investigational product. A serious adverse event is an AE which also fulfills the following criteria: 1. Results in death 2. Is life-threatening 3. Requires in-patient hospitalization 4. Results in persistent or significant disability/incapacity 5. Cause congenital anomaly/birth defect 6. Important medical event that requires intervention to prevent permanent impairment or damage
|
0.00%
0/35 • Adverse event data were collected as subjects completed exit surveys at the end of visit 2. Completion of the exit survey took about 15-20 minutes. Assessment administrators also followed up with study participants up until the completion of the study to confirm whether any adverse events occurred or resolved. Study participants confirmed that all adverse events were resolved. Adverse event data was collected at the end of visit 2.
An adverse event (AE) is an untoward medical occurrence in a patient who was administered an investigational product. A serious adverse event is an AE which also fulfills the following criteria: 1. Results in death 2. Is life-threatening 3. Requires in-patient hospitalization 4. Results in persistent or significant disability/incapacity 5. Cause congenital anomaly/birth defect 6. Important medical event that requires intervention to prevent permanent impairment or damage
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place