Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institute of Cannabis Research | UNKNOWN |
Not provided
Not provided
Not provided
The main objectives of this study were to test if a singular dose of Cannabidiol (1) enhances the learning and memory of healthy human subjects, (2) test if Cannabidiol has negative effects on Retroactive and Proactive Interference during learning, (3) and test if demographic factors will influence CBD's modulation of human learning and memory.
Using a randomized, double-blind, placebo-controlled two-arm case-crossover trial, this study investigates the effect of 246 milligrams (mg) of Cannabidiol (CBD) on the learning and memory scores of human subjects, as well as the effect of Cannabidiol on Proactive and Retroactive Interference. This study also investigated the influence of demographic factors on CBD's modulation of human learning and memory.
This study was conducted at Colorado State University-Pueblo (CSU Pueblo) with volunteers recruited from CSU Pueblo and the local Pueblo community. Fifty-seven subjects were randomized in a double-blind manner to receive either CBD or placebo before completing two versions of learning and memory assessments. Each version of the learning and memory assessment included the Montreal Cognitive Assessment (MOCA), the Rey Auditory Verbal Learning Task-Revised (RAVLT-R), and the Logical Memory Subject of the Weschler Memory Scale. Several components of the RAVLT-R were evaluated including the Sum of Trials (Trials I-V) score, Proactive Interference Ratio (PI Ratio), and Retroactive Interference (RI Ratio).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo, Then Cannabidiol | Placebo Comparator | Participants first received a Placebo 246 mg press pill during visit 1. After a washout period of 1 week, subjects received a Cannabidiol press pill during visit 2. |
|
| Cannabidiol, Then Placebo | Active Comparator | Participants first received a Cannabidiol 246 mg press pill during visit 1. After a washout period of 1 week, subjects received a Placebo press pill during visit 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol (246mg press pill) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Trials (I-V) | 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. | Each trial is 45 seconds for encoding and recall |
| Proactive Interference Ratio (PI Ratio) | 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). | Each trial is 45 seconds for encoding and recall |
| Retroactive Interference Ratio (RI Ratio) | 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). | Each trial is 45 seconds for encoding and recall |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Moussa M Diawara, PhD | Colorado State University-Pueblo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado State University Pueblo | Pueblo | Colorado | 81001 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39849639 | Derived | Gebregzi HH, Zeiger JS, Smith JP, Stuyt L, Cullen L, Carsella J, Rogers DC, Lafebre J, Knalfec J, Vargas A, Diawara MM. Oral cannabidiol did not impair learning and memory in healthy adults. J Cannabis Res. 2025 Jan 23;7(1):5. doi: 10.1186/s42238-025-00262-2. |
Not provided
Not provided
Individual (de-identified) participant data is to be made available to other researchers.
Data will become available upon request.
Data will become available upon request.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Enrollment was stopped after interim analyses were completed. 57 subjects were enrolled in the study, but 35 were included in the final analyses. Subjects were required to come for visits 1 and 2. A large dropout between visits 1 and 2 was due to the COVID pandemic which caused for subjects to be lost to follow up. The baseline characteristics are reported for the 35 repeat subjects which is representative of the participant population that results were reported for.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo First, Then Cannabidiol | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sum of Trials (I-V) | 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. | 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). | Posted | Mean | Standard Error | score on a scale | Each trial is 45 seconds for encoding and recall |
|
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:
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (Administered During Visits 1 or 2) | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness | Nervous system disorders | Systematic Assessment | Subjects were asked to complete an exit survey with possible adverse events or asked to fill in the line. 4 subjects reported drowsiness or fatigues. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Moussa Diawara | Colorado State University Pueblo | 719-549-2813 | Moussa.Diawara@csupueblo.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 28, 2024 | Sep 29, 2024 | Prot_SAP_002.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
Two-arm Case-Crossover
Not provided
Not provided
Triple (Participant, Care Provider, Outcomes Assessor)
|
| Placebo (246mg press pill) | Drug | Placebo press pills were 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. |
|
| Total Prose Recall |
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. |
| Each recall takes about 5 min for encoding and recall |
| Montreal Cognitive Assessment Score | 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. | 10 minutes total for encoding and recall |
| BG001 | Cannabidiol First, Then Placebo | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| History of CBD Use, categorical | Count of Participants | Participants |
|
| Urine THC Result, categorical | Count of Participants | Participants |
|
| History of Nicotine Use, categorical | Count of Participants | Participants |
|
| Placebo (Administered During Visits 1 or 2) |
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. |
| OG001 | Cannabidiol (Administered During Visits 1 or 2) | 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. |
|
|
| Primary | Proactive Interference Ratio (PI Ratio) | 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). | Adult healthy human subjects | Posted | Mean | Standard Error | ratio | Each trial is 45 seconds for encoding and recall |
|
|
|
|
| Primary | Retroactive Interference Ratio (RI Ratio) | 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). | Adult healthy human subjects | Posted | Mean | Standard Error | ratio | Each trial is 45 seconds for encoding and recall |
|
|
|
| Primary | Total Prose Recall | 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. | Adult healthy human subjects | Posted | Mean | Standard Error | Score on a scale | Each recall takes about 5 min for encoding and recall |
|
|
|
| Primary | Montreal Cognitive Assessment Score | 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. | Adult healthy human population | Posted | Mean | Standard Error | Score on a scale | 10 minutes total for encoding and recall |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 1 |
| 35 |
| EG001 | Cannabidiol (Administered During Visits 1 or 2) | 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. | 0 | 35 | 0 | 35 | 4 | 35 |
|
| Hunger | Gastrointestinal disorders | Systematic Assessment | Participants were given an exit survey with a list of possible adverse events or asked to fill in the line. 1 Subject reported hunger. |
|
Not provided
Not provided