Acute Psychological and Physiological Effects of Cannabigerol

NCT06638996 | Recruiting DMC

• 1 other identifier: 20668-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the acute effects of cannabigerol (CBG) on various psychological (e.g., anxiety, stress, mood, memory, impairment, intoxication, side effects) and physiological (blood pressure, cortisol, heart rate variability, electrodermal activity, pain tolerance, temperature) outcomes. Further, potential side effects of CBG (sleepiness/fatigue, dry mouth/eyes, increased appetite, and dizziness nausea) will be assessed. As such, the study is focused on better understanding some of the potentially beneficial and detrimental effects of CBG on humans.

Conditions

No Disease or Condition is Being Studied

Keywords

CBG; Stress; Anxiety; Memory; Heart Rate; Electrodermal Activity; Cortisol; Blood Pressure; Pain

Outcome Measures

Primary Outcomes (11)

• Anxiety

  Anxiety will be assessed along a 0 to 10 rating scale at baseline (T0), \~40 minutes after ingesting placebo or CBG (T1), after the stress test (T2), and after the memory tests (T3). Change scores from baseline to each time point will be examined.

  Anxiety ratings will occur within a 2.5 hour time frame for each session with sessions scheduled approximately one week apart

• Stress

  Stress will be assessed along a 0 to 10 rating scale at baseline (T0), \~40 minutes after ingesting placebo or CBG (T1), after the stress test (T2), and after the memory tests (T3). Change scores from baseline to each time point will be examined.

  Stress ratings will occur within a 2.5 hour time frame for each session with sessions scheduled approximately one week apart

• Mood

  Mood will be assessed along a 0 to 10 rating scale at baseline (T0), \~40 minutes after ingesting placebo or CBG (T1), after the stress test (T2), and after the memory tests (T3). Change scores from baseline to each time point will be examined.

  Mood ratings will occur within a 2.5 hour time frame for each session with sessions scheduled approximately one week apart

• Salivary Cortisol

  Salivary Cortisol will be collected using Salivettes at baseline (T0), \~40 minutes after ingesting placebo or CBG (T1), after the stress test (T2), and after memory the memory tests (T3). Change scores from baseline to each time point will be examined.

  Saliva samples will be collected within the 2.5 hour time frame for each session with sessions scheduled approximately one week apart

• Electrodermal Activity

  Electrodermal Activity will be assessed continuously using an Embrace wristband device from baseline to the end of the study. Primary points of interest include baseline (T0), after ingesting placebo or CBG (T1), after the stress test (T2), and after the memory tests (T3).

  Electrodermal Activity will be measured continuously for the duration of the 2.5 hour session for each session with sessions scheduled approximately one week apart

• Heart Rate/Heart Rate Variability

  Heart rate/heart rate variability will be assessed continuously using an Embrace wristband device from baseline to the end of the study. Primary points of interest include baseline (T0), after ingesting placebo or CBG (T1), after the stress test (T2), and after the memory tests (T3).

  Heart Rate/Heart Rate Variability will be assessed continuously for the duration of the 2.5 hour session with sessions scheduled approximately one week apart

• Blood Pressure

  Blood Pressure will be assessed at baseline (T0), \~40 minutes after ingesting placebo or CBG (T1), after the stress test (T2), and after the memory tests (T3). Change scores from baseline to each time point will be examined.

  Blood Pressure will be obtained multiple times throughout the 2.5 hour session for each session with sessions scheduled approximately one week apart

• Pain Tolerance

  Pain tolerance will be assessed by computing the duration of time they keep their hand in the cold pressor on each of the three cold pressor trials.

  Pain tolerance will be assessed within a 2.5 hour time frame for each session with sessions scheduled approximately one week apart

• Verbal Memory

  Participants will complete the California Verbal Learning Test

  Participants will complete this test within a 2.5 hour time frame for each session with sessions scheduled approximately one week apart

• Short-Term/Working Memory

  Participants will complete the Digit Span Forwards and Digit Span Backwards Tests

  Participants will complete this test within a 2.5 hour time frame for each session with sessions scheduled approximately one week apart

• False Memory

  Participants will complete the Deese-Roediger-McDermott paradigm.

  Participants will complete this test within a 2.5 hour time frame for each session with sessions scheduled approximately one week apart

Secondary Outcomes (3)

• Impairment

  Participants will complete the DRUID app within the 2.5 hour time frame for each session with sessions scheduled approximately one week apart

• Subjective Drug Effects

  Subjective drug effect ratings will occur within a 2.5 hour time frame for each session with sessions scheduled approximately one week apart

• Side Effects

  Side effect ratings will occur within a 2.5 hour time frame for each session with sessions scheduled approximately one week apart

Study Arms (2)

Placebo Arm

PLACEBO COMPARATOR

Participants in this arm will receive a placebo

Other: Placebo Intervention

CBG Arm

EXPERIMENTAL

Participants in this arm will receive CBG

Dietary Supplement: CBG Intervention

Interventions

CBG Intervention DIETARY_SUPPLEMENT

50 mg CBG Administered

CBG Arm

Placebo Intervention OTHER

Participants will be administered a placebo

Placebo Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years of age Fluent in English

You may not qualify if:

• Illiterate Serious psychiatric disorders (i.e., psychotic disorders, bipolar disorders) Intellectual disability Chronic neurological disorders (e.g., head injuries, brain tumors, Parkinson's disease) Diabetes Low blood pressure Pregnant or breastfeeding Recent illicit drug use (past 2 months) - does not include cannabis Dietary restrictions preventing them from eating muffin, yogurt, milk/juice

Sponsors & Collaborators

• Washington State University: lead

Study Sites (1)

Washington State University - Pullman Campus

Pullman, Washington, 99163, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Carrie Cuttler Dr. Cuttler, Ph.D., Psychology

CONTACT

(509) 335-0151; carrie.cuttler@wsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The research assistants who administer the protocol will be masked.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 15, 2024
• Study Start: October 28, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Deidentified data will be retained indefinitely
• Access Criteria: Researchers wanting to conduct secondary data analysis following my own publication

Locations

US (1)