The Pharmacokinetics and Pharmacodynamics of Hemp-based Topical Cannabinoid Products

NCT04741477 | Completed Phase 1 FDA Drug

• 2 other identifiers: IRB002775561-340-0216610-65527L
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the pharmacokinetic and pharmacodynamic effects of hemp-based Cannabidiol (CBD) topical products (e.g., lotions, creams, patches) that contain low levels of delta-9-tetrahydrocannabinol (THC).

Conditions

Cannabis; Drug Effect

Outcome Measures

Primary Outcomes (2)

• Change in Urine cannabinoids

  Concentration of cannabinoids will be measured in urine (unit of measurement: nanograms/mL)

  Days 1, 2, 3, 7, 10, and 17

• Change in Blood cannabinoids

  Concentration of cannabinoids will be measured in blood (unit of measurement: nanograms/mL)

  Days 1, 2, 3, 7, 10, and 17

Secondary Outcomes (6)

• Change in Oral fluid cannabinoids

  Days 1, 2, 3, 7, 10, and 17

• Change in Hair cannabinoids

  Days 1 and 17

• Change in Subjective drug effects as assessed by the Drug Effect Questionnaire

  Days 1, 2, 3, 7, 10, and 17

• Change in Cognitive performance as assessed by the Divided Attention Task

  Days 1, 2, 3, 7, 10, and 17

• Change in Working memory performance as assessed by the Paced Serial Addition Task

  Days 1, 2, 3, 7, 10, and 17

Study Arms (2)

Topical CBD Product with low level of THC

EXPERIMENTAL

Participants will topically apply a high CBD-product that also contains low levels of THC.

Drug: CBD; Drug: THC

Placebo topical product

PLACEBO COMPARATOR

Participants will topically apply a placebo product that does not contain cannabinoids.

Drug: Placebo

Interventions

CBD DRUG

CBD will be topically applied

Topical CBD Product with low level of THC

THC DRUG

THC will be topically applied

Topical CBD Product with low level of THC

Placebo DRUG

a placebo product (without cannabinoids) will be topically applied

Placebo topical product

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have provided written informed consent
• Be between the ages of 18 and 55
• Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
• Test negative for recent cannabis use in urine at the screening visit and again upon admission for each experimental session
• Test negative for other drugs of abuse, including alcohol, at the screening visit and upon arrival for each experimental session
• Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at each study visit.
• Have a body mass index (BMI) in the range of 19 to 36 kg/m\^2
• Have head hair that is at least 4 cm (approximately one and a half inches) in length on the back of the head.
• Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
• Report prior experience using cannabis or CBD products.
• Have not donated blood in the prior 30 days.
• Have a smart phone, tablet, computer, etc. capable of recording videos and operating Redcap.

You may not qualify if:

• Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the month prior to the screening visit.
• History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.
• Use of an over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), vitamin(s), or prescription medications (with the exception of birth control prescriptions) within 14 days of study entry; which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the subject.
• Use of hemp seeds or hemp oil in any form in the past 3 months.
• Use of dronabinol (Marinol) within the past 6 months.
• History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, or other significant oral cavity disease or disorder that in the investigator's opinion may affect the collection of oral fluid samples.
• History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
• Known allergy to any ingredients in the active or placebo topical products.
• Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.
• Epilepsy or a history of seizures.
• Individuals with anemia.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Substance Abuse and Mental Health Services Administration (SAMHSA): collaborator

Study Sites (1)

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Tory Spindle, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 5 topical cannabinoid products will be examined in this study. The study will be conducted in 5 discrete stages, one for each product. In each stage, participants (N=20), will be randomized to 1 of 2 double-blind drug conditions that entail the use of: 1) a topical product that contains CBD and a low amount of THC (N=15), or 2) a placebo topical product that does not contain cannabinoids (N=5), but which contains similar non-cannabinoid ingredients to the active product.

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: July 14, 2021
• Primary Completion: September 16, 2022
• Study Completion: September 16, 2022
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)