The Pharmacokinetics and Pharmacodynamics of Hemp-based Topical Cannabinoid Products

NCT ID: NCT04741477

Last Updated: 2023-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-14
• Study Completion Date: 2022-09-16

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).

Detailed Description

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. Thus, overall 100 participants will complete the study (75 active, 25 placebo).

Participants in each stage will complete a three-phase outpatient protocol that will last a total of 17 days. Phase 1 (Day 1) will be an acute laboratory dosing session (approximately 7 hours in duration). Phase 2 (Days 2-10) will be an outpatient dosing period, during which participants will continue to use participants' assigned product twice daily (morning and evening) in participants' own environment. During Phase 2, participants will visit the laboratory for brief study sessions on Days 2, 3, 7, and 10. Phase 3, will consist of a final follow-up visit on Day 17, after a 1-week drug washout. Pharmacokinetic and pharmacodynamic assessments (subjective and cognitive effects) will be assessed during each phase.

Conditions

Cannabis; Drug Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Topical CBD Product with low level of THC

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

Group Type: EXPERIMENTAL

CBD

Intervention Type: DRUG

CBD will be topically applied

THC

Intervention Type: DRUG

THC will be topically applied

Placebo topical product

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

a placebo product (without cannabinoids) will be topically applied

Interventions

CBD

CBD will be topically applied

Intervention Type: DRUG

THC

THC will be topically applied

Intervention Type: DRUG

Placebo

a placebo product (without cannabinoids) will be topically applied

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Have provided written informed consent

2. Be between the ages of 18 and 55

3. Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests

4. Test negative for recent cannabis use in urine at the screening visit and again upon admission for each experimental session

5. Test negative for other drugs of abuse, including alcohol, at the screening visit and upon arrival for each experimental session

6. 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.

7. Have a body mass index (BMI) in the range of 19 to 36 kg/m^2

8. Have head hair that is at least 4 cm (approximately one and a half inches) in length on the back of the head.

9. 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

10. Report prior experience using cannabis or CBD products.

11. Have not donated blood in the prior 30 days.

12. Have a smart phone, tablet, computer, etc. capable of recording videos and operating Redcap.

Exclusion Criteria

1. Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the month prior to the screening visit.

2. 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.

3. 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.

4. Use of hemp seeds or hemp oil in any form in the past 3 months.

5. Use of dronabinol (Marinol) within the past 6 months.

6. 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.

7. History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).

8. Known allergy to any ingredients in the active or placebo topical products.

9. Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.

10. Epilepsy or a history of seizures.

11. Individuals with anemia.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Substance Abuse and Mental Health Services Administration (SAMHSA)

FED

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tory Spindle, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

1-340-0216610-65527L

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00277556

Identifier Type: -

Identifier Source: org_study_id