The Pharmacokinetics and Pharmacodynamics of Hemp-based Topical Cannabinoid Products

Sponsor
Johns Hopkins University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04741477
Collaborator
Substance Abuse and Mental Health Services Administration (SAMHSA) (U.S. Fed)
200
1
2
19.5
10.2

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model 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.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.
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
The Pharmacokinetics and Pharmacodynamics of Hemp-based Topical Cannabinoid Products
Actual Study Start Date :
Jul 14, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Topical CBD Product with low level of THC

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

Drug: CBD
CBD will be topically applied

Drug: THC
THC will be topically applied

Placebo Comparator: Placebo topical product

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

Drug: Placebo
a placebo product (without cannabinoids) will be topically applied

Outcome Measures

Primary Outcome Measures

  1. Change in Urine cannabinoids [Days 1, 2, 3, 7, 10, and 17]

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

  2. Change in Blood cannabinoids [Days 1, 2, 3, 7, 10, and 17]

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

Secondary Outcome Measures

  1. Change in Oral fluid cannabinoids [Days 1, 2, 3, 7, 10, and 17]

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

  2. Change in Hair cannabinoids [Days 1 and 17]

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

  3. Change in Subjective drug effects as assessed by the Drug Effect Questionnaire [Days 1, 2, 3, 7, 10, and 17]

    Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect.

  4. Change in Cognitive performance as assessed by the Divided Attention Task [Days 1, 2, 3, 7, 10, and 17]

    Cognitive performance will be evaluated with the Divided Attention Task. Will be measured as the mean distance (in computer pixels) of the mouse cursor from the central stimulus.

  5. Change in Working memory performance as assessed by the Paced Serial Addition Task [Days 1, 2, 3, 7, 10, and 17]

    Working memory performance will be evaluated with the Paced Serial Addition Task (scores can range from 0-90) with 90 indicating perfect performance.

  6. Change in Psychomotor performance as assessed by the Digit Symbol Substitution Task [Days 1, 2, 3, 7, 10, and 17]

    Psychomotor performance will be evaluated with the Digit Symbol Substitution Task. Will be measured as the number of correct trials within 90 seconds.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins Behavioral Pharmacology Research Unit Baltimore Maryland United States 21224

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Tory Spindle, PhD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT04741477
Other Study ID Numbers:
  • IRB00277556
  • 1-340-0216610-65527L
First Posted:
Feb 5, 2021
Last Update Posted:
Jul 6, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 6, 2022