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Behavioral Pharmacology of THC and D-limonene

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ClinicalTrials.gov Identifier: NCT03609853
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : January 13, 2021
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE July 11, 2018
First Posted Date  ICMJE August 1, 2018
Last Update Posted Date January 13, 2021
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2018)
Level of Anxiety as assessed by the Drug Effect Questionnaire (DEQ) [ Time Frame: 6 hours ]
Peak rating (0-100) of Anxiety on the DEQ, a visual analog scale (VAS) self-report questionnaire with 0 being No anxiety and 100 being maximum anxiety
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2018)
  • Level of Unpleasant Effect as assessed by the Drug Effect Questionnaire (DEQ) [ Time Frame: 6 hours ]
    Peak rating (0-100) of Unpleasant Effect on the DEQ, with 0 being no unpleasant effect and 100 being worst unpleasant effect
  • Difficulty in Performing Routine Tasks as assessed the Drug Effect Questionnaire (DEQ) [ Time Frame: 6 hours ]
    Peak rating (0-100) of Difficulty Performing Routine Tasks on the DEQ, 0 being no difficulty and 100 being inability to perform task all together
  • Change in Heart Rate [ Time Frame: 6 hours ]
    Peak change from baseline in Heart Rate (bpm) measured in seated position by automated monitor
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Behavioral Pharmacology of THC and D-limonene
Official Title  ICMJE Behavioral Pharmacology of THC and D-limonene
Brief Summary This study will evaluate the pharmacokinetics and pharmacodynamics of vaporized d-limonene and THC administered via inhalation.
Detailed Description The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). Participants will complete 9 acute drug administration periods in which they will administer THC alone, limonene alone, THC and limonene together, or placebo. Subjective drug effects and vital signs will be assessed following drug administration. Each participant will receive all 9 dose conditions in a randomized order using a placebo controlled within-subject crossover design. The study will help us understand the individual and interactive effects of THC and d-limonene, two common constituents found in cannabis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
placebo controlled, double-blind
Primary Purpose: Basic Science
Condition  ICMJE D-limonene and THC Pharmacodynamics
Intervention  ICMJE
  • Drug: Placebo
    Placebo vapor (distilled water)
  • Drug: Vaporized THC, limonene, or THC and limonene
    Acute drug exposure
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo (5mL distilled water)
    Intervention: Drug: Placebo
  • Experimental: Vaporized low THC
    15mg of pure THC
    Intervention: Drug: Vaporized THC, limonene, or THC and limonene
  • Experimental: Vaporized high THC
    30mg of pure THC
    Intervention: Drug: Vaporized THC, limonene, or THC and limonene
  • Experimental: Vaporized low d-limonene
    1mg of d-limonene
    Intervention: Drug: Vaporized THC, limonene, or THC and limonene
  • Experimental: Vaporized high d-limonene
    5mg of d-limonene
    Intervention: Drug: Vaporized THC, limonene, or THC and limonene
  • Experimental: Low THC and low d-limonene
    15mg of THC paired with 1mg of d-limonene
    Intervention: Drug: Vaporized THC, limonene, or THC and limonene
  • Experimental: High THC and low d-limonene
    30mg of THC paired with 1mg of d-limonene
    Intervention: Drug: Vaporized THC, limonene, or THC and limonene
  • Experimental: Low THC and high d-limonene
    15mg of THC paired with 5mg of d-limonene
    Intervention: Drug: Vaporized THC, limonene, or THC and limonene
  • Experimental: High THC and high d-limonene
    30mg of THC paired with 5mg of d-limonene
    Intervention: Drug: Vaporized THC, limonene, or THC and limonene
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 25, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2022
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, 12-lead ECG and screening urine and blood tests
  4. Test negative for drugs of abuse other than cannabis, including breath alcohol at the screening visit and at clinic admission
  5. 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 clinic admission.
  6. Have a body mass index (BMI) in the range of 18 to 36 kg/m2
  7. 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
  8. Have no allergies to any of the ingredients used to prepare vapor (THC, d-limonene).
  9. Report having experienced anxiety after consuming cannabis in the past.

Exclusion Criteria:

  1. Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine 3 month prior to the Screening Visit;
  2. History of or current evidence of significant medical (e.g. seizure disorder) or psychiatric illness (e.g. psychosis) 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 OTC, systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
  4. Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
  5. Use of dronabinol (Marinol®) within the past month.
  6. Average use of cannabis more than 2 times per week in the prior 3 months.
  7. History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
  8. Abnormal EKG result that in the investigator's opinion is clinically significant.
  9. Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.
  10. Having previously sought medical attention to manage adverse effects following acute cannabis use.
  11. Individuals with anemia or who have donated blood in the prior 30 days
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Joshua Elmore 410-550-9491 jelmore4@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03609853
Other Study ID Numbers  ICMJE IRB00085652
R01DA043475 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Ryan Vandrey, PhD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP