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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 : October 14, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This study will evaluate the pharmacokinetics and pharmacodynamics of vaporized d-limonene and THC administered via inhalation.

Condition or disease Intervention/treatment Phase
D-limonene and THC Pharmacodynamics Drug: Placebo Drug: Vaporized THC, limonene, or THC and limonene Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: placebo controlled, double-blind
Primary Purpose: Basic Science
Official Title: Behavioral Pharmacology of THC and D-limonene
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : April 30, 2020

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo (5mL distilled water)
Drug: Placebo
Placebo vapor (distilled water)

Experimental: Vaporized low THC
15mg of pure THC
Drug: Vaporized THC, limonene, or THC and limonene
Acute drug exposure

Experimental: Vaporized high THC
30mg of pure THC
Drug: Vaporized THC, limonene, or THC and limonene
Acute drug exposure

Experimental: Vaporized low d-limonene
1mg of d-limonene
Drug: Vaporized THC, limonene, or THC and limonene
Acute drug exposure

Experimental: Vaporized high d-limonene
5mg of d-limonene
Drug: Vaporized THC, limonene, or THC and limonene
Acute drug exposure

Experimental: Low THC and low d-limonene
15mg of THC paired with 1mg of d-limonene
Drug: Vaporized THC, limonene, or THC and limonene
Acute drug exposure

Experimental: High THC and low d-limonene
30mg of THC paired with 1mg of d-limonene
Drug: Vaporized THC, limonene, or THC and limonene
Acute drug exposure

Experimental: Low THC and high d-limonene
15mg of THC paired with 5mg of d-limonene
Drug: Vaporized THC, limonene, or THC and limonene
Acute drug exposure

Experimental: High THC and high d-limonene
30mg of THC paired with 5mg of d-limonene
Drug: Vaporized THC, limonene, or THC and limonene
Acute drug exposure




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Change in Heart Rate [ Time Frame: 6 hours ]
    Peak change from baseline in Heart Rate (bpm) measured in seated position by automated monitor



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03609853


Contacts
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Contact: Sarah Moshman 410-550-5254 smoshma1@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Behavioral Pharmacology Research Unit Recruiting
Baltimore, Maryland, United States, 21224
Contact: Ryan Vandrey         
Principal Investigator: Ryan Vandrey, PhD         
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Ryan Vandrey, PhD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03609853     History of Changes
Other Study ID Numbers: IRB00085652
R01DA043475 ( U.S. NIH Grant/Contract )
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists