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Behavioral Pharmacology of THC and D-limonene

NCT ID: NCT03609853

Last Updated: 2023-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2023-10-25

Brief Summary

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

Detailed Description

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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.

Conditions

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D-limonene and THC Pharmacodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
placebo controlled, double-blind

Study Groups

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Placebo

Placebo (5mL distilled water)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo vapor (distilled water)

Vaporized low THC

15mg of pure THC

Group Type EXPERIMENTAL

Vaporized THC, limonene, or THC and limonene

Intervention Type DRUG

Acute drug exposure

Vaporized high THC

30mg of pure THC

Group Type EXPERIMENTAL

Vaporized THC, limonene, or THC and limonene

Intervention Type DRUG

Acute drug exposure

Vaporized low d-limonene

1mg of d-limonene

Group Type EXPERIMENTAL

Vaporized THC, limonene, or THC and limonene

Intervention Type DRUG

Acute drug exposure

Vaporized high d-limonene

5mg of d-limonene

Group Type EXPERIMENTAL

Vaporized THC, limonene, or THC and limonene

Intervention Type DRUG

Acute drug exposure

Low THC and low d-limonene

15mg of THC paired with 1mg of d-limonene

Group Type EXPERIMENTAL

Vaporized THC, limonene, or THC and limonene

Intervention Type DRUG

Acute drug exposure

High THC and low d-limonene

30mg of THC paired with 1mg of d-limonene

Group Type EXPERIMENTAL

Vaporized THC, limonene, or THC and limonene

Intervention Type DRUG

Acute drug exposure

Low THC and high d-limonene

15mg of THC paired with 5mg of d-limonene

Group Type EXPERIMENTAL

Vaporized THC, limonene, or THC and limonene

Intervention Type DRUG

Acute drug exposure

High THC and high d-limonene

30mg of THC paired with 5mg of d-limonene

Group Type EXPERIMENTAL

Vaporized THC, limonene, or THC and limonene

Intervention Type DRUG

Acute drug exposure

High THC and 15mg d-limonene

30mg of THC paired with 15mg of d-limonene

Group Type EXPERIMENTAL

Vaporized THC, limonene, or THC and limonene

Intervention Type DRUG

Acute drug exposure

Interventions

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Placebo

Placebo vapor (distilled water)

Intervention Type DRUG

Vaporized THC, limonene, or THC and limonene

Acute drug exposure

Intervention Type DRUG

Eligibility Criteria

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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 over the counter, 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ryan Vandrey, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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R01DA043475

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00085652

Identifier Type: -

Identifier Source: org_study_id