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Completed

NCT Number: NCT03609853

Behavioral Pharmacology of THC and D-limonene

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have provided written informed consent
  • Be between the ages of 18 and 55
  • Be in good general health based on a physical examination, medical history, vital signs, 12-lead ECG and screening urine and blood tests
  • Test negative for drugs of abuse other than cannabis, including breath alcohol at the screening visit and at clinic admission
  • 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.
  • Have a body mass index (BMI) in the range of 18 to 36 kg/m2
  • 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
  • Have no allergies to any of the ingredients used to prepare vapor (THC, d-limonene).
  • Report having experienced anxiety after consuming cannabis in the past.

Exclusion criteria

  • Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine 3 month prior to the Screening Visit;
  • 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.
  • 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.
  • 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.
  • Use of dronabinol (Marinol®) within the past month.
  • Average use of cannabis more than 2 times per week in the prior 3 months.
  • History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
  • Abnormal EKG result that in the investigator's opinion is clinically significant.
  • Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.
  • Having previously sought medical attention to manage adverse effects following acute cannabis use.
  • Individuals with anemia or who have donated blood in the prior 30 days

Treatment and study plan

Placebo

Drug

Placebo vapor (distilled water)

Vaporized THC, limonene, or THC and limonene

Drug

Acute drug exposure

Primary outcomes

  1. Mean Peak Change From Baseline Anxiety as Assessed by the Drug Effect Questionnaire (DEQ)

    Time frame: 0-6 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 outcomes

  1. Mean Peak Change From Baseline Paranoid as Assessed by the Drug Effect Questionnaire (DEQ)

    Time frame: 0-6 hours

    Peak change from baseline rating of Paranoid on the DEQ, a 100pt VAS scale with 0 being no paranoia and 100 being extreme paranoia

  2. Mean Peak Change From Baseline Subjective "Heart Racing" as Assessed by the Drug Effect Questionnaire (DEQ)

    Time frame: 0-6 hours

    Mean peak change from baseline for subjective heart racing on the DEQ, a 0-100 VAS scale with 0 being no feeling of heart racing and 100 being an extreme feeling of heart racing.

  3. Mean Peak Change From Baseline Heart Rate

    Time frame: 0-6 hours

    Peak change from baseline in Heart Rate (bpm) measured in seated position by automated monitor

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Aug 1, 2018
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.