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Behavioral Pharmacology of THC and Alpha-pinene

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04130633
Recruitment Status : Not yet recruiting
First Posted : October 17, 2019
Last Update Posted : December 16, 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 alpha-pinene and THC administered via inhalation.

Condition or disease Intervention/treatment Phase
THC Alpha-pinene Drug: Placebo Drug: THC Drug: Alpha-Pinene 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, pinene alone, THC and pinene together, or placebo. Subjective drug effects, cognitive performance, 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 the investigators understand the individual and interactive effects of THC and pinene, two common constituents found in cannabis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: All participants will complete all dose conditions (study arms) in a randomized order
Masking: Double (Participant, Outcomes Assessor)
Masking Description: placebo controlled, double-blind
Primary Purpose: Basic Science
Official Title: Behavioral Pharmacology of THC and Alpha-pinene
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

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

Experimental: Vaporized high THC alone
25mg of vaporized pure THC
Drug: THC
Pure THC vapor

Experimental: Vaporized low alpha-pinene
0.5mg of vaporized alpha-pinene
Drug: Alpha-Pinene
Pure alpha-pinene vapor

Experimental: Vaporized high alpha-pinene
5mg of vaporized alpha-pinene
Drug: Alpha-Pinene
Pure alpha-pinene vapor

Experimental: Vaporized high THC and low alpha-pinene
0.5mg of vaporized alpha-pinene with 25mg vaporized THC
Drug: THC
Pure THC vapor

Drug: Alpha-Pinene
Pure alpha-pinene vapor

Experimental: Vaporized high THC and high alpha-pinene
5mg of vaporized alpha-pinene with 25mg vaporized THC
Drug: THC
Pure THC vapor

Drug: Alpha-Pinene
Pure alpha-pinene vapor

Experimental: Vaporized low THC alone
10mg of vaporized pure THC
Drug: THC
Pure THC vapor

Experimental: Vaporized low THC and low alpha-pinene
0.5mg of vaporized alpha-pinene with 10mg vaporized THC
Drug: THC
Pure THC vapor

Drug: Alpha-Pinene
Pure alpha-pinene vapor

Experimental: Vaporized low THC and high alpha-pinene
5mg of vaporized alpha-pinene with 10mg vaporized THC
Drug: THC
Pure THC vapor

Drug: Alpha-Pinene
Pure alpha-pinene vapor




Primary Outcome Measures :
  1. Self-reported Drug Effect as assessed by the Drug Effect Questionnaire (DEQ) [ Time Frame: 6 hours ]
    Peak rating (0-100) of Drug Effect on the DEQ, with 0 being no effect and 100 being maximum effect.

  2. Psychomotor performance as assessed by the Digit Symbol Substitution Task (DSST) [ Time Frame: 6 hours ]
    Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Total correct trials in 90-seconds. Minimum score of 0 but no maximum score (higher scores indicate better performance).

  3. Working memory performance as assessed by the Paced Auditory Serial Addition Task (PASAT) [ Time Frame: 6 hours ]
    Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Total correct trials out of 90 recorded is primary outcome (higher scores indicate better performance).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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, pinene).
  • Demonstrate competency on cognitive performance measures at screening visit (e.g., PASAT score of 75/90).

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 (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.
  • 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

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): NCT04130633


Contacts
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Contact: Ryan Vandrey, PhD 410-550-4036 rvandrey@jhmi.edu

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: NCT04130633    
Other Study ID Numbers: IRB00182689
R01DA043475 ( U.S. NIH Grant/Contract )
First Posted: October 17, 2019    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 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
Additional relevant MeSH terms:
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Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists