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 : June 22, 2022
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Sponsor:
Johns Hopkins University
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University
Tracking Information | |||||||
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First Submitted Date ICMJE | July 11, 2018 | ||||||
First Posted Date ICMJE | August 1, 2018 | ||||||
Last Update Posted Date | June 22, 2022 | ||||||
Actual Study Start Date ICMJE | April 1, 2019 | ||||||
Estimated Primary Completion Date | September 1, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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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
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Condition ICMJE | D-limonene and THC Pharmacodynamics | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
20 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 30, 2022 | ||||||
Estimated Primary Completion Date | September 1, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE |
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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 ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Johns Hopkins University | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Johns Hopkins University | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||||
Investigators ICMJE |
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PRS Account | Johns Hopkins University | ||||||
Verification Date | November 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |