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NCT02177513 · ClinicalTrials.gov registry record · Phase 1
Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics
A Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT02177513 is a Phase 1 study that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 28 participants.
The verdict
NCT02177513, a Phase 1 study, has completed, sponsored by National Institute on Drug Abuse (NIDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
Background: \- Marijuana (cannabis) is an illegal drug. Researchers want to study people s reactions, attention, and behavior after they take marijuana in different ways. They want to learn better ways to detect drugs in a person s body They also want to know how long marijuana can be found in blood, urine, saliva, and breath. Objectives: \- To learn how people respond to delta-9-tetrahydrocannabinol (THC, a marijuana component) and how their bodies handle it after it is given in different ways. Eligibility: \- Adults age 18 50 who use marijuana. Design: * Participants are screened under another NIDA protocol. * This study involves up to 6 visits to NIDA. * At the first visit, participants will practice the tasks and tests they will do at their dosing sessions. They will learn how to give breath and saliva samples. * Dosing sessions 1 4 will last 3 5 days each. All participants will be admitted to a research clinic the night before these sessions. Some participants can stay at the clinic and some must go home between sessions. * At each session, participants will eat a brownie with placebo or marijuana. Then they will smoke a placebo or marijuana cigarette. Some will inhale placebo or marijuana after it is vaporized. * Throughout the sessions: * Participants will give urine, saliva, and breath samples. Their blood will be taken with a tube in a vein and finger pricks. Their vital signs will be checked. * Participants will answer questionnaires and take thinking tests. They will also take tests that assess eye movement, balance, and time estimation. * Participants may have a 5th dosing session. They will eat a marijuana brownie and have the above tests and samples.
Interventions
- DRUG Placebo + Placebo
- DRUG Oral Cannabis + Placebo
- DRUG Placebo + Inhaled Cannabis
- DRUG Placebo + Smoked Cannabis
- DRUG 6.9% cannabis oral
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2014-06-14 |
| Est. Completion | 2016-04-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02177513
The ClinicalTrials.gov registry entry for NCT02177513 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo + Placebo is the first listed.
NCT02177513 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02177513 about?
NCT02177513 is a clinical study titled "Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics". Background: \- Marijuana (cannabis) is an illegal drug. Researchers want to study people s reactions, attention, and behavior after they take marijuana in different ways. They want to learn better ways to detect drugs in a person s body They also want to know how long marijuana can be found in bloo...
What is the current status of trial NCT02177513?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2014-06-14. Estimated completion is 2016-04-27.
What interventions are being tested in trial NCT02177513?
The interventions under investigation include: Placebo + Placebo (DRUG), Oral Cannabis + Placebo (DRUG), Placebo + Inhaled Cannabis (DRUG), Placebo + Smoked Cannabis (DRUG), 6.9% cannabis oral (DRUG).
Who is sponsoring clinical trial NCT02177513?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
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