Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics
Completed · Phase 1 · Has a placebo group
Conditions studied: Cannabis Use
In brief
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.
Key facts
- Study ID
- NCT02177513
- Run by
- National Institute on Drug Abuse (NIDA)
- People needed
- 28
- Starts
- 2014-06-14
- Expected to finish
- 2016-04-27
- Last updated by the study team
- 2019-12-16
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Current physical dependence on any drug other than cannabis, caffeine, or nicotine;
- Currently using cannabis for medical purposes under the explicit recommendation of a physician providing medical care;
- History or presence of any clinically significant illness, as detected by history, physical examination, and/or laboratory tests , that might put the subject at increased risk of adverse events such as history of psychotic disorder, clinically significant mood and/or anxiety disorder, diabetes, liver, renal or cardiovascular disease;
- Liver enzymes greater than or equal to 2 times upper normal limit and/or clinical signs/symptoms consistent with liver disease including but not limited to nausea, vomiting, jaundice, itching, abdominal pain, and swelling;
- History of clinically significant adverse events associated with cannabis intoxication such as severe anxiety and panic, paranoia and psychosis, sustained tachycardia, or severe hypotension;
- Donation of more than 450 mL blood within 8 weeks of study treatment phase;
- Hemoglobin less than 12.0 g/dL and/or clinical signs/symptoms consistent with anemia including but not limited to fatigue, tachycardia, shortness of breath, and dizziness;
- If female, pregnant or nursing;
- Currently interested in or participating in drug abuse treatment, or participated in drug abuse treatment within 90 days preceding study enrollment;
- History of food allergy or sensitivity to gluten, dairy, egg, soy, and/or chocolate.
- Any form of color blindness
Where it is running
- National Institute on Drug Abuse — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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