Pharmacokinetic and Pharmacodynamic Effects of Oral Cannabis

NCT ID: NCT02165176

Last Updated: 2018-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-09-30

Brief Summary

Few studies have been conducted to assess the pharmacokinetic and pharmacodynamic effects of orally consumed intact cannabis (e.g., cannabis-containing brownies). Careful analysis of oral cannabis dose effects on these parameters is required to determine the level and duration of biological cannabinoid exposure and associated subjective, cardiovascular and cognitive effects. In the present study we evaluated the detection of cannabinoids in oral fluid, plasma, hair, and urine for up to 9 days following consumption of oral cannabis (10mg, 25mg, or 50mg THC). The outcomes of the study will extend scientific knowledge about the behavioral pharmacology and toxicology of oral cannabis administration and can inform policies regarding clinical, workplace and roadside drug testing programs.

Conditions

Cannabis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

10mg acute oral cannabis

10mg acute oral cannabis

Group Type: EXPERIMENTAL

Oral cannabis

Intervention Type: DRUG

25mg acute oral cannabis

25mg acute oral cannabis

Group Type: EXPERIMENTAL

Oral cannabis

Intervention Type: DRUG

50mg acute oral cannabis

50mg acute oral cannabis

Group Type: EXPERIMENTAL

Oral cannabis

Intervention Type: DRUG

Interventions

Oral cannabis

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Have provided written informed consent

2. Be between the ages of 18 and 45

3. Be in good general health based on a physical examination, medical history, vital signs, 12-lead ECG and screening urine and blood tests

4. Test negative for recent cannabis use in urine at the screening visit (confirmed by GC/MS laboratory test) and at clinic admission

5. Test negative for other drugs of abuse, including alcohol at the screening visit and at clinic admission

6. Demonstrate ability to expectorate 3-5 mL of "native" oral fluid over a 5-minute period

7. 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.

8. Have a body mass index (BMI) in the range of 19 to 36 kg/m2

9. Have head hair that is at least 4 cm (approximately one and a half inches) in length on the back of the head.

10. 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

11. Have no allergies to any of the ingredients used to prepare cannabis brownies (chocolate, eggs, wheat, etc.).

Exclusion Criteria

1. Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine 3 month prior to the Screening Visit;

2. History of or current evidence of significant medical or psychiatric illness 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.

3. Use of an 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.

4. 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.

5. Use of hemp seeds or hemp oil in any form in the past 3 months.

6. Use of dronabinol (Marinol) within the past 6 months.

7. History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, or other significant oral cavity disease or disorder that in the investigator's opinion may affect the collection of oral fluid samples.

8. History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).

9. Abnormal EKG result that in the investigator's opinion is clinically significant.

10. Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Substance Abuse and Mental Health Services Administration (SAMHSA)

FED

Sponsor Role: collaborator

RTI International

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Ryan Vandrey

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan Vandrey, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

Johns Hopkins School of Medicine Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00035394

Identifier Type: -

Identifier Source: org_study_id