Vaping THC From Electronic Cigarettes

Summary

This study aims to understand THC pharmacology and the safety of cannabis vaping, including the pharmacology and safety of co-administration of nicotine and THC. The study is designed as a within-subjects single-blinded crossover study. Fourteen smokers of tobacco cigarettes and cannabis will switch between three conditions, namely: (a) vaping cannabis leaf, (b) vaping tobacco containing nicotine and (c) vaping a combination of cannabis leaf and tobacco containing nicotine. All participants will vape each product with the PAX loose-leaf vaporizer. The study will be conducted during three outpatient visits separated by at least 48 hours. The order of treatment (cannabis leaf, tobacco with nicotine, cannabis leaf \& tobacco with nicotine) will be counterbalanced between subjects. Subjects will be blinded to the content of the vaporizer on the study day but will be told during screening that they will vape cannabis alone, tobacco alone, and cannabis plus tobacco with nicotine.

Conditions

• Marijuana Dependence

Interventions

DRUG

Nicotine

Participants will vape tobacco leaves with nicotine out of the PAX device.

DRUG

Cannabis

Participants will vape marijuana leaves with nicotine out of the PAX device.

DEVICE

PAX Loose Leaf Vaporizer

In all three arms, the participant will be using the same PAX electronic cigarette device. The only difference is whether the participant will be vaping nicotine only, THC only, or nicotine and THC.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Neal L Benowitz, MD · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-03-20

Primary Completion

2019-11-30

Completion

2019-11-30

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations