CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 8 enrolled
Drug / intervention
Nicotine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02955329
NCT02955329Phase 3Completed

Vaping THC From Electronic Cigarettes: a Novel Evaluation of Intake and Pharmacokinetics

University of California, San Francisco·interventional·Posted Nov 4, 2016·Updated Jun 29, 2023

In Brief

A Phase 3 clinical trial evaluating Nicotine, Cannabis, and 1 other intervention for Marijuana Dependence. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 4, 2016
Enrollment StartMar 20, 2019
Primary CompletionNov 30, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.7 years ago

Interventions

Nicotinedrug

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

Cannabisdrug

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

PAX Loose Leaf Vaporizerdevice

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.