NCT02470754

Brief Summary

The purpose of this study is to learn more about nicotine exposure and the safety of electronic cigarettes (EC). It will focus on the areas that are thought to most closely relate to the addictive potential of EC, namely: (1) EC as nicotine delivery devices, covering issues of nicotine intake and pharmacokinetics, temporal patterns of use and titration of nicotine; and (2) subjective effects of EC use, including relationship of use to reward, withdrawal and craving.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 23, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2018

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

November 13, 2019

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

2.5 years

First QC Date

April 30, 2015

Results QC Date

April 22, 2019

Last Update Submit

June 15, 2023

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (4)

  • Standardized Session: Mean CMax

    Maximum Plasma Nicotine Concentration (Cmax) (ng/mL)

    Inpatient Day 1, Up to 4 Hours post Nicotine Administration

  • Standardized Session: Mean TMax

    Time (min) when Max Plasma Nicotine Concentration was achieved

    Inpatient Day 1, Up to 4 Hours post Session

  • Standardized Session: AUC 0-240

    Plasma Nicotine area-under-the curve from 0 to 4 Hours (min\*ng/ml)

    Inpatient Day 1, Up to 4 Hours post Session

  • PK-estimated Nicotine Dose

    Estimated in dose received (in milligrams) during the Standardized Session.

    Inpatient Day 1, Up to 4 Hours post Session

Secondary Outcomes (6)

  • Standardized Session: QSU Factor 1 (Vaping)

    Inpatient Day 1, Up to 4 Hours post Session

  • Standardized Session: Positive and Negative Affect Score (Negative Affect)

    Inpatient Day 1, Up to 4 Hours post Session

  • Standardized Session: Minnesota Nicotine Withdrawal Scale

    Inpatient Day 1, Up to 4 Hours post Session

  • Standardized Session: QSU Factor 2 (Vaping)

    Inpatient Day 1, Up to 4 Hours post Session

  • Standardized Session: QSU Factor 1 (Smoking)

    Inpatient Day 1, Up to 4 Hours post Session

  • +1 more secondary outcomes

Other Outcomes (1)

  • Standardized Session: Half-life

    Inpatient Day 1, Up to 4 Hours post Session

Study Arms (2)

EC Block1/TC Block 2

ACTIVE COMPARATOR

Participants will be randomized into one of two groups. In this group, participants will be assigned to Electronic Cigarettes only for Study Block #1, then crossover to Tobacco Cigarettes only for Study Block #2.

Device: Tobacco CigaretteDevice: Electronic Cigarette

TC Block 1/EC Block 2

ACTIVE COMPARATOR

Participants will be randomized into one of two groups. In this group, participants will be assigned to Tobacco Cigarettes only for Study Block #1, then crossover to Electronic Cigarettes only for Study Block #2.

Device: Tobacco CigaretteDevice: Electronic Cigarette

Interventions

Tobacco CigaretteDEVICE

Usual brand tobacco cigarette smoked by study participant.

Also known as: TC, Cigarette
EC Block1/TC Block 2TC Block 1/EC Block 2
Electronic CigaretteDEVICE

Usual brand electronic cigarettes smoked by study participant.

Also known as: EC, E-cig, E-cigarette
EC Block1/TC Block 2TC Block 1/EC Block 2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy on the basis of medical history and limited physical examination as described below:
  • Heart rate \< 105 BPM\*
  • Systolic Blood Pressure \< 160 and \> 90\*
  • Diastolic Blood Pressure \< 100 and \> 50\*
  • Body Mass Index ≤ 38.0 \*Considered out of range if both machine and manual readings are above/below these thresholds.
  • Current regular "dual" user of both EC and conventional TC
  • EC device is one of the most popular 1st, 2nd or 3rd generation brands (with the exception of rebuildable atomizers) as determined at time of study commencement
  • Carbon monoxide ≥ 5 ppm or per discretion of Principal Investigator
  • Saliva cotinine ≥50 ng/ml or urine cotinine
  • Age: ≥ 21 years

You may not qualify if:

  • Current regular use of selected psychiatric medications
  • Current regular use of cardiovascular medications for cardiovascular conditions including hypertension (Example: beta and alpha-blockers)
  • Current regular use of medications inducers of nicotine metabolizing enzymes CYP2A6 (Example: rifampicin, dexamethasone, phenobarbital, and other anticonvulsant drugs).
  • Use of other tobacco products
  • Pregnancy or breastfeeding (by history and pregnancy test)
  • Concurrent use of nicotine-containing medications
  • Drug/Alcohol Dependence
  • Positive toxicology test at the screening visit (THC okay)
  • Concurrent participation in another clinical trial
  • Inability to communicate in English
  • Planning to quit smoking within the next 60 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Francisco General Hospital (SFGH)

San Francisco, California, 94110, United States

Location

University of California, San Francisco (UCSF)

San Francisco, California, 94110, United States

Location

Related Publications (1)

  • Benowitz NL, St Helen G, Nardone N, Addo N, Zhang JJ, Harvanko AM, Calfee CS, Jacob P 3rd. Twenty-Four-Hour Cardiovascular Effects of Electronic Cigarettes Compared With Cigarette Smoking in Dual Users. J Am Heart Assoc. 2020 Dec;9(23):e017317. doi: 10.1161/JAHA.120.017317. Epub 2020 Nov 19.

    PMID: 33208019DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Natalie Nardone, PhD
Organization
University of California, San Francisco
natalie.nardone@ucsf.edu
415-514-1450

Study Officials

  • Neal L Benowitz, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2015

First Posted

June 12, 2015

Study Start

July 23, 2015

Primary Completion

February 2, 2018

Study Completion

February 2, 2018

Last Updated

June 22, 2023

Results First Posted

November 13, 2019

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)