NCT02433015

Brief Summary

The objective of this study is to examine the cognitive, immunological, and neurophysiological effects of transitioning from tobacco cigarettes to electronic cigarettes. The central hypothesis of this study is that this transition will be accompanied by a decrease in peripheral inflammation, which will lead to significant changes in the neurocircuitry underlying interoception and appetite.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2016

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

1.7 years

First QC Date

April 24, 2015

Last Update Submit

June 27, 2017

Conditions

Tobacco SmokingNicotine Dependence

Keywords

Electronic Cigarette

Outcome Measures

Primary Outcomes (1)

  • Change in overall levels of peripheral inflammatory cytokines

    A composite measure of change in overall blood serum levels of multiple peripheral cytokines (CRP, TNF-alpha, sVCAM, IL-1RA, IL-6) between study visits two and three.

    2-8 weeks

Secondary Outcomes (7)

  • Change in cotinine levels

    2-8 weeks

  • Frequency of Electronic Cigarette use

    2-8 weeks

  • Change in exhaled Carbon Monoxide

    2-8 weeks

  • Frequency of Tobacco Cigarette use

    2-8 weeks

  • Change in Blood Oxygen Level-Dependent (BOLD) resting state functional connectivity during fMRI

    2-8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Tobacco Cigarette Group

ACTIVE COMPARATOR

This group will not receive an electronic cigarette and will continue to smoke combustible tobacco cigarettes as previously.

Other: Tobacco Cigarette

Electronic Cigarette Group

EXPERIMENTAL

This group will receive an electronic cigarette to use for the duration of the study.

Other: Electronic Cigarette

Interventions

Electronic CigaretteOTHER

eGo-type electronic cigarette with a supply of 18mg/ml nicotine solution

Electronic Cigarette Group
Tobacco CigaretteOTHER

Smoke own brand of cigarette as previously

Tobacco Cigarette Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • current cigarette smokers who have smoked for at least one year
  • right-handed adults
  • able to provide written informed consent

You may not qualify if:

  • use of anticonvulsant, stimulant, or antipsychotic medication for 3 weeks prior to scanning
  • any medical conditions or medications likely to influence cerebral blood flow or neurological function including cardiovascular, respiratory, endocrine and neurological diseases
  • any history of drug (other than nicotine) or alcohol abuse within 1 year
  • current pregnancy or breast feeding
  • primary language other than English
  • Past history of any axis I psychiatric condition, other than major depressive disorder and post-traumatic stress disorder
  • Current major depression or post-traumatic stress disorder
  • Serious suicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

MeSH Terms

Conditions

Tobacco SmokingTobacco Use DisorderVaping

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

SmokingBehaviorTobacco UseSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • William K Simmons, Ph.D

    Laureate Institute for Brain Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2015

First Posted

May 4, 2015

Study Start

January 1, 2015

Primary Completion

September 24, 2016

Study Completion

September 24, 2016

Last Updated

June 28, 2017

Record last verified: 2017-06

Locations

US(1)