NCT03050853

Brief Summary

This study will evaluate behavioral and psychological appeal, toxicity, and effect of e-cigarettes on smoking behavior and nicotine addiction in chronic smokers with serious mental illness (SMI) who have failed to quit smoking. A total of 240 participants will be enrolled and randomly assigned to either receive a supply of e-cigarettes for 8 weeks plus assessments (baseline \& weeks 2, 4, 6, 8, 13, \& 26) or assessments only. This single-blinded study will provide e-cigarettes and instructions on their safe use. Level of appeal will be inferred from carefully assessed use of e-cigarettes and reduction in combustible tobacco. Qualitative data will also be collected from participants assigned to e-cigarettes, given that unanticipated issues will almost certainly arise in connection with e-cigarette use that can only be captured within a qualitative debriefing at the conclusion of participants' time in the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 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

February 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

3.5 years

First QC Date

February 9, 2017

Last Update Submit

March 25, 2021

Conditions

Tobacco DependenceSchizophreniaBipolar DisorderSchizoaffective Disorder

Outcome Measures

Primary Outcomes (3)

  • Change in Carbon Monoxide Level

    Carbon Monoxide Measurement

    Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week

  • Change in Cancer Related Toxin, 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol or NNAL

    Urine NNAL analysis

    Baseline, 4 week, 8 week, 13 week, 26 week

  • Change in the use of e-cigarettes

    Count of e-cigarettes

    Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week

Secondary Outcomes (1)

  • Change in Nicotine Dependence

    Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week

Study Arms (2)

E-Cigarette

EXPERIMENTAL

The E-cigarette arm will be asked to use e-cigarettes in place of regular tobacco products. The group will be assessed at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 13 weeks, and 26 weeks.

Behavioral: E-cigarette

Assessments only

NO INTERVENTION

The Assessment only group will be asked to refrain from use of e-cigarettes during participation. The group will be assessed at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 13 weeks, and 26 weeks.

Interventions

E-cigaretteBEHAVIORAL

The e-cigarette arm will be provided with 8 weeks of free e-cigarettes based on self-report of regular tobacco use. Participants assigned in this arm will be asked to switch combustible tobacco with e-cigarettes. The appeal of e-cigarettes and health impacts will be measured, but we are not targeting quitting combustible tobacco or reducing craving.

E-Cigarette

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder
  • Enrolled in services at the research site for a minimum of 3 months
  • Regular smoker (approximately 10 cigarettes for the past 5 years) with a history of at least 1 quit attempt
  • Fluent in English

You may not qualify if:

  • Regular use of e-cigarettes in the past month
  • Current interest/plan to quit smoking
  • Regular use of nicotine replacement therapy to quit smoking or use of bupropion or varenicline to quit smoking
  • Use of emergency room or hospitalization for psychiatric reasons in the past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centerstone Kentucky

Louisville, Kentucky, 40211, United States

Location

Vinfen Corp

Lawrence, Massachusetts, 01843, United States

Location

Related Publications (6)

  • Benowitz NL. Clinical pharmacology of nicotine: implications for understanding, preventing, and treating tobacco addiction. Clin Pharmacol Ther. 2008 Apr;83(4):531-41. doi: 10.1038/clpt.2008.3. Epub 2008 Feb 27.

    PMID: 18305452BACKGROUND

  • Polosa R, Rodu B, Caponnetto P, Maglia M, Raciti C. A fresh look at tobacco harm reduction: the case for the electronic cigarette. Harm Reduct J. 2013 Oct 4;10:19. doi: 10.1186/1477-7517-10-19.

    PMID: 24090432BACKGROUND

  • Etter JF, Bullen C. Electronic cigarette: users profile, utilization, satisfaction and perceived efficacy. Addiction. 2011 Nov;106(11):2017-28. doi: 10.1111/j.1360-0443.2011.03505.x. Epub 2011 Jul 27.

    PMID: 21592253BACKGROUND

  • Pratt SI, Sargent J, Daniels L, Santos MM, Brunette M. Appeal of electronic cigarettes in smokers with serious mental illness. Addict Behav. 2016 Aug;59:30-4. doi: 10.1016/j.addbeh.2016.03.009. Epub 2016 Mar 19.

    PMID: 27043170BACKGROUND

  • Sargent JD, Pratt SI, Brunette MF, Ferron JC, Santos MM, Stoolmiller M. Level and timing of product substitution in a trial of e-cigarettes for smokers not interested in quitting. Tob Induc Dis. 2024 Jun 13;22. doi: 10.18332/tid/189220. eCollection 2024.

    PMID: 38873183DERIVED

  • Pratt SI, Ferron JC, Brunette MF, Santos M, Sargent J, Xie H. E-Cigarette Provision to Promote Switching in Cigarette Smokers With Serious Mental Illness-A Randomized Trial. Nicotine Tob Res. 2022 Aug 6;24(9):1405-1412. doi: 10.1093/ntr/ntac082.

    PMID: 35363874DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderSchizophreniaBipolar DisorderPsychotic Disorders

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Sarah I Pratt, Ph.D.

    Dartmouth College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All follow-up assessments will be conducted by the masked outcome assessor with the exception of the tobacco use and e-cigarette use self report and the satisfaction with e-cigarettes scale administered to the intervention group.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This is a study to learn about the appeal and health impacts of using e-cigarettes in people with serious mental illness who are not currently thinking about qutting smoking. Reduction of craving or quitting are not targets
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientist, Psych Research

Study Record Dates

First Submitted

February 9, 2017

First Posted

February 13, 2017

Study Start

March 1, 2017

Primary Completion

August 31, 2020

Study Completion

January 31, 2021

Last Updated

March 29, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)