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Low Nicotine Cigarettes Plus Electronic Cigarettes

Primary Purpose

Tobacco Dependence

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Normal Nicotine Content research cigarettes
High Nicotine e-cigarette
Very Low Nicotine Content research cigarettes
Zero Nicotine e-cigarette
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tobacco Dependence

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Smoke >5 cigarettes per day for at least the prior 12 months
  • Smoke regular, filtered cigarettes or machine-rolled cigarettes with a filter
  • Exhaled CO measurement of ≥ 6 parts per million at baseline
  • No serious cigarette smoking quit attempt or use of any FDA-approved smoking cessation medication in the prior 30 days (includes any nicotine replacement, varenicline, bupropion [used specifically as a quitting aid])
  • No plans to quit smoking within the next 3 weeks
  • Must be willing to both switch to a different type of cigarette that may contain a different amount of nicotine and to try an e-cig to substitute for some of their cigarettes
  • Must be willing and able to respond to contacts from study staff or attend visits over the study period (not planning to move, not planning extended vacation, no planned surgeries)
  • 9. Must meet lifetime diagnostic criteria for a current or lifetime unipolar or bipolar mood disorder (e.g. major depressive disorder, major depressive episode, manic episode, hypomanic episode, bipolar disorder), an anxiety disorder (e.g. panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, , agoraphobia, social anxiety disorder, generalized anxiety disorder), a psychotic disorder (e.g. mood disorder or other psychotic disorder), or an eating disorder (e.g. anorexia or bulimia) based on the MINI-International Neuropsychiatric Interview Standard (version 7.0.2)
  • Able to read and write in English
  • Able to understand and give informed consent
  • Access to a computer/smartphone with e-mail and a reliable internet connection

Exclusion Criteria:

  • Women who are pregnant and/or nursing or trying to become pregnant
  • Unstable or significant medical condition in the past 3 months (e.g., recent heart attack or other serious heart condition, stroke, severe angina, high blood pressure [systolic >159 mmHg or diastolic >99 mmHg during screening)
  • Respiratory diseases (e.g., exacerbations of asthma or COPD, require oxygen, require oral prednisone), kidney (e.g., dialysis) or liver disease (e.g., cirrhosis), severe immune system disorders (e.g., uncontrolled HIV/AIDS, multiple sclerosis symptoms) or any medical disorder/medication that may affect participant safety or biomarker data
  • Uncontrolled mental illness or substance abuse, or inpatient treatment for these in the past 6 months
  • Current suicide risk on clinical assessment (above "low risk" score (or ≥ 9) on MINI diagnostic interview suicide module during screening (34))
  • Use of any non-cigarette nicotine delivery product (e.g., pipe, cigar, dip, chew, snus, hookah, e-cig, strips or sticks, IQOS) in the past 7 days at screening
  • Use of an e-cig for 5 or more days in the past 28 days or any use in the past 7 days at screening
  • Use of marijuana or other illegal drugs/prescription drugs for non-medical use daily/almost daily or weekly in the past 3 months per NIDA Quick Screen
  • Any known allergy to propylene glycol or vegetable glycerin
  • Surgery requiring general anesthesia in the past 6 weeks
  • Unwilling to remain on one flavor of cigarette (regular or menthol) for the duration of the trial
  • Previous use of SPECTRUM research cigarettes in the past 6 months
  • Other member of household currently participating in the study
  • History of a seizure disorder or had a seizure in the past 12 months
  • Currently taking or have taken medications prescribed to prevent seizures (such as Carbamazepine or Phenobarbital). Using seizure medications for off-label use (indications other than treatment for seizures) will not be included as an exclusion, these will be assessed on a case-by-case basis

Sites / Locations

  • Penn State College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

NNC cigarettes + High Nicotine Containing E-cigarette

NNC cigarettes + Zero Nicotine Containing E-cigarette

VLNC cigarettes + High Nicotine Containing E-cigarette

VLNC cigarettes + Zero Nicotine Containing E-cigarette

Arm Description

Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.

Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid.

Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.

Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid

Outcomes

Primary Outcome Measures

Urinary NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol)
Measure of tobacco-specific nitrosamine

Secondary Outcome Measures

Exhaled Carbon Monoxide
Measure of cigarette smoke exposure
Kessler-6 score
Measure of serious psychological distress
Penn State Cigarette Dependence Index
Measure of cigarette dependence
Penn State Electronic Cigarette Dependence Index
Measure of e-cigarette dependence
Cigarette abstinence
No cigarette use in the past 7 days and exhaled carbon monoxide < 6ppm

Full Information

First Posted
August 14, 2019
Last Updated
October 18, 2023
Sponsor
Milton S. Hershey Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04058717
Brief Title
Low Nicotine Cigarettes Plus Electronic Cigarettes
Official Title
Randomized Trial of Low Nicotine Cigarettes Plus Electronic Cigarettes in Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to determine the health effects of very low nicotine content in cigarettes, in conjunction with the availability of nicotine-containing electronic cigarettes (e-cigs) among smokers with mental health conditions (SMHC).
Detailed Description
The specific objective of this study is to recruit a cohort of 240 current exclusive daily SMHC (diagnosed using the MINI International Neuropsychiatric Interview) and to measure a comprehensive battery of behavioral and health indicators at 4, 8, 12 and 16 weeks after being randomized to use either normal nicotine content (NNC) Spectrum cigarettes (11.6 mg nicotine/cigarette) or very low nicotine content (VLNC) Spectrum cigarettes (0.2 mg nicotine/cigarette) while also having access to an electronic cigarette (containing either 0 nicotine or high nicotine e-liquid) in a randomized double-blind, placebo-controlled, 2 by 2 design. All participants will be followed up with a study visit 4 weeks after the final randomized visit to identify whether they have continued to use e-cigs/cigarettes and to assess their motivation in smoking abstinence. Our central hypothesis is that key markers of harms to health (e.g. urinary NNAL, exhaled carbon monoxide, measures of addiction, and mental distress) will be significantly improved among SMHC who are provided VLNC cigarettes and high nicotine e-cigs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 X 2 factorial design
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NNC cigarettes + High Nicotine Containing E-cigarette
Arm Type
Experimental
Arm Description
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
Arm Title
NNC cigarettes + Zero Nicotine Containing E-cigarette
Arm Type
Experimental
Arm Description
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid.
Arm Title
VLNC cigarettes + High Nicotine Containing E-cigarette
Arm Type
Experimental
Arm Description
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
Arm Title
VLNC cigarettes + Zero Nicotine Containing E-cigarette
Arm Type
Experimental
Arm Description
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid
Intervention Type
Other
Intervention Name(s)
Normal Nicotine Content research cigarettes
Intervention Description
Research cigarettes with 11.6 mg nicotine/cigarette.
Intervention Type
Other
Intervention Name(s)
High Nicotine e-cigarette
Intervention Description
E-cigarette containing high nicotine e-liquid
Intervention Type
Other
Intervention Name(s)
Very Low Nicotine Content research cigarettes
Intervention Description
Research cigarettes with 0.2 mg nicotine/cigarette.
Intervention Type
Other
Intervention Name(s)
Zero Nicotine e-cigarette
Intervention Description
E-cigarette containing zero nicotine e-liquid
Primary Outcome Measure Information:
Title
Urinary NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol)
Description
Measure of tobacco-specific nitrosamine
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Exhaled Carbon Monoxide
Description
Measure of cigarette smoke exposure
Time Frame
Week 16
Title
Kessler-6 score
Description
Measure of serious psychological distress
Time Frame
Week 16
Title
Penn State Cigarette Dependence Index
Description
Measure of cigarette dependence
Time Frame
Week 16
Title
Penn State Electronic Cigarette Dependence Index
Description
Measure of e-cigarette dependence
Time Frame
Week 16
Title
Cigarette abstinence
Description
No cigarette use in the past 7 days and exhaled carbon monoxide < 6ppm
Time Frame
Week 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Smoke >5 cigarettes per day for at least the prior 12 months Smoke regular, filtered cigarettes or machine-rolled cigarettes with a filter Exhaled CO measurement of ≥ 6 parts per million at baseline No serious cigarette smoking quit attempt or use of any FDA-approved smoking cessation medication in the prior 30 days (includes any nicotine replacement, varenicline, bupropion [used specifically as a quitting aid]) No plans to quit smoking within the next 3 weeks Must be willing to both switch to a different type of cigarette that may contain a different amount of nicotine and to try an e-cig to substitute for some of their cigarettes Must be willing and able to respond to contacts from study staff or attend visits over the study period (not planning to move, not planning extended vacation, no planned surgeries) 9. Must meet lifetime diagnostic criteria for a current or lifetime unipolar or bipolar mood disorder (e.g. major depressive disorder, major depressive episode, manic episode, hypomanic episode, bipolar disorder), an anxiety disorder (e.g. panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, , agoraphobia, social anxiety disorder, generalized anxiety disorder), a psychotic disorder (e.g. mood disorder or other psychotic disorder), or an eating disorder (e.g. anorexia or bulimia) based on the MINI-International Neuropsychiatric Interview Standard (MINI) (version 7.0.2) Able to read and write in English Able to understand and give informed consent Access to a computer/smartphone with e-mail and a reliable internet connection Exclusion Criteria: Women who are pregnant and/or nursing or trying to become pregnant Unstable or significant medical condition in the past 3 months (e.g., recent heart attack or other serious heart condition, stroke, severe angina, high blood pressure [systolic >159 mmHg or diastolic >99 mmHg during screening) Respiratory diseases (e.g., exacerbations of asthma or COPD, require oxygen, require oral prednisone), kidney (e.g., dialysis) or liver disease (e.g., cirrhosis), severe immune system disorders (e.g., uncontrolled HIV/AIDS, multiple sclerosis symptoms) or any medical disorder/medication that may affect participant safety or biomarker data Uncontrolled mental illness or substance abuse, or inpatient treatment for these in the past 6 months Current suicide risk on clinical assessment (above "low risk" score (or ≥ 9) on MINI diagnostic interview suicide module during screening (34)) Use of any non-cigarette nicotine delivery product (e.g., pipe, cigar, dip, chew, snus, hookah, e-cig, strips or sticks, IQOS) in the past 7 days at screening Use of an e-cig for 5 or more days in the past 28 days or any use in the past 7 days at screening Use of marijuana or other illegal drugs/prescription drugs for non-medical use daily/almost daily or weekly in the past 3 months per NIDA Quick Screen Any known allergy to propylene glycol or vegetable glycerin Surgery requiring general anesthesia in the past 6 weeks Unwilling to remain on one flavor of cigarette (regular or menthol) for the duration of the trial Previous use of SPECTRUM research cigarettes in the past 6 months Other member of household currently participating in the study History of a seizure disorder or had a seizure in the past 12 months Currently taking or have taken medications prescribed to prevent seizures (such as Carbamazepine or Phenobarbital). Using seizure medications for off-label use (indications other than treatment for seizures) will not be included as an exclusion, these will be assessed on a case-by-case basis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolle Krebs, MS
Phone
717-531-5673
Email
nkrebs@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Foulds, PhD
Phone
717-531-3504
Email
jfoulds@psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Foulds, PhD
Organizational Affiliation
Penn State College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolle M Krebs, MS
Phone
717-531-5673
Email
nkrebs@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name & Degree
Jonathan Foulds, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Low Nicotine Cigarettes Plus Electronic Cigarettes

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