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Low Nicotine Cigarettes Plus Electronic Cigarettes

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ClinicalTrials.gov Identifier: NCT04058717
Recruitment Status : Not yet recruiting
First Posted : August 15, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathan Foulds, Milton S. Hershey Medical Center

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).

Condition or disease Intervention/treatment Phase
Tobacco Dependence Other: Normal Nicotine Content research cigarettes Other: High Nicotine e-cigarette Other: Very Low Nicotine Content research cigarettes Other: Zero Nicotine e-cigarette Not Applicable

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 CO, measures of addiction, and mental distress) will be significantly improved among SMHC who are provided VLNC cigarettes and high nicotine e-cigs.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 X 2 factorial design
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Randomized Trial of Low Nicotine Cigarettes Plus Electronic Cigarettes in Smokers
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: NNC cigarettes + High Nicotine Containing E-cigarette
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
Other: Normal Nicotine Content research cigarettes
Research cigarettes with 11.6 mg nicotine/cigarette.

Other: High Nicotine e-cigarette
E-cigarette containing high nicotine e-liquid

Experimental: NNC cigarettes + Zero Nicotine Containing E-cigarette
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid.
Other: Normal Nicotine Content research cigarettes
Research cigarettes with 11.6 mg nicotine/cigarette.

Other: Zero Nicotine e-cigarette
E-cigarette containing zero nicotine e-liquid

Experimental: VLNC cigarettes + High Nicotine Containing E-cigarette
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
Other: High Nicotine e-cigarette
E-cigarette containing high nicotine e-liquid

Other: Very Low Nicotine Content research cigarettes
Research cigarettes with 0.2 mg nicotine/cigarette.

Experimental: VLNC cigarettes + Zero Nicotine Containing E-cigarette
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid
Other: Very Low Nicotine Content research cigarettes
Research cigarettes with 0.2 mg nicotine/cigarette.

Other: Zero Nicotine e-cigarette
E-cigarette containing zero nicotine e-liquid




Primary Outcome Measures :
  1. Urinary NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) [ Time Frame: Week 16 ]
    Measure of tobacco-specific nitrosamine


Secondary Outcome Measures :
  1. Exhaled Carbon Monoxide [ Time Frame: Week 16 ]
    Measure of cigarette smoke exposure

  2. Kessler-6 score [ Time Frame: Week 16 ]
    Measure of serious psychological distress

  3. Penn State Cigarette Dependence Index [ Time Frame: Week 16 ]
    Measure of cigarette dependence

  4. Penn State Electronic Cigarette Dependence Index [ Time Frame: Week 16 ]
    Measure of e-cigarette dependence

  5. Cigarette abstinence [ Time Frame: Week 20 ]
    No cigarette use in the past 7 days and exhaled carbon monoxide < 6ppm



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  • Must meet lifetime diagnostic criteria for a current or lifetime unipolar or bipolar mood disorder (dysthymia, major or minor depression, premenstrual dysphoric disorder, manic episode, hypomanic episode, bipolar disorder), an anxiety disorder (panic disorder, obsessive-compulsive disorder; post-traumatic stress disorder; mixed anxiety depressive disorder, agoraphobia, generalized anxiety disorder, social phobia, specific phobia), a psychotic disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, or other psychotic disorder), an eating disorder (anorexia or bulimia), or attention-deficit/hyperactivity disorder based on the MINI-International Neuropsychiatric Interview.
  • Able to read and write in English
  • Able to understand and give informed consent

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
  • History of difficulty providing or unwilling to provide blood samples (fainting, poor veins, anxiety)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058717


Contacts
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Contact: Nicolle Krebs, MS 717-531-5673 nkrebs@pennstatehealth.psu.edu
Contact: Jonathan Foulds, PhD 717-531-3504 jfoulds@psu.edu

Locations
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United States, Pennsylvania
Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Jonathan Foulds, PhD Penn State College of Medicine

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Responsible Party: Jonathan Foulds, Principal Investigator, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT04058717     History of Changes
Other Study ID Numbers: STUDY12579
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action