Low Nicotine Cigarettes Plus Electronic Cigarettes

Completed · Not applicable

Conditions studied: Tobacco Dependence

In brief

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).

Key facts

Study ID

NCT04058717

Run by

Milton S. Hershey Medical Center

People needed

88

Starts

2021-06-01

Expected to finish

2024-08-12

Last updated by the study team

2025-09-11

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Penn State College of Medicine — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.