Study Results
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View full resultsBasic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2021-06-01
2024-08-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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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.
Normal Nicotine Content research cigarettes
Research cigarettes with 11.6 mg nicotine/cigarette.
High Nicotine e-cigarette
E-cigarette containing high nicotine e-liquid
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.
Normal Nicotine Content research cigarettes
Research cigarettes with 11.6 mg nicotine/cigarette.
Zero Nicotine e-cigarette
E-cigarette containing zero nicotine e-liquid
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.
High Nicotine e-cigarette
E-cigarette containing high nicotine e-liquid
Very Low Nicotine Content research cigarettes
Research cigarettes with 0.2 mg nicotine/cigarette.
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
Very Low Nicotine Content research cigarettes
Research cigarettes with 0.2 mg nicotine/cigarette.
Zero Nicotine e-cigarette
E-cigarette containing zero nicotine e-liquid
Interventions
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Normal Nicotine Content research cigarettes
Research cigarettes with 11.6 mg nicotine/cigarette.
High Nicotine e-cigarette
E-cigarette containing high nicotine e-liquid
Very Low Nicotine Content research cigarettes
Research cigarettes with 0.2 mg nicotine/cigarette.
Zero Nicotine e-cigarette
E-cigarette containing zero nicotine e-liquid
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
70 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Milton S. Hershey Medical Center
OTHER
Responsible Party
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Jonathan Foulds
Principal Investigator
Principal Investigators
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Jonathan Foulds, PhD
Role: PRINCIPAL_INVESTIGATOR
Penn State College of Medicine
Locations
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Penn State College of Medicine
Hershey, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STUDY12579
Identifier Type: -
Identifier Source: org_study_id
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