Summary

for people ages 21-70 (full criteria)
healthy people welcome
at San Francisco, California and other locations
study started
estimated completion
Neal L. Benowitz

Description

Summary

This is an observational, crossover study that will be examine use behaviors, chemical exposures, and biological effects of SREC compared to TC use in subjects confined to a research ward setting.

Details

Daily cigarette smokers who are familiar with e-cigarette (EC) use will be instructed to use only NIDA Standardized Research Electronic Cigarettes (SREC) and tobacco cigarettes (TC) while enrolled on the study. Our overall goals are two-fold: (1) to compare nicotine and toxicant exposure and pharmacological effects of SREC used alone vs tobacco cigarettes alone (TC), or dual use; and (2) using SREC alone, TC alone, or ad libitum SREC use combined with 50% reduction in usual TC use as a model for dual use, to examine the extent to which nicotine and toxicant exposure and biomarkers of potential harm compare among the 3 groups. The former would inform the effects of total switching, the latter would inform the potential harm reducing effects of smoking fewer TC while using EC.

Keywords

Nicotine Dependence Tobacco Toxicity Nicotine Dependence, Cigarettes Cardiovascular Risk Factor Nicotine Withdrawal nicotine tobacco research electronic cigarette e-cigarette SREC Tobacco Use Disorder Standardized Dual Use

Eligibility

You can join if…

Open to people ages 21-70

Healthy on the basis of medical history and limited physical examination as described below:

Heart rate < 105 BPM Systolic Blood Pressure < 160 and >90 Diastolic Blood Pressure < 100 and > 50 Body Mass Index ≤ 38.0 Expired CO ≥ 5ppm Current regular "dual" user of both EC and TC EC device use at least 10 or more days in the past 30 days Daily use of conventional

TC (at least 10 CPD, as confirmed by saliva cotinine >50 ng/ml and/or NicAlert=6) Age: ≥ 21 years old to ≤ 70 years old Willingness to use a non-menthol e-cigarette only (until menthol flavored SREC becomes available) Willingness to abstain from marijuana for the duration of the study

You CAN'T join if...

Unstable medical conditions (such as unstable heart disease, seizures, cancer, uncontrolled thyroid disease, diabetes, Hepatitis B or C or renal or liver impairment, glaucoma, history of stroke, an ulcer in the past year, or active use of an inhaler for Asthma or COPD).

Psychiatric conditions (such as current or past schizophrenia and/or current or past bipolar disorder, major personality disorder, or major depression current or within the past year. Participants with current or past minor to moderate depression and/or anxiety disorders will be reviewed by the study physician and considered for inclusion. Psychiatric hospitalizations are not exclusionary, but study participation will be determined as per study physician's approval.

Psychiatric medications with the exception of SSRIs and SNRIs and current evaluation by the study physician that the participant is otherwise healthy, stable and able to participate.

Pregnancy or breastfeeding (by history and pregnancy test); women of childbearing potential must be using an acceptable method of contraception

Concurrent regular use of marijuana [occasional users of these products may be enrolled if they agree to abstain from their use during the period of the study]

Use of other tobacco products, smokeless tobacco, pipes, cigars/cigarillos, blunts/spliffs[no more than 15 times in combination in the past month and must agree to abstain from their use during the period of the study.]

Concurrent use of nicotine-containing medications

Alcohol or illicit drug dependence within the past 12 months (with the exception of those who have recently completed an alcohol/drug treatment program). Positive toxicology test at the screening visit (THC ok). Must not be on opioid replacement therapy.

Medications: Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6(Example: rifampicin, dexamethasone, phenobarbital, and other anticonvulsant drugs). Use of medications for cardiovascular conditions including hypertension (Example: beta and alphablocking drugs). Use of stimulants (Example: Adderall)

Other/Misc Health Conditions: Oral thrush; fainting within the last 30 days; untreated thyroid disease; other "life threatening illnesses" as per study physician's discretion.

Concurrent participation in another clinical trial Inability to read and write in English Planning to quit smoking or vaping within the next 60 days A known propylene glycol/vegetable glycerin allergy

Locations

  • UCSF Tobacco Research Center not yet accepting patients
    San Francisco California 94110 United States
  • Zuckerberg San Francisco General Hospital - CTSI
    San Francisco California 94110 United States

Lead Scientist

  • Neal L. Benowitz
    Neal Benowitz has been conducting research at SFGH since 1973. His research focus is on the human pharmacology of nicotine in relation to pathogenesis of and individual differences in vulnerability to tobacco-related disease, and the use of pharmacologic data as a basis for public health policies to prevent and reduce such disease.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03473483
Study Type
Interventional
Last Updated