Healthy Subject Clinical Trial
— ENDSOfficial title:
Nicotine Delivery From Novel Non-tobacco Electronic Systems (ENDS)
Verified date | June 2018 |
Source | Roswell Park Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized pilot clinical trial studies nicotine delivery from novel non-tobacco electronic system (ENDS) in smokers. Studying the levels of nicotine delivered by various types and brands of ENDS to the bloodstream, and comparing this to the levels delivered from conventional cigarettes (the participant's own brand) may help provide information about the use of nicotine-containing products that may help inform/reform current tobacco policy, practice, and harm reduction approaches.
Status | Completed |
Enrollment | 36 |
Est. completion date | June 6, 2018 |
Est. primary completion date | June 6, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Healthy on the basis of medical history - Current moderate-to-heavy smoker as determined by: - Has smoked >=10 cigarettes per day regularly for the past year (by history) and (>=5 cigarettes per day Study 2 ONLY) - Has an expired carbon monoxide (CO) at screening visit of 8 parts per million (ppm) or more (6 ppm or more Study 2 ONLY) - Nicotine dependence assessed as > 4 with the Fagerstrom Test for Nicotine Dependence - Willingness to abstain from smoking for 8 hours (overnight abstinence) prior to study visits - Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: - Unstable medical conditions (such as unstable heart disease, uncontrolled hypertension, thyroid disease, diabetes, renal or liver impairment, glaucoma, or prostatic hypertrophy) or psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder, or current regular use of psychiatric medications such as major tranquilizers and antidepressants - Pregnancy or lactation (by history) or positive pregnancy test at screening visit - Positive urine drug test at screening visit - History of serious side effects from nicotine or from any nicotine replacement therapies - Alcohol or illicit drug dependence within the past 12 months (by history and urine tests) - Concurrent participation in another clinical trial - Unable to communicate in English - Unwilling or unable to follow protocol requirements - Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study intervention |
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute | National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | maximum concentration of nicotine in plasma (Cmax) (Study 1 and Study 2) | Cmax will be analyzed using a repeated measures analysis of variance, including terms for gender , race and order of treatment | 2 hours post using ENDS product | |
Other | The maximum concentration of nicotine in the area under the plasma concentration - time curve from 0 to 90 minutes (AUC) | AUC will be analyzed using a repeated measures analysis of variance, including terms for gender, race and order of treatment. | 2 hours post using ENDS product | |
Other | The time to maximum concentration of nicotine in plasma (tmax) | tmax will be analyzed using a repeated measures analysis of variance, including terms for gender , race and order of treatment | 2 hours post using ENDS product | |
Other | Estimated puff volume | Puff volume as determined with Cress Micro monitors | 2 hours post using ENDS product | |
Other | Estimated puff duration | Puff duration as determined with Cress Micro monitors | 2 hours post using ENDS product | |
Primary | Determine Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes | The maximum concentration of nicotine in plasma (Cmax) will be determined for each product. | Up to 1 year | |
Primary | Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes | Time to maximum concentration (Tmax) will be determined for each product . | Up to 1 year | |
Primary | Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes | Area under the plasma concentration versus time curve (AUC) will be determined for each product. | up to 1 year | |
Primary | Changes in withdrawal symptoms | Will be measured with Minnesota Withdrawal Scale | up to 1 year | |
Primary | Subjective nicotine effect will be analyzed | Will be measured with Drug Effect Questionnaire | up to 1 year | |
Primary | Changes in feelings and emotions | Will be measured with The Positive Negative Affect Scale | up to 1 year | |
Secondary | Amounts of nicotine present in various brands and types of ENDS (Study 3) | Nicotine content (mean, median, minimum and maximum) will be determined for each product | Up to 1 year | |
Secondary | Nicotine yields in vapors from various types of ENDS under laboratory conditions (Study 4) | Nicotine yield in vapor will be determined for each product. | Up to 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
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