- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03473483
Cigarette Harm Reduction With Electronic Cigarette Use (NIDA-SREC)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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California
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San Francisco, California, United States, 94110
- UCSF Tobacco Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy on the basis of medical history and limited physical examination as described below:
- - Heart rate < 105 beats per minute (BPM)
- - Systolic Blood Pressure < 160 and > 90
- - Diastolic Blood Pressure < 100 and > 50
- - Body Mass Index ≤ 38.0
- - Expired Carbon Dioxide (CO) >=5ppm
- Current regular "dual" user of both electronic cigarette (EC) and tobacco cigarette (TC)
- EC device use at least 10 or more days in the past 30 days
- Daily use of conventional TC (at least 10 cigarettes per day (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
Exclusion Criteria:
- 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 Chronic obstructive pulmonary disease (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 Selective Serotonin Reuptake Inhibitors (SSRI) and Serotonin and norepinephrine reuptake inhibitors (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 alpha-blocking 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SREC only or cigarette only use
Four days of SREC/Usual cigarette/product use as regular with daily diary.
Admitted to hospital research ward on Day 5 and 6 for 2 hospital day visits that includes a standardized session of product use; 4-hr abstinence; pharmacokinetic (PK) blood draws; ad libitum use of product; cardiovascular (CV) monitoring, 12-hr urine collections, and 12-hr circadian blood draws.
|
The Standardized Research E-Cigarette (SREC) was developed by NIDA to help researchers assess uncertainties in electronic nicotine delivery devices. Tank:
E-Liquid Characteristics:
Other Names:
|
Experimental: Alternate product from Arm 1
Four days of SREC/Usual cigarette/product use as regular with daily diary.
Admitted to hospital research ward on Day 5 and 6 for 2 hospital day visits that includes a standardized session of product use; 4-hr abstinence; PK blood draws; ad libitum use of product; CV monitoring, 12-hr urine collections, and 12-hr circadian blood draws.
|
The Standardized Research E-Cigarette (SREC) was developed by NIDA to help researchers assess uncertainties in electronic nicotine delivery devices. Tank:
E-Liquid Characteristics:
Other Names:
|
Experimental: Standardized Dual Use
Four days of SREC and/or usual product use as regular with daily diary.
Admitted to hospital research ward on Day 5 and 6 for 2 hospital day visits that includes ad libitum SREC use and less than usual amount of cigarette use; CV monitoring, 12-hr urine collections, and 12-hr circadian blood draws.
|
The Standardized Research E-Cigarette (SREC) was developed by NIDA to help researchers assess uncertainties in electronic nicotine delivery devices. Tank:
E-Liquid Characteristics:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak Nicotine Concentration
Time Frame: Up to 2 years
|
Compare peak nicotine concentration between SREC vs. Tobacco Cigarette (TC) use
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Up to 2 years
|
Time of Peak Nicotine Concentration
Time Frame: Up to 2 years
|
Compare time of peak nicotine concentration between SREC vs. Tobacco Cigarette (TC) use
|
Up to 2 years
|
Mean overall systemic nicotine exposure
Time Frame: Baseline through study completion, approximately 2 years
|
Descriptive statistics will be used to examine systemic nicotine exposure from daily use of SREC and compare daily nicotine intake to TC use
|
Baseline through study completion, approximately 2 years
|
Change in Mean score on the Modified Cigarette Evaluation Questionnaire (mCEQ)
Time Frame: Baseline through study completion, approximately 2 years
|
The mCEQ use three multi-item domains (subscales) and two single items: "Smoking Satisfaction", "Psychological Reward", "Aversion", "Enjoyment of Respiratory Tract Sensations" and "Craving Reduction".
Scores for each subscale are calculated as the average of its individual item responses of The items are rated on a seven-point scale ranging from 1 (not at all) to 7 (extremely).
Higher scores indicate greater intensity of each smoking effect with, for example, greater satisfaction or psychological reward after smoking.
Scores will be compared between SREC, TC, and dual use
|
Baseline through study completion, approximately 2 years
|
Patterns of puffing
Time Frame: Baseline through study completion, approximately 2 years
|
Compare the pattern of puffing between SREC and TC use by coding the recorded ad libitum use of SREC vs TC.
|
Baseline through study completion, approximately 2 years
|
Change in Mean score on the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R)
Time Frame: Baseline through study completion, approximately 2 years
|
The MTWS-R features two separate measures for examining the severity of nicotine withdrawal symptoms in a participant: a self-report scale and an observer scale.
The observer scale asks the scale-taker to rate the severity of four symptoms in someone the they know who is experiencing nicotine withdrawal: "angry/irritable/frustrated," "anxious/tense," "depressed," and "restless/impatient."
The self-report version asks for rankings of the severity of those same four symptoms, plus eleven others that cannot be observed by outsiders (including such things as "desire or craving to smoke," "insomnia, sleep problems, awakening at night," or "dizziness).
Both scales use a Likert-type scale for the severity ratings, ranging from 0 ("not at all") to 4 ("severe").
These scores are tallied to calculate an a total withdrawal discomfort score and will be compared between SREC, TC, and dual use.
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Baseline through study completion, approximately 2 years
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Change in Mean score on the Questionnaire on Smoking Urges (QSU-Brief)
Time Frame: Baseline through study completion, approximately 2 years
|
The QSU-Brief consists of 10 statements about the respondent's feelings and thoughts about his or her desire to smoke cigarettes as he or she is completing the questionnaire (i.e., right now).
Each response is scored a number ranging from 1 (strongly disagree) to 7 (strongly agree) and total scores are calculated by summing the item scores to compare craving between SREC, TC, and dual use.
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Baseline through study completion, approximately 2 years
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Change in Mean score on the Positive and Negative Affect Scale (PANAS)
Time Frame: Baseline through study completion, approximately 2 years
|
The Positive and Negative Affect Schedule (PANAS) is a brief scale is comprised of 20 items, with 10 items measuring positive affect (e.g., excited, inspired) and 10 items measuring negative affect (e.g., upset, afraid).
Each item is rated on a five-point Likert Scale, ranging from 1 = Very Slightly or Not at all to 5 = Extremely, to measure the extent to which the affect has been experienced in a specified time frame and the final score is derived out of the sum of the ten items on both the positive and negative side.
Scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect.
The scores will be comparted between SREC, TC, and dual use.
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Baseline through study completion, approximately 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in mean circadian heart rate
Time Frame: Baseline through study completion, approximately 2 years
|
Compare changes in mean circadian heart rate between SREC-only and TC-only use
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Baseline through study completion, approximately 2 years
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Changes in mean blood pressure
Time Frame: Baseline through study completion, approximately 2 years
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Compare changes in blood pressure between SREC-only and TC-only use
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Baseline through study completion, approximately 2 years
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Changes in mean urinary catecholamine
Time Frame: Baseline through study completion, approximately 2 years
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Compare mean urinary catecholamine excretion between SREC-only and TC-only use
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Baseline through study completion, approximately 2 years
|
Mean Level of exposure to Tobacco smoke toxicant
Time Frame: Baseline through study completion, approximately 2 years
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Compare levels of exposure of tobacco smoke toxicant between dual SREC-TC use and TC-only use
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Baseline through study completion, approximately 2 years
|
Sensitivity of anabasine or nicotelline to nicotine metabolites
Time Frame: Baseline through study completion, approximately 2 years
|
Sensitivity is defined as the ratio of anabasine or nicotelline to nicotine metabolites (cotinine or total nicotine equivalents) in urine from SREC-only and TC-only use.
|
Baseline through study completion, approximately 2 years
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Specificity of anabasine or nicotelline to nicotine metabolites
Time Frame: Baseline through study completion, approximately 2 years
|
Specificity of anabasine or nicotelline will be compared to nicotine metabolites (cotinine or total nicotine equivalents) in urine from SREC-only and TC-only use.
|
Baseline through study completion, approximately 2 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Neal L. Benowitz, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-23142
- U01DA045519 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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