Nicotine DependenceNIDA-SRECNCT03473483
Cigarette Harm Reduction With Electronic Cigarette Use
A study testing SREC in people with Nicotine Dependence and Tobacco Toxicity, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Tobacco Toxicity, Nicotine Dependence, Cigarettes
- What is being tested?
- SREC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.]
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Tobacco Research Center
San Francisco, California, 94110
About this study
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.
Read the detailed description
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.
- Conditions
- Nicotine Dependence, Tobacco Toxicity, Nicotine Dependence, Cigarettes, Cardiovascular Risk Factor, Nicotine Withdrawal
- Being tested
- SREC
- Keywords
- nicotine, tobacco, research electronic cigarette, e-cigarette, SREC
- Medical subject headings
- Tobacco Use Disorder, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRECOther
Also called Standardized Research E-Cigarette
The Standardized Research E-Cigarette (SREC) was developed by NIDA to help researchers assess uncertainties in electronic nicotine delivery devices.
Tank:
- Sealed and disposable
- Minimum 350 puffs per tank
- Volume of e-liquid per tank ~ 3ml
E-Liquid Characteristics:
- Tobacco flavored
- Nicotine concentration: 15 mg/ml
- Propylene Glycol:~ 50% (wt / wt)
- Glycerin: ~ 50% (wt / wt)
- Cotinine: <1 μg/g
- Nornicotine: 5 μg/g
- Myosmine : 3 μg/g
- Anabasine: <1 μg/g
- Anatabine: <1 μg/g
- Beta:nicotyrine: <1 μg/g
- Diacetyl: <2 μg/g
- 2,3:Pentanedione: <1 μg/g
- Arsenic: <0.1 μg/g
- Cadmium: <0.1 μg/g
- Chromium: <0.1 μg/g
- Lead: <0.1 μg/g
- Nickel: <0.1 μg/g
- Mercury: <0.05 μg/g
| Study group | Role | What they receive |
|---|---|---|
| SREC only or cigarette only use | Experimental | 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. Receives: Other: SREC |
| Alternate product from Arm 1 | Experimental | 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. Receives: Other: SREC |
| Standardized Dual Use | Experimental | 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. Receives: Other: SREC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Nicotine Concentration
Compare peak nicotine concentration between SREC vs. Tobacco Cigarette (TC) use
Measured: Up to 2 years
Time of Peak Nicotine Concentration
Compare time of peak nicotine concentration between SREC vs. Tobacco Cigarette (TC) use
Measured: Up to 2 years
Mean overall systemic nicotine exposure
Descriptive statistics will be used to examine systemic nicotine exposure from daily use of SREC and compare daily nicotine intake to TC use
Measured: Baseline through study completion, approximately 2 years
Change in Mean score on the Modified Cigarette Evaluation Questionnaire (mCEQ)
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
Measured: Baseline through study completion, approximately 2 years
Patterns of puffing
Compare the pattern of puffing between SREC and TC use by coding the recorded ad libitum use of SREC vs TC.
Measured: Baseline through study completion, approximately 2 years
Change in Mean score on the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R)
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.
Measured: Baseline through study completion, approximately 2 years
Change in Mean score on the Questionnaire on Smoking Urges (QSU-Brief)
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.
Measured: Baseline through study completion, approximately 2 years
Change in Mean score on the Positive and Negative Affect Scale (PANAS)
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.
Measured: Baseline through study completion, approximately 2 years
Secondary outcomes (6)
Changes in mean circadian heart rate
Compare changes in mean circadian heart rate between SREC-only and TC-only use
Measured: Baseline through study completion, approximately 2 years
Changes in mean blood pressure
Compare changes in blood pressure between SREC-only and TC-only use
Measured: Baseline through study completion, approximately 2 years
Changes in mean urinary catecholamine
Compare mean urinary catecholamine excretion between SREC-only and TC-only use
Measured: Baseline through study completion, approximately 2 years
Mean Level of exposure to Tobacco smoke toxicant
Compare levels of exposure of tobacco smoke toxicant between dual SREC-TC use and TC-only use
Measured: Baseline through study completion, approximately 2 years
Sensitivity of anabasine or nicotelline to nicotine metabolites
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.
Measured: Baseline through study completion, approximately 2 years
Specificity of anabasine or nicotelline to nicotine metabolites
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.
Measured: Baseline through study completion, approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start1 Aug 2022
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Why it stopped: Major study re-design prior to participant enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Neal L. Benowitz, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473483
- Sponsor's protocol ID
- 17-23142
- Other IDs
- U01DA045519
- Acronym
- NIDA-SREC
- Status last verified
- Dec 2022
- First submitted
- 9 Feb 2018
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cigarette Harm Reduction With Electronic Cigarette Use
- ClinicalTrials.gov ID
- NCT03473483
- Acronym / sponsor ID
- NIDA-SREC / 17-23142
- Conditions
- Nicotine Dependence, Tobacco Toxicity, Nicotine Dependence, Cigarettes, Cardiovascular Risk Factor, Nicotine Withdrawal
- Keywords
- nicotine, tobacco, research electronic cigarette, e-cigarette, SREC
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Major study re-design prior to participant enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SREC only or cigarette only use | Experimental | Other: SRECFour 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. |
| Alternate product from Arm 1 | Experimental | Other: SRECFour 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. |
| Standardized Dual Use | Experimental | Other: SRECFour 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. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRECAlso: Standardized Research E-CigaretteThe Standardized Research E-Cigarette (SREC) was developed by NIDA to help researchers assess uncertainties in electronic nicotine delivery devices. Tank: * Sealed and disposable * Minimum 350 puffs per tank * Volume of e-liquid per tank ~ 3ml E-Liquid Characteristics: * Tobacco flavored * Nicotine concentration: 15 mg/ml * Propylene Glycol:~ 50% (wt / wt) * Glycerin: ~ 50% (wt / wt) * Cotinine: <1 μg/g * Nornicotine: 5 μg/g * Myosmine : 3 μg/g * Anabasine: <1 μg/g * Anatabine: <1 μg/g * Beta:nicotyrine: <1 μg/g * Diacetyl: <2 μg/g * 2,3:Pentanedione: <1 μg/g * Arsenic: <0.1 μg/g * Cadmium: <0.1 μg/g * Chromium: <0.1 μg/g * Lead: <0.1 μg/g * Nickel: <0.1 μg/g * Mercury: <0.05 μg/g | Other | Alternate product from Arm 1, SREC only or cigarette only use, Standardized Dual Use |
Primary outcome
Peak Nicotine Concentration
Time frame: Up to 2 years
Compare peak nicotine concentration between SREC vs. Tobacco Cigarette (TC) use
Time of Peak Nicotine Concentration
Time frame: Up to 2 years
Compare time of peak nicotine concentration between SREC vs. Tobacco Cigarette (TC) use
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
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
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.
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.
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.
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.
6 secondary outcomes
Changes in mean circadian heart rate
Time frame: Baseline through study completion, approximately 2 years
Changes in mean blood pressure
Time frame: Baseline through study completion, approximately 2 years
Changes in mean urinary catecholamine
Time frame: Baseline through study completion, approximately 2 years
Mean Level of exposure to Tobacco smoke toxicant
Time frame: Baseline through study completion, approximately 2 years
Sensitivity of anabasine or nicotelline to nicotine metabolites
Time frame: Baseline through study completion, approximately 2 years
Specificity of anabasine or nicotelline to nicotine metabolites
Time frame: Baseline through study completion, approximately 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal L. Benowitz, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SREC in people with Nicotine Dependence and Tobacco Toxicity, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Nicotine Concentration (time frame: Up to 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022; AzTrials last refreshed its copy on 27 Oct 2026.