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Trial record 4 of 10 for:    anatabine

Cigarette Harm Reduction With Scheduled Electronic Cigarette Use (NIDA-SREC)

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ClinicalTrials.gov Identifier: NCT03473483
Recruitment Status : Not yet recruiting
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Tobacco Toxicity Nicotine Dependence, Cigarettes Cardiovascular Risk Factor Nicotine Withdrawal Other: SREC Not Applicable

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. The overall goals are two-fold: (1) to compare nicotine and toxicant exposure and pharmacological effects of SREC used alone vs tobacco cigarettes (TC); and (2) using scheduled SREC use combined with ad libitum TC use as a model for dual use, to examine the extent to which nicotine and toxicant exposure and biomarkers of potential harm compare with dual use vs TC alone use. 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cigarette Harm Reduction With Scheduled Electronic Cigarette Use
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes
U.S. FDA Resources

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 for 3 day in-patient stay that includes a standardized session of product use; 4-hr abstinence; PK blood draws; ad libitum use of product; CV monitoring, 24-hr urine collections, and circadian blood draws.
Other: SREC

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
Other Name: Standardized Research E-Cigarette
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 for 3 day in-patient stay that includes a standardized session of product use; 4-hr abstinence; PK blood draws; ad libitum use of product; CV monitoring, 24-hr urine collections, and circadian blood draws.
Other: SREC

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
Other Name: Standardized Research E-Cigarette
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 for 3 day in-patient stay that includes 8 standardized sessions of SREC use each day; ad libitum SREC and cigarette use; CV monitoring, 24-hr urine collections, and circadian blood draws.
Other: SREC

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
Other Name: Standardized Research E-Cigarette



Primary Outcome Measures :
  1. Nicotine delivery [ Time Frame: Through study completion, approximately 2 years ]
    Compare peak nicotine concentration and time of peak nicotine concentration between SREC vs. Tobacco Cigarette (TC)

  2. Systemic nicotine exposure [ Time Frame: Through study completion, approximately 2 years ]
    Examine systemic nicotine exposure from daily use of SREC and compare daily nicotine intake to TC use

  3. Subjective effects of Nicotine [ Time Frame: Through study completion, approximately 2 years ]
    Average measures from the modified Cigarette Evaluation Questionnaire used to compare satisfaction, reward, and craving between SREC, TC, and dual use.

  4. Patterns of puffing [ Time Frame: 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.

  5. Nicotine withdrawal [ Time Frame: Through study completion, approximately 2 years ]
    Average measures from the Minnesota Nicotine Withdrawal Scale (MNWS) will be used to compare nicotine withdrawal symptoms between SREC, TC, and dual use.

  6. Nicotine craving [ Time Frame: Through study completion, approximately 2 years ]
    Average measures from the Questionnaire of Smoking Urges (QSU-Brief) will be used to compare craving between SREC, TC, and dual use.

  7. Changes in Affect [ Time Frame: Through study completion, approximately 2 years ]
    Average measures from the Positive and Negative Affect Scale (PANAS) will be used to compare changes in affect between SREC, TC, and dual use.


Secondary Outcome Measures :
  1. Tobacco toxicants [ Time Frame: Through study completion, approximately 2 years ]
    Compare levels of exposure of tobacco smoke toxicants between SREC and TC use measured in collected biospecimens.

  2. Cardiovascular symptoms [ Time Frame: Through study completion, approximately 2 years ]
    Compare circadian heart rate, blood pressure, urinary catecholamine excretion between SREC-only and TC-only use

  3. Aspects of harm in dual use [ Time Frame: Through study completion, approximately 2 years ]
    Compare levels of exposure of tobacco smoke toxicants, circadian heart rate, blood pressure, and urinary catecholamine excretion between dual SREC-TC use and TC-only use

  4. Validate biomarkers to distinguish EC from TC use [ Time Frame: Through study completion, approximately 2 years ]
    Examine specificity and sensitivity of the ratio of anabasine or nicotelline to nicotine metabolites (cotinine or total nicotine equivalents) in urine from SREC-only and TC-only use.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

  • Current regular "dual" user of both EC:

using an EC at least once in the past 30 days; daily use of conventional TC (at least 5 CPD, as confirmed by saliva cotinine >50 ng/ml and/or NicAlert=6)

Exclusion Criteria:

  • Unstable medical conditions (such as unstable heart disease, uncontrolled hypertension, thyroid disease, diabetes, Hepatitis B or C or renal or liver impairment, glaucoma, or prostatic hypertrophy).
  • Psychiatric conditions (such as current or past schizophrenia and/or current or past bipolar disorder, adult onset ADHD (if being treated). Participants with current or past 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)
  • 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) or current illicit drug use (by history or urine test). Any methadone 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).
  • Other/Misc Health Conditions: Oral thrush; fainting; untreated thyroid disease; other "life threatening illnesses" as per study physician's discretion.
  • Concurrent participation in another clinical trial
  • Inability to communicate in English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03473483


Contacts
Contact: Natalie Nardone, PhD 415-514-1450 natalie.nardone@ucsf.edu
Contact: Jennifer Ko 415-641-4788 jennifer.ko@ucsf.edu

Locations
United States, California
UCSF Tobacco Research Center Not yet recruiting
San Francisco, California, United States, 94110
Contact: Natalie Nardone, PhD    415-514-1450    natalie.nardone@ucsf.edu   
Contact: Jennifer Ko    (415) 641-4788    jennifer.ko@ucsf.edu   
Principal Investigator: Neal L Benowitz, MD         
Zuckerberg San Francisco General Hospital - CTSI
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
National Institutes of Health (NIH)
Investigators
Principal Investigator: Neal L. Benowitz, MD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03473483     History of Changes
Other Study ID Numbers: 17-23142
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:
nicotine
tobacco
research electronic cigarette
e-cigarette
SREC

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders