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Gender Differences in Switching From Smoking Regular Cigarettes to E-Cigarettes

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ClinicalTrials.gov Identifier: NCT03856515
Recruitment Status : Not yet recruiting
First Posted : February 27, 2019
Last Update Posted : July 11, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This trial studies potential differences between men and women when switching from the use of combustible cigarettes to the National Institute on Drug Abuse's Standard Research E-Cigarette (SREC). Studying the differences between men and women may increase understanding about the effects of switching from smoking regular cigarettes to electronic cigarettes.

Condition or disease Intervention/treatment Phase
Cigarette Smoker Drug: Nicotine-Containing Standard Research Electronic Cigarette Device: Non-Nicotine Standard Research Electronic Cigarette Early Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

I. To characterize the effects of switching to nicotine vs. placebo standard research E-cigarettes (SRECs) from combustible cigarettes (CCs) on product use, product acceptability, reinforcement, and nicotine dependence symptoms among adult daily CC smokers.

II. To characterize the differences between male and female CC smokers when switching to nicotine versus (vs.) placebo SRECs from CCs on product use, product acceptability, reinforcement, and nicotine dependence symptoms.

EXPLORATORY OBJECTIVES:

I. To characterize which factors moderate or mediate the effects of switching to nicotine and placebo SRECs from CCs among male and female CC smokers.

OUTLINE:

Participants will be instructed to smoke their usual brand cigarette as they normally would in weeks 1-2 (Phase I) and to use only the SREC (with or without nicotine) in weeks 3-4 (Phase II) and in weeks 5-6 (Phase III). Participant assignment to SREC type at Phases II and III will be counter-balanced within group, with half of men and women receiving the placebo SREC during Phase II and half during Phase III. Participants will attend 4 laboratory visits with study investigators for 3 hours each over 6 weeks of study participation.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Official Title: Gender Differences in Standardized Research E-Cigarette (SREC) Product Use, Acceptability, Reinforcement, and Nicotine Dependence Symptoms
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: E-cigarettes with Nicotine
Participants will be instructed to smoke their usual brand cigarette as they normally would in weeks 1-2 (Phase I) and to use only the SREC (with or without nicotine) in weeks 3-4 (Phase II) and in weeks 5-6 (Phase III). Participant assignment to SREC type at Phases II and III will be counter-balanced within group, with half of men and women receiving the placebo SREC during Phase II and half during Phase III. Participants will attend 4 laboratory visits with study investigators for 3 hours each over 6 weeks of study participation.
Drug: Nicotine-Containing Standard Research Electronic Cigarette
E-cigarettes with Nicotine

Device: Non-Nicotine Standard Research Electronic Cigarette
E-cigarettes without Nicotine

Placebo Comparator: E-cigarettes without Nicotine
Participants will be instructed to smoke their usual brand cigarette as they normally would in weeks 1-2 (Phase I) and to use only the SREC (with or without nicotine) in weeks 3-4 (Phase II) and in weeks 5-6 (Phase III). Participant assignment to SREC type at Phases II and III will be counter-balanced within group, with half of men and women receiving the placebo SREC during Phase II and half during Phase III. Participants will attend 4 laboratory visits with study investigators for 3 hours each over 6 weeks of study participation.
Drug: Nicotine-Containing Standard Research Electronic Cigarette
E-cigarettes with Nicotine

Device: Non-Nicotine Standard Research Electronic Cigarette
E-cigarettes without Nicotine




Primary Outcome Measures :
  1. Change in Cigarettes per day (CPD) [ Time Frame: Baseline (week 0) and at the end of weeks 2,4, and 6 ]
    At each visit, study staff will complete a Time Line Follow Back (TLFB) interview to record nicotine product use since their last in-person session.


Secondary Outcome Measures :
  1. Tobacco Products and Risk Perceptions Survey (TPRPS) [ Time Frame: Baseline (week 0) ]
    Prior E-cig use will be collected using the e-cig items of the Tobacco Products and Risk Perceptions Survey

  2. Demographics, smoking, tobacco product use, and health history questionnaire [ Time Frame: Baseline (week 0) ]
    As part of the in-person screening session, participants will complete basic demographics, smoking, tobacco product use, and health history questionnaires

  3. Change in time Line Follow Back (TLFB) of combustible cigarette (CC) & other product use [ Time Frame: All in-person sessions (weeks 0, 2, 4, and 6) ]
    We will use the TLFB to collect self-reported daily use of CCs and other tobacco products

  4. Change in Time Line Follow Back (TLFB) of Standard Research E-Cigarettes (SREC) use [ Time Frame: At weeks 4 and 6 ]
    We will use the TLFB to collect self-reported daily use of SRECs after Phases 2 & 3

  5. Change in Expired carbon monoxide (CO) [ Time Frame: All in-person sessions (weeks 0, 2, 4, and 6) ]
    Expired CO will be assessed using the Micro Pro-Smokerlyzer

  6. Change in Standard Research E-Cigarette (SREC) cartridge weight [ Time Frame: Weeks 4 and 6 ]
    Participants will be required to return used and unused SREC sealed cartridges at weeks 4 and 6 for product accounting and weighing.

  7. Change in Urine sample to measure nicotine, cotinine, and anabasine [ Time Frame: All in-person sessions (weeks 0, 2, 4, and 6) ]
    Cotinine is a major metabolite of nicotine, with 70% to 80% of nicotine metabolized to cotinine. While cotinine is less sensitive to acute fluctuations in nicotine intake due to its longer half-life, we will also include measures of nicotine for generalization of our findings to the broader literature.

  8. Change in smartphone Ecological Momentary Assessment (EMA) of product use [ Time Frame: Once daily for 6 weeks ]
    Participants will complete SMS-prompted once daily smartphone Qualtrics assessments of product use (CPD, number of EC episodes, minutes of use, and number of cartomizers used [Phases 2 & 3], other tobacco use)

  9. Change in Product evaluation scale (PES) [ Time Frame: All in-person sessions (weeks 0, 2, 4, and 6) ]
    Explicit product liking will be measured using Product Evaluation Scales (PES), which are modified versions of the Cigarette Evaluation Scale. The CES is an 11-item questionnaire that evaluates the cigarette smoking experience in terms of satisfaction, tastiness, dizziness, ability to calm, concentration, wakefulness, reduction of hunger, nausea, irritability, enjoyment of sensations of smoke, and craving reduction. We will use 2 product-specific versions of the PES to evaluate CC and SREC product liking (with SRECs evaluated at weeks 4 & 6 only)

  10. Change in Implicit Association Tests (IAT) [ Time Frame: All in-person sessions (weeks 0, 2, 4, and 6) ]
    To assess implicit product liking, participants will complete 2 Implicit Association Tests (IAT) designed to evaluate attitudes towards CCs and EC

  11. Change in Perceived Health Risk Questionnaires (PHRQs) [ Time Frame: All in-person sessions (weeks 0, 2, 4, and 6) ]
    To assess perceived product harm, we will administer modified Perceived Health Risk Questionnaires (PHRQs) that will assess participants' beliefs about their risks of developing lung cancer, emphysema, bronchitis, other cancers, heart disease, risk of addiction, and stroke on a scale of 1 (very low risk of disease) to 10 (very high risk of disease). These scales will be modified so that participants will assess the perceived risks associated with their UB CC, e-cigs (e-cigs "in general") at each time point, and a SREC-specific version at weeks 4 & 6 only.

  12. Brief Smoking Consequences Questionnaire-Adult (BSCQ-A) [ Time Frame: All in-person sessions (weeks 0, 2, 4, and 6) ]
    To assess CC-specific expectancies (i.e., perceived outcomes of product use), we will administer the Brief Smoking Consequences Questionnaire-Adult (BSCQ-A).

  13. Change in E-cigarette specific Brief Smoking Consequences Questionnaire-Adult (EC-BSCQ-A) [ Time Frame: All in-person sessions (weeks 0, 2, 4, and 6) ]

    To assess EC-specific expectancies (i.e., perceived outcomes of product use), we will administer the EC-specific Brief Smoking Consequences Questionnaire-Adult (ECBSCQ- A). To assess EC-specific expectancies (i.e., perceived outcomes of product use), we will administer the EC-specific Brief Smoking Consequences Questionnaire-Adult (EC-BSCQ-A).

    [2/12/2019 10:55 AM] Pollock,Carmen G: To assess EC-specific expectancies (i.e., perceived outcomes of product use), we will administer the EC-specific Brief Smoking Consequences Questionnaire-Adult (EC-BSCQ-A).


  14. Change in Product-specific purchase tasks (PT) [ Time Frame: All in-person sessions (weeks 0, 2, 4, and 6) ]
    We will assess CC and SREQ product relative reinforcing efficacy (RRE) using two separate product-specific purchase tasks (PT) at each in-person visit (with SRECs evaluated at weeks 4 & 6 only)

  15. Change in Symptoms of nicotine dependence (in-session) [ Time Frame: All in-person sessions (weeks 0, 2, 4, and 6) ]
    Participants will complete questionnaires assessing nicotine dependence symptoms.

  16. Change in smartphone EMA of nicotine dependence symptoms [ Time Frame: Twice daily for 6 weeks ]
    During all phases, SMS/Qualtrics will be used to collect 2 daily random smartphone EMA measures of nicotine dependence symptoms, including nicotine withdrawal, craving, and affect.


Other Outcome Measures:
  1. Participant Health Questionnaire (PHQ-9) [ Time Frame: Baseline (week 0) ]
    The PHQ-9 will be used to assess for current MDD and suicidality, which are exclusion criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Current smoker, defined as smoking 5 or more cigarettes per day during the past 30 days.
  • Produce an expired carbon monoxide (CO) of 5 parts per million (ppm) or more.
  • A stable address and working telephone.
  • Able to follow verbal and written instructions in English and complete all aspects of the study as determined by principal investigator (PI).
  • Interested in trying electronic cigarettes (ECs).

Exclusion Criteria:

  • Use of electronic cigarettes on more than 2 days in the past 30 days.
  • Meet criteria for current major depressive disorder or suicidality.
  • Report more than once weekly use of tobacco products other than cigarettes during the past 30 days.
  • Report recent (past 30 days) or planned (within the next 45 days) involvement in smoking cessation activities.
  • Uncontrolled or unstable medical condition (e.g., uncontrolled hypertension, angina, diabetes).
  • Evidence of cognitive deficits or instability that would preclude reliable study participation.
  • Women who are pregnant, breastfeeding, or are not using an acceptable method of birth control (if capable of becoming pregnant).
  • Considered by the investigator to be an unsuitable or unstable candidate (including but not limited to the following situations: planned absences from Houston area, or unwilling or unable to comply with study procedures).

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): NCT03856515


Contacts
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Contact: Jason Robinson 713-792-2265 nicotinestudy@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Jason Robinson    713-792-2265    nicotinestudy@mdanderson.org   
Principal Investigator: Jason Robinson         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Jason Robinson M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03856515     History of Changes
Other Study ID Numbers: 2018-0794
NCI-2018-03354 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0794 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
U01DA047875 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Cigarette
Smoker
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action