- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02964182
Very Low Nicotine Content Cigarettes and E-Cigarettes in Promoting Smoking Cessation in Daily and Intermittent Cigarette Smokers
Evaluating Concomitant Use of Very Low Nicotine Content Cigarettes and E-Cigarettes Among Daily and Non-Daily Smokers
Study Overview
Status
Detailed Description
PRIMARY OBJECTIVES:
I. To characterize the effects of switching to VLNCCs plus ECIG-Hi or ECIG-Lo nicotine doses on abuse liability among daily and intermittent smokers.
EXPLORATORY OBJECTIVES:
I. To explore the effects of switching to VLNCCs plus ECIG-Hi or ECIG-Lo nicotine doses on abuse liability using biochemical measures of product use, compensation, and toxicant exposure, and self-reported measures of withdrawal, craving, affect, and satisfaction.
II. To explore the effects of switching from usual-brand cigarettes to VLNCCs, and from VLNCCs to VLNCC+ECIGs on measures of abuse liability.
III. To characterize the effects of dual use of VLNCC and JUUL ECIGs on abuse liability.
OUTLINE:
PHASE I: Patients smoke their usual cigarettes brand during week 1.
PHASE II: Patients smoke VLNCC cigarettes provided during weeks 2-4.
PHASES III-IV: Patients are randomized to 1 of 2 arms.
ARM I: Patients smoke ECIG-high (Hi) for 3 weeks and then ECIG-low (Lo) for 3 weeks
ARM II: Patients smoke ECIG-Lo for 3 weeks and then ECIG-Hi for 3 weeks.
After completion of study, patients are followed up for 30 days.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Sign consent and agree to all study procedures
- Have an address where he/she can receive mail
- Have a device available to conduct telehealth visit (e.g., smartphone, computer, tablet, internet access, etc.)
- Able to follow verbal and written instructions in English
- Willing and able to complete two spirometry sessions (this criterion waived during COVID-19 pandemic)
- Be the only participant in their household
- Interested in trying novel nicotine products
- Daily smokers: >= 1 cigarette/little cigar per day
- Intermittent smokers: >= 1 cigarette/little cigar per day 4 to 27 days per month
- Agrees to comply with all MD Anderson institutional policies related to COVID-19 screening prior to each in-person research visit
- The individual agrees to not engage in study procedures or interactions with study personnel while operating a vehicle
Exclusion Criteria:
- Unwilling to refrain from other e-cigarette use for the duration of the study, other than what is provided to them for study purposes
Current/recent use of certain medications:
- Smoking cessation meds (past 90 days; e.g., wellbutrin, bupropion, Zyban, nicotine replacement therapy [NRT], Chantix)
- Certain medications to treat depression (last 14 days; e.g., amitriptyline)
- A case by case determination will be made by study physician for medication on the precautionary list, (e.g. nitroglycerin)
- Self-reported daily use of opioids for 30 days or more on phone screen or at screening is exclusionary however pro re nata (PRN) use is allowed (e.g., 3 to 7 days per week or less or if more frequent, use less than a month's duration
- Unstable medical condition as determined by the medical team
- Self-reported bronchial or respiratory infection in the last 14 days (this criterion waived during COVID-19 pandemic)
- Subject's spirometry forced expiratory volume in 1 second (FEV1) percentage reading is < 50 (severe to very severe obstruction) (this criterion waived during COVID-19 pandemic)
- Self-reported abnormal heart rhythms or cardiovascular disease (stroke, chest pain, heart attack) in the last 3 months
- Meet criteria for major depressive syndrome or suicidality on the Patient Health Questionnaire-9 (PHQ-9)
- Self report of past or current diagnosis of bi-polar disorder or schizophrenia/schizoaffective disorder
- Self-reported other tobacco use besides cigarettes or little cigars (e.g., hookah, cigarillos, smokeless tobacco, chewing tobacco, pipes, cigars, etc.) on 10 or more days in the last month
- Recent (past 90 days), current, or planned (within the next 45 days) involvement in smoking cessation activities
- Positive urine pregnancy test at screening. Women who are two years post-menopausal, or who have had a tubal ligation or a partial or full hysterectomy will not be subject to a urine pregnancy test
Women that are breastfeeding or of childbearing potential and not protected by a medically acceptable, effective method of birth control while enrolled in the study. Medically acceptable contraceptives include:
- Approved hormonal contraceptives (such as birth control pills, patches, implants or injections)
- Barrier methods (such as condom or diaphragm) used with a spermicide, or
- An intrauterine device (IUD)
- Contraceptives sold for emergency use after unprotected sex are not acceptable methods for routine use
- Subject considered by the investigator to be unsuitable to participate in the study (e.g., due to cognitive deficits or instability to last the entire duration of the study)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo)
PHASE I: Patients smoke their usual cigarettes brand during week 1. PHASE II: Patients smoke VLNCC cigarettes provided during weeks 2-4. PHASES III-IV: Patients smoke ECIG-Hi for 3 weeks and then ECIG-Lo for 3 weeks. |
Ancillary studies
Ancillary studies
Smoke usual brand of cigarettes
Received NRT (Electronic Cigarette - ECIG-Hi)
Other Names:
Smoke very low nicotine content cigarette
Other Names:
Patients smoke ECIG-Hi for 3 weeks and then ECIG-Lo for 3 weeks.
Patients smoke ECIG-Lo for 3 weeks and then ECIG-Hi for 3 weeks
|
Experimental: Arm II (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo)
PHASE I: Patients smoke their usual cigarettes brand during week 1. PHASE II: Patients smoke VLNCC cigarettes provided during weeks 2-4. PHASES III-IV: Patients smoke ECIG-Lo for 3 weeks and then ECIG-Hi for 3 weeks. |
Ancillary studies
Ancillary studies
Smoke usual brand of cigarettes
Received NRT (Electronic Cigarette - ECIG-Hi)
Other Names:
Smoke very low nicotine content cigarette
Other Names:
Patients smoke ECIG-Hi for 3 weeks and then ECIG-Lo for 3 weeks.
Patients smoke ECIG-Lo for 3 weeks and then ECIG-Hi for 3 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To characterize the effects of switching to VLNCCs plus ECIG-Hi or ECIG-Lo nicotine doses on abuse liability among daily and intermittent smokers.
Time Frame: up to 10 weeks
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Our primary measures of abuse liability will be CPD (product use) and nicotine equivalent (TNE) levels (nicotine compensation).
|
up to 10 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul Cinciripini, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Carcinoma
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- 2015-0638 (Other Identifier: M D Anderson Cancer Center)
- National Cancer Institute (P50CA058187)
- NCI-2019-02501 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- R01DA042526 (U.S. NIH Grant/Contract)
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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