Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Very Low Nicotine Content Cigarettes and E-Cigarettes in Promoting Smoking Cessation in Daily and Intermittent Cigarette Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02964182
Recruitment Status : Recruiting
First Posted : November 16, 2016
Last Update Posted : June 16, 2020
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 how well different levels of nicotine in very low nicotine content cigarettes and electronic cigarettes (e-cigarettes) work in promoting smoking cessation in current daily and intermittent smokers. Different levels of nicotine may effect certain behaviors, including withdrawal symptoms, nicotine cravings, and mood and may lead to changes in smoking behavior, including finding it easier to quit smoking, in current daily and intermittent smokers.

Condition or disease Intervention/treatment Phase
Cigarette Smoker Current Every Day Smoker Current Non-Daily or Intermittent Smoker Drug: Cigarette Other: Electronic Cigarette Other: Questionnaire Administration Other: Survey Administration Drug: Very Low Nicotine Content Cigarette Early Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

I. To characterize the effects of dual use of very low nicotine content cigarettes (VLNCC) and electronic cigarettes (ECIG) on abuse liability (nicotine compensation and product use, liking, and relative reinforcing efficacy [RRE]) and toxicant exposure among daily (DS) smokers.

II. To characterize the effects of dual use of VLNCC and ECIG on abuse liability (nicotine compensation and product use, liking, and RRE) and toxicant exposure among intermittent (ITS) smokers.

III. To characterize the effects of dual product use on abuse liability using measure of withdrawal, craving, affect, and satisfaction (reinforcement).

EXPLORATORY OBJECTIVE:

I. To characterize the effects of dual use of VLNCC and JUUL ECIG on abuse liability (nicotine compensation and product use, liking, and RRE) and toxicant exposure among daily (DS) smokers.

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Evaluating Concomitant Use of Very Low Nicotine Content Cigarettes and E-Cigarettes Among Daily and Non-Daily Smokers
Actual Study Start Date : October 26, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

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.

Drug: Cigarette
Smoke usual brand of cigarettes

Other: Electronic Cigarette
Smoke ECIG-Hi
Other Names:
  • e-Cigarette
  • Electronic Nicotine Delivery System

Other: Electronic Cigarette
Smoke ECIG-Lo
Other Names:
  • e-Cigarette
  • Electronic Nicotine Delivery System

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies

Drug: Very Low Nicotine Content Cigarette
Smoke very low nicotine content cigarette
Other Name: VLNCC

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.

Drug: Cigarette
Smoke usual brand of cigarettes

Other: Electronic Cigarette
Smoke ECIG-Hi
Other Names:
  • e-Cigarette
  • Electronic Nicotine Delivery System

Other: Electronic Cigarette
Smoke ECIG-Lo
Other Names:
  • e-Cigarette
  • Electronic Nicotine Delivery System

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies

Drug: Very Low Nicotine Content Cigarette
Smoke very low nicotine content cigarette
Other Name: VLNCC




Primary Outcome Measures :
  1. Effects of dual use of very low nicotine content cigarettes (VLNCC) and e-cigarettes (ECIG) on nicotine abuse liability among daily smokers (DS) [ Time Frame: 10 weeks ]
    Measured by number of VLNCC cigarettes per day and the number of puffs of eCigarette use per day in the DS group

  2. Effects of dual use of VLNCC and ECIG on nicotine abuse liability among intermittent smokers [ Time Frame: 10 weeks ]
    Measured by number of VLNCC cigarettes per day and the number of puffs of eCigarette use per day in the ITS group



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.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Sign consent and agree to all study procedures
  • Have a telephone and address where they may be reached
  • Able to follow verbal and written instructions in English
  • 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

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
  • Positive urine screen for illicit drugs except marijuana

    • Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded
    • Participants failing the urine drug screen (except marijuana which is not exclusionary) will be allowed to re-screen once. If they test positive again, they will not be allowed to return)
  • 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)
    • 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
  • Bronchial or respiratory infection in the last 14 days
  • Subject's spirometry forced expiratory volume in 1 second (FEV1) percentage reading is < 50 (severe to very severe obstruction)
  • Subject experienced abnormal heart rhythms or cardiovascular disease (stroke, chest pain, heart attack) in the last 3 months
  • Subject's screening blood pressure reading >= 180/110
  • 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
  • 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)

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): NCT02964182


Contacts
Layout table for location contacts
Contact: Paul Cinciripini, PHD, MS, BS 713-792-0919 pcinciri@mdanderson.org
Contact: Jennifer Ferguson 713-563-7018

Locations
Layout table for location information
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Paul Cinciripini    713-792-0919    pcinciri@mdanderson.org   
Principal Investigator: Paul Cinciripini         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
National Institute on Drug Abuse (NIDA)
Investigators
Layout table for investigator information
Principal Investigator: Paul Cinciripini M.D. Anderson Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02964182    
Other Study ID Numbers: 2015-0638
NCI-2019-02501 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2015-0638 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
R01DA042526 ( U.S. NIH Grant/Contract )
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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