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Concomitant Use of Very Low Nicotine Content Cigarettes and e-Cigarettes

This study is currently recruiting participants.
Verified October 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02964182
First Posted: November 16, 2016
Last Update Posted: October 27, 2017
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.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

The goal of this research study is to learn more about the effects of different nicotine levels in cigarettes and electronic cigarettes (e-cigarettes). E-cigarettes use water vapor to deliver nicotine.

This is an investigational study.

Up to 480 participants will be screened to take part in the study, but only about 160 participants will be enrolled. All will take part at MD Anderson.


Condition Intervention
Mental and Behavioral Disorders Due to Use of Tobacco Procedure: Carbon Monoxide (CO) Testing Behavioral: Questionnaires Behavioral: Smartphone Assessments Other: Urine Sample Other: Usual Brand (UB) Cigarettes Other: Very Low Nicotine Content Cigarettes (VLNCC) Other: VLNCC and e-cigs (VLNCC+ECIG)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Evaluating Concomitant Use of Very Low Nicotine Content Cigarettes and e-Cigarettes Among Daily and Non-Daily Smokers

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Effects of Dual Use of VLNCCC and ECIG on Nicotine Abuse Liability Among Daily Smokers (DS) [ Time Frame: 10 weeks ]
    Generalized linear mixed modeling (GLMM) used to evaluate the effects of ECIG dose on measures of nicotine abuse liability among daily smokers.

  • Effects of Dual Use of VLNCCC and ECIG on Nicotine Abuse Liability Among Intermittent Smokers (ITS) [ Time Frame: 10 weeks ]
    Generalized linear mixed modeling (GLMM) used to evaluate the effects of ECIG dose on measures of nicotine abuse liability among intermittent smokers.


Estimated Enrollment: 480
Actual Study Start Date: October 26, 2017
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Usual Brand (UB) Cigarettes

Carbon monoxide levels measured at Baseline and at Weeks 1, 2, 4, 5, and 8.

Questionnaires completed at Baseline and at Weeks 1, 2, 4, 5, and 8.

Participants answer questions and maintain a daily log every day for up to 75 days. Participants also complete electronic assessments at various points every day for up to 42 days. Participants complete an electronic survey at Weeks 1, 2, 4, 5, and 8.

Urine sample given at Baseline and at Weeks 1, 2, 4, 5, 8, and on or about Day 10 of Phases 1, 2, and 3 to bring to Weeks 5, 8, and 10 study visits.

Participants smoke their usual brand (UB) during Phase 1 (Baseline; week 1) and exclusively smoke VLNCC during Phase 2 (weeks 2-4). During phases 3 (weeks 5-7) & 4 (weeks 8-10), smokers instructed to freely use any combination of assigned VLNCC and e-cigs (VLNCC+ECIG).

Procedure: Carbon Monoxide (CO) Testing
Carbon monoxide levels measured at Baseline and at Weeks 1, 2, 4, 5, and 8. Participants blow air through a CO-measuring device.
Other Name: CO
Behavioral: Questionnaires
Participants complete questionnaires about their demographics, physical and emotional health, and smoking behavior at Baseline and at Weeks 1, 2, 4, 5, and 8. These questionnaires should take about 30 minutes to complete.
Other Name: Surveys
Behavioral: Smartphone Assessments
Using a smartphone, participants answer questions and maintain a daily log every day for up to 75 days. Participants also complete electronic assessments at various points every day for up to 42 days. Participants complete an electronic survey at Weeks 1, 2, 4, 5, and 8.
Other: Urine Sample
Urine sample given at Baseline and at Weeks 1, 2, 4, 5, 8, and on or about Day 10 of Phases 1, 2, and 3 to bring to Weeks 5, 8, and 10 study visits.
Other: Usual Brand (UB) Cigarettes
Participants smoke their usual brand (UB) during Phase 1 (Baseline; week 1).
Other: Very Low Nicotine Content Cigarettes (VLNCC)
Participants smoke VLNCC during Phase 2 (weeks 2-4).
Other: VLNCC and e-cigs (VLNCC+ECIG)
During Weeks 5-10, participants smoke only the cigarettes and e-cigarettes provided to them. Participants smoke either low ECIG-Lo 8 mg/ml, or high nicotine content ECIG-Hi 36 mg/ml cigarettes for the first 3 weeks (Phase 3), and then switch to whichever one they had not yet received for the remaining 3 weeks (Phase 4).
Experimental: Very Low Nicotine Content Cigarettes (VLNCC)

Carbon monoxide levels measured at Baseline and at Weeks 1, 2, 4, 5, and 8.

Questionnaires completed at Baseline and at Weeks 1, 2, 4, 5, and 8.

Participants answer questions and maintain a daily log every day for up to 75 days. Participants also complete electronic assessments at various points every day for up to 42 days. Participants complete an electronic survey at Weeks 1, 2, 4, 5, and 8.

Urine sample given at Baseline and at Weeks 1, 2, 4, 5, 8, and on or about Day 10 of Phases 1, 2, and 3 to bring to Weeks 5, 8, and 10 study visits.

Participants smoke their usual brand (UB) during Phase 1 (Baseline; week 1) and exclusively smoke VLNCC during Phase 2 (weeks 2-4). During phases 3 (weeks 5-7) & 4 (weeks 8-10), smokers instructed to freely use any combination of assigned VLNCC and e-cigs (VLNCC+ECIG).

Procedure: Carbon Monoxide (CO) Testing
Carbon monoxide levels measured at Baseline and at Weeks 1, 2, 4, 5, and 8. Participants blow air through a CO-measuring device.
Other Name: CO
Behavioral: Questionnaires
Participants complete questionnaires about their demographics, physical and emotional health, and smoking behavior at Baseline and at Weeks 1, 2, 4, 5, and 8. These questionnaires should take about 30 minutes to complete.
Other Name: Surveys
Behavioral: Smartphone Assessments
Using a smartphone, participants answer questions and maintain a daily log every day for up to 75 days. Participants also complete electronic assessments at various points every day for up to 42 days. Participants complete an electronic survey at Weeks 1, 2, 4, 5, and 8.
Other: Urine Sample
Urine sample given at Baseline and at Weeks 1, 2, 4, 5, 8, and on or about Day 10 of Phases 1, 2, and 3 to bring to Weeks 5, 8, and 10 study visits.
Other: Usual Brand (UB) Cigarettes
Participants smoke their usual brand (UB) during Phase 1 (Baseline; week 1).
Other: Very Low Nicotine Content Cigarettes (VLNCC)
Participants smoke VLNCC during Phase 2 (weeks 2-4).
Other: VLNCC and e-cigs (VLNCC+ECIG)
During Weeks 5-10, participants smoke only the cigarettes and e-cigarettes provided to them. Participants smoke either low ECIG-Lo 8 mg/ml, or high nicotine content ECIG-Hi 36 mg/ml cigarettes for the first 3 weeks (Phase 3), and then switch to whichever one they had not yet received for the remaining 3 weeks (Phase 4).
Experimental: VLNCC + e-Cigarettes (ECIG)

Carbon monoxide levels measured at Baseline and at Weeks 1, 2, 4, 5, and 8.

Questionnaires completed at Baseline and at Weeks 1, 2, 4, 5, and 8.

Participants answer questions and maintain a daily log every day for up to 75 days. Participants also complete electronic assessments at various points every day for up to 42 days. Participants complete an electronic survey at Weeks 1, 2, 4, 5, and 8.

Urine sample given at Baseline and at Weeks 1, 2, 4, 5, 8, and on or about Day 10 of Phases 1, 2, and 3 to bring to Weeks 5, 8, and 10 study visits.

Participants smoke their usual brand (UB) during Phase 1 (Baseline; week 1) and exclusively smoke VLNCC during Phase 2 (weeks 2-4). During phases 3 (weeks 5-7) & 4 (weeks 8-10), smokers instructed to freely use any combination of assigned VLNCC and e-cigs (VLNCC+ECIG).

Procedure: Carbon Monoxide (CO) Testing
Carbon monoxide levels measured at Baseline and at Weeks 1, 2, 4, 5, and 8. Participants blow air through a CO-measuring device.
Other Name: CO
Behavioral: Questionnaires
Participants complete questionnaires about their demographics, physical and emotional health, and smoking behavior at Baseline and at Weeks 1, 2, 4, 5, and 8. These questionnaires should take about 30 minutes to complete.
Other Name: Surveys
Behavioral: Smartphone Assessments
Using a smartphone, participants answer questions and maintain a daily log every day for up to 75 days. Participants also complete electronic assessments at various points every day for up to 42 days. Participants complete an electronic survey at Weeks 1, 2, 4, 5, and 8.
Other: Urine Sample
Urine sample given at Baseline and at Weeks 1, 2, 4, 5, 8, and on or about Day 10 of Phases 1, 2, and 3 to bring to Weeks 5, 8, and 10 study visits.
Other: Usual Brand (UB) Cigarettes
Participants smoke their usual brand (UB) during Phase 1 (Baseline; week 1).
Other: Very Low Nicotine Content Cigarettes (VLNCC)
Participants smoke VLNCC during Phase 2 (weeks 2-4).
Other: VLNCC and e-cigs (VLNCC+ECIG)
During Weeks 5-10, participants smoke only the cigarettes and e-cigarettes provided to them. Participants smoke either low ECIG-Lo 8 mg/ml, or high nicotine content ECIG-Hi 36 mg/ml cigarettes for the first 3 weeks (Phase 3), and then switch to whichever one they had not yet received for the remaining 3 weeks (Phase 4).

  Show Detailed Description

  Eligibility

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:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject has signed informed consent and has agreed to all study related procedures.
  2. Age: 18-65 years old
  3. Have a telephone and address where they may be reached
  4. Able to follow verbal and written instructions in English
  5. Be the only participant in their household
  6. Interested in trying novel nicotine products
  7. Daily Smokers: greater than or equal to 1 cigarette/little cigar per day
  8. Intermittent Smokers: greater than or equal to 1 cigarette/little cigar per day 4 to 27 days per month

Exclusion Criteria:

  1. Used e-cigarettes in the past 30 days
  2. Positive urine screen for illicit drugs except marijuana but must agree to refrain from marijuana use for the duration of the study (a. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded b. Participants failing the urine drug screen will be allowed to re-screen once. If they test positive again, they will not be allowed to return)
  3. Exclusionary medications taken in the last two weeks: Phenytoin (Dilantin), Carbamazepine (Tegretol, Carbatrol, Equetro, Epitol), Oxcarbazepine (Trileptal), Primidone (Mysoline), Phenobarbital, Clopidogrel (Plavix), Olanzapine (Zyprexa), Ropinirole (Requip), Methadone (Diskets, Methadose, Dolophine), Theophylline (Theolair, Elixophyllin, Theo-24, Quibron-T, Uniphyl), Clozapine (Clozaril, FazaClo), or Warfarin (Coumadin, Jantoven).
  4. Unstable medical condition as determined by the medial team
  5. Subject experienced abnormal heart rhythms or cardiovascular disease (stroke, chest pain, heart attack) in the last 3 months
  6. Subject's screening blood pressure reading greater than or equal to 160/100.
  7. Meet criteria for Major Depressive Syndrome or suicidality on the PHQ-9
  8. Self report of past or current diagnosis of bi-polar disorder or schizophrenia/ schizoaffective disorder
  9. 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.
  10. Recent (past 90 days), current, or planned (within the next 45 days) involvement in smoking cessation activities
  11. 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.
  12. 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: (1) approved hormonal contraceptives (such as condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). Contraceptives sold for emergency use after unprotected sex are not acceptable methods for routine use
  13. 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).
  Contacts and Locations
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
Contact: Paul Cinciripini, PHD, MS, BS 713-792-0919 CR_Study_Registration@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Research Operations       CR_Study_Registration@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Paul Cinciripini, PHD, MS, BS M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02964182     History of Changes
Other Study ID Numbers: 2015-0638
R01DA042526 ( U.S. NIH Grant/Contract )
First Submitted: November 11, 2016
First Posted: November 16, 2016
Last Update Posted: October 27, 2017
Last Verified: October 2017

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

Keywords provided by M.D. Anderson Cancer Center:
Mental and Behavioral Disorders Due to Use of Tobacco
Carbon monoxide Testing
CO
Questionnaires
Surveys
Smartphone assessments
Electronic assessments
Usual brand cigarettes
UB
Very Low Nicotine Content Cigarettes
VLNCC
E-cigarettes
ECIG

Additional relevant MeSH terms:
Problem Behavior
Mental Disorders
Behavioral Symptoms
Nicotine
Carbon Monoxide
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
Antimetabolites
Gasotransmitters