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Trial record 10 of 100 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Texas, United States ) | NIH, U.S. Fed

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

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ClinicalTrials.gov Identifier: NCT02964182
Recruitment Status : Recruiting
First Posted : November 16, 2016
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE November 11, 2016
First Posted Date  ICMJE November 16, 2016
Last Update Posted Date February 19, 2019
Actual Study Start Date  ICMJE October 26, 2017
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02964182 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Concomitant Use of Very Low Nicotine Content Cigarettes and e-Cigarettes
Official Title  ICMJE Evaluating Concomitant Use of Very Low Nicotine Content Cigarettes and e-Cigarettes Among Daily and Non-Daily Smokers
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Mental and Behavioral Disorders Due to Use of Tobacco
Intervention  ICMJE
  • 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.
  • Drug: 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).
  • Drug: 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).
Study Arms  ICMJE
  • 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).

    Interventions:
    • Procedure: Carbon Monoxide (CO) Testing
    • Behavioral: Questionnaires
    • Behavioral: Smartphone Assessments
    • Other: Urine Sample
    • Drug: Usual Brand (UB) Cigarettes
    • Other: Very Low Nicotine Content Cigarettes (VLNCC)
    • Drug: VLNCC and e-cigs (VLNCC+ECIG)
  • 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).

    Interventions:
    • Procedure: Carbon Monoxide (CO) Testing
    • Behavioral: Questionnaires
    • Behavioral: Smartphone Assessments
    • Other: Urine Sample
    • Drug: Usual Brand (UB) Cigarettes
    • Other: Very Low Nicotine Content Cigarettes (VLNCC)
    • Drug: VLNCC and e-cigs (VLNCC+ECIG)
  • 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).

    Interventions:
    • Procedure: Carbon Monoxide (CO) Testing
    • Behavioral: Questionnaires
    • Behavioral: Smartphone Assessments
    • Other: Urine Sample
    • Drug: Usual Brand (UB) Cigarettes
    • Other: Very Low Nicotine Content Cigarettes (VLNCC)
    • Drug: VLNCC and e-cigs (VLNCC+ECIG)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 11, 2016)
480
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. Use of e-cigarettes more than 3 days 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. Current/recent use of certain medications: a. Smoking cessation meds (past 90 days; e.g., Wellbutrin, Bupropion, Zyban, NRT, Chantix) b. Certain medications to treat depression (last 14 days; e.g., Amitriptyline) c. A case by case determination will be made by study physician for medication on the precautionary list, (e.g. nitroglycerin) d. Daily use of opioids for 30 days or more on phone screen or at screening is exclusionary however 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.)
  4. Unstable medical condition as determined by the medical 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 180/110.
  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 birth control pills, patches, implants or injections), (2) barrier methods (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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Paul Cinciripini, PHD, MS, BS 713-792-0919 pcinciri@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02964182
Other Study ID Numbers  ICMJE 2015-0638
R01DA042526 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Paul Cinciripini, PHD, MS, BS M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP