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



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:2/21/2019
Start Date:October 26, 2017
End Date:October 2020
Contact:Paul Cinciripini, PHD, MS, BS
Email:pcinciri@mdanderson.org
Phone:713-792-0919

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Evaluating Concomitant Use of Very Low Nicotine Content Cigarettes and e-Cigarettes Among Daily and Non-Daily Smokers

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.


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).
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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