Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised-controlled Clinical Trial to Evaluate the Effectiveness and Safety of Combining Nicotine Patches With E-cigarettes (With and Without Nicotine) Plus Behavioural Support, on Smoking Abstinence
Brief Summary: A randomised trial to determine whether e-cigarettes (with and without nicotine) combined with nicotine patches and behavioural support can assist smokers in remaining abstinent for at least six months.


Options:
A: Inclusion Criteria:

* Smoke and want to quit in the next three months
* Reside in New Zealand
* At least 18 years of age
* Able to provide verbal consent
* Have access to telephone (mobile and/or landline)
* Are prepared to use a nicotine patch or a nicotine patch and e-cigarette together.
* Only one person per household is eligible.

Exclusion Criteria:

* Pregnant women
* Women who are breastfeeding
* Current users of NRT products
* People currently enrolled in another smoking cessation programme or other cessation study
* People who have used an e-cigarette for more than one week in the last year for smoking cessation
* Current users of non-nicotine based cessation therapies (e.g. buproprion, clonidine, nortriptyline or varenicline).
* People who have had a heart attack, stroke or severe angina within the previous two weeks.
* People who self-report a history of severe allergies and/or poorly controlled asthma.
B: Inclusion Criteria:

* Eligible participants will be 68 (34 male and 34 female) smokers aged 18-65, who smoke ≥ 10 cigarettes per day, provide a baseline CO reading ≥ 10 ppm and who plan to live in the area for the next 6-months.

Exclusion Criteria:

* Smoking Behavior

  1. Use of chewing tobacco or snuff
  2. Current enrollment or plans to enroll in another smoking cessation program in the next 5 months
  3. Plan to use other nicotine substitutes or smoking cessation treatments in the next 5 months
  4. Provide a baseline CO reading \< 10 ppm

Alcohol/Drug Exclusion Criteria

1. History of substance abuse and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants)
2. Current alcohol consumption that exceeds \>25 standard drinks/week

Medication Exclusion Criteria

1. Current use or recent discontinuation (within last 14-days) of the following medications:

1. Any form of smoking cessation medication (zyban, wellbutrin, wellbutrin SR, Chantix, NRT)
2. Any form of anti-psychotic medications that includes:

   * antipsychotics,
   * atypical antipsychotics,
   * mood-stabilizers,
   * anti-depressants (tricyclics, SSRI's, MAOI's),
   * anti-panic agents,
   * anti-obsessive agents,
   * anti-anxiety agents, and
   * stimulants (e.g., Provigil, Ritalin).
3. Medication for chronic pain
4. Anti-coagulants
5. Any heart medications
6. Daily medication for asthma

Medical Exclusion Criteria

1. Women who are pregnant, planning a pregnancy, or lactating.
2. History or current diagnosis of psychosis, major depression or bipolar disorder, schizophrenia, or any Axis 1 disorder as identified by the SCID.
3. Serious or unstable disease within the past 6 months (e.g., cancer \[except melanoma\], heart disease, HIV).
4. History of epilepsy or a seizure disorder.
5. History or current diagnosis (last 6-months) of abnormal rhythms and/or tachycardia (\>100 beats/minute); history or current diagnosis of COPD, cardiovascular disease (stroke, angina, coronary heart disease), heart attack in the last 6 months, uncontrolled hypertension (SBP\>150 or DBP\>90)
6. History of Kidney and/or liver failure (including transplant).
7. Wears a device to aid in hearing (hearing aid, cochlear implant, etc.).
8. Hearing threshold \< 40 dB SPL at 1000 Hz.
9. Color blindness.

General Exclusion

1. Any medical condition or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
2. Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.
3. Any physical or visual impairment that may prevent the individual from using a computer keyboard or completing any study tasks.
C: Inclusion Criteria:

* Age 18 or older
* English speaking
* Smoked at least 100 cigarettes/lifetime
* Smokes 5 or more cigarettes per day
* Interested in quitting smoking (preparation or contemplation state of change)
* Enrolled in Einstein/Montefiore methadone program for 3 or more months
* Stable methadone dose for 2 weeks
* Agree to use contraception throughout the trial (among women with reproductive potential)
* Willing to participate in all study components
* Able to provide informed consent

Exclusion Criteria:

* Serious or unstable HIV/AIDS, liver, cardiovascular, or pulmonary disease
* Psychiatric instability
* Women who are pregnant, breastfeeding, or contemplating pregnancy
* Creatinine clearance less than 30 mL/min
D: Inclusion Criteria:

1. an ambulatory ICD-10 code for COPD in the last 12 months and a COPD Assessment Tool (CAT) score on the screening ≥10.
2. ages 21-75 (the legal age for purchasing e-cigarettes is 21)
3. current CC smokers (more than 5 packs in a lifetime; smokes 4 or more days/week)
4. smokes at least 10 cigarettes per day on days they smoke CC
5. motivated to quit smoking (at least a 5 on a 10-point Likert scale)
6. Participants must be able to provide consent, agree to be randomized and followed-up with, a working telephone number and/or a system with teleconferencing capabilities (e.g. smartphone or computer), a phone with text messaging capabilities, and be willing to use an e-cigarette or NRT for 12 weeks. To reduce attrition, participants will be asked to provide one additional contact as a backup for follow up on appointments.

Exclusion Criteria:

1. A CAT score \>30 representing severe COPD
2. are pregnant (as determined by urine pregnancy test for women under age 52) or breastfeeding (self-reported). Women of childbearing age must also be willing to use an approved form of birth control during the course of the study if not practicing abstinence. Approved birth control methods include: hormonal birth control (e.g. "the pill"), barrier methods (e.g. condoms, diaphragm), and intrauterine devices (IUDs).
3. diagnosis of any medical condition (unstable angina/heart disease) or psychiatric condition precluding use of nicotine patch or gum as determined by the MD of this study, Dr. Scott Sherman (NYS license #171632), or by the subject's primary care doctor.
4. reporting using NRTs or e-cigarettes within the last 30 days

Answer: A