Please select the eligibility criteria that correspond to the clinical trial below.
Title: Personalized Dosing of Nicotine Replacement for Smoking Cessation: An Effectiveness Randomized Placebo-controlled Trial
Brief Summary: Medications for smoking cessation are currently only effective in helping a minority of smokers quit. Drug development is slow and expensive, so there is much interest in optimizing the effectiveness of existing treatments and medications. Current standard doses of nicotine replacement therapy (NRT) are not effective for many smokers and in many cases provide less nicotine compared to when a smoker is smoking their usual number of cigarettes. The proposed study will test if a personalized dose of nicotine patch (up to 84mg) will improve quitting success in those who do not respond to a standard dose of NRT (21mg).


Options:
A: Inclusion Criteria:

* At least 18 years old
* Able to get to research lab in Burlington, Vermont or Omaha, Nebraska
* Daily smoker
* Smoke at least 8 cigarettes per day
* No reduction in smoking in last 30 days
* No intention to quit in the next 30 days
* Never used Varenicline before
* Not currently using smoking cessation medications or nicotine replacement therapy
* Willing to use Varenicline for at least 2 weeks
* Fluent in English

Exclusion Criteria:

* Cannot be currently pregnant or breastfeeding
* Kidney disease
* Frequent nausea
* On certain medications for asthma and/or depression
* Another household member in study
B: Inclusion Criteria:

* Smoker seeking treatment
* Aged 18 and over
* Consenting to take part
* Report little or no change in enjoyment of cigarettes and/or nausea

Exclusion Criteria:

* Pregnant or breastfeeding
* Have severe kidney disease
* Have severe heart problems
* Have a current psychiatric illness
* Are unable to fill in questionnaires in English
* Have an allergy to varenicline
* Are currently involved in another clinical trial
C: Inclusion Criteria:

1. Daily tobacco smoker of ≥10 cigarettes per day
2. Aged 18 to 75 years old
3. Interested in using tNRT as the only smoking cessation aid
4. Intending to quit smoking within the next 30 days

Exclusion Criteria:

1. At least weekly use of tobacco products other than cigarettes and not willing to stop for the duration of the study
2. Breast feeding, pregnancy or not using a reliable form of birth control
3. Any generalized skin disorders precluding the use of the patch
4. Any life threatening arrhythmias or severe/worsening angina pectoris or within two weeks of experiencing a myocardial infarction or cerebral vascular accident
5. Currently using or has used NRT or other smoking cessation pharmacotherapy within the past two weeks
6. Any known hypersensitivity or allergies to any of the components comprising the nicotine patch
7. Current active substance dependence (excluding caffeine) which would compromise study compliance
8. Current unstable psychiatric condition which would compromise study compliance
9. Diagnosis of terminal illness
10. Current regular use of e-cigarettes or other vaping devices containing nicotine and not willing to stop for the duration of the study
D: Inclusion Criteria:

1. Between the ages of 18 and 75
2. Smoking 10 or more cigarettes per day
3. Fewer than 3 months of smoking abstinence in the past year
4. Motivated to stop smoking

Exclusion Criteria:

1. Current use of opiates, and/or a urine toxicology screen positive for opiates
2. Chronic pain conditions necessitating opioid treatment (naltrexone, an opioid antagonist will make these medications ineffective)
3. Evidence of significant hepatocellular injury as evidence by AST or ALT \>3 x normal or elevated bilirubin
4. History of cirrhosis
5. Any serious or unstable disease within 6 months
6. Seizure risk
7. Diabetes mellitus requiring insulin or oral hypoglycemic medications
8. Hepatic or renal impairment
9. Use of a monoamine oxidase inhibitor in the prior 14 days
10. Clinically significant cardiovascular disease within 6 months
11. Uncontrolled hypertension
12. Baseline systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 95 mm Hg
13. Severe chronic obstructive pulmonary disease
14. History of cancer (except treated basal cell or squamous cell carcinoma of the skin)
15. History of clinically significant allergic reactions
16. Major depressive disorder within the past year requiring treatment
17. History of or current panic disorder, psychosis, bipolar disorder, or eating disorders
18. Alcohol or drug abuse/dependency within the past year
19. Use of another investigational drug within 30 days
20. Intention to donate blood or blood products during the treatment phase of the study
21. Use of tobacco products other than cigarettes or use of marijuana
22. Use of nicotine replacement therapy, clonidine, varenicline, bupropion, or nortriptyline within the month prior to enrollment or intention to use medication that might interfere with study medication
23. Body Mass Index (calculated as weight in kilograms divided by the square of height in meters) less than 15 or greater than 38 or weight less than 45 kg.
24. Females of childbearing potential who are pregnant, nursing, or not practicing effective contraception (oral injectable, or implantable contraceptives, intrauterine device, or barrier method with spermacide)

Answer: C