Please select the eligibility criteria that correspond to the clinical trial below.
Title: Nicotine Replacement Treatment for Pregnant Smokers
Brief Summary: Smoking during pregnancy is an important modifiable cause of poor pregnancy outcomes. Even with augmented behavioral interventions, smoking cessation rates in pregnancy trials rarely exceed 20%. These low quit rates may be due to inadequate treatment of the physical dependence on nicotine. Indeed, medications, which may help to reduce nicotine withdrawal symptoms, are a first-line treatment for smoking treatment in non-pregnant smokers. However, little information is available on the safety or efficacy of medications to treat pregnant smokers.

The purpose of this trial is to evaluate the safety and effectiveness of 2 mg nicotine gum in promoting smoking cessation during pregnancy. The design is a randomized, placebo controlled trial where subjects are randomized to nicotine gum (6 weeks ad libitum use followed by a 6 week taper) or a matching placebo. Women who are doing well at the end of the trial will also be offered gum post-partum for relapse prevention.


Options:
A: Inclusion Criteria:

* Patient's gestational age is 26 weeks or less.
* Patient is at least 16 years of age.
* Patient is able to speak English or Spanish.
* Patient intends to carry to term.
* Patient has stable residence.
* Patient has smoked five or more cigarettes everyday for the past seven days.

Exclusion Criteria:

* Evidence that the patient is pregnant with a fetus with a known congenital abnormality.
* Unstable medical problems (i.e., hyperthyroidism, temporomandibular joint disorder, pre-eclampsia, threatened abortion, hyperemesis gravidarum)
* Multiple Gestation
* Unstable psychiatric disorder
* Current drug or alcohol abuse or dependence
B: Inclusion Criteria:

* Male or female cigarette smokers, 18- 75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt.
* Smoked an average of at least 10 cigarettes per day during past year and during the month prior to the screening visit, and exhaled carbon monoxide (CO) \>10 ppm at screening.
* For Neuropsychiatric cohort- subjects must have proper diagnosis as outlined in protocol.

Exclusion Criteria:

* Subjects with a past or current diagnosis of one of the following disorders:

  a. Psychotic Disorders:
* Schizophreniform
* Delusional Disorder
* Psychotic Disorder NOS b. All Delirium, Dementia, and Amnestic and Other Cognitive Disorders c. All Substance Induced Disorders (Other than nicotine)
C: Inclusion Criteria:

* Smoke at least 10 cigarettes per day for the previous 6 months - Expired CO \> 9 ppm - Motivated to quit smoking - Able to read and write English - Willing to complete required study assessments

Exclusion Criteria:

* Uncontrolled hypertension (systolic \>180mm Hg or diastolic \>110mm Hg) - History of bipolar disorder or psychosis - Myocardial infarction or other serious cardiac problem in the previous 4 weeks - History of diagnosed anorexia and/or bulimia - Diagnosis of Alcohol Dependence in the previous 6 months by participant self-report or drinking 6 or more drinks on six or more days a week - History of seizure and/or serious head injury involving loss of consciousness - Use of contraindicated medications (MAO inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) - Currently pregnant or breast-feeding - Unwilling to use effective contraception during the treatment phase - More than one participant from the same household - Allergic reactions to 3 or more classes of drugs
D: Inclusion Criteria:

* Smokers smoking at least 15 cigarettes/day as a mean within the 2 months preceding the screening visit
* Motivated to quit with a score greater than or equal to 6 on the ten-point Motivation Scale

Exclusion Criteria:

* non tobacco cigarettes consumption
* chronic use of marijuana
* pregnancy
* breastfeeding
* any clinically significant disease that might interfere with the efficacy or safety evaluation of the study drug
* Concomitant use of drugs as an aid to smoking cessation or that might induce weight change

Answer: A