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:

* Participants are over 16 and will need to agree to i) receive counselling ii) to set a quit within two weeks and iii) consent to follow up processes.

Exclusion Criteria:

* Telephonists will not enrol potential participants who are not capable of giving informed consent or who have not got access to a phone contact number to which calls can be made by Essentia staff.
B: Inclusion Criteria:

* African American or Latina (by self report)
* At least 18 years of age
* English speaking
* Pregnant less than or equal to 28 weeks gestation
* Receiving prenatal care in the District of Columbia
* Had one or more of the following risk factors: active smoking, environmental tobacco smoke exposure, depression and intimate partner violence

Exclusion Criteria:

* Non-minority race (by self report)
* Younger than 18 years of age
* Non-English speaking
* Not pregnant or pregnant greater than 28 weeks gestation
* Receiving prenatal care outside the District of Columbia
* Responded negatively to questions about risk factors
* Suicidal ideation
C: 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
D: * INCLUSION CRITERIA

At least 18 years of age

Resident of the District of Columbia or Greater Metropolitan Area

Minority Woman (Either African American or Hispanic)

No more than 30 weeks estimated gestational age

Able to read and speak English

Current cigarette smoker

Baseline saliva continine level equal to or exceeding 30 ng/ml

Expresses desire to quit smoking in this pregnancy

EXCLUSION CRITERIA

Currently participating in any other smoking cessation treatment program

Has the following conditions: heart disease, irregular heart beat, high blood pressure, diabetes, liver condition, kidney condition, stomach ulcer, asthma, chronic pulmonary disease, or skin condition

Currently being treated for psychiatric illness, alcoholism, or other drug addiction.

Answer: C