Please select the eligibility criteria that correspond to the clinical trial below.
Title: Nicotine Replacement Therapy Methods for Pregnant Women
Brief Summary: This study will compare the effectiveness of counseling plus use of a nicotine patch with counseling alone for helping pregnant women quit smoking. Smoking during pregnancy is the most preventable cause of fetal and newborn health problems such as low birth weight, fetal growth retardation, sudden infant death syndrome, spontaneous abortion, decreased lung function and premature delivery.

African-American and Hispanic women 18 years of age or older, smoke cigarettes, and live in the District of Columbia metropolitan area may be eligible for this study. Candidates are recruited from the George Washington University and Providence Hospital prenatal health clinics. They are screened with a review of their medical records and a survey that includes questions about their age, residency, race and ethnicity, educational level and employment status, number of weeks pregnant, and exposure to cigarette smoke and other types of tobacco.

Participants answer questions about their smoking behavior, then receive a 10-minute counseling session and watch a videotape about quitting smoking. Women who are not able to quit smoking in 1 week are then randomly assigned to one of two treatment groups. One group continues to receive counseling sessions during the remainder of their pregnancy; the second group receives nicotine patches as well as the counseling sessions. In addition, all participants watch a video about smoking and receive a guide to help them quit. Women who receive the patches must stop smoking completely. If they cannot stop immediately, their participation in the study ends. The behavioral counseling sessions for all the women are a series of conversations between the women and a trained counselor to help the woman through the process of quitting.

Participants are followed during the study with six clinic visits and three telephone calls. During the first visit, the women answer a series of questions about their smoking habits and health concerns. A portion of the urine sample they provide during their routine prenatal visit is used by this study to assess their cotinine (a breakdown product of nicotine) levels. Saliva and breath samples to test for cotinine and carbon monoxide levels are collected at each visit. Saliva is collected by brushing the inside of the cheek with a cotton swab, and breath samples are collected by having the woman blow into a tube connected to a machine. Participants are evaluated four times during the study with questions about their smoking behavior.

With the women's permission, their medical records, health, and treatments during pregnancy are reviewed. At the end of the pregnancy, the infant's weight and health are also reviewed.


Options:
A: Inclusion Criteria:

* smoking at least 5 cigarettes per day for the preceding 7 days
* previous attempt to quit smoking during pregnancy by self report
* 13-26 weeks gestation
* at least 16 years of age
* able to speak English or Spanish
* intent to carry pregnancy to term
* stable residence

Exclusion Criteria:

* current drug or alcohol abuse or dependence (other than methadone maintenance)
* twins or other multiple gestation
* unstable psychiatric disorder
* unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis gravidarum)
* known congenital abnormality
B: * 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.
C: Inclusion Criteria:

* smoking pregnant woman unable to quit smoking during the first 3 months of pregnancy
* smoking ≥ 5 cigaret/day despite standard medical advice and cognitive-behavioral counselling
* aged ≥ 18 years
* health insured
* motivated to stop smoking; motivation score ≥ 5 on a scale ranging from 0 to 10
* amenorrhea of 9 to 20 weeks
* having signed the written informed consent

Exclusion Criteria:

* non-pregnant women
* men

Pregnant woman:

* who does not agree to use a nicotine or placebo patch
* with presence of chronic psychiatric comorbidity treated continuously by antidepressant, neuroleptic or anxiolytic
* with skin disorder contraindicating the use of a transdermal patch
* with known hypersensitivity to transdermal patch or to one of its constituents
* using other nicotine containing pharmaceutical products (gum, lozenge, inhaler, sublingual tablets)
* using other forms of tobacco than cigaret (cigaret, pipe or any form of smokeless tobacco)
D: Inclusion Criteria:

* Be at least 18 years of age
* Be between 13 and 25 weeks of pregnancy
* Be receiving prenatal care at one of the participating clinics
* Have smoked at least 100 cigarettes in their lifetime
* Be currently smoking and have smoked at least 5 cigarettes per day in the past 7 days
* Speak and write English

Exclusion Criteria:

* Evidence of cognitive or mental health problems
* Evidence of possible drug or alcohol addiction
* Documented history in medical chart of mental retardation, significant chronic or recurrent psychiatric disorder such as schizophrenia or severe depression, history of cardiac arrhythmias, history of myocardial infarction within the past 6 months, history of previous pregnancy with congenital anomaly,family history of congenital anomalies
* Complications of pregnancy during the current pregnancy, including: threatened miscarriage, congenital anomalies, unexplained vaginal bleeding, pelvic or abdominal surgical procedures, deep venous thrombosis, malignancy

Answer: B