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NCT ID: NCT00519766 Completed - Smoking Clinical Trials

Examining a New Biomarker of Nicotine Use Among Pregnant Women Who Participated in the New England SCRIPT

SCRIPT
Start date: September 1997
Phase: N/A
Study type: Observational

Smoking during pregnancy is the single most preventable cause of illness and death among mothers and infants. Because of the stigma associated with tobacco use during pregnancy, pregnant women are less likely to disclose their smoking status to doctors or study researchers. This study will evaluate the use of a new biomarker of nicotine metabolism to estimate tobacco use in a group of pregnant women who participated in the New England Smoking Cessation and Reduction in Pregnancy Trial (SCRIPT).

NCT ID: NCT00507975 Completed - Smoking Clinical Trials

Study of Nicotine Patch in Pregnancy (SNIPP)

SNIPP
Start date: November 2007
Phase: Phase 3
Study type: Interventional

There are no established evidences as to the effectiveness in smoking pregnant women of nicotine patches in increasing birth weight, smoking abstinence during pregnancy and concerning the safety their for the fetus/newborn. Moreover, recent studies have shown that the metabolism of nicotine is speeded up in pregnant women suggesting that dose adaptation may be necessary in this population. The main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother.

NCT ID: NCT00505869 Completed - Pregnancy Clinical Trials

A Mood Management Intervention for Pregnant Smokers

Start date: August 2004
Phase: Phase 3
Study type: Observational

This proposal is aimed at testing the following hypotheses: 1. Cessation rates will be significantly greater for smokers in a mood management condition versus a health & wellness condition during pregnancy and at 3 and 6 months postpartum. 2. Pregnant smokers who have a higher level of depressive symptomatology will quit significantly less often in the health & wellness condition vs. mood management condition; those with a lower level of depressive symptomatology will not demonstrate this treatment difference. 3. Pregnant smokers who show higher levels of current depression at the start of the intervention will quit significantly less often than those smokers with lower levels. The mood management intervention will result in higher levels of adaptive coping behavior, self-efficacy, social support, and perceived support from the counselor, and lower levels of negative affect, rumination, and perceived stress, than the health & wellness intervention and these variables will be related to abstinence. Thus, we will evaluate the effects of the intervention (health & wellness and mood management) on hypothesized treatment mechanisms, and assess the impact of those mechanisms on abstinence.

NCT ID: NCT00502216 Completed - Smoking Clinical Trials

Naltrexone and Varenicline: Weight Gain and Tolerability in Cigarette Smokers

Start date: July 2007
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether the combination of naltrexone (Depade) and varenicline (Chantix) minimizes post-smoking cessation weight gain and how well the combination is tolerated.

NCT ID: NCT00463827 Completed - Asthma Clinical Trials

Effect of Statins on Asthma Control in Smokers With Asthma

Start date: August 2007
Phase: Phase 2
Study type: Interventional

Asthma is a chronic inflammatory condition of the lungs. There is evidence that cigarette smoking can make asthma symptoms worse and that smokers with asthma do not respond as well to standard therapies as non-smokers. Statins are drugs which are already used to lower cholesterol. They have also been shown to have some anti-inflammatory properties. In this trial the investigators will give a randomised group of smokers Atorvastatin and the remaining group a placebo or blank tablet. The investigators will then monitor patients' responses in terms of peak flow data, symptom diaries, questionnaires and breathing tests.

NCT ID: NCT00452894 Completed - Smoking Clinical Trials

Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers

Start date: March 2007
Phase: Phase 1
Study type: Interventional

This study is to measure how much of varenicline tartrate is in Chinese healthy smokers' blood and urine after taking a single dose and several doses respectively, and also to test the safety (the impact of the study drug on Chinese healthy smokers' body) of varenicline.

NCT ID: NCT00420498 Completed - Schizophrenia Clinical Trials

Effects of Atomoxetine on Cognitive Function in Schizophrenia

Start date: August 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine the effects of atomoxetine (Strattera™) on prefrontal cognitive functioning in persons with schizophrenia. Secondarily, the effects of atomoxetine on positive and negative symptoms and on cigarette smoking consumption in persons with schizophrenia will be examined.

NCT ID: NCT00411320 Completed - Asthma Clinical Trials

Determinants of Corticosteroid Insensitivity in Smokers With Asthma

Start date: January 2007
Phase: N/A
Study type: Interventional

Smokers with asthma display a relative insensitivity to inhaled and oral corticosteroids. The causes of this phenomenon are currently unknown. The investigators will perform a number of blood & breathing tests to try to discover the cause/s behind this phenomenon with the aim of producing leads for further investigation and possible new treatments for smokers with asthma.

NCT ID: NCT00407277 Completed - Schizophrenia Clinical Trials

Neural Inhibition as a Mechanism of Nicotine Dependence Among Persons With Schizophrenia

Start date: February 2007
Phase: N/A
Study type: Interventional

Cigarette smoking decreases life expectancy, causes devastating health complications, and costs society billions of dollars each year. These untoward consequences are especially pronounced among persons with schizophrenia (SCZ) because approximately 80% to 95% of this group smokes cigarettes. These high prevalence rates underscore the need for research investigating the determinants of smoking in patients with SCZ. Several researchers have observed that nicotine improves specific symptoms of SCZ including negative symptoms, negative affect, and cognitive deficits. This has led to the hypothesis that patients with SCZ smoke in an attempt to self-medicate. However, the mechanism(s) by which nicotine has its positive effect on symptoms remains unclear. The current proposal posits that neural inhibition (NI) is a physiological mechanism of this effect, while variation in the alpha-7-nicotinic receptor subunit gene (CHRNA7) represents the genetic underpinnings of these processes. The proposed study will assess NI and symptom improvement after acute administration of nicotine to both smokers and nonsmokers with SCZ. In addition, NI and CHRNA7 variation will be tested as predictors of patients' ability to reduce/quit smoking following smoking treatment. These data may lead to the development of new pharmacological strategies for treating the symptoms of SCZ and new methods for assisting these patients to quit smoking.

NCT ID: NCT00405912 Completed - Smoking Clinical Trials

St. John's Wort for Tobacco Cessation

Start date: September 2005
Phase: Phase 2
Study type: Interventional

After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 23%. Currently available treatments among adults are expensive and not efficacious for all tobacco users. New pharmacologic agents need to be developed and tested to achieve the Healthy People 2010 goal of less than a 12% adult tobacco use prevalence. Bupropion, an FDA approved agent for tobacco cessation, acts by inhibiting central synaptosomal reuptake of dopamine and norepinephrine. A widely used herbal antidepressant, St. John's Wort (SJW), shares a similar mechanism of action and is effective for treating mild to moderate depression. SJW is well tolerated, available over the counter, and is significantly less expensive than the established treatments for tobacco dependence. To date, no prospective clinical trial evaluating the efficacy of SJW for the treatment of tobacco use has been published. We propose to evaluate the efficacy of SJW for increasing tobacco abstinence and decreasing nicotine withdrawal symptoms in a randomized, double-blind, placebo-controlled, three-arm, parallel group, dose-ranging clinical trial. Participants (N=120) will be randomly assigned to one of the three groups and will receive a twelve-week course of SJW 900 mg per day, 1800 mg per day, or a matching placebo. This study is anticipated to provide the data needed to develop a larger randomized controlled clinical trial submitted through the R01 funding mechanism.