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NCT ID: NCT00547118 Terminated - Obesity Clinical Trials

The Effects of Rimonabant, on Weight and Metabolic Risk Factors

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

1) To examine the efficacy of rimonabant in decreasing weight and metabolic parameters/cardiovascular disease risk in people with schizophrenia receiving second generation antipsychotics 2) To examine the safety and tolerability of rimonabant as an adjunctive agent for decreasing weight and metabolic risk in people with schizophrenia 3) To examine the efficacy of rimonabant for neurocognitive impairments in people with schizophrenia treated with second-generation antipsychotics (secondary outcome) 4) To examine the efficacy of rimonabant for patient perceived health outcomes and quality of life (secondary outcome) 5) To test the effect of rimonabant on cigarette smoking, nicotine dependence and nicotine craving in people with schizophrenia 6) To examine the effects of rimonabant on food satiety in people with schizophrenia There is an increasing awareness of the problem of metabolic issues in people with schizophrenia and renewed focus on physical health care for this population. There is under-treatment, in general, of medical conditions in people with schizophrenia, and increased mortality from natural causes. People with schizophrenia are at risk for developing obesity due to many factors including inactive lifestyle, poor dietary choices, and side effects of the commonly used atypical antipsychotics. Metabolic syndrome has been discussed in the cardiology and endocrinology for over two decades, but its prevalence in the mentally ill is only now being fully realized. Diabetes mellitus may be twice as prevalent among patients with schizophrenia as in the general population and metabolic syndrome is probably even more prevalent than diabetes among people with schizophrenia. There is now an opportunity to address this serious problem. A new drug, rimonabant, has recently been approved in several European and Latin American countries. This drug represents the first of a new class of psychoactive drugs witch may improve metabolic problems through decreasing appetite drive. This may also help decrease the drive for cigarette use, which is also a great problem for people with schizophrenia. Is this a safe and effective treatment in this population? This study proposes to test this question in a rapid study, which will develop the basis for future work in this important area.

NCT ID: NCT00525928 Withdrawn - Smoking Clinical Trials

Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients

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

This study of psychiatric inpatients will assess mood effects of varenicline, as well as assess if varenicline decreased nicotine cravings acutely. This study will also measure side effects of varenicline when given in addition to other psychiatric and non-psychiatric medications.

NCT ID: NCT00525837 Completed - Smoking Clinical Trials

Study of Mood Effects of Varenicline (Chantix) in Depressed Outpatient Smokers

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

This study will assess whether varenicline (chantix) has antidepressant properties when used in addition to other psychiatric medication. It will also assess whether varenicline improves the inability to feel pleasure (i.e. anhedonia), and if it is well-tolerated when used with psychiatric medications. Enrolled patients will be assessed for improved mood, improved anhedonia, overall sense of health, side effects as well as tobacco use for 6-8 weeks. Medication will be provided free of charge.

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: NCT00494728 Active, not recruiting - Depression Clinical Trials

Smoking Cessation for Depressed Smokers

Start date: June 28, 2007
Phase: Phase 1/Phase 2
Study type: Interventional

Objectives: Primary Aim: To conduct a preliminary randomized trial in smokers with current recurrent major depressive disorder (MDD), current MDD with a single episode of 2 years or more, and current dysthymia comparing combined cognitive behavioral analysis system of psychotherapy (CBASP) and standard smoking cessation treatment (ST) (CBASP/ST) to combined Health Education and ST treatment (HE/ST) to: 1. Examine the effects of CBASP/ST on both short and long-term point prevalence abstinence Secondary Aims: 1. To test the hypothesis that depressed smokers in the CBASP/ST treatment will experience greater decreases in depressive symptoms from baseline to each of our follow-up assessment points, compared to depressed smokers in the HE/ST treatment, and; 2. That depressed smokers in the CBASP/ST treatment will experience greater improvements in psychosocial functioning from baseline to follow-up assessment points, compared to depressed smokers in the ST treatment. 3. To evaluate between subject neurophysiological predictors of abstinence at 3 and 6 months, and: 4. To evaluate within-subject changes in neurophysiological responses to emotional and smoking-related stimuli across treatment sessions, and the relation of these changes to abstinence and depressive symptoms at end of treatment, and 3- and 6-months.

NCT ID: NCT00492310 Unknown status - Smoking Clinical Trials

Yoga for Women Attempting Smoking Cessation

Start date: August 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to examine the feasibility, acceptability and initial effectiveness of adding yoga to a traditional, group-based treatment for smoking cessation for women smokers.

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.