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NCT ID: NCT00356967 Completed - Smoking Clinical Trials

Efficacy and Safety of Dianicline Versus Placebo as an Aid to Smoking Cessation

EURODIAN
Start date: June 2006
Phase: Phase 3
Study type: Interventional

The primary objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are: to assess the craving for cigarettes, nicotine withdrawal symptoms and the safety of dianicline.

NCT ID: NCT00352781 Completed - Smoking Clinical Trials

Stop Smoking Therapy for Ontario Patients

STOP
Start date: July 2006
Phase: N/A
Study type: Interventional

Approximately 2 million Ontarians are current smokers. While smoking rates have declined over the past 25 years, these rates have remained constant since 2002. The rate of smoking cessation in Ontario has not kept up with the rest of Canada. A new strategy is necessary to increase the number of smokers making quit attempts and to increase the odds of quitting over the long term. The overall goal of the Stop Smoking Therapy for Ontario Patients (STOP) Study is to evaluate the methods and effectiveness of providing nicotine replacement therapy (NRT) to Ontario smokers. The study will develop an evidence-based protocol for providing NRT, provide faculty development on combining pharmacotherapy with behavioural interventions and will provide an evaluation framework to inform future coverage models. The goal for this phase of the STOP study is to provide faculty development on combining pharmacotherapy with behavioural interventions. This will be achieved by partnering with Public Health Units across Ontario who have established smoking cessation clinics but do not have the finances in place to offer NRT to their clients at a subsidized rate or free of charge. Cost has been shown to be a significant barrier to the access and use of NRT in individuals trying to quit smoking. However, combining pharmacotherapy with behavioural interventions may be more effective than either alone. Therefore, we hypothesize that providing NRT free of charge to clients enrolled in a smoking cessation clinic will be more effective for smoking cessation than behavioural interventions alone.

NCT ID: NCT00341432 Completed - Pregnancy Clinical Trials

Effectiveness of Nicotine Replacement Therapy in Reducing the Risk of Nicotine Exposure in Pregnant Minority Smokers

Start date: August 16, 2005
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT00326781 Completed - Smoking Clinical Trials

Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy (NRT)

Start date: December 1999
Phase: Phase 4
Study type: Interventional

The purpose of this research study is to: 1. compare the effectiveness of a nicotine patch and nicotine nasal spray for smoking cessation; and 2. identify predictors of response to these alternate forms of nicotine replacement therapy (NRT).

NCT ID: NCT00317213 Completed - Smoking Clinical Trials

Smoking Cessation Assistance With LIBERTAL, A Phospholipid Mixture

Start date: February 2002
Phase: Phase 2
Study type: Interventional

It has been shown in rodent models that chronic substance abuse is associated with a rigidification of cell membrane fluidity due to a change in the membrane cholesterol/phospholipids ratio. Upon substance withdrawal the membrane undergoes reequilibration of this ratio, a process resulting both in an acute and a prolonged severe withdrawal syndrome. MBM has developed a patented,phosphatidic acid-enriched phospholipid platform ("LIBERTAL"), which is supposed to facilitate the membrane fluidity recovery. The company has focused on nicotine withdrawal in smoking cessation,as primary target.

NCT ID: NCT00314197 Completed - Physical Activity Clinical Trials

Improving Health Behaviors Through Telephone Linked Care

Start date: April 2006
Phase: N/A
Study type: Interventional

The investigators propose to conduct a randomized controlled trial at the patient level of the Telephone Linked Care - Behavioral Change (TLC-BC) system, which is designed to promote smoking cessation, reduce risky drinking, and improve physical activity and diet. They expect to: 1. successfully integrate an automated telephone behavior change intervention into primary care practices; 2. demonstrate improvement in health behaviors for individuals randomized (assigned by systematic chance) to use the TLC-BC system compared to individuals who receive written health education informational packets; and 3. evaluate the direct costs associated with the use and operation of the TLC-BC system. Project aims and hypotheses follow: Aim 1: Integrate a proven, totally automated computer telephone intervention, Telephone Linked Care - Behavior Change (TLC-BC), into primary care practices. This will be assessed by the patient and clinician/staff surveys at the end of data collection. Aim 2: Demonstrate an improvement in health behaviors for individuals randomized to use the TLC-BC system compared to individuals who receive written informational packets. Aim 3: Evaluate the direct costs associated with the use and operation of the TLC-BC system within the primary care setting. Hypothesis 1: The Telephone Linked Care - Behavioral Change system will be successfully implemented by patients and practices. Hypothesis 2: At 6 months a clinically significant improvement in behavioral change rates will be demonstrated for diet, physical activity, and smoking in the intervention group compared to patients in the control group. Hypothesis 3: At baseline, 3, 6, and 9 months risky drinking will be identified, but there will be no difference in improvement between the study groups.

NCT ID: NCT00299117 Completed - Breast Cancer Clinical Trials

Brief Smoking Intervention for Women Undergoing Breast Cancer Surgery

Start date: April 2006
Phase: N/A
Study type: Interventional

The primary purpose of this study is to examine the effect of a brief preoperative smoking intervention on postoperative complications in women undergoing breast cancer surgery. Secondary purposes are to examine long-term smoking cessation rates and experienced stress and nicotine withdrawal symptoms during the smoking cessation period.

NCT ID: NCT00297700 Active, not recruiting - Smoking Clinical Trials

Implementing Tobacco Control in Dental Practice

Start date: May 2004
Phase: Phase 3
Study type: Interventional

Our goal is to test a dentist-hygienist team intervention to help dental patients quit smoking and determine if it can be effectively and cost-effectively implemented and sustained. Staff in half of the HMO's 14 large dental facilities will be trained to provide brief cessation advice and assistance and to encourage smokers to talk by phone with a tobacco counselor before they leave the dental office. Phone counselors will provide brief counseling, assess stage, and offer a full list of cessation services. The Active Referral intervention strategy is both practical and innovative, as it takes advantage of available resources; efficiently distributes intervention activities between dentists, hygienists, and counseling specialists; and could be delivered in individual, small, or large dental practices. This intervention is provided as part of routine care to all patients seen for annual dental and periodontal exams.Consented patients will receive a short phone survey shortly after the exam to assess smoking status, satisfaction with delivery of support services,and satisfaction with intervention. Consented patients in treatment and control facilities will be surveyed by phone at one year to re-assess smoking status and satisfaction with services.

NCT ID: NCT00297479 Completed - Smoking Clinical Trials

Group Therapy for Nicotine Dependence: Mindfulness and Smoking

Start date: April 2005
Phase: N/A
Study type: Interventional

The goal of this behavioral research study is to create and study a Mindfulness-Based Addiction Treatment (MBAT) for nicotine dependence. Mindfulness is a method to help focus attention on being in the "here and now." It can be learned through training in how to control one's attention. It is usually taught through meditation. The overarching goals of the study are to evaluate the efficacy of MBAT for nicotine dependence and the mechanisms and effects posited to mediate MBAT's impact on abstinence.

NCT ID: NCT00297440 Active, not recruiting - Smoking Clinical Trials

Exercise, Smoking Cessation and Adolescents

Start date: March 2006
Phase: Phase 1/Phase 2
Study type: Interventional

We seek to: 1) conduct the formative work to adapt the cessation materials and exercise protocol from focus on adult women to adolescent girls, and 2) conduct a small randomized pilot trial to determine the preliminary efficacy of the intervention in a sample of adolescent girls. Therefore, this study, will serve as a pilot for a larger clinical trial. Successful smoking cessation in adolescent girls could contribute to the future reduction of chronic disease morbidity and mortality in this group.