View clinical trials related to Smoking Cessation.
Filter by:The objectives of this project are to develop, implement, and test the feasibility and effectiveness of an artificial intelligence adaptive mobile pregnancy tobacco cessation app-based intervention using deep tailoring and a self-nominated support person, and to build mHealth research capacity in Romania. The central hypothesis is that the intervention will show evidence of feasibility and effectiveness in increasing positive support, pregnancy cessation, and postnatal abstinence. The intervention is grounded in Self-Determination Theory (SDT) and Motivational Interviewing (MI), a counselling style that is effective in assisting people to quit smoking. The app will be novel in its use of the unique functionality of smartphones, use of reinforcement learning (RL) and deep tailoring to continuously adapt the intervention, the emphasis on increasing positive support, and the use of the app by both smoker and support person. The long-term goal of the research program is to use mHealth for smoking cessation leveraging the unique functionality of smartphones and to continue building mHealth research capacity and developing research networks in Central and Eastern Europe (CEE) and other LMICs. Aim 1 (R21 phase). Develop and test the feasibility and acceptability of the SFT2.0 app-based mobile smoking cessation intervention with a support person during pregnancy and postpartum in Romania. Through a user-centered and iterative design the investigators will enhance the SFT1.0 app, deepen the tailoring, incorporate RL, expand the app for use by any support person, and test the intervention including the app and MI video counseling in a series of usability studies and a 12-week open trial (n=20). Aim 2 (R33 phase). Test the SFT2.0 app-based smoking cessation intervention in a hybrid effectiveness and implementation randomized controlled trial. The investigators will randomize 375 pregnant smokers and their support persons to i) a fixed arm, including the SFT2.0 app for both, and fixed pre- and postnatal MI counseling; ii) an RL-adaptive arm, with the app continuously optimizing as-needed MI counseling; or iii) control group. Aim 3 (R21 and R33 phases). Develop mHealth research capacity by enhancing individual and institutional research capabilities in Romania and expanding the existing international research network.
The objective of this R01 application is to conduct a randomized controlled trial to test the efficacy of the Be Smoke Free, telephone-based, guided imagery (GI) intervention (IC) for smoking cessation compared to active behavioral control (CC). The study will recruit 1,200 diverse smokers from three states, Arizona, New York, and West Virginia to increase generalizability. Participants will be randomly assigned to receive either the IC or CC delivered by telephone by University of Arizona study coaches and will be assessed at 3- and 6-months post-enrollment by study staff. The primary outcome is biochemically verified 7-day point prevalence abstinence at 6 months. This innovative and rigorously designed project conducted by an experienced team has the potential to improve public health through the delivery of an innovative integrative GI intervention via telephone.
Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from F8 coil or active rTMS from H coil for smoking cessation. Smoking and brain functional connectivity changes will be assessed at baseline, different stages of rTMS and/or follow-ups.
This project investigates the effect of honey on lessening the withdrawal symptoms according to the body constitution.
This series of studies will explore the acceptability, feasibility, and preliminary efficacy of making access to smartphone applications contingent on objective evidence of smoking abstinence.
This three-group randomized double-blind placebo-controlled trial (N=180) will evaluate the impact of combination zonisamide and bupropion on the process of switching from combustible cigarettes (CCs) to an e-cigarette. There will be a data collection period of at least five days to obtain baseline information on the use of combustible cigarettes. All participants enrolled in the study will receive a JUUL e-cigarette at Visit 2 for ad libitum use. After the first week of e-cigarette use (at Visit 3), participants will be given bupropion (150 mg each morning for days 1-3, then 300 mg daily) with either zonisamide (100 mg daily) or placebo (group 1 and group 2 respectively), or placebo for both medications (group 3) in addition to continued use of the e-cigarette. At each visit, participants will receive enough study drugs (or placebos) and e-cigarettes to last until their next study visit. The combination of zonisamide and bupropion use will continue until Visit 6 (7 weeks of treatment), and e-cigarette use will continue until the end of treatment (Visit 7).
Background: At present, effectively implementing smoking cessation programs in the health care system constitutes a major challenge. A unique opportunity to initiate smoking cessation focuses on smokers scheduled for surgery. These patients are not only highly motivated to quit smoking but also likely to benefit from a reduction in postoperative complications which may translate into a decrease of costs. Nevertheless, surgical patients are not routinely informed about the benefits of preoperative smoking cessation. Potential reasons for this missed opportunity may be lack of time and training of surgeons and anesthesiologists. The investigators therefore aim to analyse the impact of a preoperative high-intensity smoking cessation intervention on surgical complications up to a 90-day postoperative period in patients of various surgical disciplines. The hypothesis is that preoperative smoking cessation program improves outcomes in smokers undergoing intermediate to high-risk surgery. The primary objective is to compare complications between patients with an institutional multifaceted smoking cessation intervention starting four weeks before surgery compared to patients in the advice only group (control group) within a 90-day postoperative period. The primary endpoint is the Comprehensive Complication Index (CCI®) within 90 days of surgery. Secondary outcomes include length of hospital stay, cost of hospital stay, smoking abstinence, reduction in nicotine consumption. Methods: The present study is a single center, randomized trial with two parallel groups of smokers scheduled for surgery comparing surgery alone and surgery with preoperative smoking cessation. The investigators plan to randomize 251 patients. The primary endpoint is the Comprehensive Complication Index up to a 90-day postoperative period. The secondary endpoints include comparison of smoking abstinence, quality of life, mental health, length of stay, costs of care and difference in hospital reimbursement between the two groups. Discussion: The hypothesis is that preoperative smoking cessation program improves outcomes in smokers undergoing surgery.
Smoking cessation is a public health priority. Tobacco is directly responsible for 75,000 deaths per year in France. Without help, less than 5% of smokers are still abstinent after 12 months of smoking cessation. The use of nicotine replacement therapy only increases the chances of successful smoking cessation by 2-3%. Brain imaging research shows that the dorsolateral prefrontal cortex (DLPC) is involved in tobacco addiction. Disorders induced in the DLPC cause an irrepressible urge to smoke (craving) and largely explain relapse during smoking cessation. Transcranial Magnetic Stimulation (TMS) could be a promising tool in the quest for an effective approach to smoking cessation. This technique is used for direct stimulation of the DLPC via a magnetic coil in order to reduce the cortical activity of the DLPC and thus to reduce cravings. A first randomized controlled study using TMS was conducted at the University Hospital of Dijon in highly addicted smokers who had failed to quit with the usual withdrawal strategies. In this study, entitled Tabacstim 1, we found that the combination of nicotine substitutes (to reduce physical withdrawal symptoms) with 10 "attack" sessions of TMS (to reduce cravings) increased the rate of abstinence during the first 2 weeks of withdrawal (% abstinence = 88. However, in this study, the therapeutic effect of the nicotine-SMT combination was not prolonged once the stimuli were stopped. At 6 and 12 weeks from the start of withdrawal, abstinence rates in the active SMT and placebo SMT groups were no longer significantly different. We therefore initiated a new study, entitled Tabacstim 2, to add maintenance brain stimulation to the Tabacstim 1 protocol after the "attack" sessions (this therapeutic scheme is classically used in the treatment of depression with TMS). This study started in July 2020 and will end very soon (71 inclusions completed out of the 78 expected). In both Tabacstim 1 and Tabacstim 2, the stimulations are delivered at low frequency (1 Hz) on the right DLPC. However, a recently published meta-analysis shows that, in addictions, stimulations delivered at a high frequency (10 Hz) on the left DLPC appear to be more effective in reducing craving. But above all, another meta-analysis carried out by our team (in progress of publication), finds that excitatory stimulations (such as 10 Hz rTMS) on the left DLPC are very effective in maintaining smoking abstinence in the medium term (3 and 6 months), which does not seem to be the case for inhibitory stimulations (such as 1 Hz rTMS). We therefore wish to carry out the Tabacstim 3 study, which only differs from Tabacstim 2 in two stimulation parameters: 10 Hz stimulations on the left DLPC instead of 1 Hz stimulations on the right DLPC. We therefore propose in Tabacstim 3 to use excitatory stimulations on the left instead of inhibitory stimulations on the right. Tabacstim 3 could be more effective for prolonged smoking cessation than the 2 previous protocols.
The study team will develop and assess the feasibility and acceptability of a WeChat-based peer-group mobile messaging smoking cessation intervention targeting Chinese immigrant smokers in New York City (NYC). For Aim 1, the study team will develop a message library for the WeChat Quit Coach smoking cessation program and conduct in-depth interviews with 20 Chinese immigrant smokers in person to assess content relevance. For Aim 2, a two-arm, open-labeled, pilot randomized controlled trial (RCT) will be conducted to test the feasibility and acceptability of the WeChat Quit Coach intervention among 60 Chinese immigrant smokers. Participants will be randomized to intervention (n=40) or control group (n=20). Participants in the intervention group will receive a 6-week WeChat Quit Coach intervention through WeChat private group. Participants in the control group will receive a leaflet with information about existing smoking cessation programs that focus on Chinese American smokers. All the 60 participants will be offered a 4-week supple of nicotine replacement therapy (NRT) patches and/or lozenges. Participants will complete a baseline in-person survey at enrollment, a 6-week follow-up phone survey immediately after the intervention, and a 6-month follow-up phone survey. Biochemical test (exhaled carbon monoxide test) will be conducted to confirm abstinence among those who report no smoking in past 7-day at 6-week and 6-month follow-up surveys. Post-test in-depth interviews will be conducted with at least 20 participants in person from the intervention group at 6-week follow-up to obtain more information about the usability and perceptions about the WeChat Quit Coach program. For Aim 3, the investigators will conduct an open-labeled, 3-arm pilot RCT to test the preliminary effectiveness of the WeChat Quit Coach intervention with 90 Chinese immigrant smokers. Participants will be randomized to one of the three groups, including a 6-week intervention group A (IA; n = 30), a 12-week intervention group B (IB; n = 30), and a control group (n = 30). Participants in the intervention groups will either receive a 6-week (IA) or 12-week (IB) WeChat Quit Coach intervention through WeChat private groups. Participants in the control group will receive a leaflet with information of existing smoking cessation programs targeting Chinese American smokers. All 90 participants will be offered a 4-week free supply of NRT patches and/or lozenges. Participants will complete a baseline phone survey at enrollment, 12-week and 6-month follow-up phone surveys. A remote biochemical validation (saliva cotinine test) will be conducted at 12-week and 6-month follow-up to confirm smoking abstinence among those who self-report no smoking in the past 7 days. Post-test in-depth phone interviews will be conducted with up to 30 intervention participants to obtain more information about their perceptions and experience with the WeChat Quit Coach program.
PREVENT is a multicentre, 2x2 factorial, randomized clinical trial that aims to determine the effect of cytisine versus placebo, as well as the effect of video messaging to support smoking cessation versus standard of care in perioperative patients. This trial aims to investigate the effects of cytisine and text messaging on 6-month continuous abstinence rates. PREVENT will also assess secondary outcomes at 30 days, 56 days and 6 months post-randomization: 7-day point prevalence abstinence, urge to smoke, time to first lapse, time to relapse, number of cigarettes smoking if still smoking, pulmonary complications, vascular complications, wound and infectious complications, stroke, time in hospital and acute hospital care.