Tobacco Use Disorder

This research aims to understand the views of teachers, parents, and students on preventing substance abuse among adolescents and to develop a school-based prevention program. The study evaluates the effectiveness of a bilingual, multicomponent training called the School-based Substance abuse Prevention Programme (SSPP) designed to improve awareness, attitudes, resistance to peer pressure, and life skills related to substance abuse prevention among adolescents aged 13 to 15 years in selected public schools of Pokhara, Nepal. The SSPP intervention includes four modules delivered to the experimental group: psychoeducation with video-assisted teaching and informational booklets to raise awareness; role play and case-based scenarios to foster positive attitudes and peer pressure resistance; storytelling on life skills like problem solving and emotion management; and demonstrations on communication, decision making, creative thinking, and stress management. The control group does not receive the intervention during the study but is given information booklets and video teaching after the posttest. Participants will be assessed at baseline, 3 months, and 6 months for changes in awareness, attitudes, peer pressure resistance, and life skills related to substance abuse prevention. Data collection involves focus group discussions for initial qualitative insights and cluster randomization of schools for the trial. The study includes 210 adolescents and tracks demographic factors and family history potentially related to substance abuse. The total study duration extends through these follow-up points to measure the program's impact.

Smoking negatively affects many organs and gradually worsens health, especially lung function. It causes mild airway obstruction and slows lung growth, impacting breathing and overall quality of life. This study evaluates balloon-blowing exercises combined with abdominal and lumbar core muscle activation positions to see if they can improve lung function and quality of life in smokers. Participants will be randomly assigned to one of two groups: one will perform balloon-blowing exercises with abdominal and lumbar core muscle activation three times a week for four weeks, supervised by a physical therapist. The other group will perform diaphragmatic breathing exercises with the same frequency and duration. Both interventions last four weeks, with measurements taken before and after. Participants will undergo evaluations of lung function including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), peak expiratory flow (PEF), dyspnea levels, oxygen saturation, and quality of life assessments. These measures will be collected at the start and end of the four-week period to monitor changes and effects of the exercises on respiratory health.

Researchers are studying how bite force and bone turnover markers change during the retention phase after orthodontic treatment in patients with different vertical facial growth patterns. The study compares patients with vertical (hyperdivergent) and horizontal (hypodivergent) craniofacial growth to understand relapse and bone remodeling processes over a 12-month retention period. This prospective clinical trial aims to provide insights into maintaining teeth alignment using retention appliances after fixed orthodontic treatment. The trial includes two groups of patients who have completed fixed orthodontic treatment and are ready for retainer delivery. Group 1 consists of patients with vertical growth patterns (FMA 26° or more), while Group 2 includes those with horizontal growth patterns (FMA 24° or less). Both groups will receive a Begg's retainer formed conventionally and delivered within 24 hours of debonding. Changes in bite force will be measured using a bite force device, and bone turnover markers CTX (bone resorption) and BALP (bone formation) will be assessed using ELISA at baseline and at 1, 3, 6, and 12 months after retainer delivery. Participants will undergo bite force measurements and biomarker testing at five timepoints during the 12 months retention phase: at retainer delivery, then after 1, 3, 6, and 12 months. Data on bone turnover markers and bite force changes will be collected and compared between the two groups. The study includes monitoring of functional occlusion, oral hygiene, and retainer compliance. The total participation time spans 12 months, during which researchers will assess both clinical and biochemical indicators of bone remodeling and bite function after orthodontic treatment.

Researchers are conducting a multi-site, double-blind, randomized clinical trial to study the effects of the 5-HT2A receptor agonist psilocybin compared to niacin for helping adults with tobacco use disorder to quit smoking. This Phase 2 study addresses prior findings from an open-label pilot trial and aims to include a diverse sample across four research sites to better evaluate psilocybin's potential efficacy in smoking cessation. Participants will receive two sessions one week apart of either oral psilocybin (30 mg in the first session and either 30 mg or 40 mg in the second session based on their response) or oral niacin (150 mg in the first session and either 150 mg or 200 mg in the second session). Both groups also receive cognitive behavioral therapy (CBT) to support quitting smoking. Niacin serves as an active placebo to help maintain study blinding. During the study, participants will undergo screenings including medical exams, blood tests, ECG, and smoking assessments. Researchers will measure biologically-verified abstinence rates up to 12 months and assess cognitive control and smoking urges at multiple time points before and after the target quit date. Safety monitoring and adherence to abstaining from smoking and psychoactive drugs around dosing sessions are included. The total study participation duration spans up to 12 months with follow-up to evaluate smoking cessation outcomes.

Researchers are studying whether treatment decision-making can be improved for smokers who have difficulty quitting with medications. This trial focuses on smokers seeking to quit and evaluates adaptive treatment strategies using FDA-approved options. The goal is to find the best approach for each person by adjusting the treatment based on early response to medications. The study is sponsored by the Medical University of South Carolina and is designed as a randomized clinical trial without masking. Participants will receive a free 12-week course of nicotine replacement therapies (patches and lozenges), varenicline, or e-cigarettes as harm reduction products. Initially, smokers are randomized to either varenicline or combination NRT for four weeks. Those showing early success continue the same medication, while non-responders may switch to the other medication or continue the same one, with further adjustments made at weeks 4 and 8. After 12 weeks, no more products are provided. All study visits and assessments are conducted remotely through phone calls and surveys. Participants will complete eight surveys over six months, including a follow-up survey six months after the initial call. Researchers will measure smoking cessation success and dependence outcomes, with primary outcomes assessed at 8 weeks and final outcomes at 24 weeks. The study allows for safety monitoring throughout and involves no in-person visits.

Researchers are studying cigarette smokers to compare the effects of tobacco-flavored electronic cigarettes (ECs), non-tobacco flavored ECs, and nicotine replacement therapy (NRT) on smoking habits. The study aims to understand how different EC flavors impact appeal, use, cigarette craving, withdrawal symptoms, motivation, and cigarette smoking behavior. The trial is sponsored by Ohio State University Comprehensive Cancer Center and explores how these options may influence smoking dependence and cessation efforts. Participants are randomly assigned to one of three groups: preferred flavor ECs (PEC), tobacco-flavored ECs (TEC), or NRT involving nicotine patches and lozenges. Each group receives their assigned products for 14 weeks, including a 2-week pre-switch period to get familiar with usage. Throughout the study, participants engage in discussions, and after the 14-week treatment period, they enter a 12-week surveillance phase to monitor continued use and outcomes. During the trial, researchers will assess cigarette smoking patterns, including switching rates and abstinence, cigarette craving, withdrawal symptoms, nicotine dependence, and product appeal. Data will be collected at various time points up to 26 weeks. Participants will also be monitored for the number of days they use the products and whether they continue EC use after the treatment phase. The study collects information through questionnaires and biochemical verification, aiming to understand the impact of these interventions on smoking behavior over time.

Researchers are studying people who use intravenous drugs (PWIDs) to understand how often needle fragments remain in the body after injecting drugs and what factors contribute to this condition. Retained needle fragments can cause local pain, infections, or serious complications like needle emboli to the heart or lungs. The study aims to be the first large investigation into the frequency and risks of needle fragment retention among PWIDs, focusing on those receiving outpatient care at drug abuse service units. Participants will complete a questionnaire covering their drug use history, injection sites, and any related local symptoms. They will then undergo targeted low-dose X-ray imaging of common injection areas to detect retained needle fragments. Female participants under 50 will have a pregnancy test before imaging. The study includes an initial pilot with 20 participants to refine procedures, followed by recruitment of up to 100 total participants. During the study, researchers will collect information through questionnaires and X-ray imaging to identify needle fragment retention and related risk factors. They will also track how many participants have fragments surgically removed within five years after detection. The study involves outpatient volunteers who are currently in treatment and will last up to five years for follow-up of surgical outcomes and mortality risks associated with retained fragments.

This research aims to develop and test a culturally tailored smartphone app called HealthyCells to help African American smokers quit smoking and reduce sedentary behavior. African Americans have higher quit attempts but lower success rates compared to other groups. By integrating two proven smartphone interventions, the study seeks to address barriers and promote cessation and activity using tailored content that considers cultural strengths and challenges. HealthyCells combines a smoking cessation app with features like facial recognition to verify smoking status twice daily using carbon monoxide breath samples, and activity monitoring via a Google smartwatch. The app sends real-time prompts to encourage movement after 30 minutes of sitting and delivers motivational messages twice daily to support quitting and reduce sedentary time. The study includes a pilot phase with 15 African American smokers to refine the app, followed by a main phase where 30 participants will use HealthyCells during a planned quit attempt. Participants will engage in smoking status assessments and activity monitoring remotely, with rewards for abstinence based on biochemical verification at 8 weeks. Sedentary time will be measured by accelerometer for 7 days before quitting and 7 days at 8 weeks post-quit. The research team will evaluate smoking abstinence rates and changes in sedentary behavior to determine the app's feasibility. The total study participation is focused on the 8-week period post-quit date, with frequent assessments and feedback via the app.

This research aims to evaluate a smartphone application called Acceptance and Commitment Therapy (ACT) on Vaping, designed to help young adults quit using electronic cigarettes. E-cigarettes pose various risks, especially for youth and young adults, and this study explores a digital behavioral therapy approach to support quitting. The study is focused on young adults aged 18 to 30 who currently use e-cigarettes weekly. The ACT on Vaping app delivers tailored sessions that increase awareness of triggers for tobacco use and teach coping skills based on readiness to quit. Participants are randomly assigned to one of two groups. One group uses the ACT on Vaping app (Version A) alongside a text messaging program that motivates and supports quitting, plus incentivized text message check-ins at 2 weeks, 2 months, and 4 months to monitor vaping status. The other group uses the ACT on Vaping app (Version B) with health education content and also receives incentivized check-ins at the same time points. After the intervention, follow-up assessments occur at 3, 5.5, and 6 months post-randomization. During the study, participants complete regular check-ins via text messages to report vaping status and engage with the app content. Researchers will measure abstinence from all nicotine and tobacco products at 6 months using cotinine confirmation, along with self-reported vaping abstinence at 3 and 6 months. Additional outcomes include quit attempts and readiness to quit. The study involves digital engagement, surveys, and behavioral support, with safety and progress monitored remotely throughout the trial period.

Researchers are evaluating a new smartphone app called IndigeQuit to help American Indians and Alaska Natives (AI/ANs) quit smoking, comparing it to the existing National Cancer Institute (NCI) QuitGuide app. AI/ANs face much higher rates of smoking-related cancers and deaths compared to other groups, often due to limited access to effective cessation interventions. This trial aims to test whether the IndigeQuit app, designed to teach skills for coping with urges and preventing relapse, is more effective in supporting smoking cessation for this population. Participants are randomly assigned to one of two groups: one uses the IndigeQuit app, which involves creating a personalized quit plan, completing eight content levels, accessing on-demand help, and tracking daily smoking for at least 45 days; the other group uses the NCI QuitGuide app for at least the same duration. After completing the intervention period, participants are followed up at 3, 6, and 12 months to assess ongoing smoking status and app effects. During the study, participants provide information through surveys and may contribute biospecimens for ancillary studies. Researchers measure smoking abstinence rates, focusing on 30-day abstinence at 12 months as the primary outcome, with additional assessments at earlier intervals. The study lasts over a year with multiple follow-up points, ensuring detailed monitoring of smoking behavior changes and app engagement.