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NCT03745339
Background: People with addictions often find it hard to choose the long-term benefits of abstinence over the short-term effects of using drugs. Researchers think this is partly due to parts of the brain involved in certain types of learning and decision-making. Researchers want to test these basic functions using a simple task with pictures and odors. Objective: To see if performance in a learning task differs between people who have opioid-use disorder and people who don t. Eligibility: Adults 21-60 years old who are willing to fast for at least 6 hours and smell food odors. Those with an opioid-use disorder must either not use for at least 3 weeks or be in treatment. Design: Participants will have 1 visit that will take up to 5 hours. Before the visit, participants will be asked to not eat or drink anything except water for at least 6 hours. At the visit, participants will be checked for signs of intoxication. Participants will give urine and breath samples. Participants will have tests of learning and behavior. They will look at shapes on a computer screen. The shapes will be paired with different food odors. The odors will come from a sterile tube placed under the nose. Participants will have their breathing monitored with a belt around the upper abdomen. About 30 days and 60 days later, participants will be called and asked about their drug use over the past 30 days.
NCT07123194
In today's world where digital technologies are integrated into every aspect of life, adolescents' unhealthy and uncontrolled use of digital media causes important psychosocial problems such as digital addiction and cyberbullying. This research aims to examine the effects of an art-based nursing intervention program in order to help adolescents born into the digital world gain healthy digital habits. The art-based nursing intervention program that helps gain healthy digital habits aims to increase adolescents' expressive expression skills, develop their skills in coping with challenging situations in the digital environment and strengthen their self-efficacy levels through creative art activities. The research is a randomized controlled trial designed as an experimental type, pre-test-post-test design. The research will be carried out in Prof. Dr. Fuat Sezgin Secondary School in Karatay district of Konya province. The sample group was determined as a total of 64 adolescents, 32 intervention and 32 control. Adolescents will be randomly assigned to the intervention and control groups. The pre-test data of the intervention and control groups were collected before the program started; The post-test data will be collected face-to-face by the researcher after the program is completed using the Personal Information Form, Digital Addiction Scale for Children, Revised Cyberbullying Scale (YSZE-II) and Self-Efficacy Scale for Children. It is expected that the digital addiction and cyberbullying levels of adolescents who are applied the art-based nursing intervention program that helps them gain healthy digital habits will be lower than the control group, and their self-efficacy levels will be higher than the control group. It is anticipated that the findings to be obtained as a result of the research will enable the development of creative and holistic intervention approaches that will increase the functionality of school health nurses against the risks posed by the digital age on young people. It is also thought that it can provide an evidence-based basis for the usability of art-based interdisciplinary practices in the field.
NCT07547696
The purpose of this study is to identify the best combination of new intervention components to use with CARRII, the first automated online intervention for alcohol-exposed pregnancies (AEP). This intervention is specifically designed for Native women and others who can become pregnant. Our goal is to maximize the effectiveness of the online intervention while keeping costs manageable for Native communities.
NCT06968078
Smartphone usage has increased significantly in the last decade and smartphones have changed our lives to a great extent. Smartphone usage has advantages as well as disadvantages and therefore brings phone addiction with it. Smartphone addiction is defined as excessive use of smartphones to the extent that it disturbs the daily lives of users. It has been stated in the literature that phone addiction can cause some disorders in individuals. Changes in neck posture and balance may be among the symptoms affected in this context. However, the relationship between excessive smartphone usage and neck proprioception, angle and balance is not clear in the literature. Therefore, the aim of our study was to examine the relationship between smartphone addiction and neck angle, proprioception and balance.
NCT07292883
The goal of this clinical trial is to examine whether a 5-day course of bilateral accelerated deep transcranial magnetic stimulation (aTMS) is a feasible treatment to help adults (18-65) with Tobacco Use Disorder to quit smoking. This study aims to enroll 30-40 participants and will examine treatment tolerability, treatment acceptability, participant retention, and adherence to scheduled treatment sessions. There are two key objectives and hypotheses: Objective 1: To evaluate whether a 1-week course of bilateral aTMS (4 sessions per day for 5 days) is feasible and tolerable as a smoking cessation treatment. Hypothesis 1: Feasibility will be demonstrated by acceptable tolerability, acceptability, retention, and adherence, with a practical target of 30 out of 40 participants completing the treatment. Objective 2: To explore how aTMS affects smoking outcomes, including: * Point-prevalence abstinence at end of treatment and at Weeks 3, 5, and 9. * Prolonged/continuous abstinence at Weeks 13 and 26. * Craving, cigarettes per day, and dependence severity. Hypothesis 2: Participants will show improvements on these outcomes from post-treatment through follow-up.
NCT07071883
The purpose of this study is to pilot the use of Holotropic Breathwork (HB) for individuals seeking to recover from addiction. The study will have two arms: A--for individuals in residential treatment programs, B--for individuals living in the community. Arm A will use a cluster randomized intervention, providing HB for individuals at two facilities and a Multiple Modality (MM) intervention (soundbath, meditation, and a film/discussion) at a third facility. In Arm B, we seek to measure the feasibility, acceptability, and preliminary impact of HB among people with addiction living in the community. Arm B will be comprised of a single group and participants in this group will receive the same HB experience as the participants in the Arm A HB group. HB is the practice of self-directed hyperventilation while lying down with the support of a selected music set and trained facilitators. Participants may experience an expanded state of consciousness with altered cognition, perception, and emotions. HB has been associated improved mental functioning among the general public and people in addiction treatment, but has never been evaluated in a controlled trial. Inclusion criteria consist of being 19 years of age or older and having met criteria for a substance use disorder within the past five years. Additional inclusion criteria for participants in arm A include being in a residential addiction treatment program at CenterPointe or the Bridge. Exclusion criteria form the Arm A HB group and the Arm B group include having been diagnosed with a bipolar disorder or a psychotic disorder or having had psychotic symptoms at any point in life, diagnosed with a cardiac condition, received care for a cardiac condition, or have current cardiac symptoms, ever diagnosed with a seizure disorder, current uncontrolled hypertension (140/90 or greater), diagnosed with glaucoma or retinal detachment, recent surgeries, or currently pregnant. Four breathwork sessions will be held: two at the UNMC College of Nursing in Lincoln, one at CenterPointe in Omaha, and one at The Bridge in Lincoln. One MM session will be held at The Bridge in Lincoln.
NCT07022782
The MED-DOPE (MEDiterranean diet-driven Detoxification of OPioid addicted patiEnts) study is a randomized controlled trial that aims to investigate the role of a nutritional intervention based on the principles of Mediterranean diet on craving, which is the primary outcome, and blood redox status of opioid-addicted patients under medication-assisted treatment with buprenorphine and methadone. In detail, the patients of the intervention group will consume three meals per day (i.e., breakfast, lunch and dinner) based on the principles of Mediterranean diet for 90 days. The patients of the control group will follow their normal nutritional habits. Craving as the primary outcome, quality of sleep and biochemical parameters such as blood redox status will be evaluated. It is hypothesized that the applied nutritional intervention will reduce craving, probably through the improvement of blood redox status, of the patients of the intervention group compared to the patients of the control group.
NCT07510256
Emotional wellness can play a vital role in supporting recovery from substance use disorder (SUD). Developing skills to regulate emotions and manage stress during early stages of recovery can help manage triggers and prevent relapse. Controlled breathing (i.e., intentional manipulation of rate and/or depth of breathing over time - often referred to as "breathwork") can enhance emotion regulation, but their effects have been minimally studied in individuals recovering from SUD. This randomized controlled pilot study will examine the impact of breathwork and meditation training program ("SKY Recovery") designed for people in substance use recovery. It will take place at a residential substance use recovery treatment center in upstate New York with patients in recovery who have elected to participate in the SKY Recovery program delivered at the treatment center. The study will compare two groups (SKY Recovery vs. Control) to assess the intervention's impact on emotional well-being and craving. Participants randomized to the SKY group will complete a 5-day intensive workshop followed by weekly follow-up sessions. The Control group will receive the same intervention after a delay. Validated measures of emotion regulation, craving, and sleep quality will be collected at baseline, one week after the program, and again 3 weeks after the program to determine efficacy and feasibility for a larger trial.
NCT06613698
The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.
NCT07495839
Addiction is a major public health issue. According to the World Health Organization (2024), approximately 400 million people worldwide suffer from alcohol- or drug-related disorders, resulting in nearly 3.2 million deaths per year. In France, the situation is also cause for concern: approximately three million people engage in risky alcohol consumption, thirteen million smoke daily, and nearly one and a half million use illicit drugs, primarily cannabis. Addiction, defined by the National Institute on Drug Abuse (NIDA) as a chronic, relapsing brain disorder, is characterized by the compulsive pursuit and use of a substance despite knowledge of its harmful effects. Its development depends on multiple factors: personal (trauma, psychiatric disorders, genetic predispositions), environmental (stress, isolation, family context), and those related to the substance itself (addictive potential). The diagnosis of substance use disorders is based on 11 criteria defined in the \*Diagnostic and Statistical Manual of Mental Disorders\* (DSM-5), the main ones being: loss of self-control, interference of substance use with academic or occupational activities, continued use despite awareness of the problems it causes, and a new central criterion, craving, defined as an irresistible urge to use, which serves as both a symptom and a diagnostic and prognostic marker because it is a predictor of relapse. The cumulative total of criteria allows the disorder to be classified as mild (2-3), moderate (4-5), or severe (≤ 6). Since the 2020 health crisis, researchers have observed an increase in the use of psychoactive substances, particularly among vulnerable populations. Despite public policy efforts and treatment programs, relapses remain common after treatment, affecting 60 to 70% of patients within six months of their hospitalization. This phenomenon is also observed at La Musse Hospital, where many patients admitted to the nutrition and alcoholism unit express a sense of emptiness upon returning home: a void in relationships, therapy, and daily activities. This feeling often contributes to a return to substance use. To address these relapses, this study aims to evaluate the impact of a post-hospitalization equine-assisted therapy program on the mental health and addictive behaviors of patients receiving addiction treatment. Already used at La Musse Hospital as part of the care pathway, equine-assisted therapy is based on the interaction between the patient and the horse in a therapeutic setting. Several studies have demonstrated the benefits of this approach on emotional regulation, self-confidence, stress management, and overall well-being. This prospective, single-center, interventional study will include twenty-two patients who have been hospitalized at least once in the nutrition and alcoholism unit at La Musse Hospital or another facility. Participants will be randomly assigned to either a group receiving post-hospitalization equine-assisted therapy or a control group.
NCT07221383
This study is a pilot randomized controlled trial to evaluate feasibility, acceptability, and preliminary efficacy of a digital intervention called Let's Do Addiction Recovery Together! (LDART) in adults with alcohol use disorder, relative to a control group.
NCT01036971
Background: \- The Neuroimaging Research Branch of the National Institute on Drug Abuse (NIDA) is interested in developing a pool of potential research participants who may be eligible for research studies on drug abuse and addiction, pharmacological and psychosocial therapies for substance addiction, and the long-term effects of drugs on the development, function, and structure of the brain and other organ systems. To develop this pool of potential participants, researchers intend to screen adolescents and adults who may be eligible for future research studies. Objectives: \- To identify, recruit, and screen participants for NIDA neuroimaging research protocols. Eligibility: \- Individuals 18 years of age and older who are able to provide informed consent. Design: * Eligible participants will undergo two screening interviews: a telephone interview and an in-person interview. The phone interview will determine eligibility for the in-person interview. Adolescents who are eligible for further screening must bring a parent or guardian with them to the in-person interview. * The in-person interview may require up to five visits to the NIDA clinical center. The in-person visit will involve any or all of the following procedures: (1) full physical examination and medical history; (2) psychiatric interview; (3) psychological testing; (4) electrocardiogram; (5) samples of blood, urine, and hair; and (6) other minimally invasive procedures as directed by the research staff. * During the screening process, participants will be explicitly asked for permission to recontact them after the 1-year duration of the screening protocol. For minors, both the adolescent and the parent/guardian must agree to future contact. * No clinical care will be provided under this protocol.
NCT02836080
Among youth, the prevalence of mental health and addiction (MHA) disorders is roughly 20%, yet youth are challenged to access services in a timely fashion. To address MHA system gaps, this study will test the benefits of an Integrated Collaborative Care Team (ICCT) model for at-risk youth with MHA challenges. In partnership with community agencies, adolescent psychiatry hospital departments, and family health teams, investigators have developed an innovative model of service provision involving rapid access to MHA services. This model will be implemented and compared to the usual treatment youth receive in hospital-based, outpatient, mental health clinics in Toronto. A rapid, systematic, approach to MHA services geared to need in a youth-friendly environment is expected to result in better MHA outcomes for youth. Moreover, the ICCT approach is expected to decrease service wait-times, be more youth- and family-centred, and be more cost-effective.
NCT03911466
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial. It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development).
NCT07455981
Problem gambling (PG) is influenced by environmental, psychological, and socioeconomic factors, including impulsivity, depression, anxiety, and characteristics such as marital status, age, and educational level. In France, approximately 5% of adults are affected by PG. Workers with atypical schedules or periods of inactivity at work are at risk of developing problematic gambling behavior. Stress, burnout, and boredom at work can exacerbate these risks. Working atypical hours, such as night shifts, is linked to mental health disorders such as depression and anxiety, which may increase the risk of PG. However, there is a lack of research on the impact of atypical schedules and periods of inactivity on PG. This research will explore the association between work schedules, periods of inactivity, and PG, particularly among workers who may be influenced by gambling norms and the specific characteristics of their jobs.
NCT06636929
There is no study that examines the effect of problematic use of smartphones, which has become a global problem today, on reaction time and cognitive functions together. This study was planned to examine the effect of problematic smartphone use on upper extremity functions and cognitive functions. Participants' problematic smartphone use will be evaluated with the Smartphone Addiction Scale Short Form. Within the scope of upper extremity functions, Quick Disabilities of Arm, Shoulder \& Hand Questionnaire, reaction time and grip strength will be evaluated. Reaction time will be measured with BlazePod Trainer (Blazepod Trainer Device, Play Coyotta Ltd, Tel Aviv, Israel). Jamar dynamometer (Performance Health, Warrenville, IL) will be used to evaluate grip strength. Cognitive functions will be assessed using the Stroop Test ÇAPA Form, Trail Making Test and Cognitive Failures Questionnaire.
NCT07460973
We Are Here Now - Plus (NE+) is a holistic, culturally centered, and multilevel intervention for American Indian youth to improve sexual health, mental health, and substance use outcomes. The goal of this intervention is to learn if NE+ can decrease substance use during sex, decrease sexual activity, increase condom use, increase positive mental health, increase caregiver(parent)-youth communication, increase communication between school personnel and youth, and increase utilization of clinical services. Researchers will compare one intervention arm to one control arm to see if the aforementioned indicators improve among the intervention arm for youth participants. Youth participants (ages 12-18) will participate in a 9-month educational program consisting of 18 modules that discuss healthy relationships, puberty \& physiology (separate girls \& boys), parenting, pregnancy and sexually transmitted infections (STIs) and Human Immunodeficiency Virus (HIV) prevention, sexual avoidant behaviors with a focus on abstinence, substance use prevention with a focus on abstinence and refusal skills, \& positive mental health, resources; skills (high school)- self-efficacy, refusal skills, decision making, communication, abstinence; skills (middle school) - health knowledge, self-efficacy, boundaries, communication, abstinence. Youth will also participate in six teachings offered by local cultural leaders that coincide with educational modules, including: kinship networks \& family; cultural values; 7 sacred roles of tribal members; ceremonies; cultural teachings and responsibilities of women \& men in tribe \& ceremonies; Indigenous worldview; skills - knowledge of traditional ways, language \& cultural people to go to for help; community members roles \& responsibilities in tribe \& ceremonies. Caregiver (parent) participants will participate in three in-person visits/meetings to discuss the following: visit 1 - age specific physical, cognitive, emotional, spiritual development; visit 2: prevention of substance use, promoting positive mental health, promotion of healthy relationships; skills -communication with youth; visit 3 - pregnancy and STIs/HIV prevention and abstinence from sex, parental monitoring, tribal resources. School personnel participants will participate in three workshops during teacher in-service training days, including the following information: Workshop 1 - cultural teachings on kinship \& family networks, cultural values, cultural age \& community roles; Workshop 2 - sexual risk avoidant behaviors, substance use prevention, positive mental health promotion, pregnancy STIs/HIV prevention, tribal resources; Workshop 3 - culturally respectful communication skills by age \& youth (boy/girl) and age \& caregiver (male/female); skills - knowledge of cultural ways, substance use prevention, positive mental health promotion, sexual risk avoidant behaviors, culturally respectful communication.
NCT06285253
The clinical trial will assess the safety of miroliverELAP for the treatment of acute liver failure, severe acute alcohol-associated hepatitis, or acute on chronic liver failure. miroliverELAP is an external liver assist combination product consisting of a single-use MIRO-001 bioengineered liver graft and an extracorporeal blood circuit. miroliverELAP Is intended to support the native (failed) liver for up to 48-hours of continuous treatment to allow time for liver recovery or to identify a transplantable liver.
NCT05315492
This study aims to develop and test an intervention to enhance the addiction service continuum with the joint effort of commune health workers and family members of people who use drugs in Vietnam.
NCT05505942
Brief Summary: Alcohol use disorder (AUD) is a significant and costly public health problem that affects one-third of the U.S. population in their lifetime. Specifically, unhealthy alcohol use is common among persons living with HIV (PLWH) and increases the risk of developing negative outcomes. Antiretroviral therapy (ART) has shown increasing life expectancy and decreased HIV-related deaths, leading to a growing older adult HIV population. Yet, HIV accelerates the aging process and increases the risk for numerous chronic health conditions that compromise physical and mental health functioning and quality of life. Thus, PLWH continue to have shorter life expectancies relative to the general population and these multimorbidities explain this increased risk. In this context, unhealthy alcohol use among PLWH can further increase the risk for negative outcomes. Physical activity (PA) interventions can be used as an effective way to address unhealthy alcohol use among PLWH. Previous PA interventions have shown low generalizability and high loss to follow-up. Therefore, an intervention that is home-based, including lifestyle physical activity (LPA) with mobile health-delivered components is designed following the physical activity (PA) paradigm. Participants in this randomized controlled trial will be assigned to one of two study arms -- either the LPA or Fitbit Only intervention - both lasting 12-weeks. Both study arms will utilize a Fitbit to track daily step counts. In addition to utilizing a Fitbit, the LPA arm will receive 7 LPA sessions with a trained interventionist to assist in adding LPA to the participant's routine. The Fitbit only arm will receive only brief check-in phone calls and only related to assisting with any Fitbit functioning issues. Follow-up assessments will take place at 3 and 6 months.