A Prospective Observational Study in Naturalistic Settings to Describe Long Acting Buprenorphine Introduction in France: Change in Severity of Addiction and Health Related Quality of Life Over a Period of 6 Months.
The current available pharmacological treatment formulations (i.e., daily formulations of buprenorphine or methadone) for OUD in France may have several inconveniences, such as: compliance, burden of daily intake, and risk of misuse; that may hinder their effectiveness. Long acting formulations of buprenorphine (LAB) such as Buvidal have been developed to favor retention and compliance and minimize the risk of diversion. Previous studies are promising on the advantage of LAB to treat opioid addiction, however more evidence is needed in the French healthcare context. However, in addition to randomized clinical trials, the French National Healthcare Agency (HAS "Haute Autorité de Santé") recommends conducting "real-life" studies (i.e., in naturalistic conditions) during the development of a medication and the use of "Patient Reported Outcome Measures" (PROMs) to analyze patient quality of life and/or other measures relevant to patients (e.g., severity, efficiency), without interpretation of the answers by a health professional. In this regard, our study proposes to use the Addiction Severity Index (ASI) self-report questions and several scales on treatment satisfaction and quality of life to collect the patient's opinion of perceived changes following the use of Buvidal. Main objectives: The objectives of this prospective open observational study, in naturalistic conditions, are to examine in individuals with an opioid use disorder, over a period of 6 months after LAB treatment initiation: the change in substance addiction severity and the changes in health-related quality of life, craving, opioids and other substance and non-substance uses and misuses, alcohol, tobacco and non-substance addiction severity, satisfaction with LAB treatment, severity of others domains related to addiction severity (i.e., medical, social, psychological) and psychiatric comorbidities Main hypotheses: 1. Hypothesize was that LAB will be associated with a stable (if prior remission) or a reduction of the CS of "Drug use" (i.e., substance addiction severity) at 6 months compared to baseline. 2. Hypothesize was that LAB will be associated with a stable (if prior remission) or a reduction of opioids and other substance and non-substance uses and misuses, other substances and non-substances addiction severity, craving, severity of others domains related to addiction (i.e., medical status, employment and support, family/social status, psychological status), an improvement of quality of life and a good satisfaction with treatment at follow-ups compared to baseline.
NCT06266039 — Addiction Opiate
Status: Recruiting
http://inclinicaltrials.com/addiction-opiate/NCT06266039/
Development and Pilot Testing of an Addiction Clinic-Based PrEP Adherence Intervention for Women With Substance Use Disorders
The goal of this clinical trial is to test an addiction-clinic based behavioral intervention for increasing PrEP uptake and adherence among women who engage in high-risk sexual behaviors and problematic substance use. The main question it aims to answer is: • If the integrated intervention increase PrEP uptake and adherence compared to standard treatment Participants will - receive provision of PrEP information through 4 counseling sessions - prevention navigation - receive nurse practitioner prescribed PrEP in an addiction treatment setting Researchers will compare intervention group with standard treatment to see if the integrated intervention help increase PrEP uptake and adherence
NCT06158607 — Substance Use
Status: Recruiting
http://inclinicaltrials.com/substance-use/NCT06158607/
Early Warning Model Construction on Cognition, Resistance and Using Risk of the New Psychoactive Substances in Adolescents Based on Behavioral Expression of Addiction Susceptibility Genes and Adverse Childhood Experience
Based on the biological-psychology-sociological medicine pattern, this study aims to construction an early warning model of the New Psychoactive Substances (NPS) using for adolescents aged 14-35 years old. This study intends to obtain the data related to the behavioral expression of addiction susceptibility genes, adverse childhood experience, cognition, resistance and the use of NPS in adolescents by questionnaire survey (sample size: 200), and then use logistic regression and machine learning to construct an early warning model.
NCT05958641 — Drug Addiction
Status: Not yet recruiting
http://inclinicaltrials.com/drug-addiction/NCT05958641/
The Use of Nursing-students-led bCBTMI for Internet Addiction Among Adolescents: a Feasibility Cluster Randomised Controlled Trial
The use of the internet is very popular in adolescence. Notwithstanding the benefits from the internet, many users are addicted to the internet and develop problematic behaviours which are regarded as "Internet addiction" (IA). Trained nursing students, who are the future nurses and well-equipped with basic health knowledge, as the interventionists to deliver a bCBTMI intervention to the eligible subjects. The result of this study is expected to provide evidence of the feasibility and effectiveness of training nursing students to conduct bCBTMI in Hong Kong Chinese adolescents with IA for a definitive RCT.
NCT05897359 — Internet Addiction
Status: Recruiting
http://inclinicaltrials.com/internet-addiction/NCT05897359/
Scalable Digital Delivery of Evidence-based Training for Addiction Professionals to Maximize Treatment Admission and Retention Rates of Opioid Use Disorder in Affected Families
The goal of this project is to develop and evaluate the technical feasibility and commercial viability of a scalable digital counselor training program for CRAFT. This pilot project will develop an enhanced training model for CRAFT and digitize it to maximize scalability. In this project, investigators will: Aim 1: Produce the digital counselor training prototype and coaching process, tailored to OUD - with stakeholder input. Aim 2: Conduct a pilot study of 3 levels of digital training (Level 1 - Digital tutorial only [T]; Level 2 - Tutorial & digital training materials for self-study [TM]; Level 3 - Tutorial, digital materials, feedback and coaching [TMC]) to establish feasibility, acceptability, and examine the effects of training on CRAFT knowledge, fidelity, and treatment entry and retention.
NCT05875142 — Substance-Related Disorders
Status: Completed
http://inclinicaltrials.com/substance-related-disorders/NCT05875142/
Pomegranate Juice Consumption by Patients Under Medication for Addiction Treatment as a Regulator of Craving and Blood Redox Status: The Study Protocol of a Randomized Control Trial (the NUTRIDOPE Study)
The NUTRIDOPE (NUTRItion-driven Detoxification of OPioid addicted patiEnts) study is a clinical trial that aims to investigate the role of pomegranate juice consumption by opioid-addicted patients under buprenorphine and methadone on craving, which is the primary outcome, and other parameters. In detail, fresh pomegranate juice will be administered for 120 days (250 ml, 7 days/week) to the patients and craving as well as other psychosocial (e.g., depression, mood state, quality of life) and biochemical (i.e., blood redox status and inflammation) parameters will be evaluated. It is hypothesized that pomegranate juice will reduce craving probably through the improvement of blood redox and inflammation status. Pomegranate juice, which is the examined nutritional intervention, will be administered to the participants of the experimental group, whereas their counterparts in the control group will not consume any similar beverage as a placebo due to the objective difficulties of making one that will be identical and not separable with the fresh pomegranate juice.
NCT05861544 — Psychiatry
Status: Enrolling by invitation
http://inclinicaltrials.com/psychiatry/NCT05861544/
The Evaluation of a Real-time Natural Language Processing Decision Support Tool for Screening Opioid Misuse With Addiction Consult Intervention for Hospitalized Adults
This is a clinical study to implement and evaluate a hospital-wide, operational intervention for a real-time natural language processing (NLP)-driven clinical decision support (CDS) tool, called Substance Misuse Algorithm for Referral to Treatment Using Artificial Intelligence (SMART-AI). The SMART-AI CDS tool will be evaluated via implementation in the UW Health electronic health record (EHR). The CDS tool is meant for screening inpatient adults for opioid misuse as part of a best practice alert to nurses and providers for addiction consult service needs.
NCT05745480 — Opioid Use Disorder
Status: Completed
http://inclinicaltrials.com/opioid-use-disorder/NCT05745480/
A Randomized Controlled Trial Comparing Avatar Intervention to an Addiction Supportive Intervention to Reduce Cannabis Use in Patients With Psychotic Disorders
The goal of this clinical trial is to conduct a single-blind randomized controlled trial to verify whether the Avatar Intervention has greater efficacy over supportive intervention to reduce cannabis use in patients with psychotic disorders.
NCT05704582 — Psychotic Disorders
Status: Recruiting
http://inclinicaltrials.com/psychotic-disorders/NCT05704582/
Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO): A Randomized Trial (R33 Phase)
This work will involve conducting a randomized trial that will evaluate preliminary efficacy of "assisted" rate cycling, voluntary rate cycling and psychotherapy for pain individually and in combination as adjunctive treatments on cravings (primary outcome) in adults with an opioid use disorder. The investigators will also evaluate the effects of "assisted" rate cycling, voluntary rate cycling and I-STOP on secondary outcomes including depression, anxiety and sleep.
NCT05688410 — Pain
Status: Recruiting
http://inclinicaltrials.com/pain/NCT05688410/
A Cluster Randomized, 2x2 Factorial, Superiority Study to Compare the Effectiveness of Adding a Remote Self-reporting Tool for Distress and a Fit-for-purpose Mental Health & Addictions Service to Usual Case Management on Program Completion and Employment Among Unemployed Visible Minorities and Women Enrolled in a Vocational Training Program
Youth unemployment is a chronic problem in most societies. Some young adults are neither in employment, eduction or training (NEET), and are at high risk of chronic unemployment, social disengagement and poor quality of life. Identifying this high risk population and providing them with career skills training and opportunities is critical for their full participation in society. Vocational training programs provide an opportunity for these NEET youth to develop a skilled trade. Barriers to successful completion of these programs include high prevalence of mental health and substance use disorders among NEET youth. This study will use a daily self-report distress tool to identify vocational program trainees at risk of absence or drop-out due to mental health and/or substance abuse issues. These at-risk trainees will then be referred to a mental health crisis program through a fit-for-purpose referral process to accommodate their training program requirements. It is hypothesized that early identification and referral for mental health and substance abuse issues will reduce both program absence and drop-out rates and result in improved in long-term employment for these NEET youth.
NCT05626374 — Substance Use Disorders
Status: Not yet recruiting
http://inclinicaltrials.com/substance-use-disorders/NCT05626374/