Active clinical trials for "Substance-Related Disorders"

The purpose of this trial is to test new programs to see if they might help people manage their health and health behaviors related to alcohol use and well-being. The program sessions focus on getting to know what's important to the participants, reviewing or setting goals, and using different skills and behaviors to better manage health. The trial will help the study team learn about ways to deliver health information in a way that is useful and interesting. This research will take place remotely (e.g., Zoom, Facetime, Phone) and participants will be randomized to the Telehealth (TeleTx) group intervention or the Enhanced Usual Care (EUC) control group. Both groups will be asked to have follow-up visits up to 12 months from the baseline visit.

Adolescents in residential substance use treatment have serious substance-related problems and poor outcomes following discharge: follow-up studies indicate that 60% of adolescents treated in residential treatment will relapse within the first 90 days. Parenting practices have been established as a critical predictor of adolescents' substance use outcomes and likelihood of relapse following treatments, but parents are notoriously difficult to engage in adolescent substance use treatment. Findings such as these provide strong justification for targeting parents of adolescents in residential substance use treatment via easily accessible interventions. This study tests the effectiveness of a technology-assisted parenting intervention called Parent SMART (Substance Misuse among Adolescents in Residential Treatment). The intervention combines an off-the-shelf computer program that teaches parenting skills called Parenting Wisely, four telehealth coaching sessions, and a networking forum that allows parents to connect with a clinical expert and with other parents. The investigators will compare adolescents who receive standard residential substance use treatment to adolescents who receive the same treatment plus whose parents receive Parent SMART. Investigators will test the comparative effectiveness of Parent SMART versus residential treatment as usual on parental monitoring and communication, adolescent substance use (i.e., days of substance use and substance-related problems), and substance-related high-risk behaviors (i.e., school-related problems, criminal involvement, externalizing behavior). The investigators will also test whether improvements in parenting partially mediate any observed changes in adolescent substance use and other high-risk behaviors.

Millions of people in the US misuse opioids each year, leading to thousands of deaths and costing billions of dollars in total economic burden. Medication assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious, but only a fraction of OUD persons access MAT, and treatment non-adherence is common and associated with poor outcomes. This STTR Fast Track proposal is designed to increase rates of Suboxone (buprenorphine/naloxone) treatment initiation and adherence among OUD patients recruited from emergency and inpatient acute care. To accomplish these aims, the project will enhance the Opioid Addiction Recovery Support (OARS), an existing Q2i company technology, with a new evidence-based reward, contingency management (CM) function. CM interventions systematically reward (reinforce) specific behaviors like treatment initiation and adherence with therapy attendance and drug-free urine tests and are highly efficacious. An OARS solution enhanced with a CM component (OARSCM) that allows for the automatic calculation, delivery, and redemption of rewards contingent on objective evidence of treatment behaviors may be key to improving Suboxone initiation and adherence. In Phase 1 of this proposal, the existing OARS clinician portal and patient mobile application will be modified to accommodate entry into the software system from an acute care setting and to automatically manage and deliver rewards to create OARSCM using patient-centered design principles. Focus groups with OUD patients and other key stakeholders will inform design. Primary usability outcomes will be examined, and the program iteratively updated. After meeting milestones, there was a proof-of-concept pilot of usability, acceptability, and effects on initial behavior targets with approximately 20 patients and at least 4 providers. After meeting milestones, this RCT will follow, in which acute care OUD patients appropriate for outpatient Suboxone (N = 102) are recruited and allocated to one of two study conditions: 1) treatment as usual (TAU) with MyMAT, comprised of screening, brief intervention, referral to treatment by a trained clinician, and an educational mobile app (MyMAT), 2) OARSCM. The active intervention window for the two intervention groups will be 12 weeks. Patients will be onboarded prior to discharge from acute care. In the outpatient Suboxone setting, data on treatment adherence and opioid use will be captured from clinical records for six months. Telephone follow-up assessments and vital statics registry reviews will be at month 1, month 3 (end-of-study intervention period), and month 6. Primary Suboxone treatment initiation outcomes will be completing the Suboxone intake. Primary Suboxone treatment outcomes will be sustained abstinence at Month 6 and longest duration of abstinence. Analysis will examine data on cost avoidance and cost savings through reduced acute care visits between study conditions.

Impaired cognitive function is common among patients with substance use disorder (SUD). This is particularly related to executive functions (EF), which includes abilities like decision-making, consequence analysis and impulse/self-control. EF is recognized as an important determinant of treatment outcome as it is associated with dropout rate, attendance to therapy sessions and absence of relapse following treatment termination. Exercise seem to improve cognitive/executive functions, particularly in individuals with cognitive impairments. Aerobic exercise also affects signaling substances and growth factors known to inhibit neural degeneration, and improves cerebral insulin sensitivity and blood flow, contributing to improved brain function. There is a lack of knowledge regarding how to improve EF in SUD patients, and whether such improvements can benefit other parts of the treatment, such as psychotherapy. Aerobic exercise is a well-recognized and cost-effective intervention for cardiovascular and metabolic health, with promising effects on cognitive/executive functions. A randomized controlled trial will be carried out to investigate the effects of aerobic exercise on EF, molecular markers of neuroplasticity and brain function, and treatment outcome in SUD patients. The investigators expect to achieve new knowledge regarding cognitive impairment among SUD patients and to what extent aerobic exercise can improve cognitive abilities and treatment outcome.

The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication for opioid use disorder (MOUD) and reduce polysubstance use among patients with OUD and polysubstance use in an underserved, rural area. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this hybrid, Type-1 effectiveness-implementation randomized controlled trial (RCT), the investigators will evaluate the effectiveness and implementation of Peer Activate vs. treatment as usual (TAU) over twelve months.

The goal of this clinical study is to learn whether treating sleep problems is helpful in people with substance abuse problems who are living in a residential treatment program. Another goal is to study whether treating sleep problems will help individuals stay in substance abuse recovery treatment for a greater amount of time. Participants will be asked to complete surveys at the time of enrollment and every week for the next 9 weeks for a total of 8 times. Participants will be asked to wear a watch that measures sleep (sleep watch) while the participants are in the group and for a 2-week period after the participants complete the group. Participants may also be asked to participate in an interview about the experience with the group and wearing the watch. Participants will also have "homework" throughout a 4 week period. Homework is to complete a sleep diary each morning. The first group of 50 participants will be enrolled in the brief behavioral treatment for insomnia (BBTI) group where the participants receive typical treatment plus the sleep intervention program. The investigators will use qualitative and quantitative data to identify implementation facilitators and barriers, then further modify BBTI to improve feasibility. After modifying the BBTI protocol and re-training staff, study procedures will remain intact with the exception that the investigators will double the recruitment and randomize participants to the modified BBTI (N=50) or standard-of-care (SOC) (N=50). All participants will complete all assessments except the SOC group will not complete treatment satisfaction surveys.

Methadone is a very long-acting opiate very difficult to detox from. In Spain there are a lot of methadone dependent people in the aftermath of the heroin epidemic of the 1980s. Many have been dependent for more than 15 years and a number of them have a relatively stable life condition (have work, family, housing, etc.) and a relatively good health condition in comparison with current heroin users. This Phase-II RCT is a collaboration with the Sant Joan Hospital in Reus, Spain. Twenty patients on the methadone maintenance program will be recruited. Patients will be randomized to two groups: One receiving 6 doses of 100 mg of ibogaine; and the other one receiving ascending doses of ibogaine (100-200-300-400-500-600). Methadone use will be interrupted and for both groups ibogaine will be administered when clinical symptoms of opioid withdrawal appear. After an ibogaine dose, when symptoms of opioid withdrawal appear again, half of the methadone dose used last time will be administered. By doing so, methadone doses will be progressively reduced until no withdrawal symptoms appear.

This study compares the effects of high dose and low dose, high intensity, endurance training and strength training in substance use disorder patients. The hypothesis is that the increase in endurance (measured as maximal oxygen uptake) and strength (measured as maximal strength) will be similar in both the high dose and low dose training groups after 24 training sessions over eight weeks. The rationale for this assumption is based on the patient groups poor physical capacity, supporting that a lesser physical workload is needed to achieve a substantial increase in physical capacity. The practical implication could be higher training attendance, because it is likely easier to motivate the patient group when they only have to perform half the workload. It is paramount for this patient group to increase their physical capacity and consequently augment their physical health status since they are in a high-risk group for developing life-threatening lifestyle related diseases.

Alcohol and/or drug abuse problems (ADAPs) have been consistently identified in the scientific literature as a risk factor of intimate partner violence against women (IPVAW). Around 50% of IPVAW offenders referred to batterer intervention programs (BIPs) have ADAPs. ADAPs are also one of the main predictors of BIPs dropout. In Spain, the majority of BIPs do not fit the intervention to specific needs or characteristics of IPVAW offenders, such as those with ADAPs. The aim of this research is to assess the effectiveness of a new motivational strategy adapted to IPVAW offenders with ADAPs, aiming to increase treatment adherence and to improve BIPs outcomes. The motivational strategy will include an individualized motivational plan (IMP) developed for each participant with ADAPs (IMP-ADAPs). In these IMPs one of the main aims will be to reduce alcohol and/or drug consumption. The current study will use a randomized control trial. Participants with ADAPs will be allocated to one of two treatment conditions: experimental condition: Standard batterer intervention program (SBIP) plus individualized motivational plan focused in ADAPs (SBIP+ ADAPs-IMP), and control condition: Standard batterer intervention program plus individualized motivational plan (SBIP+IMP). Primary/final outcomes will be recidivism and ADAPs reduction. Secondary/proximal outcomes will include treatment adherence related variables, violence related attitudes and attributions, self-control and psychological adjustment. Outcome variables will be assessed at baseline, at the end of the intervention, and at six months after the intervention will be finished.

This is a two phase study investigating combinations of pharmacological and behavioral interventions to optimize the treatment of Opioid Use Disorder (OUD). The Retention Phase will assess strategies for improving retention on buprenorphine (BUP) and extended-release injectable naltrexone (XR-NTX). The Discontinuation Phase will assess which approaches are most likely to lead to long-term success (absence of relapse), and what characteristics of participants distinguish those who can safely discontinue Medications for Opioid Use Disorder (MOUD) from those who remain at risk of relapse and should not discontinue.