View clinical trials related to Substance Use Disorders.
Filter by:National mandates for increasing accountability in behavioral healthcare have created an urgent need for effective quality assurance (QA) procedures featuring pragmatic measures of treatment implementation quality in usual care (UC). The most practical method for assessing treatment quality in UC is therapist self-report; unfortunately, therapist-report measures of fidelity to evidence-based practices (EBPs) have demonstrated weak validity to date. This study addresses this need for effective QA procedures by first developing treatment quality assurance procedures designed to increase the adoption and quality of empirically supported family-based services (FBS) for adolescent substance use (ASU) in usual care, and then testing two system-level implementation strategies for installing the new quality procedures in ASU treatment sites. FBS have achieved the strongest evidence base for treating ASU and are a prime candidate for upgrading the quality of ASU services in various systems of care. FBS comprise both family participation in services, the systemic parameters wherein family members are included in assessment and treatment activities; and family therapy techniques, the specific interventions that clinicians use to directly target family members and family functioning for change. For FBS to fulfill their potential to enhance ASU treatment systems, FBS implementation must be supported by effective quality assurance procedures designed to ensure that FBS are delivered with fidelity. The proposed study will leverage a strong research-government partnership between the applicant organization and the New York single-state agency for SU services. The study will first develop innovative quality procedures (Aim 1) that use existing FBS quality metrics to promote high-fidelity FBS: Measurement Training and Feedback System for Implementation (MTFS-I), a pragmatic evidence-based method for increasing FBS quality by providing monthly feedback on therapist-reported FBS delivery along with brief online FBS training modules. The study will then experimentally compare two system-level implementation strategies designed to foster MTFS-I utilization in usual care for ASU. Core Training Only will contain two 3-hour training sessions: Mapping existing FBS and identifying site goals for FBS improvement; and Installing and sustaining the MTFS-I. Core + Facilitation is an additive strategy that will begin with the Core Training sessions and then continue with monthly facilitation meetings for one year to promote MTFS-I use and progress toward FBS improvement. The study will feature a three-group cluster randomized trial testing Core Training Only versus Core + Facilitation versus no-intervention Control in 9 ASU clinics across New York State. MTFS-I utilization data will be collected from Core Training and Core + Facilitation sites for one-year follow-up (after initial Core Training); FBS quality data on family participation and family therapy technique use will be collected from all sites over one-year follow-up; observational coding methods will verify therapist reports of FBS quality; and client outcome data for all sites will be retrieved from administrative data warehouses over one-year baseline and one-year follow-up. These data will enable between-condition comparisons of FBS delivery (Aim 2: MTFS-I utilization, family participation, family therapy technique use) and client outcomes (Aim 3: therapeutic goal achievement, substance use change). If study aims are achieved, investigators would be positioned to mount a fully powered RCT to test the effectiveness of these FBS quality improvement procedures at scale.
The investigators seek to assess the effectiveness of Project POINT (Planned Outreach, Intervention, Naloxone, and Treatment). As originated in Indianapolis, Project POINT is a collaboration between Indianapolis Emergency Medical Services (EMS), the Eskenazi Emergency Department, Midtown Mental Health, and researchers at Indiana University. POINT is a quality improvement initiative that connects trained outreach workers with emergency department (ED) patients who experienced a non-fatal overdose. A member of the POINT team (a recovery coach or care coordinator with specialized training) meets patients after they have experienced an opioid overdose and, following a model of patient-centered care, offers them a range of evidence-based services including a brief assessment of high-risk behaviors, Hepatitis C and HIV testing, harm reduction counseling informed by motivational interviewing, and treatment referrals with follow-up to either a medication for opioid use disorder (MOUD) provider, detoxification services, or an inpatient treatment setting The primary goal of this project is the establishment of POINT as an effective and scalable intervention for engaging patients in MAT. This study employs a Hybrid Type 1 effectiveness implementation design to take full advantage of current POINT expansion efforts currently happening in Indiana. The goal of this study is to replicate POINT in new hospitals and test its feasibility through (a) assessment of the chosen implementation strategy and (b) the testing of research protocols and secondary data collection procedures.
The proposed 2-week, double-blind, crossover, proof of concept study aims to measure and manipulate core neurochemical (i.e., dysregulated brain GABA/glutamate homeostasis) and neurobehavioral (i.e., elevated impulsivity) dysfunctions characteristic of individuals with cannabis use disorder (CUD) and Bipolar Disorder (BD), using a medication that has been shown to increase cortical GABA (i.e., gabapentin) levels in past research, and to evaluate medication-related changes in response inhibition (go no-go) and cannabis cue reactivity functional Magnetic Resonance Imaging tasks, as well as cannabis use, mood symptoms (including anxiety and sleep), and impulsivity in individuals with CUD+BD.
The overall aim of this pilot study is to conduct a preliminary trial to evaluate the acceptability and feasibility of adding a transdiagnostic, emotion-focused group intervention (the Unified Protocol, UP) to treatment as usual (TAU) in a comprehensive outpatient program for adolescents and young adults with substance use disorders and emotional distress. Only patients seeking services or engaged in care at an existing outpatient program at MGH (the Addiction Recovery Management Service) are eligible for participation.
Veterans seeking compensation for musculoskeletal (MSD) conditions often develop chronic pain and are at high risk for substance misuse. This study is designed to pilot test the Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM) intervention. SBIRT-PM is designed to reduce pain and reduce risky substance use among veterans applying for VA Benefits for a musculoskeletal condition, in part by helping Veterans get connected to comprehensive pain treatment. This pilot will involve a 2-year period to arrange for SBIRT Counselors at a single site to counsel Veterans throughout New England by phone with SBIRT-PM to test the acceptability and feasibility of the intervention.
People who inject drugs (PWID) represent the overwhelming majority of both HCV and HIV/HCV infected people in the United States. Though new, direct-acting HCV medications are highly efficacious and have the potential to end the HCV epidemic, few PWIDs ever initiate treatment. This study seeks to improve HCV treatment uptake and cure among HCV and HIV/HCV+ PWIDs by testing a primary care based HCV Group Evaluation and Treatment UPtake (GET-UP) intervention. If efficacious, this innovative care intervention could provide a means to reduce the growing mortality from HCV, as well as decrease the current reservoir for HCV transmission.
This investigation will be the first study assessing genetic modulation of naltrexone's NTX effects upon the abuse liability of a stimulant drug (methamphetamine). The study team will assess the ability of oral NTX to block the reinforcing and positive subjective effects of intranasal (IN) methamphetamine (30mg/70kg). This investigation could identify an important Gene x Pharmacological interaction, contributing to the personalization of stimulant abuse pharmacotherapy.
Substance use disorders (SUDs) are a prevalent and impairing condition, particularly among trauma exposed individuals. The current proposal aims to address the critical need for targeted direct SUD prevention in this population by intervening on a novel, malleable risk factor for SUD common among trauma-exposed individuals: sleep disturbance. Sleep disturbance prospectively predicts the development of SUD and may confer risk for SUD by increasing stress reactivity, decreasing decision-making abilities, and ultimately promoting substance use to relieve negative affect, a core etiological factor in SUD. However, to our knowledge, no experimental studies have determined whether improving sleep leads to reductions in SUD risk. As such, the current study will use a randomized controlled trial design to test the effects of brief behavioral treatment for insomnia (BBTI) against a waitlist control among a sample of trauma-exposed young adults with poor sleep and risk for SUD (N = 60). We aim to determine the direct and indirect effects of condition (BBTI vs. waitlist control) on SUD symptoms, substance use-related problems, coping motives, and posttraumatic stress symptoms through improvements in sleep. Furthermore, we will test direct and indirect effects of condition on theoretically proposed mechanisms underlying the association between sleep disturbance and SUD risk (i.e., stress reactivity, cravings in response to stress).
Substance use disorders (SUDs), depression and anxiety in HIV-infected patients result in poor HIV outcomes, yet are often unrecognized and untreated. To address these problems, this study examines the implementation and effectiveness of a clinical intervention consisting of self-administered tablet-based SUD and depression screening at routine HIV primary care clinic visits, followed by evidence-based treatments for SUD, anxiety and depression delivered by a behavioral health specialist. If successful, this study has potential to reduce SUD-, anxiety- and depression-related problems and reduce HIV treatment disparities for patients with these comorbidities.
Substance Use Disorders (SUDs) and insomnia are major public health concerns, and each are independently linked to reduced quality of life, disability, and high healthcare costs. Insomnia, characterized by difficulty initiating or maintaining sleep, or nonrestorative sleep, is prevalent in 10% of the general population and is co-morbid in 70% of patients with SUDs. Primary insomnia and SUDs are chronic, unremitting diseases and have a complex bidirectional relationship. Insomnia symptoms may predate the onset of SUDs and may explain high prevalence of self-treatment. Insomnia may also be a direct effect of intoxication, withdrawal, or abstinence from the substance of abuse. Subjective and objective measures of sleep disruption have been shown in various stages of abuse and recovery. Insomnia is the most well documented predictor of substance use relapse. Treatment specifically targeting chronic insomnia is essential for improved clinical outcomes. Although, chronic insomnia is a well-established, modifiable risk factor, to our knowledge, there are no interdisciplinary residential treatment programs that specifically treat chronic insomnia during acute SUDs treatment. We propose that improved treatment of insomnia as part of a comprehensive reinforcement-based outpatient treatment program will provide an efficient and cost effective opportunity to improve standard outpatient SUD. Converging evidence suggests that prophylactic CBT-I during SUD treatment may have short and long-term efficacy for sleep, and improve attrition. In the proposed study, patients with co-morbid SUDs and insomnia will engage in an 8-week group CBT-I (gCBT-I) program in addition to receiving treatment as usual for SUDs. This study may provide new hope to effectively treat insomnia in SUD and lead to a new standardization of outpatient care. We hypothesize that a CBT-I intervention can be implemented as part of an evidence-based SUD treatment program within a residential facility.