Substance Use Clinical Trials

This pilot research study will provide timely access to behavioral health services through the provision of a single-session narrative therapy intervention. The goal of this 6-month study is to test the acceptability, feasibility, and fit of the intervention in an integrated primary care clinic serving people living with HIV. Read Less

The purpose of this study is to develop transcranial magnetic stimulation (TMS), specifically TMS at a frequency known as theta burst stimulation (TBS), to see how it affects the brain and changes the brain's response to alcohol-related pictures. TMS and TBS are stimulation techniques that use magnetic pulses to temporarily excite specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). TBS, which is a form of TMS, will be applied over the medial prefrontal cortex, (MPFC), which has been shown to be involved with drinking patterns and alcohol consumption. This study will test whether TBS can be used as an alternative tool to reduce the desire to use alcohol and reducing the brain's response to alcohol-related pictures. Read Less

Phase 1 will consist of a small pilot Open Trial (OT). The objective of Phase 1 is to develop an organization-level Youth Engagement (YE) prevention strategy and implement it in a community-based organization to test feasibility and acceptability in an open trial with one organization. This will include developing a manual for systematically incorporating YE into prevention efforts in community settings. Phase 2 will consist of a small pilot Randomized Controlled Trial (RCT). Four prevention organizations will be randomized either to include Youth Engagement in prevention efforts (treatment) or not (control). The study team will attempt to match the treatment and control groups on relevant characteristics such as geographic location (e.g., urban, rural), population served (e.g., church-based, school-based), and/or prior Youth Engagement involvement. The objective of the second phase of this study is to evaluate the preliminary effectiveness of YE as a prevention strategy for opioid misuse in a small pilot randomized control trial (RCT). This pilot study will examine the effects of the YE prevention strategy on (a) organization-level outcomes, such as perceived value added to prevention programming and (b) individual-level outcomes such as personal skills and attitudes as well as knowledge and attitudes about substances including opioids. Up to 15 leaders/staff and 45 youth/young adults (60 people overall) will be recruited for the study. Read Less

This research study will test the effectiveness of a culturally grounded parenting intervention called Parenting in 2 Worlds (P2W). This intervention is designed for American Indian / Alaska Native (AI) parents/guardians of adolescents who reside in urban areas. This will be a multi-regional effectiveness trial across four regions: Northeast (Buffalo/Niagara), Midwest (St. Paul/Minneapolis), Mountain (Denver), and Southwest (Phoenix). There are four specific aims. First, this study will test the effectiveness of Parenting in Two Worlds (P2W) as compared to an informational family health intervention, Healthy Families in 2 Worlds (HF2W), in improving parenting and family functioning. Second, this study will test if the relative effectiveness of P2W, compared to HF2W, varies by parent's/guardian's level of socioeconomic vulnerability, experiences of historical loss, or AI cultural identity. Third, this study will examine if P2W can reduce adolescent (ages 12 - 17) risky health behaviors including substance use, depressive symptoms, suicidality, and risky sexual behaviors. Fourth, this study will examine whether positive changes in parenting and family functioning that result from P2W lead to positive changes in adolescent's health behaviors. Read Less

The investigator aims to conduct an open pilot study (N=12; 10 completers) to test the feasibility, acceptability, and credibility of an asynchronous web-based mind-body intervention (Toolkit for Resilient Life beyond Pain and Substance Use; Web-TIRELESS) for adult patients with a comorbidity of non-traumatic painful upper-extremity condition(s) (NPUC) and risky substance use. Deliverables: 1) Adapt and refine open pilot protocol, patient recruitment, and other study materials. 2) Assess the feasibility, acceptability, and credibility of Web- TIRELESS in preparation for a future feasibility RCT. Participants will complete 4 on-demand video sessions at their own pace (approximate pace of 1 session per week) and complete baseline and post-test assessments. participants may also partake in an exit interview to provide feedback on Web-TIRELESS to further refine the program and study protocol for future iterations. Read Less

This randomized Type 1 hybrid effectiveness-implementation trial (N=186) will evaluate the effectiveness and implementation of a peer-delivered problem solving and behavioral activation intervention for adherence to LAI-PrEP/ART ("Peer Activate-LAI") compared to enhanced treatment as usual (ETAU) for a largely Black, substance-using population living with or at high risk for HIV. Specific aims are to: Aim 1: Evaluate the effectiveness of Peer Activate-LAI over 12-months on: a) LAI-PrEP/ART adherence (primary; receipt of all 6 maintenance injections within 7-day window); and b) substance use (secondary; WHOASSIST, urine toxicology); and c) Explore the moderating role of SRD-related factors (exploratory) Aim 2: To evaluate the implementation of Peer Activate-LAI including feasibility, acceptability, fidelity, and adoption guided by RE-AIM and Proctor's model,12,13 assessed using mixed methods, including a rapid ethnographic assessment of how SRD-related factors may affect implementation. Aim 3: To evaluate the economic viability of Peer Activate-LAI, including a) cost of implementation and sustainment, and b) cost-effectiveness from multiple stakeholder perspectives. This study will inform a potentially scalable, cost-effective model for facilitating effective adherence to LAI formulations of PrEP/ART within Black, substance-using populations with multiple minority identities who to date have had limited support for improving LAI adherence for HIV treatment and prevention. Read Less

The study will test a computerized treatment with subjects ages 13-17 years who are seeking treatment for alcohol and/or cannabis use. Follow-up assessments will be conducted at one- and three-months following treatment. Read Less

The goal of this treatment study is to learn about the mental health, substance use and physical health outcomes associated with participating in the EASE holistic behavioral health and wellness program for individuals identifying as LGBTQ+ and/or living with HIV. The main questions it aims to answer are: 1. Do important health outcomes, including substance use, mental health and social support related outcomes of individuals living with HIV and/or identifying as LGBTQ who participated in the holistic behavioral health and wellness program change after study participation? 2. Does a tailored approach to meet the specific needs of different subpopulations including 1) older (40+) PLWH and/or LGBTQ individuals with or at risk for additional health comorbidities and 2) PLWH and/or LGBTQ young adults (18-40) improve health outcomes including improvement in health and health behaviors . Participants will be asked to: * participate in 6 months of behavioral health treatment tailored to their needs, which may include individual counseling, group counseling, case management, peer support, and related education. * Complete surveys at the time of study entry and 6 months later to measure changes in health outcomes over time. Read Less

This study will use a randomized control trial (RCT) design to administer two versions of a multisession remote behavioral intervention for youth seeking Emergency Department care for a violent injury with the goal to reduce their violence involvement and associated negative behaviors and consequences. The study examines two versions of the remote therapy intervention - a standard RTI (S-RTI) and an Artificial Intelligence RTI (AI-RTI). The application of a just-in-time adaptive strategy to address youth violence is an important and novel direction for this research, particularly given the need to understand best practices for delivering behavioral interventions among lower-income populations. Read Less

The purpose of this study is to evaluate Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) for families experiencing early psychosis and substance use delivered exclusively or primarily via telehealth (video conferencing). Read Less

Montefiore will engage fathers in families at risk of substance misuse in the Bronx and neighboring communities. Families will be referred from Bronx and neighboring community-based child welfare systems, substance use disorder (SUD) treatment providers, and medical providers if identified at risk of substance use concerns and will be randomly assigned to receive services as usual as part of the comparison group, or to receive enhanced services as part of the program group. Enhanced services include: (1) Motivational Enhancement; (2) referral to Healthy, Empowered, Resilient, and Open (HERO) Dads fatherhood engagement program; (3) Contingency Management; and (4) Case Management. Read Less

The STop UNhealthy (STUN) Substance Use Now Trial (STUN II) is a multisite trial aiming to evaluate the comparative effectiveness of the following strategies for improving the implementation of screening and interventions for substance use disorders in primary care: practice facilitation (PF), PF plus a learning collaborative (LC), PF plus performance incentives (PI), and PF+LC+PI. We plan to enroll 144 clinic staff participants from 48 primary care practices Read Less