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NCT01148381
The influence of genes on addictive and neuropsychiatric disorders is complex, especially given that multiple genes likely influence certain behaviors that are correlated with addiction. Researchers are interested in looking at the genetic information of individuals who are enrolled on National Institute for Drug Abuse studies to investigate specific genetic variants that may be related to substance abuse. Researchers will study the effects of genes on several aspects of thinking such as attention, memory, decision making, problem solving, learning, and emotional feelings, and investigate the ways in which genetic information affects addictive behaviors and substance abuse. In addition, researchers will study how genes may explain differences in imaging data in substance users. Objectives: \- To collect genetic information for research on genetic aspects of addiction and substance abuse. Eligibility: * Adults age 18 or older * (1) healthy, non-drug-using nonsmokers, * (2) healthy smokers, * (3) healthy individuals dependent on other commonly abused drugs, and * (4) individuals with other psychiatric disorders. * Participants must be enrolled in another National Institute on Drug Abuse, Intramural Research Program imaging protocol. Design: * This study involves one to two visits to National Institute on Drug Abuse, Intramural Research Program that may be separate from the participant's current research protocol study visits or on the same day as those visits. * Participants will provide a blood sample and complete questionnaires about mood, memory, and learning. * Participants may also be asked to do a few tasks, such as playing computer games involving coin tosses and money management, or responding to questions on a computer screen.
NCT05976646
The overall goal of this project is to collect initial human data on the effects of novel compounds on safety (interactions with an opioid drug, e.g., buprenorphine) and early efficacy signals (subjective effects on negative affect, craving, and opioid withdrawal) in OUD subjects currently in MOUD treatment with buprenorphine.
NCT04768920
The objective of this pilot intervention study is to iteratively refine motivational interviewing and psychosocial intervention programs delivered via telehealth (Teletx) to help improve substance use and other related outcomes in SUD patients who are not receiving SUD care. We will examine feasibility and acceptability of these pilot psychosocial programs in a total of n=50 participants. The goal is to refine the programs to improve acceptability and feasibility and collect preliminary data for a future fully powered randomized controlled trial (RCT) in the future. In addition to study sessions, participants that are enrolled in the study will complete surveys prior to, during, and after treatment.
NCT04198974
Despite having made some strides with respect to reducing adolescent drinking rates, illicit substance use and substance use disorders (SUDs) remain significantly above national targets for health promotion and disease prevention in Canada and the United States. Now, more than ever, there is a pressing need for effective substance abuse prevention in Canada, particularly for those most at risk of developing substance use problems including prescription drug misuse. Clearly, new approaches to prevention (with lower numbers needed to treat) are needed and which translate new research on addiction vulnerability to personalised prevention and early intervention. The PreVenture Program involves brief cognitive-behavioural interventions targeting personality traits from a neurocognitive perspective. While the personality-targeted approach has been shown to be effective in reducing most substance use behaviors, it has yet to be evaluated for its impact on uptake of prescription drug misuse in adolescents. The Canadian Underage Substance use Prevention (CUSP) Trial aims to evaluate the long-term effects of a personality-targeted school-based prevention program on delaying the onset of drug and alcohol use in adolescence over three years across Canada. This is a hybrid effectiveness \[E\] and implementation-facilitation \[IF\] trial on delaying the onset of drug and alcohol use in adolescence. In the \[E\] part, the effects of a personalized prevention program will be tested against usual school-based prevention curricula. PreVenture is delivered through a TtT implementation model with or without \[IF\], e.g. with ongoing supervision and web-based support. The \[IF\] package is designed to support long-term sustainability of PreVenture after a community accesses PreVenture training.
NCT03485430
This randomized controlled study compares tapering of long-term opioid therapy in a population with chronic non-cancer pain with control group constituted of waiting list. Half of participants receives intervention at baseline and the other half are controls but receives intervention after 4 months. Ethical approval to follow up excluded participants denying tapering at baseline.
NCT06413979
This R34 will develop and test an adjunctive treatment protocol for addressing co-occurring internalizing disorders among adolescents enrolled in usual care for substance use problems. Internalizing disorders (ID), primarily depression and anxiety, are highly prevalent among youth receiving community-based treatment for substance use disorder (SUD). Comorbidity rates range from 30-70% due to the multiple developmental pathways by which adolescent SUD and ID cause and exacerbate one another. Moreover, unresolved ID issues significantly interfere with youth SUD treatment and recovery processes. Yet, the youth SUD clinical workforce is not systematically educated or trained in evidence-based practices for ID; thus, line services for youth SUD do not systematically target ID. The research literature offers a few integrated behavioral models for simultaneously treating both SUD and ID in youth; however, such models feature intensive manualized procedures that have proven cumbersome to scale and deliver in frontline settings. As a result, the clinical workforce, though desiring ID-focused training, currently has inadequate resources for treating ID effectively. A promising solution to diminish this quality gap is developing an adjunctive, modular protocol to augment routine care for comorbid SUD/ID by directly targeting ID as a key treatment goal: Family Support Protocol for Adolescent Internalizing Disorders (Fam-AID). As an adjunctive protocol, Fam-AID will not require clinicians to markedly alter existing base practices for SUD. It will be anchored by three evidence-based foundations for treating co-occurring adolescent ID. First, it prioritizes family engagement in services and family-oriented treatment goals, which have been shown to enhance outcomes for youth SUD and ID alike. Second, it is a modular protocol that features core elements of manualized treatment for ID; core element interventions enhance treatment effectiveness by fostering implementation feasibility and sustainability in usual care. Third, it seeks to reinforce the family safety net to prevent teen self-harm. In accord with these foundations, and pending pilot development, we anticipate that Fam-AID will contain five treatment modules that can be delivered in any sequence to meet client needs: (1) Family Engagement of caregivers and primary supports in treatment planning and services; (2) Relational Reframing of family constraints, resiliencies, and social capital connected to the youth's ID symptoms; (3) Functional Analysis of the youth's ID symptoms and related behaviors; (4) Cognitive-behavioral therapy (CBT) core techniques to address the youth's ID symptoms and functional needs, featuring three transdiagnostic interventions (emotion acceptance, emotional exposure, behavioral activation) to address negative affect and emotional dysregulation underlying both depression and anxiety; and (5) Family Psychoeducation and Safety Planning focused on education about comorbid SUD/ID and prevention of youth self-harm. All interventions featured in each module have strong empirical support. The Fam-AID protocol will contain several innovations intended to boost treatment feasibility and impact for this vulnerable group. Aligned with the core elements strategy, it will be designed for uptake by all motivated clinicians regardless of their clinical orientation and training. It will use evidence-based family engagement techniques to systematically integrate caregivers in the treatment process; typically, families are not centralized in SUD services for youth despite compelling empirical and clinical rationale to do so. It will feature a treatment customization exercise in which clients and therapists collaboratively select CBT techniques to integrate in ongoing treatment based on functional ID assessment. To achieve study aims we will first develop a Fam-AID implementation toolkit during a three-part Pilot Phase at one pilot site: (a) Solicit provider input on Fam-AID components; (b) Create video-based training and fidelity procedures, leveraging the PI's existing online therapist training and consultation resources in core CBT techniques for adolescent SUD, as well as the Co-I's equivalent training resources for adolescent ID; (c) Pilot the toolkit with 4-6 clients. In Years 2-3 we will conduct an Interrupted Time Series Study for N = 60 SUD/ID cases across two sites serving diverse youth: 30 will receive TAU, and then following line staff training, 30 new cases will receive TAU enhanced by adjunctive Fam-AID. Aim 1: Feasibility will examine Fam-AID cases for acceptability via client and therapist interviews and fidelity benchmarks via therapist- and observer-report of module coverage and protocol dose. Aim 2: Outcomes will test TAU vs. TAU + Fam-AID for immediate impact on family member attendance and ultimate impacts on adolescent ID symptoms at 3- and 6-month 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.
NCT05713695
This 3-year Hybrid Type 1 study will randomize 208 people with co-occurring substance use and mental health disorders (COD) referred from the Worcester Hub. This study seeks to evaluate the effectiveness of MISSION, a multi-component team approach, versus linkage with a Peer Specialist on improving outcomes among individuals with CODs. We expect that individuals receiving MISSION versus linkage only will show greater improvement in treatment engagement, substance use, and mental health outcomes. This study will also concurrently conduct a process evaluation to inform sustainability and future implementation of such interventions.
NCT06489522
Children of mothers with substance use disorder (SUD) constitute a growing and highly vulnerable population. Evidence-based parenting interventions have the potential to both support parents' recovery and mental health by helping them cope with stress of parenthood and promote the optimal development of their children by supporting responsive parenting. The Supporting Our Families through Addiction and Recovery (SOFAR) pediatric medical home for families and children impacted by SUDs, with integrated behavioral health (IBH), provides an opportune setting for addressing the needs of mothers and children impacted by SUDs. While many families are thriving in the program, there is a strong unmet need for evidence-based parent-training interventions, particularly during the preschool period. This study aims to evaluate the implementation of a brief, parent child interaction therapy (PCIT)-based intervention, entitled Threat, harm, risk, investigation, vulnerability and engagement (THRIVE), that will be offered in the SOFAR Clinic at Boston Medical Center. THRIVE is a safe, 6-session telehealth intervention that has been tested in pediatric and community-based settings. The evidence-based suggests that THRIVE is associated with significant improvements in child behaviors and parenting stress. The investigators hypothesize that offering THRIVE through the SOFAR pediatric primary care program will be feasible and acceptable, improving access to and engagement in evidence-based parenting interventions among mothers with substance use disorder who receive parenting support through our integrated behavioral health model. In addition to studying the implementation of this evidence-based intervention, this study will allow the researchers to test data collection procedures (pre and post-interventions assessments) to inform a future clinical trial.
NCT05492825
This is a pragmatic, open label, randomized controlled trial with 1:1:1 allocation to 12 weeks of: (1) onsite yoga at opioid treatment programs (OTPs), (2) onsite physical therapy (PT) at OTPs, or (3) treatment as usual (TAU). Participants will be 180 individuals with chronic back pain receiving treatment for opioid use disorder (OUD) in community-based OTPs. Through research visits at screening, baseline, and months 1, 2, 3, 6, and 9, the investigators will evaluate pain and opioid use outcomes and implementation outcomes.
NCT07490717
Opioid overdose is the leading cause of death among people recently released from incarceration. Recent evidence also shows a rise in stimulant use among justice-involved populations, as well as growing rates of concurrent opioid and stimulant use. Yet, while there is growing research on opioid use disorder (OUD), stimulant use disorder (STUD), and substance use treatment in jails and prisons, studies find that few people who are referred to community substance use treatment actually initiate treatment after release. But, emerging research suggests that therapy for posttraumatic stress disorder (PTSD), a common and deleterious OUD and STUD comorbidity, could profoundly increase the likelihood of engagement with substance use treatment; however, this has not been tested in jails, and acceptable, appropriate, and feasible ways to identify and link people with probable PTSD and OUD/STUD in this setting to treatment are required to be able to examine this possibility. Therefore, this 4-year R33 aims to 1) describe engagement in and examine the implementation outcomes of an innovative approach to identifying and referring people with probable PTSD and OUD/STUD to needed treatment services and 2) the effectiveness and implementation outcomes of two competing models of subsequent trauma-focused therapy initiation timing (i.e., immediate initiation of therapy vs initiation upon community reentry) among people who demonstrate need for OUD/STUD services and who accept referral. To address Aim 1, the investigators will assess the implementation context for and subsequently implement a screening, brief intervention, and referral to treatment model that was adapted to identify and address the substance use and mental health needs of adults with probable PTSD and OUD/STUD in the jail setting (SBIRT-J) in the Pulaski County Regional Detention Facility; the investigators will describe engagement in and examine the implementation outcomes of the SBIRT-J model via a summative evaluation guided by the Consolidated Framework for Implementation Research. Specifically, there will be a survey and interview jail stakeholders (e.g., jail leadership, officers) to understand perceptions of the acceptability, appropriateness, and feasibility of the SBIRT-J model as well as SBIRT-J implementation determinants (i.e., barriers and facilitators), and use administrative data to understand the degree to which SBIRT-J is adopted during active enrollment in the R33 Aim 2 research trial and sustained in the 6 months after enrollment end. Fidelity to the SBIRT-J model will also be monitored and reported. To address Aim 2, the investigators will conduct a patient-randomized Hybrid type I implementation-effectiveness trial in which adults who are identified as having probable PTSD and OUD/STUD through the SBIRT-J model and who consent to participate in the trial are randomly assigned to either immediate initiation of therapy for PTSD in jail or initiation of PTSD therapy upon release. The primary effectiveness outcome will be post-release substance use treatment initiation by 6-months post-release from jail; secondary and exploratory outcomes will include substance use treatment readiness and retention, OUD/STUD severity, PTSD symptoms, victimization, overdose, and additional drug use. Participants in the effectiveness portion of the trial (N = 338; \~50% female) will be enrolled from the largest jail in Arkansas. Jail stakeholders will also be enrolled to provide implementation-related data. The overall goal is to translate research to practice to increase the provision of high-quality care for justice-involved persons with probable PTSD and OUD/STUD. Indeed, this study will be the first trial of a treatment for PTSD in jails as a method for improving OUD/STUD outcomes, providing foundational information on PTSD as a novel intervention target for meeting the needs of a particularly vulnerable population and providing the implementation data to inform rapid scale-up, if effective.
NCT04197921
The purpose of this clinical trial is to investigate Low Intensity Focused Ultrasound (LIFU) using the Exablate® Model 4000 Type 2.0/2.1 as an adjunctive neuromodulatory treatment for OUD (Opioid Use Disorder) and/or other Substance Use Disorders (SUDs) by assessing its safety and tolerability in subjects with OUD.
NCT07218549
The purpose of this study is to understand how kratom affects people. In this study, kratom will be compared with another substance and a placebo (an inactive substance). Researchers will also study how the substances move through and affect the body. This includes examining how the body absorbs, processes, and eliminates the drug (pharmacokinetics), as well as how the drug affects the body and how it may make you feel (pharmacodynamics). The information collected will help researchers better understand the effects and potential risks of kratom.
NCT05828849
The purpose of this research study is to investigate if a personalized intervention including parts such as navigation (focus on patient outreach efforts, missed and completed encounters), personalization (individual health benefits) and compensation (value health-related costs borne by patients) will help people reduce their chances of dying from preventable causes, including heart attacks, strokes, drinking alcohol, substance abuse, HIV, and other conditions.
NCT07232641
"Gold-standard" medications for opioid use disorder (MOUD) treatment combines FDA-approved medications, primarily methadone and buprenorphine, with behavioral therapies to provide "whole-patient" treatment. Prior to the pandemic, methadone and buprenorphine were subject to greater federal regulations than medications for other substance use disorders, including medication for alcohol use disorder (MAUD), which created barriers to MOUD initiation and retention. These barriers were exacerbated by physical distancing and diminished clinic capacities during the COVID-19 pandemic. To prevent healthcare disruption and expand access to MOUD treatment during the public health emergency, federal and state authorities implemented several MOUD policy changes during the pandemic to reduce barriers to MOUD initiation and retention, which subsequently became permanent. This study is an evaluation of the impacts of these policies on treatment use, retention, and patient outcomes pre- and post-MOUD policy implementation.
NCT05327504
The proposed project will evaluate the efficacy of written exposure therapy (WET) among Veterans engaged in substance use disorder (SUD) treatment, who present with co-occurring posttraumatic stress disorder (PTSD). While SUD treatment programs traditionally do not address PTSD, effective trauma treatments have been used successfully among those with substance use comorbidities. WET is a brief trauma-focused intervention shown to effectively treat PTSD. In a recent acceptability and feasibility pilot study among Veterans with co-occurring SUD and PTSD, results showed a decrease in PTSD symptoms among participants receiving WET. The goal of the present study is to improve outcomes for Veterans who present for SUD treatment with comorbid SUD/PTSD.
NCT07417579
Mindfulness and meditation based relapse prevention has been proposed as an adjunctive approach for individuals with substance use disorders (SUDs). This completed pilot observational case series describes outcomes from three de-identified participants who completed an eight-week mindfulness and meditation program designed to reduce stress, enhance coping skills, and support sustained recovery. Participants demonstrated improvements in perceived stress and mindfulness following the intervention. Two participants experienced relapse within 10-12 months, while one participant maintained long-term sobriety. This small case series provides descriptive clinical insights and supports the feasibility of mindfulness-based interventions in real-world treatment settings.
NCT05934877
ASK-PrEP is a two-arm randomized controlled trial (RCT), with a Stepped Care approach, among HIV-negative trans women and men who have sex with men with a substance use disorder (SUD). Participants will be randomized (3:1) to the ASK-PrEP Stepped Care arm or Standard of Care (SOC). Participants in the ASK-PrEP Stepped Care arm will receive 5 PrEP navigation sessions, with weekly text-messaging support, delivered over 3 months, at which point they will be assessed for intervention response. Responders will be maintained for an additional 3 months in ASK-PrEP to receive an additional 5 PrEP navigation session with weekly text-messaging support, while non-responders will receive added attention to their SUD via contingency management (CM). Non-responders will be re-randomized (1:1) to either a) receive ASK-PrEP + CM, or b) shift the primary focus to their SUD (CM alone) for an additional 3 months.
NCT07210268
This clinical study is testing whether a new non-invasive brain stimulation method, called temporal interference (TI), can reduce nicotine cravings and usage in people who vape. TI delivers mild electrical currents to the scalp in a way that targets deep brain areas involved in addiction, without the need for surgery. In this randomized controlled trial, participants will be assigned to one of three groups: TI stimulation to the nucleus accumbens, TI stimulation to the anterior insula, or a placebo (sham) condition. Each participant will attend a single stimulation session after 8 hours of nicotine abstinence and will use a custom vape device that measures real-time nicotine inhalation. Craving levels will be reported during and after the session. The study aims to determine whether TI to the insula or nucleus accumbens is more effective at decreasing cravings and nicotine inhalation, and whether either is more effective than sham stimulation. For one week after the session, participants will use a smartphone app to track nicotine use and cravings. The primary hypothesis is that TI stimulation to deep brain regions will reduce both nicotine craving and actual use, immediately after stimulation and over the following week, compared to the sham condition.
NCT07395700
This observational study evaluates the psychometric properties of the Behavioral Activation for Depression Scale (BADS) in individuals with substance use disorders. The study examines the scale's internal structure, reliability, and validity using data from 289 participants who completed the BADS. External and incremental validity analyses were conducted in a subsample of 127 participants for whom additional clinical measures were available, including assessments of symptom severity, anxiety, impulsivity, and anger expression. This approach reflects the availability of complete data for each analytic component and allows for a comprehensive evaluation of the BADS in a clinical population.