Treatment Trials

594 Clinical Trials for Various Conditions

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NOT_YET_RECRUITING
Short, Animated Storytelling (SAS) Video to Reduce Smartphone Addiction in the US
Description

This study will test the effect of a short, animated storytelling video on participants' perceived risk of smartphone overuse immediately after exposure and two weeks later.

SUSPENDED
Just-In-Time Adaptive Interventions for Addictive Behaviors
Description

Background: Many smartphone apps intend to help people with addictions. But not enough is known about how they should work. Researchers want to study an app that gives people the advice they need, just when they need it. This is a JITAI. It stands for Just-In-Time Adaptive Intervention. To create a good JITAI, researchers need to know what approaches work best at different moments. Objective: To develop ways to treat addiction with a smartphone app. Eligibility: Adults ages 18-75 who use heroin or other opioids Design: Participants will be screened in another protocol. Participants will visit a Baltimore clinic 3 days a week to give urine and breath samples. Some participants will get their treatment at this clinic. Participants will answer questions about their personality and stress. Participants will randomly be assigned to the JITAI group or a comparison group. Participants will have a training session on using the smartphone app. JITAI participants will also watch a video about the written messages they ll see in the app. Weeks 3-10: participants will carry a smartphone. Four times a day, it will beep and ask questions. These will be about the participant s activities and mood. The JITAI group will see a short message after. The message is meant to be helpful. For the first 16 evenings, JITAI participants will get more information on the phone. Answers to the app s questions will be transferred automatically from the smartphone to secure computers at the NIH. During the last week, participants can choose the kind of messages they see. Week 11: participants will return the smartphone and answer questions. Weeks 12-16, participants who are getting their medicine from the research clinic will be encouraged to transfer to other clinics. Otherwise, they will have their dose slowly reduced to zero.

Conditions
COMPLETED
Effect of Exercise on Chocolate Addiction
Description

The study will use stress inducing tasks to determine if there are significant improvements in mood, chocolate cravings, and attentional bias to chocolate in overweight/obese chocolate abusers following rest and a bout of high intensity interval exercise.

COMPLETED
Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 2
Description

The purpose of this study is to determine whether long-term exposure to the Therapeutic Workplace intervention could sustain drug abstinence over an extended period of time in heroin- and cocaine-dependent, unemployed, treatment-resistant young mothers.

RECRUITING
Effects of E-cigs vs Pouches on Cigarette Smoking and Addiction
Description

The study will recruit an anticipated 256 adults who currently smoke cigarettes and report a willingness to try switching to alternative, non-combustible products. Participants will be randomized to receive either e-cigarettes or nicotine pouches for a duration of 4 weeks and to 1 of 4 possible regulatory scenarios within products where flavor availability is either menthol and tobacco/unflavored available or tobacco/unflavored only available, and nicotine concentration is either higher (5% e-cig, 6mg pouch) or lower (2.4% e-cig, 3mg pouch). Participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. Participants will complete a final follow-up at Week 6 to assess maintenance of cigarette reduction and willingness to continue using products once they are no longer provided. The investigators expect to observe which products and constituents lead to greater smoking reduction.

RECRUITING
Implementing Contingency Management for Stimulant Use in Specialty Addiction Treatment Organizations
Description

Stimulants constitute a new and deadly fourth wave of the opioid epidemic. Contingency management is the most effective intervention for stimulant use and is an evidence-based adjunct to medication for opioid use disorder. Yet, uptake of contingency management in opioid treatment programs that provide medication for opioid use disorder remains low; in fact, access to contingency management is arguably one of the greatest research-to-practice gaps in the addiction treatment services field. The goal of this study is to conduct a type III hybrid effectiveness-implementation trial to evaluate a multi-level implementation strategy, the Science of Service Laboratory, to install contingency management for stimulant use in opioid treatment programs. The Science of Service Laboratory has three core components: didactic training, performance feedback, and external facilitation. Utilizing a stepped wedge design, a regional cohort of 10 public sector opioid treatment programs will be randomized to receive Science of Service Laboratory at five distinct time points. At six intervals, each of the 10 opioid treatment programs will provide de-identified electronic medical record data from all available patient charts on contingency management delivery and patient outcomes. Staff from each opioid treatment program will provide feedback on contextual determinants influencing implementation. This study will rigorously evaluate whether a multi-level implementation strategy developed by one of the longest-standing national intermediary purveyor organizations-the SAMHSA Technology Transfer Centers, will improve both implementation and patient outcomes.

COMPLETED
Reducing Stigma Among Individuals With Addiction and Staff in the Criminal Justice System
Description

Stigma is one of the most pervasive barriers to addiction care in the U.S. criminal justice (CJ) system. However, there have been no stigma reduction interventions developed for this context. This project addresses this gap with a new multi-level stigma intervention, Combatting Stigma to Aid Reentry and Recovery (CSTARR), for justice-involved people with addiction and criminal justice staff. This intervention will be implemented in 6 (mostly rural) counties in TN for clients and staff in the Tennessee Recovery Oriented Compliance Strategy (TN-ROCS) program, which coordinates multiple CJ sectors (i.e., courts, corrections, probation, treatment) to divert and treat people with addiction. This project aims to 1) examine the feasibility, acceptability, and implementation considerations of integrating CSTARR in the TN-ROCS program, and 2) determine whether CSTARR impacts individual, staff, and program-level outcomes. We aim to recruit 25 stakeholders, 80 clients, and 75 staff over the course of this 18-month project to participate in our intervention and evaluation efforts. Staff and clients will be asked to complete online surveys before and after the intervention, as well as 1- and 3-month follow ups, for which they will receive gift-cards. The overall goal of this project is to examine the feasibility and utility of stigma reduction efforts in the criminal justice system to determine whether they can help facilitate engagement with evidence-based addiction care and improve client and staff outcomes.

COMPLETED
Addiction and Behavior Related to Menthol Cigarette Substitutes
Description

The goal of the proposed study is to examine the abuse liability and substitutability of plausible menthol cigarette alternatives currently on the market, including menthol filtered little cigars (mFLC), menthol roll-your-own (mRYO) pipe tobacco and cigarette tubes, and non-menthol cigarettes (nmC). In addition, the study will elucidate real-time mechanisms including product characteristics and perceived effects associated with greater substitution.

ENROLLING_BY_INVITATION
Alliances to Disseminate Addiction Prevention and Treatment (ADAPT)
Description

Youth involved in the juvenile justice system (YJJ) bear a disproportionate burden of the addiction crisis. YJJ substance use (SU) is extremely prevalent, with a third of YJJ meeting criteria for a substance use disorder (SUD). The investigators seek to address the national addiction crisis at its epicenter. Despite their high need for SUD services, and the proliferation of evidence-based interventions to reduce SU, YJJ are rarely connected to needed, high-quality SU care. A care cascade model highlights gaps in YJJ achieving the full continuum of SUD care (i.e., SUD risk identification, treatment referral, treatment initiation, and treatment engagement). YJJ on community supervision/probation face a unique problem accessing SUD services; while the courts or probation may identify YJJ need for SUD care, YJJ must receive care through healthcare agencies in the community. The primary goal of the project, Alliances to Disseminate Addiction Prevention and Treatment (ADAPT) is to address this and other gaps along the care cascade for YJJ. The investigators will accomplish this goal by creating alliances between the juvenile justice system (JJ) agencies and community mental health centers (CMHCs) in eight Indiana counties. ADAPT takes a two-pronged approach. First, the investigators will employ a Learning Health System (LHS) to develop collaborative alliances between JJ agencies and CMHCs, organizations that traditionally operate independently. Second, the investigators will present local Cascade data during continuous quality improvement cycles within the LHS alliances. By offering agency representatives an opportunity to view and discuss, for example, the local rate at which YJJ with SUD risk are initiating CMHC SU services, the investigators will facilitate development of tailored, local solutions to improve the Cascade for each county's YJJ. To maximize long-term sustainability of ADAPT's JJ-CMHC alliances, the investigators will conduct this research in collaboration with leaders from an existing statewide initiative, the Juvenile Detention Alternatives Initiative (JDAI). JDAI is a juvenile justice reform effort that utilizes data-driven decision-making and is implemented in almost 300 counties across the US. If this project is successful, the JDAI infrastructure and support for this research will inform sustainment and expansion across Indiana and the nation. The investigators hypothesize that ADAPT - novel LHS alliances using Cascade data to implement localized solutions to YJJ receiving evidence-based addictions care - will positively impact SU and recidivism outcomes over time. The investigators seek to complete the following specific aims: AIM 1: Implement LHS alliances between JJ agencies and CMHCs. The investigators will establish LHS alliances: novel, collaborative partnerships between JJ agencies and CMHCs. AIM 2: Generate and track local solutions to address gaps in the Cascade for YJJ in rural Indiana counties. Quantifying local Cascade data will enable JJ agencies and CMHCs to suggest and implement tailored, evidenced-based interventions, which will be tracked through LHS quality improvement cycles. AIM 3: Assess implementation outcomes and processes. We will assess implementation outcomes, such as system alliance, among JJ and CHMC personnel using mixed methods. AIM 4: Assess the impact of ADAPT. Conduct a stepped wedge cluster randomized controlled trial to assess the impact of LHS alliances on the Cascade for YJJ. We will analyze administrative data linked across JJ and health systems to assess the long-term, community-wide effects of ADAPT on public health and safety outcomes (e.g., lower rates of SU-related outcomes and criminal recidivism).

COMPLETED
Assessment of and Treatment Applied to Food Addiction in a Rural Healthy Behaviors Clinic
Description

Research purpose: The purpose of this pilot study is to assess obese clients for two phenotypes, those testing positive and those testing negative for Food Addiction (FA) (Yale Food Addiction Scale, YFAS) and determining the efficacy of four treatments: usual care (IC, dietary and physical activity instruction), individual motivational interviewing alone (MI), individual MI with pharmacotherapy (MI+P) for improving outcome measures within each phenotype, and pharmacological therapy (P). Background/significance: Obesity has long been an epidemic in the U.S. and other countries. Numerous approaches have been tried to address obesity with limited success. The YFAS is a relatively new, validated instrument that can help researchers and practitioners assess obese clients for food addiction. Meeting the YFAS diagnosis criteria for FA suggests the need for a stronger intervention with close monitoring to assist these clients in self-management of their eating and physical activity behaviors. Proposed methods/approach: The investigators propose assessing obese clients with the YFAS as part of their intake once they are referred to the Healthy Behaviors Clinic by Regional West physicians/practitioners. A nurse researcher with expertise in MI and a nurse practitioner will perform intake assessments, obtain consent and randomly assign participants in each phenotype (positive or negative for FA) to one of three treatment groups (usual care, individual MI alone, and individual MI with pharmacotherapy). Interventions will occur over 6 months. A clinical psychologist with expertise in the YFAS (University of Michigan) will serve as a consultant on this project and a registered dietitian (University of NebraskaLincoln) will serve as a co-investigator. Expected outcomes: The investigators expect that MI and MI+P and P will be more effective in improving outcome measures than IC. We also expect that response to the treatments will differ between the two obesity phenotypes (those testing positive and those testing negative for FA).

Conditions
TERMINATED
Oxytocin and Brain Responses in Maternal Addiction
Description

A prior study by the principal investigator of this project identified dopamine- and oxytocin-related brain pathways that showed a diminished response when addicted mothers viewed the faces of their own vs. unknown infants, compared with non-addicted mothers. These areas include the hypothalamus, striatum and ventromedial prefrontal cortex. In addition, the investigators plan to examine activation patterns within the salience network, which includes the anterior cingulate cortex and the anterior insula. Oxytocin, a neuropeptide with decreased blood levels seen in addicted mothers, is integrally involved in maternal brain and behavioral responses. When administered intranasally, the pilot data has shown enhanced activation of the striatum, prefrontal cortex (PFC) and amygdala. The purpose of this study is to continue and expand upon the previous investigation of maternal addiction, by conducting a randomized, double-blinded, placebo controlled, crossover study of intranasal oxytocin on maternal brain responses. 150 mothers from the University of Iowa and the Yale Child Study Center will be enrolled (75 with a history of drug addiction and 75 matched control mothers), along with their 2 to 12-month-old infants, to participate in four study visits over a two-month period.

COMPLETED
Cognitive Behavioral Therapy for Post Traumatic Stress Disorder in Addiction Treatment
Description

The purpose of this phase of the study is to further assess the efficacy of cognitive behavioral therapy (CBT) for posttraumatic stress disorder (PTSD), as delivered by routine addiction counselors, and to compare CBT for PTSD with individual addiction counseling (IAC) on our primary outcomes.

COMPLETED
Cognitive Therapy for PTSD in Addiction Treatment
Description

The purpose of this phase of the study is to assess the feasibility of a cognitive behavioral therapy for post-traumatic stress disorder (PTSD) in persons receiving outpatient services at an addiction treatment program. The next phase of the study will be a more rigorous investigation of the efficacy of the PTSD therapy within addiction treatment settings.

COMPLETED
Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 1
Description

This application is a competing continuation of a grant in which we developed and pilot tested a computerized Therapeutic Workplace designed to train and employ adults as data entry operators. A randomized trial is planned over 5 years to investigate the Therapeutic Workplace business as a maintenance intervention to sustain long-term abstinence and employment. Welfare recipients in methadone treatment, actively using cocaine, and at risk for contracting or spreading HIV infection will participate in an initial Therapeutic Workplace training phase. Participants who become abstinent and skilled will be randomly assigned to an Abstinence \& Employment, or an Employment Only group. Participants in the Abstinence \& Employment group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary. Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work. This study will provide a rigorous evaluation of the efficacy of the Therapeutic Workplace business as a long-term treatment of cocaine addiction and unemployment; determine the benefits of requiring daily evidence of abstinence to work; and provide information on the extent to which a Therapeutic Workplace business can become self-sustaining. This research could provide firm scientific foundation for the dissemination of Therapeutic Workplace businesses in the long-term treatment of cocaine addiction and unemployment. The main hypothesis being tested is that cocaine abstinence will be reliably maintained during the yearlong intervention evaluation period only in the group exposed to the explicit abstinence maintenance intervention. We expect that cocaine abstinence in the Abstinence and Employment group will be significantly greater than cocaine abstinence in the Employment Only group.

COMPLETED
DBT Compared to I/GDC for the Treatment of Opiate Addiction in Emotionally Dysregulated Patients. - 1
Description

The purpose of this study is to examine the efficacy of DBT compared to a standard drug counseling approach for the treatment of opiate addiction and borderline personality disorder (BPD). Treatment research has repeatedly shown that retention of BPD and substance addicted individuals to be the among the most challenging for therapists. DBT has established itself as one of the most effective treatments for treatment retention of these patients and for reducing parasuicidal and self-injurious behaviors. This study is one of two in a multi-site RCT for the treatment of opiate addiction. DBT has been shown to be efficacious for the treatment of BPD patients and it has been extended in this study to target addictive behaviors in these patients. The study consists of three treatment parts: weekly individual and group therapy and suboxone maintenance medication. Participants are provided therapy on a weekly basis for one year and suboxone for 2 years. Assessments for tracking outcome are conducted every 4 months. It is hypothesized patients in the DBT condition will show a reduction of substance use, parasuicidal and other psychological difficulties and these gains will be maintained through the year of follow-up assessments. In addition, it is predicted that adherence to DBT treatment protocols will be associated with improved outcomes. Finally, it is predicted that treatment "dosage" (average hours of therapy/week) will be positively related to clinical improvement.

COMPLETED
Modafinil Combined With Cognitive Behavior Therapy to Treat Cocaine Addiction - 1
Description

Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Modafinil, a medication that enhances mood, increases energy, and improves concentration, may be useful in preventing relapse among individuals with cocaine addiction. This study will evaluate the effectiveness of modafinil, in combination with cognitive behavior therapy (CBT), to prevent drug relapse among cocaine addicts.

NOT_YET_RECRUITING
Emotional Brain Training for Addiction Medicine Treatment - A Pilot Study
Description

The goal of this clinical trial is to determine whether Emotional Brain Training (EBT), a behavioral modification method, can help manage stress and health problems related to addiction. EBT teaches skills to deactivate harmful circuits (automatic reactions) and activate healing circuits to quickly shift mood from negative to positive. Participants in the EBT group will receive focused, intensive instruction on using these skills to rewire unwanted brain circuits, with the aim of achieving lasting improvements in emotional health and quality of life. The study will assess whether EBT is an effective tool when added to standard of care (SOC), which includes medications for addiction treatment (MAT). Researchers will compare changes in stress, anxiety, and cravings after 8 weeks of EBT plus SOC versus SOC alone. Participants: * will either continue receiving standard treatments (SOC) at the Addiction Recovery Clinic (ARC) at SAC Health in San Bernardino * or receive both EBT and SOC at ARC * in the SOC group will continue monthly visits at ARC and weekly counseling * in the EBT plus SOC group will continue monthly visits and weekly counseling at ARC, along with weekly EBT group sessions by telephone * will complete online assessments at weeks 0, 4, and 8 Upon completion of the study, all participants will resume SOC

NOT_YET_RECRUITING
Telehealth vs In-Person Evaluation of Addiction Treatment After Visiting the Emergency Department
Description

Main study objective: compare long-term buprenorphine treatment outcomes for patients who start buprenorphine for opioid use disorder (OUD) in the emergency department and are then referred to get outpatient buprenorphine treatment either via telehealth or at an in-person clinic. Researchers will: Compare rates of establishing outpatient OUD treatment, how long patients stay on buprenorphine, and patients' experience with care to determine whether patient experiences and outcomes are better for patients referred to telehealth treatment versus patients patients referred to in-person treatment after they leave the emergency department. Participants will: Be recruited from 3 different hospital emergency departments. Answer questionnaires at baseline and then 1, 3, 6, and 9 months after their initial emergency department visit.

RECRUITING
Adaptive Decision Support for Addiction Treatment Master
Description

This study refines and optimizes the EMBED\* clinical decision support (CDS; see NCT03658642) to increase number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder. This study does not have open enrollment. Investigators will use a Multiphase Optimization STrategy (MOST) framework study with preparation, optimization, and confirmatory phases. Optimization Phase: This phase has two stages. In stage 1, investigators will conduct a 2x2x2 factorial trial to expand EMBED is expanded to include sustainable implementation strategies: nurse prompt for withdrawal assessment, and targeted clinician prompts to use the CDS along with individualized patient resources to promote equity and motivate readiness to start treatment. In Stage 2, investigators will improve CDS usability via serial randomized testing to inform iterative refinement of the CDS interface and workflow to minimize user errors, task disruption, and abandonment through identification of specific targets for improvement via application of novel CDS outcome measures in serial randomized tests. Evaluation phase: Investigators will conduct a randomized trial to compare the efficacy effectiveness of the optimized package compared to the original on ED-initiation of buprenorphine rates in patients with OUD. \*EMBED is a user user-centered, clinician clinician-facing clinical decision support system integrated into the electronic health record workflow to facilitate initiating buprenorphine in the emergency department by: diagnosing opioid use disorder with a checklist based on the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, fifth edition), assessing the severity of withdrawal with the Clinical Opioid Withdrawal Scale (COWS), motivating patients to accept treatment with a scripted brief negotiation interview, and automating the electronic health record workflow, including clinical and after visit documentation, order entry, prescribing, and referral for ongoing treatment in the community

RECRUITING
Adaptive Decision Support for Addiction Treatment (ADAPT) Factorial Trial
Description

This study is stage 1 of a larger study which refines and optimizes the EMBED\* clinical decision support (CDS; see NCT03658642) to increase number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder. This study does not have open enrollment. Investigators will use a Multiphase Optimization STrategy (MOST) framework study with preparation, optimization, and confirmatory phases. In the current project, optimization phase, stage1 investigators will conduct a 2x2x2 factorial trial in which they expand EMBED to include sustainable implementation strategies: nurse prompt for withdrawal assessment, and targeted clinician prompt to use the CDS along with patient resources to promote equity and motivate readiness to start treatment. Later study phases will include optimization phase, stage 2: rapid-cycle randomized testing, and evaluation phase: a randomized trial of the optimized package compared to the original EMBED and the evaluation phase in which investigators will compare the efficacy of the optimized, multicomponent CDS package to the original EMBED CDS on ED-initiation of buprenorphine rates in patients with OUD in a randomized trial. \*EMBED is a user centered, clinician facing clinical decision support system integrated into the electronic health record workflow to facilitate initiating buprenorphine in the emergency department by: diagnosing opioid use disorder with a checklist based on the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, fifth edition), assessing the severity of withdrawal with the Clinical Opioid Withdrawal Scale (COWS), motivating patients to accept treatment with a scripted brief negotiation interview, and automating the electronic health record workflow, including clinical and after visit documentation, order entry, prescribing, and referral for ongoing treatment in the community

RECRUITING
Addiction Potential of Very Low Nicotine Filtered Little Cigars
Description

The goal of this clinical trial is to learn how reducing the nicotine content in filtered little cigars can affect the the use of these cigars and lung health in current adult filtered little cigar users. The main question\[s\] it aims to answer are: Are puffing behaviors, appeal/satisfaction, craving suppression, pharmacokinetic effects, and demand similar between the regular cigars smoked by participants, normal nicotine study cigars and very low nicotine study cigars? Are health effects and toxicant exposure similar between the regular cigars smoked by participants, normal nicotine study cigars and very low nicotine study cigars? Participants will attend three study visits at OSU. Each visit would last up to 4 hours. During visits, they will * fill several surveys * provide blood samples * perform breathing tests * complete smoking sessions using either their own cigars or the study cigars.

COMPLETED
Stop Addiction Stigma
Description

This clinical trial evaluates the impact of a Stop Addiction Stigma (SAS) training workshop with a short description of the conditions related to addiction (vignettes) on stigmatizing attitudes toward individuals with substance abuse disorders. Reviews have shown that patients with substance abuse disorders have experienced negative attitudes from their health care providers. Negative attitudes may lead to less involvement from the provider and the patient and may lead to less effective care. Using case vignettes with a SAS workshop may be an effective method to help people learn about addiction, reduce the stigma toward addiction and improve the quality of health care.

RECRUITING
Leveraging Artificial Intelligence and Multi-Omics Data to Predict Opioid Addiction
Description

The primary goal of this proposal is to validate a novel genomic and microbiome predictive model that may be used to assess a person's risk of developing opioid use disorder (OUD). The following will be tested: (1) MODUS (Measuring risk for Opioid use Disorder Using SNPs), which is a genomic panel consisting of a set number of proven single nucleotide polymorphisms (SNP) that utilizes machine learning to determine an individual's risk; and (2) MICROUD (MICRObiome for Opioid Use Disorder), which will be a novel microbiome prediction panel for OUD risk. MODUS and MICROUD will be developed using existing public datasets with genomic and microbiome data (e.g., All of Us, Human Microbiome Project). During development of these predictive models, in parallel, an external prospective validation cohort will be recruited consisting of subjects from the University of California, San Diego, Veteran Affairs of San Diego, and Veteran Affairs of Palo Alto (each site with separate IRB). The hypothesis is that MODUS and MICROUD will have high predictive potential for identifying high risk patients for OUD.

RECRUITING
Retention and Re-Engagement in Treatment for Addiction Following Serious Injection Related Infections (RETAIN)
Description

This project is a pilot study of an adapted intervention of an existing Opioid Use Disorder (OUD) treatment retention intervention called Recovery Management Checkups (RMC). This intervention has been adapted to better fit the experiences and unique issues of those that have been hospitalized with serious injection related infections (SIRI) based on the findings from a prior qualitative study from the principal investigator. This project plans to test the adapted intervention within a smaller group of participants to assess feasibility, acceptability, and calculate early findings of intervention efficacy. Hospitalizations for SIRIs are a unique entry point for patients to start their recovery journey with medications for OUD (MOUD), but many people do not remain on long-term treatment, despite evidence that indicates MOUDs reduce death and re-hospitalization after SIRIs. The study objectives are to: * Assess the implementation feasibility of the adapted RMC model for patients with SIRI and OUD. * Establish preliminary estimates of intervention efficacy. * Make further adaptions to the intervention that will reduce both known and unknown barriers to care and increase effectiveness in future larger scale trials. Findings from this pilot study will result in further intervention refinement to better fit the target population, and serve as the basis for a larger randomized control trial that will have aims focused on more in-depth analysis of the efficacy of this program

NOT_YET_RECRUITING
Person-Centered Quality Measurement and Management in a System for Addictions Treatment in New York State (Project 3)
Description

The goal of this study is to implement Opioid Use Disorder Quality Measurement and Management (OUD-QM2) strategy by the Office of Addiction Services and Supports (OASAS) to drive change and improve treatment practices. Through a concurrent mixed methods approach that iteratively examines quantitative and qualitative data to inform the process, the investigators will examine the effects of the strategy on stakeholders-PWUD/patients, families, and providers-and outcomes. This comprehensive approach will allow for a "global" view of the perceived effects of the OUD-QM2 strategy for all stakeholders while allowing us to use administrative data to test the effects of the strategy on patient outcomes. Through qualitative interviews and focus groups conducted in years 1, 3, and 5 of the phase, the investigators will derive information from stakeholders about their perceptions and use of the quality measures. Through surveys conducted with all clinics, the investigators will elicit data on changes in provider use of quality measures, clinical practice, and use of measures for incentive-based contracting. Finally, the investigators will conduct a stepped wedge trial to examine the effects of performance coaching that guides clinics on use of the quality measures for clinical practice improvement. The trial will also benefit from a treatment as usual (TAU) condition of clinics not participating in the trial to examine secular trends in patient outcomes across the period of the OASAS QM2 strategy rollout. The overall aim is to build and test a science-based OUD-QM2 strategy for person-centered treatment.

NOT_YET_RECRUITING
HIV, Equity, and Addiction Training (HEAT) Program
Description

This project is a pilot study to determine the feasibility and acceptability of a telemedicine intervention for substance use disorder service delivery in diverse people living with HIV in Alabama.

WITHDRAWN
Ultrasonic Treatment of Food Addiction
Description

This study will evaluate a new form of non-invasive deep brain therapy for food addiction. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled trial. The trial will evaluate brain target engagement using magnetic resonance imaging, Food Cravings Questionnaire-State, and changes in subject's weight over the course of the study.

COMPLETED
Social Support Intervention for Addiction Recovery
Description

The purpose of this research study is to determine whether using a web-based intervention is feasible, acceptable, and helpful for people who engage in hazardous alcohol use and want to cut down or quit.

RECRUITING
Following Outcomes Remotely Within Addiction Recovery Domains
Description

The aim of this study is to describe outcome of people with opioid use disorder over the long-term by collecting monthly and yearly data on their recovery. Adults with opioid use disorder who participate will complete surveys monthly online and once per year by phone about their substance use, mental health, treatment involvement and functioning. The goal of this study is to better understand how people with opioid use disorder recover over time to improve intervention for this group.

RECRUITING
Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO; R33 Phase)
Description

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.