149 Clinical Trials for Various Conditions
Substance-using adults are admitted to hospital for medical complication from their drug and alcohol use at very high rates; yet, their care is often defined by low rates of referral to addiction treatment programs and recidivism. In 1997, we instituted an integrated medical-substance use treatment program at Johns Hopkins, the First Step Day Hospital, designed for intensive post-acute care of previously hospitalized substance using adults. We have shown that patients with dual diagnoses admitted to First Step more often complete their course of medical care and stay in recovery longer than patients not admitted to First Step.(1;2) On discharge from First Step, patients are medically stable and drug-free. Their substance abuse care is transferred to an out-patient substance abuse treatment facility and their medical care is transferred to their primary care provider. Unfortunately, many patients are lost to follow-up during this transition. We believe that a peer mentor-based disease management program (PM) can provide continuity of care that begins in First Step and continues after discharge thereby increasing the proportion of patients who remain in treatment for their addiction and medical conditions. Peer mentors are persons from the target community who have been in recovery for 5 or more years. In cooperation with patients and providers, peer mentors improve the integration of care, quality of care, and access to healthcare services. This pilot study will test the effectiveness of a peer mentor-based disease management program. The specific aims are to compare the impact of the PM intervention verses enhanced usual care on outcomes in three domains (1) medical/psychiatric health status, (2) addiction recovery, and (3) social resource acquisition. If successful, this study will provide evidence supporting a larger randomized controlled trial of the impact of field workers on post-acute care among patients with dual diagnoses.
This study is testing a new mutual-help group called "the TLC program" for transgender adults who use substances or are recently in recovery. The TLC Program is based on Acceptance and Commitment Therapy or "ACT" which is a type of mental health counseling that focuses on using mindfulness skills to connect a person to their values and improve their mental health. The TLC Program was developed by transgender and gender diverse community members, mental health providers, and researchers.
This project examines computer-delivered cognitive-behavioral intervention (CBT4CBT) as an adjunct to residential treatment for women with substance use disorders (SUD). The project will conduct a 2-arm randomized clinical trial (RCT) comparing post-discharge relapse rates for treatment as usual (TAU) with access to the CBT4CBT program vs. TAU in a residential sample of women with SUDs.
This component of a larger Center of Research Excellence Grant improves treatment for drug abuse by developing effective linkages between specialty drug treatment and primary health care.
Background: - The risk for becoming addicted to drugs varies among individual, even those using similar drugs in a similar way. It is not known why some people become addicted and others do not. Studies suggest that some genes may increase the risk of addiction. Negative life experiences may also affect the risk of addiction. Researchers want to test smokers and nonsmokers to study genetic and brain function traits that may lead to drug addiction. Objectives: - To understand brain function in people who may be at a higher risk of drug addiction. Eligibility: * Healthy volunteers between 18 and 55 years of age. * Smokers (10 to 30 cigarettes per day for more than 2 years) and nonsmokers will be eligible. Design: * Participants will be screened with a physical exam and medical history. They will be tested for drug and alcohol use. A blood sample will be collected. * The study will involve one visit. Participants will have a magnetic resonance imaging (MRI) scan. * At the visit, participants will answer questions about their health and drug use habits. They will then be trained on the tasks they will do during the MRI scan. After the training, they will have the scan and perform the tasks. The scan and tasks will look at brain function related to rewards and impulsiveness. * Other computer tests will be given after the scan. These tests will measure learning, memory, and impulsiveness.
The investigators are examining different treatment strategies of helping patients with PTSD and addiction.
The purpose of this research study is to determine whether Carvedilol, an FDA approved beta blocker, when administered for an 8-week period to veterans currently undergoing treatment for methamphetamine dependence (1) improves their ability to stay in treatment longer, (2)eases the aversive symptoms that accompany stimulant withdrawal, and (3) increases the time they remain abstinent from methamphetamine.
The purpose of this study is to evaluate whether the combination of prazosin and naltrexone will decrease alcohol cravings and drinking in individuals who have problems with alcohol and have used alcohol at risky levels compare to naltrexone and placebo (Nal/Pl), prazosin and placebo (Praz/Pl), and double-placebo (Pl/Pl). We hypothesize that those assigned to both prazosin and naltrexone would report significantly greater decreases in percent drinking days and heavy drinking days as well as significantly greater reduction in craving from pre to post-treatment than those assigned to either single medication or double-placebo. Prazosin is a medication that is approved by the U.S. Food and Drug Administration (FDA) to treat people with high blood pressure. Some studies have shown that prazosin may also decrease nightmares and improve sleep in Veterans suffering from Posttraumatic Stress Disorder (PTSD). Animal studies have consistently found that prazosin is associated with decreased alcohol consumption and that the combination of prazosin and naltrexone outperforms either medication alone. The current study is evaluating an "off-label" use of prazosin to determine whether it is helpful in decreasing alcohol cravings and consumption among people with alcohol problems. "Off-label" means that the FDA has not approved the use of prazosin for alcohol problems. Naltrexone is a medication that is FDA approved for treating alcohol problems. This study is sponsored by the Department of Defense and the Congressionally Directed Medical Research Program (DoD/CDMRP). We expect approximately 120 participants in this study, which will run over approximately 4 years. Study participants will be involved in the study for 7 weeks, or until they complete the Final Assessment.
Many American Indian (AI) women never receive services for serious mental health problems resulting from traumatic events, violence exposure and maltreatment. AI women suffer higher lifetime rates of Post-traumatic Stress Disorder (PTSD) (20-23%), that often co-occur with excessive drinking and risky sexual behaviors. These factors magnify risk for human immunodeficiency virus and sexually transmitted disease (HIV/STI). In full development with tribal partners, this application, proposes a 3-year project to culturally adapt and pilot an empirically supported trauma-focused treatment, Cognitive Processing Therapy (CPT) for PTSD, substance use and HIV/STI sexual risk behavior among 50 AI women. Additionally, the investigators will assess the feasibility, acceptability and treatment fidelity of delivering CPT via AI community health workers in a resource-limited tribal reservation. This project brings a culturally responsive intervention to an understudied and highly vulnerable population. Its significance lies in its potential to advance science in the area of PTSD, substance use treatment and HIV/STI prevention among AI women. Study data would benefit tribal and rural communities and the mental health field. Finally, it is geared toward developing the research infrastructure and mental health treatment capacity serving AI women living in rural settings, a group at risk for an expanding HIV/AIDS epidemic. If successful, findings from this pilot will provide evidence for a larger effectiveness trial. The AIMS are AIM I. Adapt the evidence-based CPT intervention in full collaboration with tribal partners. This will be done in accordance with the CDC's Map of Adaptation Process and involves formative research with tribal leaders, potential consumers, providers, and health care administrators using qualitative methodology. AIM 2. Assess this intervention delivered by Native American community health workers for feasibility and acceptability in a resource-limited rural reservation setting. AIM 3. Conduct a two-group, single-site waitlist randomized controlled pilot trial of a 12-session, 6-week CPT intervention among 56 (6 pilot) sexually active and substance using AI women with PTSD or sub-threshold PTSD. Determine preliminary efficacy and estimate an effect size in terms of three primary outcomes: (a) PTSD symptomatology; (b) substance use; (c) high risk sexual behavior.
This pilot project will evaluate a new mind-body intervention called Mind-Body Bridging (MBB) for reducing substance abuse problems in women who are undergoing a substance abuse treatment program. The main hypothesis is that MBB will be more effective than the control (standard) intervention program in helping people reduce their craving for illicit substances and/or alcohol.
The purpose of this study is to compare a culturally adapted and a non-culturally adapted group-based substance abuse treatment with Latino adolescents.
This study will examine the effectiveness of a brief intervention in a primary care setting to reduce drug use or abuse compared to enhanced care as usual.
Children born to women who abuse drugs have a high risk of being born with birth defects and developmental problems. Methadone is a drug that is commonly used for treating opioid dependence. However, its use by a pregnant woman can cause severe withdrawal symptoms in a newborn because of the prenatal exposure. The purpose of this study is to evaluate the effectiveness of buprenorphine, another drug, versus methadone in reducing withdrawal symptoms in children born to opioid-dependent women.
This research is being done to evaluate if NRP104 is a safe drug. The other purpose is to learn if NRP104 produces a high and any other effects like amphetamine and other stimulant drugs that are abused. This information will give some indication if NRP104 can be abused. NRP104 is an investigational drug. This means that it has not been approved by the U.S. Food and Drug Administration (FDA). Healthy people, between the ages of 18 and 55 with histories of substance abuse that include stimulant drugs, may join. Amphetamines are drugs that are used most often to treat attention deficit hyperactivity disorder (ADHD) in children, to treat narcolepsy (excessive sleepiness) and for weight loss.
This research is being done to evaluate if NRP 104 is a safe drug. The other purpose is to learn if NRP104, when injected into a vein, produces a high and any other effects like amphetamine and other stimulant drugs that are abused. This information will give some indication if NRP104 can be abused. Healthy people, between the ages of 18 and 55 with histories of substance abuse that include stimulant drugs, may join. Amphetamines are drugs that are used most often to treat attention deficit hyperactivity disorder (ADHD) in children, to treat narcolepsy (excessive sleepiness) and for weight loss.
This study is examining the relative effects of alternative aftercare models for ex-offenders who are recovering from substance abuse/addiction. The study is a longitudinal, randomized field trial that assigns participants to one of three conditions: Oxford House, a professionally-run residential treatment facility, or a control condition that involves usual aftercare chosen by participants (which may include no treatment at all). Oxford Houses are self-run residential recovery homes based on the premise of mutual support. These homes do not involve professional treatment staff and the expenses (e.g. rent, utilities) are paid for by the residents. The hypothesis of this study is that Oxford House participants will have as good or better outcomes in terms of substance recovery, recidivism, and health in comparison to the participants who were assigned to the residential treatment facility, and better outcomes in comparison to the control group. In addition, the cost to government/tax payers will be substantially lower given that participants pay their own way.
The proposed stage 1 intervention development study is designed to address two significant co-occurring issues for fathers with substance abuse (SA) problems: Intimate partner violence (IPV) and child maltreatment (CM). SA treatment programs are an important avenue to reduce family violence because SA treatment alone does not result in an end to these behaviors. Currently available interventions have had little success in reducing male IPV. Fathers for Change, an integrated outpatient intervention, shows promise as an intervention model targeting the intersection of SA, IPV, and CM. The intervention uses men's roles as fathers as a motivation for change and targets factors that are known to trigger SA, IPV and CM: hostile cognitions and poor emotion regulation. An intervention of this sort has not been integrated and tested as part of a residential substance abuse program for men. This project is a pilot study of 60 fathers randomly assigned to Fathers for Change or a Parent Education Program (PE) comparison. The initial feasibility of the Fathers for Change will be assessed by comparing it to PE in the areas of: participant completion rates, hostile cognitions, emotion regulation, SA relapse, IPV, and CM risk behaviors (negative parenting). Change in hostile cognitions and emotion regulation will be examined as the mechanisms through which Fathers for Change reduces relapse, IPV and CM risk behaviors.
Participants play games designed to train visual attention towards natural, non-drug-related scenarios. A biofeedback loop between gameplay and an electroencephalogram (EEG) system monitors game performance and guides game difficulty.
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.
This K23 study is an effectiveness-implementation hybrid type I design to determine the effectiveness of Motivational Interviewing at Intake (MII), relative to intake-as-usual on client engagement and mechanisms of engagement among adults seeking outpatient addiction treatment. We also will obtain personnel feedback on the feasibility of implementing MII into standard practice by having personnel from the addiction treatment study sites complete implementation climate measures before Motivational Interviewing (MI) training and post-clinical trial, as well as an individual interview on implementation feasibility post-trial.
Heart rate variability biofeedback (HRVB) is an biobehavioral intervention involving rhythmic breathing at resonance frequency that stimulates cardiovascular regulatory systems to help individuals better regulate affect and bolster cognitive control. This intervention has already shown its potential as a substance use disorder (SUD) treatment tool, but practical limitations of its accessibility, labor intensiveness, and cost have previously prevented this intervention from going to scale. Second-generation, ambulatory HRVB technology, however, has overcome these limitations and now allows patients to practice HRVB in-the-moment when its needed most. This study is testing the efficacy of second-generation, ambulatory HRVB for the first time with individuals with SUD.
Young parents aged 16 to 30, involved in the DHS system for child welfare or self-sufficiency needs are at risk for opioid use disorder and/or methamphetamine use disorder (OUD; MUD). Those identified as engaging in opioid or methamphetamine misuse are at high risk for escalation. Children of parents with OUD and MUD are at-risk for entering into foster care. Oregon is one state particularly affected by this challenge. The proposed UG3/UH3 offers one potential solution by adapting and evaluating a recently developed treatment for parental OUD and MUD, for prevention. This study seeks to collaborate with Oregon Department of Humans Services (DHS) leadership to deliver a new outpatient prevention program to high-risk, young, parents. The Families Actively Improving Relationships (FAIR) program will include community-based mental health, parent management, and ancillary needs treatment, and ongoing monitoring and prevention services for opioid and methamphetamine use. This study will randomize 240 parents, aged 16 to 30, to receive FAIR or standard case management and referral, in two counties in Oregon. Outcomes will include an evaluation of the effectiveness of FAIR in addressing risk factors associated with substance use disorders in DHS-involved populations, OUD and MUD outcomes, and implementation outcomes including implementation process and milestones, and program delivery outcomes. Intervention and Implementation costs will be assessed, and the benefit of FAIR will be evaluated in relation to standard services, but also in relation to capacity and population needs. Study hypotheses are: (1) Parents randomized to FAIR will be less likely to escalate opioid and/or methamphetamine use, and to receive a diagnosis of OUD and/or MUD; (2) Parents randomized to FAIR will experience significant reductions in mental health, parent skills, and ancillary needs compared to those receiving standard services; (3) Counties will follow the implementation plan developed in collaboration between study team members and state leadership, and that doing so will yield successful implementation of FAIR; and (4) Implementation and intervention costs for FAIR will demonstrate a benefit for offering FAIR compared to standard services, particularly in rural communities where capacity influences service delivery decisions.
The present project will evaluate the initial efficacy of approach bias retraining among dual combustible cigarette (CC) and electronic cigarette (ECIG) users. The study employs a randomized controlled design to follow 90 experienced dual CC/ECIG users motivated to quit nicotine as they engage in a self-guided quit attempt following approach bias retraining.
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.
The aim of this study was to evaluate the effects of exposure to stigma reduction message frames communicated by visual campaigns and narrative vignettes among a national sample of health professionals.
This study is a multi-site, randomized pragmatic trial being conducted at three diverse sites. The study, called the Substance Use Treatment and Recovery Team (START), will evaluate whether a collaborative care team increases the use of two interventions-medication for opioid use disorder (MOUD), and opioid use disorder (OUD) focused discharge planning-among hospitalized patients with OUD, and improves linkage to follow-up care relative to usual care. The START consists of an addiction medicine specialist and a care manager who will use evidence-based tools to decrease barriers to MOUD and engage patients with post-discharge OUD care. A total of 414 patients will be randomized from Cedars-Sinai Medical Center in Los Angeles, the University of New Mexico Hospital in Albuquerque, and Baystate Health in Springfield, Massachusetts to receive either START or usual care, stratifying by prior MOUD exposure and site.
This is a research study to assess the effectiveness of a peer-led collaborative care model for integrating treatment for substance use and or mental health disorders into HIV care settings. Depending on whether or not participants enroll in this study, participants will be assigned randomly (by chance, like drawing a number from a hat) to one of two groups. In group 1, participants would receive usual clinical care. In group 2, participants would work with a peer-case manager who would help support participants to engage in substance use or mental health disorder care. Regardless of the group participants are in, participants will fill out a survey when first enrolled in the study, and then again 12 months later.
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).
This project aims to develop a line of research using new non-invasive neurostimulation technology to treat adults with opioid use disorders (OUDs). In the short term, the investigators aim to identify novel target brain regions for neurostimulation treatment and characterize their effects behaviorally and neurally. In the longer term, investigators aim to use these preliminary data to justify NIH sponsored clinical trials to apply transcranial direct current stimulation and non-invasive deep brain stimulation to these areas to partially or completely disrupt addiction.
The implementation of screening and intervention for substance use disorders, such as Screening Brief Intervention Referral to Treatment (SBIRT), in the primary care setting has faced several challenges. In the past, physicians have cited barriers such as lack of time, lack of access to treatment, and lack of financial resources. To overcome some of the barriers to screening and prevention of substance use disorders, many researchers have begun to explore novel approaches using web-based and mobile technology. While the quality of evidence is often inconsistent, there is promising research to show that interventions utilizing web-based or mobile technology for alcohol and other substance abuse can be effective. Features such as tailored feedback have shown to be more effective than similar programs without feedback, and interventions that combine self-administered therapy in conjunction with therapist-direction interventions show greater reductions in addictive behavior. In this project, the investigators proposed to enhance the Screening Brief Intervention Referral to Treatment (SBIRT) with a digital tool that aims to save physician time and improve patient adherence to treatment goals, through extensive use of shared decision making, patient self-monitoring and goal tracking, and real-time tailored patient feedback and text follow-up for patients. Increase the screening and referral of those patients at risk for substance use disorder (SUD) thereby increasing the number of patients receiving higher level substance use treatment. A total of 500 patients will be screened and randomized into two groups. 250 in the Technology Augmented Treatment group (intervention group) and 250 in the control group. The Washington State University research team, lead by Dr. McPherson, will screen and recruit subjects at CHAS Valley Clinic in Spokane, WA. Subjects in both groups will be followed up for 30 days. At the initial study enrollment visit, the intervention group will be asked questions on an iPad about their eligibility. After the initial visit, subjects in the intervention group will receive up to 4 texts/day on his/her phone that will ask questions about their health after the visit. The control group will be asked questions on an iPad and will be given a call 30 days after to ask questions about their health.