246 Clinical Trials for Various Conditions
Clinical study participation percentages haven't always been fully representative of a given demographic. The goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through. The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future substance abuse disorder patients during clinical trials.
This study will determine the effectiveness of the STIRR (Screen, Test, Immunize, Reduce risk, and Refer) intervention in increasing rates of testing, immunization, referral, and treatment for blood-borne diseases, such as hepatitis and HIV, in people with both a mental disorder and a substance abuse disorder.
This study will determine the efficacy and safety of combination therapy with divalproex and lithium for treating mania in people with rapid cycling bipolar disorder and a substance abuse disorder.
The goal of this clinical trial is to study the relationship between substance cravings, cognitive performance, behaviors, and physiological markers in individuals with substance use disorder, as well as the effects of peer recovery intervention in response to abnormal biomarker data detected by wearable technology (e.g., Oura ring, smart watch) and participant responses to questionnaires and cognitive tasks completed on the RNI Health application.
This research is being done to evaluate the effectiveness of three different treatment strategies for helping subjects begin and adjust to methadone maintenance treatment at Addiction Treatment Services (ATS). Subjects will be randomly assigned to one of three treatment conditions: 1) Voucher-Based Stepped Care (VBSC) induction, 2) Low-threshold Stepped Care (LTSC) induction, or 3) Routine Stepped Care (RSC) induction. It is hypothesized that subjects in both the VBSC and LTSC condition will remain in treatment longer than subjects in the RSC condition. In addition, it is hypothesized that VBSC and LTSC subjects will have less drug-positive urine samples and will report less infectious disease risk behaviors than RSC subjects.
This research is being done to compare the effectiveness of standard on-site, in-person counseling with Internet web-based videoconferencing (e-therapy) in drug-dependent patients in opioid-agonist treatment programs. The study is looking to see if there are any differences in satisfaction or in treatment outcome if counseling sessions are given by e-therapy compared to standard, in-person counseling given in the clinic. The e-therapy happens in real time- it works very much like standard therapy in the clinic except that the patient is in his or her own home (or other convenient location outside the clinic) and talks to and sees the therapist through an Internet connection on the computer (the therapist will usually be at the clinic).
Background: - Relapse following cigarette abstinence remains a common problem for smokers who are attempting to quit. Most research has focused on the acute withdrawal phase that occurs within the first 48 hours to 1 week after quitting; however, more information is needed on the experiences of smokers in longer durations of abstinence. Objectives: * To study the effects of long-term smoking abstinence. * To study the effects of cigarette-related cues on craving in longer periods of smoking abstinence. Eligibility: - Individuals at least 18 years of age who are current smokers (at least 10 cigarettes per day) and who want to quit but are not currently attempting to quit. Design: * Participants will be randomly assigned to abstain from all nicotine use for 7, 14, or 35 days. A fourth group of participants will also abstain for 35 days, but will undergo more testing sessions than the other groups. * All participants will have an initial orientation session in which they will complete questionnaires about their smoking habits and will respond to smoking-related cues to provide information about their cravings. * Participants will visit the clinic daily during their abstinence period, and provide urine and breath samples to test for tobacco use. Participants will receive compensation for every day that they do not use tobacco. * On the end day of the abstinence period, participants will return to the clinic, provide urine and breath samples, and undergo testing of their responses to smoking-related cues. Participants in the fourth group will have these tests on Days 7, 14, and 35 of abstinence; other participants will have the tests only once, at the end of their abstinence period. * After the required abstinence period, participants will enter a 5-day step-down period. They will continue to report to the clinic for breath and urine testing, and they will receive payments for abstinence that decrease in value across days. * After the step-down period, for the final 12 days of the study, participants will report to the clinic every 3 days to give urine and breath samples and to report the number of cigarettes smoked.
This study evaluates theories regarding cocaine abstinence which propose that increased presynaptic and postsynaptic dopamine activity and increased serotonin activity are associated with abstinence in cocaine dependent subjects at the beginning and three to six months after a treatment program. We are using positron emission tomography (PET), Magnetic Resonance Imaging (MRI) and diffusion tensor imaging (DTI) in cortical and subcortical areas in a series of brain imaging studies testing these theories of abnormalities in the dopamine and serotonin system for cocaine addiction by examining the distribution of 18F-fallypride, 18F-altanserin, and FDG. We are evaluating genetic theories associated with cocaine addiction through the examination of genetic markers and functional genomics.
The goal of this pilot clinical trial is to learn if a community informed designed program of addiction counseling with coordinated community peer navigator for people with Opioid Use Disorder (OUD) and other medical conditions can improve engagement in primary care and retention on buprenorphine. The main questions it aims to answer are: * Does the addition of a counseling and peer referral interventions in addition to usual primary care with low-threshold buprenorphine increase retention on medications for opioid use disorder? * Does the addition of counseling and peer referral intervention in addition to usual primary care with low-threshold buprenorphine increase engagement in primary care? Researchers will compare the MOUD "Plus" intervention compared to primary care treatment as usual low-threshold buprenorphine prescribing practice to see if MOUD "Plus" improves retention and engagement. Participants will upon screening and enrollment: * Meet with prescribers who will determine dose of buprenorphine and assess other medical issues as per treatment as usual with visits every 2-4 weeks * Meet with the integrated addictions counselor to develop rapport and support around clinic engagement, brief counseling intervention, and coordination of care in support of their MOUD * Be referred to a community based peer who meets with participants outside the clinic for support and advocacy for patient directed recovery goals * Meet with the research coordinator at 2, 3, and 6 months to complete follow-up surveys about their care and experiences
Currently, 1 in 8 adolescents continue to receive prescription opioids a year or more after injury. By longitudinally surveying patients, we can identify risk factors and pathways to nonmedical opioid use. Furthermore, by assessing whether pain management and mental health treatment after injury moderates sustained opioid use and prescription opioid misuse, we can create targeted interventions to reduce future nonmedical opioid use in adolescents.
This study seeks to implement wrap around services for Veterans suffering from co-occurring mental illness and substance use and who are homeless. It will compare Implementation as Usual of MISSION to Facilitation Implementation of MISSION.
Project CONNECT ("Community-based Organizations Neighborhood Network: Enhancing Capacity Together") is a randomized controlled trial that involves 22 community-based organizations (CBOs) located in Baltimore, MD. Half of these organizations were randomly assigned to the intervention group using a constrained cluster randomization process. The remaining 11 are a part of the control intervention group. The intervention is a co-developed set of IT tools hypothesized to improve the connections among intervention CBOs, Johns Hopkins health care facilities and CBO clients.
The study examined intensive case management for homeless Veterans in addiction treatment by integrating addiction/housing case managers (AHCM), operating from a Life Skills Training perspective, into an addiction specialty program. The primary aim was to determine whether the AHCM intervention increases number of days housed during the year following treatment entry. Secondary aims were to compare costs and cost-effectiveness of AHCM vs. time and attention control, determine if AHCM improves addiction outcomes and functional status, and examine treatment process variables associated with improved outcomes.
A pilot study to evaluate the ability of photobiomodulation to alter cerebral blood flow in the frontal poles and to affect the emotional status of patients with major depression.
This study aims to examine the effects of Low-Intensity Focused Ultrasound (LIFU) on brain activity in patients with alcohol use disorder.
This is a single-center, randomized, double-blind, placebo-controlled, single-ascending-dose study to evaluate the safety and tolerability of the coadministration of up to 6 dose levels of ANS-6637 and EtOH in healthy male moderate alcohol drinkers. The study will include a screening visit, a qualification visit, a Treatment Phase and follow-up.
Background: - The National Institute of Drug Abuse (NIDA) is interested in developing a pool of potential research participants who may be eligible for research studies on drug abuse and addiction, pharmacological and psychosocial therapies for substance addiction, drug abuse and co-occurring psychiatric disorders, and the long-term effects of drugs on the development, function, and structure of the brain and other organ systems. To develop this pool of potential participants, researchers intend to screen individuals who may be eligible for future research studies. Objectives: - To identify, recruit, and screen participants for NIDA collaborative research protocols. Eligibility: - Individuals 18 years of age and older who are able to provide informed consent. Design: * Eligible participants will undergo two screening interviews: a telephone interview and an in-person interview. The phone interview will determine eligibility for the in-person interview. * The in-person interview, which may require up to five visits to the clinical center, will involve any or all of the following procedures: (1) full physical examination and medical history; (2) psychiatric interview; (3) psychological testing; (4) electrocardiogram; (5) samples of blood, urine, and hair; and (6) other minimally invasive procedures as directed by the research staff. * Participants will provide a photograph for confirmation of identity for subsequent visits and protocols. * No clinical care will be provided under this protocol.
This study assesses brain connectivity and function of individuals ages 13-25 at a prodromal or early stage of a psychotic disorder. Participation involves approximately 3 hours of MRI scanning and up to 6 hours of behavioral testing at Washington University School of Medicine's campus.
Housing instability is both a cause and consequence of mental health problems. As such youth experiencing housing instability (e.g., homeless or marginally housed) have higher rates of mental health problems.Because of their circumstances, these youth also face significant barriers to mental health care and are therefore less likely to receive the treatment that they need. Mobile technology may offer a novel platform for increasing access to mental health care in this population. The primary goals of this pilot study are to (1) establish the feasibility and acceptability of delivering automated mental health interventions via smartphone technology, (2) examine the extent to which automated mental health interventions delivered via mobile technology improve mental health in homeless, marginally-housed, and exiting foster youth.
This study is being done to see if outcomes for both a premature infant's parents and the infant born prematurely who have spent time in the neonatal intensive care unit (NICU) can be improved through parent cognitive behavioral therapy (CBT) sessions.
Youth To Text or Telehealth for Engagement in HIV Care (Y2TEC) is a randomized control pilot to assess the feasibility and acceptability of delivering a targeted problem-solving intervention to youth ages 18-29 living with HIV (YLWH) for improving HIV care engagement, mental health, and decreasing substance use. The intervention will be delivered to participants in two condition groups in remote telehealth sessions delivered via video-conference over 4 months. Participation in the study will last about 8 months. The investigators hypothesize that the Y2TEC intervention will be feasible and acceptable for YLWH, and will result in improved HIV clinical outcomes. If feasible and acceptable, it can be scaled up for a multi-site randomized clinical trial and ultimately offered in the clinical care of YLWH.
The proposed study will pilot the use of an adapted Game Squad intervention aimed at improving physical activity and other important health behaviors (nutrition, sleep hygiene, screen time habits) for children and adolescents receiving special education supports for behavioral health challenges, or who are served by the Boston Medical Center Developmental and Behavioral Pediatrics (BMC-DBP) clinic.
This application requests funding to conduct a randomized effectiveness trial of The New Beginnings Program (NBP) delivered through a partnership of domestic relations courts, community service providers and the NBP research team. This is the first attempt to offer the population of families seeking divorce an evidence-based prevention program shown to have long-term effects on youth problem outcomes. It is estimated that over a third of U.S. children experience parental divorce, which confers elevated risk for multiple problems in childhood and adulthood including substance use and abuse, smoking, mental health problems, high risk sexual behavior, and physical health problems. Efficacy trials of the NBP found positive effects at post-test, 6-year and 15-year follow-ups. For example, at 6-year follow-up the participation in NBP led to reductions in marijuana, drug and alcohol use and a 37% reduction in prevalence of diagnosed mental disorder; and reductions in externalizing problems, internalizing problems and high risk sexual behavior. Positive effects also occurred for grade point average (GPA) and self esteem. For many of the effects of the NBP, the effects were stronger for youth who were at higher risk at program entry. Many of the program effects were mediated through the program effects to strengthen parenting. Funded by an Advanced Center for Intervention and Services Research grant (NIMH P30 MH068685) the investigators modified the NBP to translate it from a prototype tested in efficacy trials into a program that can be effectively delivered by community service providers and one that is appropriate across diverse cultural groups, and fathers as well as mothers. Pilot testing of the modified NBP and training and monitoring systems has demonstrated that they are highly acceptable to parents and providers. The investigators also developed and experimentally tested a system of parent recruitment that was found to be effective in getting parents to enroll (sign up to participate) in the NBP but, similar to other prevention parenting programs, initiation (attendance at one or more sessions) in the NBP in the pilot was low.
The purpose of the study is to determine the safety and efficacy of an integrated treatment for substance abuse and posttraumatic stress disorder for young adults. The integrated treatment includes two established psychosocial treatments for substance abuse (Contingency Management) and posttraumatic stress disorder (Prolonged Exposure therapy).
The purpose of this research is to determine if pregnenolone supplement is associated with a reduction in substance use and craving in patients with recurrent major depressive disorder or bipolar disorder and substance abuse/dependence. This research also wants to explore if pregnenolone supplements are associated with improvement in psychiatric symptoms and memory, which are often negatively affected in these patients. It is hypothesized that patients receiving pregnenolone supplements would show greater improvements in mood symptoms and memory, and crave substances less than the patients receiving placebo.
Purpose: To conduct a pilot study of a cognitive-behavioral treatment (CBT) for PTSD and substance abuse among persons with serious mental illness (SMI) treated in a community setting. Participants: Participants will be 50 volunteer adult individuals with PTSD and substance use disorders (SUD), and SMI who are receiving services at the Freedom House Recovery Center, served through the Orange Person Chatham (OPC) Area Program. Procedures (methods): Participants will be randomly assigned to one of two conditions: 1) the CBT intervention plus treatment as usual; or, 2) treatment as usual.
The study seeks to measure the effect of increased coordination of care on medical costs, treatment utilization and selected clinical indicators among a Medicaid population with chronic medical conditions and substance abuse problems? We shall address this question by conducting a demonstration project consisting of the provision of integrated care management (somatic and behavioral) to Medicaid enrollees living on the Eastern Shore of Maryland and who have both chronic medical conditions and problems with substance abuse. A specific component of the study will be the participation of Maryland's Mental Health Administration (MHA) and MAPS, the administrator of psychiatric services for the Medicaid enrollees in Maryland. We shall compare the results of the integrated care management for the study sample on the Eastern Shore with a control group from the counties of western Maryland.
The purpose of this study is to examine the barriers, facilitators, and optimal processes for implementing a digitally enhanced screening, brief intervention, and referral to treatment (SBIRT) model for Substance Use Disorder SUD treatment among Mayo primary care clinics.
The overarching goal of this study phase, Phase II component is to implement Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) device in substance use disorder (SUD) clinics to demonstrate pilot effectiveness for SUD outcomes compared to treatment as usual (TAU) and Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT) device as active control. The investigators will conduct a multi-site study of 300 adult patients with opiate use disorder (OUD), stimulant (i.e., cocaine, methamphetamine) and/or alcohol use disorder (AUD) from community and clinics to evaluate whether EDITOR is associated with better patient treatment outcomes (e.g., retention in treatment and abstinence). The pilot study will provide preliminary data needed for design of a Phase III trial, including estimates of effect size. The investigators will also explore development of machine learning/AI algorithms integrating clinical and physiological data into treatment decision guides for providers.
This is a 5-year Hybrid Type 1 Effectiveness-Implementation Randomized Control Trial (RCT) that compares two models of linking and retaining individuals recently released from justice involvement to the continuum of community-based HIV prevention and treatment, HCV treatment, STI treatment, and opioid use disorder (OUD) prevention and treatment, medication for opioid use disorder (MOUD) service cascades of care.