View clinical trials related to Substance-Related Disorders.
Filter by:The proposed project seeks to achieve four objectives that will, collectively, evaluate the effectiveness of a one-year version of the Parent-Child Assistance Program (PCAP-1) -a model for a home visitation and case management program for parents who used substances during pregnancy. First, the proposed project aims to estimate the causal impact of PCAP-1 on preventing the need for foster care and promoting reunification. Second, the project will estimate PCAP-1's effectiveness in achieving other program goals: parent recovery, parent's connection with needed comprehensive community resources, and preventing future children from being exposed to drugs and alcohol prenatally. Third, the project intends to estimate any cost savings from the perspective of the state. Finally, causal evidence of program effectiveness across the prior three objectives would enable PCAP-1 to be rated according to strength of evidence on relevant federal registries (i.e., FFPSA and HOMEVEE). All four objectives will be pursued by leveraging an ongoing randomized control trial (RCT) of PCAP with substantial backing from public and private partners, including the Oklahoma Department of Human Services (OK's Title IV-E agency). This quasi-experimental project will recruit 40 new participants to receive PCAP-1 services and will use data on participants from the existing trial for the control group. This extension of the original RCT is efficient and highly feasible, drawing upon and adapting an existing evaluation framework and protocol. This design will facilitate an unbiased estimation of one-year program effectiveness while also enabling a comparison of the differential effectiveness of PCAP-1 and the original three-year PCAP model as a secondary benefit. Moreover, given that the population PCAP serves are disproportionately poor and low-income and PCAP is designed to be culturally competent and relevant, PCAP-1 harbors the potential to address inequities in child welfare outcomes, substance use disorder treatment services, and child and family well- being by improving outcomes for these families. With a strong backing by state agencies and community partners, the evaluation of PCAP-1 will contribute to a knowledge gap in the field for in-home program models serving a highly vulnerable population with high rates of child welfare involvement and use of foster care.
This study will examine the synaptotrophic effects of psilocybin among medically healthy, detoxified OUD subjects. Eligible OUD participants will undergo pre- and post- psilocybin administration PET scans with the [11C]-UCB-J radiotracer while inpatient.
The purpose of the research is to check whether services and materials made available through a smartphone app are helpful to people who have been diagnosed with opioid use disorder (OUD). Participants are asked to use an app to submit videos of themselves taking salivary drug tests to a secure online system. The app includes reminders, rewards, and activities, as well as access to live support. Study participation lasts one year and includes about 30 minutes each week submitting videos, an hour-long interview to get started, and hour-long interviews once every three months after that over the course of the year.
The goal of this research study is to investigate the effects transcutaneous auricular neurostimulation (tAN), as delivered through the Sparrow Ascent device, on helping people with co-occurring posttraumatic stress disorder (PTSD) and opioid use disorder (OUD) start and continue buprenorphine treatment. The main questions it aims to answer are: - Does the tAN help participants with OUD and PTSD remain in buprenorphine therapy for three months after starting use of the device (i.e., randomization to treatment condition)? - Do participants find the Sparrow Ascent device to be acceptable and use it? - Do participants find the Sparrow Ascent device to be tolerable and comfortable to use? - Do participants find the Sparrow Ascent device to be easy to use with their buprenorphine therapy? - Do participants follow the minimum recommended dose schedule for the Sparrow Ascent device most of the time? Participants will complete a baseline assessment to make sure that they are eligible to participate in the study. The assessment captures information about demographics, substance use and treatment history, opioid withdrawal symptoms and craving, difficult life experiences and PTSD symptoms, mental health and treatment history, quality of life, and recovery resources. After the assessment is complete and the participant has been inducted on buprenorphine as part of standard care in the clinic, they are randomized to one of two treatment conditions: active tAN and placebo. Participants are trained on how to use the device and return for 12 weekly research visits to check on recent substance use and craving, PTSD symptoms, and their experience using the device. After 12 weeks of using the device, participants will complete a post-active treatment assessment that is nearly identical to the baseline assessment to see if there have been changes in these areas. Researchers will access the medical record to determine whether there is a current prescription for buprenorphine at three months and six months after randomization.
This research study will evaluate the effectiveness of utilizing Battlefield Acupuncture (BFA) on veterans with with a history of substance use disorder and chronic pain for 8 weeks. Primary Aim: The primary aim of this study is to evaluate the effectiveness of using BFA to treat chronic pain in veterans with a history of substance use disorder. Secondary Aim: This study will also evaluate the impact that BFA treatment for pain may have on subjects' stress, mood and sleep patterns over 8 weeks. In addition, each subject will be complete behavioral research tools to measure: depression, anxiety, and substance use at 3 different points in this study. Hypothesis: The use of BFA on veterans with chronic pain will decrease their pain and substance use and improve their quality of life.
The purpose of this trial is to test the efficacy of a collaborative care intervention to address opioid- and/or stimulant-involved polysubstance use in adult primary care patients with moderate to severe substance use disorders (SUD). The primary aims are to reduce days of opioid use (illicit or nonmedical opioid use), days of illicit stimulant use (cocaine, methamphetamine), and days of heavy alcohol use.
Opioid use disorder (OUD) is a treatable medical illness with three medications FDA approved for treatment. However, persons with OUD report significant sleep disturbance, even when treated with medications for opioid use disorder, leading to high rates of relapse. In this project, we will investigate a special set of photosensitive neurons in the retina as an underlying mechanism for circadian rhythm and sleep disturbance from opioid use and medications for OUD that could lead to novel intervention and improve treatment outcomes.
The goal of this clinical trial is to evaluate the effectiveness of a social network intervention to recruit people who inject drugs and their networks for HIV testing and linkage to HIV prevention and treatment services in Maryland. Study aims are to determine the effectiveness of a social network driven intervention to increase: - HIV testing (primary); - PrEP knowledge; - Uptake of HIV services and pre-exposure prophylaxis (PrEP); - Uptake of medication for opioid use disorder (MOUD) initiation. Eligible participants who access syringe service programs (SSPs) serving two counties in Maryland and their risk network members (NMs) will be recruited using an established network inventory and coupon recruitment method. When an index successfully recruits NMs, the index-NM cluster will be randomized to either a peer-educator intervention arm or an equal-attention control arm. Index participants randomized to the peer-educator intervention arm will complete a training program adapted with stakeholder input to context that emphasizes effective communication, frequent HIV testing, and awareness of evidence-based HIV prevention and treatment services. An important innovation to the network intervention will be training indexes to use and distribute HIV self-test kits and naloxone to their NMs. Index participants randomized to the equal-attention control arm will receive training sessions focused on the opioid overdose epidemic and will not include any training to serve as a peer educator. All participants (indexes and NMs) will complete study assessments at baseline and at 3 and 9 months. We will compare the peer-educator intervention group and the equal-attention control group on rates of HIV testing, knowledge of PrEP options and resources, and rates of initiation of HIV treatment, PrEP, and MOUD treatment since the previous assessment (past 3 or 6 months).
The study is investigating the feasibility and acceptability of the story-based intervention, The Shadows of Tallystick Valley, aimed at improving the psychological wellbeing and resilience of children and young people who are affected by familial substance use. A secondary aim of the study is to identify whether there is a 'signal of efficacy'. The early intervention is a story and activity book designed and developed by Book of Beasties, in collaboration with the charity Change Grow Live (CGL), who work directly with children and young people experiencing familial substance use. The intervention is used by s at CGL with children and young people engaged with the service. In the present study, we aim to evaluate the story-based intervention within a pilot randomised controlled trial. Participants will be randomised to either receive the intervention or to join a waitlist for the same intervention. The effects of the story-based intervention will be assessed using pre and post psychological well-being and resilience measures, including KidCOPE, the Stirling Children's Wellbeing Scale and the Child and Youth Resilience Measure. The primary outcome measures are concerned with overall psychological wellbeing.
This is a human laboratory-based, randomized, cross-over study in which buprenorphine will be administered to healthy volunteers (n=22) in 3 separate inpatient 2-night visits, at least 1 week apart. At each visit, the participant will receive a single dose buprenorphine, either 0.15mg IV, 8mg PO, or 16mg PO. The order for the first dose administered will be fixed to the IV dose, and the subsequent doses will be randomized and counterbalanced to 8mg or 16mg PO. Participants will be given naltrexone to produce opioid blockade to eliminate the risk for opioid dependence in individuals without OUD. Timed blood samples will be collected up to 24 hours.