Treatment Trials

8 Clinical Trials for Various Conditions

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NOT_YET_RECRUITING
Calls and Coordination for Transitions of Care At Re-entry
Description

The goal of this clinical trial is to learn if a short program for people being released from prison can help connect them to medical care. The main question it aims to answer is: * Will there be more non-emergency, outpatient clinic visits? Researchers will compare the number of clinic visits between people who use a Nurse Case Manager (NCM) to people in enhanced usual care. Participants will: * Complete surveys * Talk to a study team member 2-3 times, or talk to a study team member 2-3 times and talk to an NCM 6-11 times

RECRUITING
Utilizing Battlefield Acupuncture to Treat Chronic Pain
Description

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.

COMPLETED
Integration of DBT Skills and Parent Training for Parents With a History of Substance Use
Description

This treatment development study is aimed at developing and pilot testing a 20-week remotely delivered group intervention that integrates two evidence-based treatments: 1) Dialectical Behavior Therapy (DBT) Skills - targeting parental emotion dysregulation and substance use, and 2) Parent Training (PT) - targeting parenting behaviors linked to children's mental health. The case study will provide preliminary data on the feasibility of the DBT Skills +PT intervention and its engagement of the targeted outcomes, and aims to complete foundational steps necessary to conducting a future, larger scale randomized controlled trial. Specific aims are to: 1. Determine feasibility, acceptability and implementation. 2. Evaluate pre-post changes in measures of parental emotion dysregulation, parenting quality and children's mental health.

COMPLETED
Real-world Momentary Assessment of Kratom Use Accompanied by Product Assays: A Natural-history Study for Interdisciplinary Characterization of Kratom Use and Pharmacology
Description

Background: Mitragyna speciosa, also called kratom, is a plant used in Southeast Asia for its psychoactive effects. Its use has increased in the US, and an estimated 10 million adults may take it at least semiregularly. Most scientific research on human use of kratom has consisted of surveys in which people looked back on their experiences with it. Results from those surveys have been useful, but, like many behaviors, kratom use can be more fully understood if it is also studied as it happens. The technical term for this procedure is ecological momentary assessment (EMA). In EMA, people report their moods and activities in real time, a few times per day, usually with a smartphone app. Objective: This natural history study will collect data about how people use kratom and how it affects them. Eligibility: People aged 18 and older who use kratom 3 or more times per week Design: Most participants will be remote only. They will fill out an online consent form. They will also answer an initial set of questions about their kratom use. They will download an app on their smartphones for EMA (described above). They will use this app to answer short sets of questions for 15 days in a row about their ongoing behaviors and moods, including kratom use. They will use a prepaid envelope to mail in a sample of their kratom product. Some participants, after doing the EMA part of the study, can also come to a clinic. They will have 1 visit for informed consent (1-3 hours) and 1 visit for a monitoring session (8 hours) where we can directly assess the effects of their usual dose of kratom. They will bring their kratom produce with them to take on site. Before they take the kratom, they will have a physical exam. They will have blood and urine tests. They will answer questions about their sleep, driving, and general feelings. They will complete tasks on a computer to measure their reflexes and response times. Their driving performance will be assessed in a simulator. Researchers will watch participants consume their kratom. A sample of their product will be taken for analysis. After taking their kratom, those participants will repeat some questionnaires and tests, including the driving simulation. They will also be interviewed about their use of kratom....

COMPLETED
Assessing the Effect of Distance Learning Vocational Rehabilitation on Employment Outcomes of Veterans With Psychiatric Illness and Histories of Legal Convictions
Description

64,000 Veterans are released annually from jails and prisons. These Veterans have a weekly unemployment rate of up to 40-55%. However, many are unable to access traditional vocational rehabilitation, not to mention specialized vocational rehabilitation for those with felony histories. Distance learning may be effective in improving access to rehabilitation as well as improving employment outcomes. The Compass system was developed to incorporate both synchronous and asynchronous distance learning to provide effective services. This study will evaluate 150 Veterans with histories of legal convictions and mental illness and/or a substance use disorder. Veterans will be randomly assigned to either a basic vocational resources condition or the the Compass condition. In the basic condition, Veterans will be provided with basic information about where they can access vocational services and a paper version of a vocational reintegration manual, specifically the About Face Vocational Manual. Veterans assigned to the Compass condition will be given access to the online instruction through Videos, live chat features, and tele-health practice interviews with feedback. Veterans will be followed for 6 months. The primary outcomes are employment and interview skills.

COMPLETED
Study to Evaluate the Likeability, Safety, and Abuse Potential of NRP 104 in Adults With Histories of Stimulant Abuse
Description

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.

COMPLETED
Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories
Description

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.

RECRUITING
Characterization of Phenotypic and Genotypic Regressors for Imaging
Description

The influence of genes on addictive and neuropsychiatric disorders is complex, especially given that multiple genes likely influence certain behaviors that are correlated with addiction. Researchers are interested in looking at the genetic information of individuals who are enrolled on National Institute for Drug Abuse studies to investigate specific genetic variants that may be related to substance abuse. Researchers will study the effects of genes on several aspects of thinking such as attention, memory, decision making, problem solving, learning, and emotional feelings, and investigate the ways in which genetic information affects addictive behaviors and substance abuse. In addition, researchers will study how genes may explain differences in imaging data in substance users. Objectives: - To collect genetic information for research on genetic aspects of addiction and substance abuse. Eligibility: * Adults age 18 or older * (1) healthy, non-drug-using nonsmokers, * (2) healthy smokers, * (3) healthy individuals dependent on other commonly abused drugs, and * (4) individuals with other psychiatric disorders. * Participants must be enrolled in another National Institute on Drug Abuse, Intramural Research Program imaging protocol. Design: * This study involves one to two visits to National Institute on Drug Abuse, Intramural Research Program that may be separate from the participant's current research protocol study visits or on the same day as those visits. * Participants will provide a blood sample and complete questionnaires about mood, memory, and learning. * Participants may also be asked to do a few tasks, such as playing computer games involving coin tosses and money management, or responding to questions on a computer screen.