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91 active trials for Substance Use Disorders

Trauma and Trauma-Focused Therapy in the University of Kentucky SMART Clinic

Opioid misuse is a national public health epidemic. More than 130 people in the United States die each day following an opioid overdose, and over 2 million people meet criteria for an opioid use disorder (OUD). Medication-assisted treatment (MAT), which involves use of medication (buprenorphine, methadone, naltrexone) in combination with behavioral therapy or counseling, is the most effective intervention for OUD. Yet, MAT remains less than optimally effective, particularly for patients with psychiatric comorbidity [6]. Novel approaches are needed to improve long-term outcomes for OUD patients. Psychological trauma and posttraumatic stress disorder (PTSD) are highly prevalent among individuals with OUD. Over 90% of adults with OUD report a lifetime history of trauma. Among OUD patients engaged in MAT, nearly 20% report experiencing at least one new traumatic event each month, and nearly a third meet criteria for a co-occurring diagnosis of posttraumatic stress disorder (PTSD). Several studies have linked new incidents of trauma as well as the presence of PTSD to poorer MAT engagement and poorer treatment outcomes, including treatment interruption and premature dropout. Preliminary evidence suggests that engaging in trauma-focused treatment for PTSD concurrent with MAT may result in better long-term adherence to medication for OUD. However, recent evidence finds that fewer than half of patients with PTSD in MAT receive any trauma-focused treatment, and even fewer receive evidence-based interventions. Trauma-focused treatments that concurrently address symptoms of PTSD and substance abuse using an integrated approach have been recommended over traditional substance abuse interventions for patients with this complex dual diagnosis presentation. Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE) is a 12-session evidence-based cognitive-behavioral therapy that integrates exposure therapy for PTSD with cognitive-behavioral skills for addressing problem substance use. COPE has demonstrated efficacy for reducing symptoms of PTSD and substance use disorder across multiple trials. Most samples have included patients with alcohol use disorder or mixed substance use disorder diagnoses. The proposed pilot study would collect preliminary feasibility data to support the first trial of COPE for patients with OUD (and other substance use disorders) who are currently engaged in MAT. As such, a primary aim of the current pilot is to obtain patient feedback regarding the acceptability and applicability of COPE for patients with PTSD receiving MAT treatment through the Supportive Medication Assisted Recovery Treatment (SMART) Program within the University of Kentucky (UK) Department of Psychiatry, an outpatient buprenorphine clinic. The investigators believe that it is critical to engage patients directly in the process of intervention development/refinement to determine how an existing evidence-based intervention like COPE might be modified to best fit the unique needs of patients receiving MAT.

Start: March 2021

Guanfacine to Improve Substance Use Outcomes in Women

Hypothesis: Guanfacine (GUA) (3mg/day) will reduce drug craving, improve cognitive flexibility and result in associated lower drug use in women with substance use disorder (SUD) in an outpatient clinical setting.

Start: November 2019

A Therapeutic Workplace to Address Poverty and Substance Use

Addiction is a chronic relapsing disorder. High magnitude and long-duration voucher-based abstinence reinforcement is one of the most effective treatments for alcohol and drug addiction and can maintain abstinence over extended periods of time, but practical methods of implementing these interventions are needed. Workplaces could be ideal and practical vehicles for arranging and maintaining abstinence reinforcement over long time periods. Investigators' research on a model Therapeutic Workplace has shown that employment-based abstinence reinforcement, in which participants must provide alcohol- or drug-free urine samples to maintain maximum pay, can maintain alcohol and drug abstinence. Now investigators need to develop effective and economically sound methods to arrange long-term exposure to employment-based abstinence reinforcement. Investigators are proposing to evaluate the effectiveness and economic benefits of a Wage Supplement Model of arranging long-term exposure to employment-based abstinence reinforcement. Under this model, successful Therapeutic Workplace participants are offered abstinence-contingent wage supplements if they obtain and maintain competitive employment. Governments have used wage supplements effectively to increase employment in welfare recipients. The Wage Supplement Model harnesses the power of wage supplements to promote employment, while simultaneously using the wage supplements to reinforce drug and alcohol abstinence. The intervention will combine 3 elements -- the Therapeutic Workplace, Individual Placement and Support (IPS) supported employment, and abstinence-contingent wage supplements. IPS is a supported employment intervention that has been proven effective in promoting employment in adults with severe mental illness. Under this model, participants will be exposed to the Therapeutic Workplace to initiate abstinence and establish job skills. To promote employment and prevent relapse to drug use, participants will receive IPS Plus Abstinence-Contingent Wage Supplements. A randomized trial will evaluate the effectiveness and economic benefits of the Abstinence-Contingent Wage Supplement Model in promoting employment and sustaining drug abstinence. Participants will be enrolled in the Therapeutic Workplace for 3 months and then randomly assigned to a Usual Care Control group or an IPS Plus Abstinence-Contingent Wage Supplement group for one year. Usual Care Control participants will be offered counseling and referrals to employment and treatment programs. IPS Plus Abstinence-Contingent Wage Supplement participants will receive the IPS intervention and abstinence-contingent wage supplements. This novel intervention could be an effective and economically sound way to promote long-term employment and drug abstinence.

Start: January 2019

Using Non-invasive Brain Stimulation (tDCS) With Varenicline for Treating Tobacco Dependence

The addition of tDCS as an adjunct to pharmacotherapy is a novel approach but one that is grounded in a growing evidence-base.The primary objective of this research is to provide preliminary evidence of the effectiveness of tDCS as an adjunct treatment to pharmacotherapy for smoking cessation. The investigators hypothesize that the addition of active tDCS to the left DLPFC will improve the effectiveness of varenicline as reflected by higher quit rates at end of treatment compared to the sham group. Smoking status will be biochemically confirmed at various time points using expired cotinine measures. Furthermore, the investigators will be collecting neuroimaging (fMRI) data as well as measures of attentional bias to explore the neurological and physiological correlates from using adjunct tDCS and varenicline therapy.

Start: October 2018

Evaluating MyPath to Enhance Reproductive Autonomy and Liberate Decision-making

This is a pilot study to evaluate the acceptability and feasibility of incorporating a patient-facing reproductive decision support tool, MyPath, into existing clinical pathways in a SUD treatment program. This study will be conducted virtually in partnership with a single substance use treatment program within the University of Pittsburgh Medical Center (UPMC). Aim 1: Assess the feasibility and acceptability of incorporating a patient-facing reproductive decision support tool (MyPath) into existing clinical pathways in a substance use treatment program. Aim 2: Assess preliminary efficacy of MyPath on reproductive health knowledge, self-efficacy, and decisional conflict as compared to usual care, as well comparisons between receipt of reproductive health services during the usual care period versus after implementing the intervention. The investigators hypothesize that the MyPath tool is acceptable and feasible for participants and their providers within a SUD treatment program. They also anticipate that preliminary efficacy data will show a positive correlation between the MyPath intervention and receipt of reproductive services, as well as increased knowledge and self-efficacy with decreased decision conflict. This pilot study will lay the groundwork for future larger trials in order to measure efficacy of this tool in substance use treatment settings.

Start: November 2020

Intervention for Comorbid Substance Use and Bipolar Disorders

This trial aims to evaluate the effectiveness of a novel intervention for patients with co-occurring bipolar and substance use disorders following a psychiatric hospitalization. Half of the participants will receive a specialized psychosocial intervention program, while the other half will receive an enhanced safety monitoring program, both provided in addition to their routine care.

Start: October 2020

Problematic Use of the Internet in Child and Adolescent Psychiatry

Pathological internet use is a blanket term for problematic behavior types (e.g. uncontrolled gaming, cyber pornography, cyber mobbing and excessive use of social media): all perpetrated through the internet. There is little documentation or research on interdependencies/interplay between problematic internet and/or media use and child-adolescent disturbances. Very few clinical examples of syndromes like attention deficiency/hyperactivity (ADHS), anxiety disorder or affective disturbances associated with pathological media/internet use, or gaming, are found in literature.

Start: December 2020

Preventing Youth Substance Use With Family Talk

Family Talk, an evidence-based parent-youth dyadic intervention, is a promising approach to improving substance use outcomes for high-risk families, and its structure lends itself to delivery by existing personnel within an Office-Based Addiction Treatment (OBAT) model of care. The investigators propose a single-arm pilot study with 25 parent-youth dyads through which a rapid cycle performance improvement approach will be employed to adapt and optimize the content and delivery of the embedded Family Talk prevention strategy. The investigators will field-test relevant baseline and outcome measures and will use qualitative methodology to identify key modifications to the intervention and generate hypotheses for how the prevention strategy may impact youth and family outcomes and prevent youth substance use. Information from this study will inform a subsequent pilot randomized controlled trial of the intervention to prevent substance use for youth whose parents are in recovery from SUD (substance use disorder).

Start: July 2021

Integrated Intervention Post-Sexual Assault

The primary objective of the proposed Stage IA/IB study is to establish feasibility of an integrated cognitive-behavioral intervention for reducing SUD and PTSD symptoms among women who experienced a sexual assault within the past six weeks. The intervention will be tested in an open label trial to make final modifications to evaluate feasibility, acceptability, and preliminary efficacy of the five to six week integrated intervention with standardized repeated measures during a one-month follow-up.

Start: February 2020

Couples ART Adherence Intervention for PWID in Kazakhstan

The fastest growing HIV epidemics globally are driven by injection drug use, but only a small percentage of HIV-positive people who inject drugs (PWID) have achieved viral suppression. The proposed project will adapt a couple-based antiretroviral therapy (ART) adherence intervention for PWID and assess the feasibility and acceptability of conducting dried blood spot testing to objectively measure ART adherence as part of an intervention in a clinical setting. This project advances HIV intervention science by providing an intervention that leverages social support within the dyad to improve ART adherence among PWID, which could lead to increased viral suppression, thus decreasing HIV transmission and HIV-related morbidity and mortality.

Start: October 2020

Continuing Care App for Probationers and Parolees

This project extends successful Phase I work that developed a Continuing Care mobile application (app) for probationers and parolees with SUDs who are at elevated risk of relapse, re-arrest, and incarceration. This Phase II STTR project will finalize app development and evaluate its efficacy in a randomized controlled trial. The project has high public health significance due to its potential to provide an accessible recovery support tool for individuals on probation or parole that could improve their substance use disorder treatment outcomes.

Start: February 2021

Substance Use Treatment and Access to Resources (STARS) Project

This study is evaluating a randomized clinical trial and a quasi-experimental observational study combined. Pregnant women with substance abuse issues are referred to the Substance Use Treatment and Recovery (STAR) prenatal clinic, and those who consent to participate in the study will be randomized to the STAR + maternal Attachment Biobehavioral Catchup (mABC) home visiting model or to the STAR only treatment group. Those who opt out of receiving prenatal care at STAR will be recruited as a control group for the QED portion. Those randomized to STAR + mABC will receive additional supports from a licensed therapist, including up to 12 home visits focused on substance exposed babies and positive parenting.

Start: December 2020

the Role of Repetitive Trans Cranial-magnetic Stimulation in Craving Reduction Among Opioid Use Disorder Patients

Repetitive Trans-cranial Magnetic Stimulation (rTMS) is a relatively safe and non-invasive method to modulate neuronal activity; rTMS uses alternating magnetic fields in a certain frequency to induce an electric current in the underlying brain tissue. Administering high frequency rTMS to the left dorsolateral prefrontal cortex is possible to increase brain activity in the stimulated area and to change brain activity in associated regions that are part of the same neural circuit which may reduce craving.

Start: December 2020

Neurobiological Mechanisms of Chess as an Add-On Treatment Against SUD

Neurobiological and neuropsychological approaches to investigate the potential mechanism of action of chess as an add-on therapy (chess based - cognitive remediation treatment, CB-CRT) to reduce cognitive deficits in individuals with alcohol use disorder (AUD).

Start: April 2020

Post-Hospital Intervention for Veterans With Comorbid Bipolar and Substance Use Disorders

This trial aims to evaluate the effectiveness of a novel intervention for Veterans with co-occurring bipolar and substance use disorders following a psychiatric hospitalization. Half of the participants will receive a specialized psychosocial intervention program, while the other half will receive an enhanced safety monitoring program, both provided in addition to their routine care.

Start: November 2020

Peer Supported Collaborative Care Mental Health and Substance Use Disorder Care

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.

Start: September 2021

Homeless Care Management App

There is a significant revolving door of incarceration among homeless adults, a population with substantial health disparities. Homeless adults who receive the professional coordination of individualized care (i.e., case management) during the period following their release from jail experience fewer mental health and substance use problems, are more likely to obtain stable housing, and are less likely to be re-incarcerated. The proposed study will use mobile technology to address these barriers and fill gaps in the understanding of the causes of the revolving door of homeless incarceration. This research represents a step toward integrated service connection and healthcare service provision for one of the most underserved, high need, and understudied populations in the United States. Smart phone apps that increase the use of available healthcare services and identify predictors of key outcomes (e.g., homelessness, re-arrest, medication compliance) could be used to reach hard to reach populations with histories of significant and persistent health disparities (e.g., homeless adults).

Start: April 2018

Exercise Training as Medicine for Substance Use Disorder Patients

This study compares the effects of high dose and low dose, high intensity, endurance training and strength training in substance use disorder patients. The hypothesis is that the increase in endurance (measured as maximal oxygen uptake) and strength (measured as maximal strength) will be similar in both the high dose and low dose training groups after 24 training sessions over eight weeks. The rationale for this assumption is based on the patient groups poor physical capacity, supporting that a lesser physical workload is needed to achieve a substantial increase in physical capacity. The practical implication could be higher training attendance, because it is likely easier to motivate the patient group when they only have to perform half the workload. It is paramount for this patient group to increase their physical capacity and consequently augment their physical health status since they are in a high-risk group for developing life-threatening lifestyle related diseases.

Start: February 2020

The Human Stress Response in a Simulated ED Setting

Stress is important for health. As emergency departments (EDs) are often stressful places, a better understanding of the human stress response is important for understanding how and why patients respond as they do when they come to the ED. Since the investigators cannot take up space in the ED for research, the investigators will instead recruit 20 methamphetamine-using participants who are not currently in treatment to the simulated ED room in the University of Arkansas for Medical Sciences (UAMS) Simulation Center. The investigators will have participants perform a stressor task involving public speaking and a simple arithmetic task. The investigators will see if this experiment can be made to be like being in an actual ED by varying what participants speak about in the task. By doing this, the investigators hope to find out several important things: 1) Is a stressor task feasible and acceptable to participants? 2) What does the stress response -- as measured by cortisol and alpha-amylase -- look like in these participants? 3) Does varying what participants talk about make the experiment seem more like an actual ED? 4) Do participants under stress show even mild symptoms of agitation as measured by clinical scales? If so, how often?

Start: August 2020

Mindfulness-based Therapeutic Sailing (MBTS) Versus Standard Recreation Therapy Activity (SRT)

This study will be a prospective randomized controlled trial (RCT) of Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity (bowling) among Veterans with psychiatric and/or substance use disorders. The specific aims of this investigation are to determine whether: MBTS will result in greater pre- to post-intervention increases in psychological flexibility and state mindfulness than a standard recreation therapy activity (SRT). MBTS participants will experience greater enjoyment of the activity than SRT participants. MBTS will result in greater pre- to post-intervention increases in positive affect and decreases in anxiety as measured as compared to the SRT participants. MBTS participants will exhibit improved outcomes, as compared to the SRT group, in the 3-month post-intervention period.

Start: July 2019