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91 active trials for Substance Use Disorders

Alliances to Disseminate Addiction Prevention and Treatment (ADAPT)

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). Research has shown that YJJ die at 1.5 times the rate of youth who have never been. The investigators seek to address the national addiction crisis at its epicenter. Despite their high need for SU services, and the proliferation of evidence-based interventions to reduce SU, YJJ are rarely connected to needed, high-quality SU care. A cascade of care model highlights implementation gaps in YJJ achieving the full continuum of SU care (i.e., SUD risk identification, treatment referral, treatment initiation, and treatment engagement). YJJ on community supervision/probation face a unique problem accessing SU services; while the courts or probation may identify YJJ need for SU 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 implementation gaps in the 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. By linking administrative data across juvenile justice and health systems, it will allow each site to quantify and visualize local Cascade data, allowing agency leaders a novel opportunity to tailor solutions to match the needs and resources of their community. 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).

Start: October 2020

Peer-Delivered Behavioral Activation for Methadone Adherence - Pilot Phase

The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication for opioid use disorder (MOUD) among low-income, minority individuals living with opioid use disorder (OUD) in Baltimore, Maryland. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this pilot trial, the investigators will evaluate the feasibility, acceptability, and fidelity of this approach (implementation outcomes) and preliminary effectiveness on methadone treatment retention at three months.

Start: October 2020

Tailored Response to Psychiatric Comorbidity to Improve HIV Care Engagement in the United States

This pilot randomized clinical trial will randomize 60 participants 1:1 to either enhanced usual care or to adapted CETA, a counseling intervention for HIV care engagement plus depression, anxiety, PTSD, and/or substance use.

Start: October 2020

Examining Feasibility and Acceptability of Telemedicine for Substance Use Disorder (SUD)

The purpose of this research study is to learn about how it can improve new counseling programs delivered by phone or video. This project will examine the feasibility and acceptability of motivational interviewing (MI) and cognitive behavioral therapy (CBT) interventions delivered via telehealth delivered treatment (Teletx). The goal is to refine the interventions to improve acceptability and feasibility and collect preliminary data for a fully powered randomized controlled trial (RCT) in the future. In addition to therapy sessions, participants that are enrolled in the study will complete surveys prior to, during, and after treatment.

Start: March 2021

Delivering Contingency Management in Outpatient Addiction Treatment

Methamphetamine misuse has become a growing concern in Alberta, creating a burden on the health care system. Further, individuals who use methamphetamine in Alberta exhibit significant difficulty remaining in treatment. These troubling patterns necessitate the provision of evidence-based practices (EBPs)-those grounded in empirical evidence-to ensure the best possible care and outcomes for those struggling with this addiction. Within the field of substance use (SU), contingency management (CM) is an extensively studied evidence-based treatment (EBT) for addictive disorders. CM is an intervention that provides incentives to encourage positive behavioural change. Compared to standard care (treatment-as-usual (TAU)), CM has resulted in improvements in abstinence, attendance, adherence, retention, and quality of life. The efficacy of CM has largely been investigated in the context of reinforcing abstinence, though the literature suggests that CM which reinforces attendance may be as effective. Research from the US has examined the cost-effectiveness of CM and found that although CM costs more, it was associated with greater abstinence, treatment completion, and substance-absent urine compared to TAU. Despite the promising literature, the uptake of CM in Canada is limited making it difficult to understand whether this EBT is equally efficacious as compared to the US. This study will implement and evaluate the efficacy of virtually delivered attendance-based CM in outpatient addiction treatment in Alberta. Participants (N=544) will be individuals seeking treatment for methamphetamine use (n=304) and individuals seeking treatment for substance use issues other than methamphetamine use (n=240). It is hypothesized that compared to participants in TAU, participants in CM will evidence: (1) greater retention, (2) greater attendance, (3) greater abstinence from methamphetamine and less methamphetamine use, (4) greater abstinence from other SU and less SU, and (5) greater improvement in quality of life over the intervention and follow-up periods. Exploratory aims include understanding how: outcomes differ based remote versus in-person delivery of CM; outcomes differ between participants who use methamphetamine and participants who use substances other than methamphetamine; the costs of CM differ from TAU; CM changes health service use.

Start: March 2021

Positive Reinforcement Interventions and Sustained Motivation

The overarching goal of this formative research is to examine whether, and in what combination, contingency management (CM) and motivational interviewing (MI) can facilitate entry of stimulant-using men who have sex with men (MSM) into the pre-exposure prophylaxis (PrEP) care continuum.

Start: October 2020

Routine Pregnancy Screening for Women on Opioid Substitution Therapy

Women who take opioid substitution therapy have higher rates of unintended pregnancy, more pregnancies, and a higher risk of pregnancy complications than the general population. Current practice is to test for pregnancy only at patient request or if the clinician suspects pregnancy. This study will compare monthly pregnancy testing to current practice in a double blind randomized control trial. As many women of childbearing age as possible will be recruited from the Hamilton Clinic for Opioid Substitutional Therapy. Women assigned to the intervention will have monthly testing at the same time as their monthly urine drug testing at the clinic. The primary objective is to assess if there is a significant difference is early pregnancy detection and the secondary objectives are to assess differences in pregnancy disposition and gestational age at entry to prenatal or abortion care.

Start: November 2019

Factors Predicting Outcome in Group Treatment of Alcohol Use Disorders (AUDs)

Harmful alcohol use is a global risk factor for disease, injuries and death. Research on treatment of Alcohol use disorders (AUDs) indicates that different treatment modalities are equally effective, but also that a large group of patients do not change their drinking pattern despite being in treatment. It is assumed that it is not random who benefits from treatment. Thirty to forty percent of outcome variance in treatment is probably explained by patient factors, and we need more knowledge on how different patient factors moderate treatment effects. Further, clinicians also need more knowledge about selecting patients to different therapies. The present study will investigate how patient factors predict outcome in group treatment of AUDs, and what predicts positive treatment outcomes over time. The study is designed as a quasi-experimental, multi-centre, follow-up study. Patients will be included from Vestfold Hospital Trust, Borgestadklinikken, Blue Cross Clinic, Behandlingssenteret Eina, Blue Cross Clinic and A-senteret, Oslo, Church City Mission. The Project will provide more knowledge about patients seeking treatment for AUDs, and specifically how patient factors predict outcome in group treatment. These results will in turn lead to better selection of treatment modalities, and patients will receive a more effective treatment earlier on. Main aims: 1) How do patient factors predict outcome in group treatment of alcohol use disorders (AUDs)? 2) Do positive treatment outcomes last over time? Specifically, do the following factors: a) psychiatric comorbidity b) severity of alcohol use pre-treatment c) personality disorders and d) cognitive impairments predict 1) completion of group treatment and 2) positive outcome after 1 year. As an additional aim, we will investigate if the Montreal Cognitive Assessment test (MoCa) is feasible as a brief screening instrument for mild cognitive impairments for AUD patients.

Start: February 2021

SMART Trial: Intrapersonal Stigma Reduction

The goal of this project is to develop a multicomponent stigma reduction intervention to address intrapersonal (individual) stigma regarding Opioid Use Disorder (OUD). The intervention will address this cost/benefit evaluation among individuals known to face intersecting stigma of OUD and African American race, with treatment elements chosen explicitly to increase the value of treatment using salient forms of reward, and to ease perceived costs through explicit services in an effort to encourage the occurrence of the first treatment visit for OUD.

Start: March 2021

Benzodiazepine Discontinuation in Opioid Agonist Therapy

The proposed study is a clinical trial, designed to pilot test a Distress Tolerance-Benzodiazepine Discontinuation (DT-BD) intervention for patients on opioid agonist therapy who currently use benzodiazepines, compared to a Relaxation Therapy (RT) control condition. Both are adjunctive psychosocial interventions in people seeking to discontinue (BZD) use. The goal of the study is to assess the applicability and feasibility of these interventions through treatment retention and qualitative interviews with eight participants who are receiving opioid agonist treatment and who regularly use BZDs.

Start: March 2021

Treatment With Quetiapine for Youth With Substance Use Disorders and Severe Mood Dysregulation

This study proposes to use quetiapine as an adjunct treatment to treatment as usual to improve both substance use disorder (SUD) and mood symptoms in youth with SUD and severe mood dysregulation (SMD). This is a randomized, double blind placebo controlled parallel design study. Youth with symptoms of mood dysregulation and active substance use that meets criteria for a SUD will be randomized to adjunct treatment with quetiapine or placebo. The investigators hypothesize that treatment with quetiapine will lead to a reduction in substance use, improvement in mood, and lead to greater engagement in outpatient treatment.

Start: January 2017

Smartphone Addiction Recovery Coach for Young Adults (SARC-YA) Experiment

At discharge from outpatient treatment, researchers will recruit 300 young adults and randomly assign them to recovery support as usual control condition or the Smartphone Addiction Recovery Coach for Young Adults (SARC-YA) experimental condition. Participants in the experimental conditions will receive a smartphone, a calling/texting/data plan, and the SARC-YA mobile applications for the first 6 months post treatment discharge. Experimental participants will 1) complete a 2-3 minute recovery-focused ecological momentary assessment (EMA) at 5 random times a day, receive feedback on their current answers, and provided access to behavioral charting of their past answers over time; and 2) receive continuous access to a suite of self-initiated ecological momentary interventions (EMI) to support their recovery via tool box of coping tools, apps related to getting support, and apps related to maintaining a healthy lifestyle. Data include standardized assessments, urine tests, mobile phone metadata, EMA responses, and EMI utilization. The study's primary aim and hypothesis are: Aim 1: Test the effects of experimental assignment on the frequency of substance use. H1 Relative to the control group, participants in the experimental group will have lower scores on the quarterly Substance Frequency Scale (3, 6, 9 months post- discharge).

Start: April 2020

EMDR Versus Treatment As Usual in Patients With Substance Use Disorder

The main objective of this project is to test whether EMDR therapy is effective in reducing substance use and improving clinical and trauma-related symptoms in SUD patients with a history of psychological trauma.

Start: September 2018

PrEP at a Syringe Services Program

The purpose of this study is to see if providing participants with pre-exposure prophylaxis (PrEP) medicine right away at the IDEA Exchange will help participants remain in HIV negative.

Start: June 2021

Sleep Treatment for Addiction Recovery

Project STAR aims to examine the feasibility, acceptability, and initial efficacy of a CBT-I supplement to outpatient alcohol and substance use treatment.

Start: August 2020

Project Matter: Intervention to Improve HIV Self-care Among Men Who Have Sex With Men (MSM) With Substance Use Disorders

This study will implement a pilot randomized controlled trial (RCT, N=60) to assess the feasibility and acceptability a refined emotion regulation intervention designed to improve engagement in HIV-care among substance using HIV+ MSM sub-optimally engaged in HIV care.

Start: April 2019

Prevention Support for People Leaving Jail

This study will provide HIV prevention and related support services to men who have sex with men and transgender women who have substance use disorders and are either leaving jail or recently released from jail. The researchers will compare the utilization of HIV prevention and other support services between individuals who receive routine case management provided following enrollment to those who have access to GeoPassport, a global position service (GPS)-based mobile app, incentives, and peer mentor support.

Start: November 2019

Promoting Caregiver-child Attachment and Recovery Through Early Intervention (pCARE): A Pilot Randomized Control Trial

This purpose of this study is to use the existing infrastructure and therapeutic relationships developed by Early Intervention, a national system of child development programs, to make an evidence-based intervention for parents with substance use disorder, Mothering from the Inside Out, more readily accessible to postpartum women with substance use disorder. This study will assess the feasibility, acceptability, and preliminary outcomes of the intervention in a pilot randomized controlled trial. We will also identify key implementation domains that impact successful delivery. We hypothesize that the intervention will be feasible and acceptable to the study participants.

Start: December 2020

Treating Adolescents With CBT and OBH

The purpose of this study is to examine various behavioral, social, and emotional changes that result from engaging in an OBH and CBT treatment program designed for adolescents.

Start: February 2021

Enhancing Adolescent Substance Abuse Treatment

The ultimate goal of this research is to facilitate rapid enhancement of youth substance abuse treatments by determining the key mechanisms of change (i.e., what to target more intensely to generate better outcomes). This work is critical because current outpatient adolescent substance abuse treatments yield only small to medium effects that diminish once treatment has ended. The proposed modern mediation study will address this serious public health problem by experimentally evaluating the most critical factors causing change in client outcomes during adolescent substance abuse treatment, directing the field to focus treatment efforts on those factors.

Start: April 2018