Active clinical trials for "Substance-Related Disorders"

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.

This study follows up patients who receive standard treatment for prescription narcotic drug use disorder, including opioids, benzodiazepines, and benzodiazepine-like drugs (z-drugs), at a specialized addiction service. The overall goal is to evaluate the proportion of patients who reduce or cease using prescription narcotics and the factors associated with treatment outcomes. No new treatments will be tested. Instead, the results will be used as the basis for a future randomized controlled trial to optimize treatment for narcotic drug use disorder.

The planned randomized clinical trial will longitudinally test a tailored, web-based drug abuse prevention program with a nationwide sample of 15- to 17-year-old sexual minority youth (youth who identify as gay, lesbian, bisexual, or unsure of their sexual orientation).

The goal of this clinical trial is to examine the usefulness of a virtual reality-delivered intervention for individuals with opioid use disorder who are taking medication. The main question it aims to answer is will people with opioid use disorder who receive the study intervention, Mindfulness-Oriented Recovery Enhancement in Virtual Reality (MORE-VR), have fewer days in which they use opioids than will people who just receive their usual treatment. Participants will be randomly assigned to either receive 8 weekly sessions of MORE-VR in addition to their usual treatment, or treatment as usual only. Researchers will compare these groups at the end of treatment and three months after treatment is over on number of days of opioid use and time until first opioid use lapse, as well as drug craving and mood.

The proposed clinical trial will address the problem of opioid withdrawal. Opioids are essential for pain-relief in the short term, but their continued use is associated with a host of adverse effects. People living with chronic pain who were initiated on opioid therapy now find themselves with a major life-changing problem - dependence on opioid medications. Opioid withdrawal symptoms are a key barrier to decreasing or stopping their opioid medication. Currently, there are few medications that ameliorate the symptoms of opioid withdrawal. This problem is a major part of the opioid crisis in Canada, and impacts people across all demographics and socioeconomic status. A misconception is that only individuals with opioid use disorder are susceptible to opioid withdrawal; on the contrary, appropriate use of prescription opioids to manage pain can lead to significant symptoms of opioid withdrawal when it is reduced or stopped. Patients in Alberta who are at risk for opioid withdrawal, either from prescribed use or misuse will be primarily impacted by this trial. The investigators have recently explored the underlying causes of opioid withdrawal and identified an important target in the spinal cord that is responsible for producing withdrawal symptoms in rats and mice. The target, a protein called pannexin-1 (Panx1), is located throughout the body, specifically in the brain and spinal cord. Using sophisticated biochemical, genetic, and pharmacological techniques, the investigators demonstrated how Panx1 on immune cells is implicated in the production of opioid withdrawal symptoms after cessation of fentanyl and morphine in opioid dependent rodents. The investigators then attenuated these symptoms of withdrawal using probenecid, a drug which inherently blocks Panx1 activity. Because probenecid is a safe and clinically available drug, the findings could be immediately translated into clinical therapy to support people who are struggling with the symptoms of opioid withdrawal and provide clinicians with a safe and effective option for caring for this population.

This project will develop and test quality measures for and a facilitation model to help addictions treatment clinics increase use of medicines for opioid use disorders, retain clients longer in care, and help more people move into successful recovery. At the end of the project, we will have developed specific training and coaching protocols as well as electronic clinical support tools to guide quality improvement that can be disseminated within New York and the rest of the country. The study will test a clinic-level intervention that uses external facilitators to provide guidance to addictions clinics and contain three key components: 1) training on data driven management; 2) training and guidance on patient-centered care and OUD medication; and 3) electronic tools for shared decision making and patient progress monitoring.

This Quality Improvement (QI) project for physician education will build on an existing platform, CHADIS (Comprehensive Health and Decision Information System; www.CHADIS.com). We plan to further develop and test innovations that will assist primary care providers (PCPs) in addressing the serious morbidity of teen substance use during routine check-up visits and follow up care using a new Module of CHADIS that facilitates guideline-based care. The CHADIS c-SBI (computer-facilitated Substance screening and provider Brief Intervention) Module will include pre-visit screening tools that cover substance use and strengths and goals. It will also include reminders to the patient about their goals and commitments for change and a teleprompter for interview hints for the PCP. These hints will be aimed at enhancing a patient focused discussion of individual strengths and barriers related to the teens' goals in a motivational interviewing style.

This Phase II SBIR tests a newly developed web-based online parenting skills training and youth drug prevention program based on the evidenced-based "Strengthening Families Program." The study design involves a three-condition parallel randomized control trial contrasting: (1) SFP Online, (2) SFP Home-use DVD/videos, and (3) Wait-Listed Controls. DELIVERY OF INTERVENTION: The intervention condition, SFP Online, is a highly interactive, multimedia condition testing a 10-session online program with two intersecting tracks, one for parents and one for youth. Both tracks involve completion of three mini-lessons per week delivered online for 10 weeks. For the parent track (biological parents, caregivers or legal guardians), each lesson entails learning nurturing parenting skills that strengthen family bonds, setting clear boundaries with positive discipline, and monitoring youth's social activities and emotional well-being. The youth lessons teach social competence-based skills and drug refusal skills. For both tracks, lesson material is scaffolded in an integrated fashion, with challenge quizzes and process evaluations interspersed throughout the lessons. Each track includes a gaming portion to increase engagement and reinforce lesson content through stealth learning. The SFP Home-use DVD/video series is an 11-session program with the same content as the online version, but is not interactive. It is viewed either online or using a DVD player at home. In the Wait-Listed control condition, parents receive emails with food recipes and nutritional information over the same 10-week period; while their children receive emails with riddles and puzzles. At the conclusion of a 2-month follow-up period the wait-listed controls receive the SFP Online intervention, thus doubling the size of the intervention treatment condition. A second design feature is the use of a non-inferiority trial (NIT) to empirically examine the efficacy of SFP Online when compared to the Home-use DVD/videos and Group Norms data. The Group Norms, which serve as a benchmark of SFP effectiveness, is a representative, demographically matched sample of n=1400 families drawn from a database of over 6,000 families that have taken the full 14-session traditional class format of SFP. Effects sizes, using the partial eta-squared statistic, will be compared between conditions for the major outcome measures.

The overall goal of this research project will be to obtain feedback from consumers to help develop a manual called I-DREM (Innovative Development of Research Engagement Manual). The researchers hope to learn information from the consented participants to help map out solutions to improve recruitment of African American/Black individuals into Substance Abuse Disorder (SUD) clinical trials.

This study will design and pilot/feasibility test a culturally grounded intervention to increase the treatment seeking of Pacific Islanders with opioid use disorders in formal services.