View clinical trials related to Substance-Related Disorders.
Filter by:The purpose of this study is to test if a parenting program can be used to prevent substance use among Latino youth and at the same time promote healthy eating. Pairs of 7th grade students and one of their parents will be enrolled in the study and randomly assigned to three groups: an existing parenting intervention focusing on substance use prevention (FPNG), the enhanced parenting intervention that also has nutrition content (FPNG+), and a comparison program focused on academic success. Only parents will attend intervention sessions. Data will be collected from the parent and their 7th grade student to see how these programs impacted substance use, nutrition, and parenting. The investigators hypothesize that families receiving the FPNG+ will have improved nutrition habits than the other conditions. Students in both FPNG and FPNG+ will have lower substance use rates as compared to the academic success program. In addition, the effects of parenting strategies and sociocultural factors on the FPNG and FPNG+ results will be studied.
This study will deploy a novel, personalized, smartphone-based intervention (PrEPSteps) that responds to real-time PrEP adherence and nonadherence detected through the use of a digital pill. The PrEPSteps intervention will be developed and refined through a series of focus groups. Participants will be screened at the Screening Visit, and, if eligible, will then begin using the digital pill system at Study Visit 1 for 2 weeks. At Study Visit 2, participants will undergo randomization to using either PrEPSteps + the digital pill, or the digital pill alone to measure PrEP adherence, for 90 days. Participants will then complete 3 monthly study visits (Study Visits 3-5) where the investigators will assess digital pill adherence, conduct manual pill counts, obtain dried blood spots to confirm adherence, provide substance use disorder counseling, and obtain urine drug screens. At Study Visit 5, the investigators will conduct a semi-structured qualitative interview with participants in the PrEPsteps arm, which will be grounded in the Technology Acceptance Model, in order to understand the user response to PrEPSteps and the digital pill. All participants will complete the final follow-up assessment 3 months after Study Visit 5 (Study Visit 6).
"Health is a state of complete physical, mental and social well-being, and not merely the absence of disease or infirmity" (World Health Organization, 1948). Diseases such as HIV/AIDS and Hepatitis-C (HCV) thrive in conditions of poverty and marginalization. Research on the quality of life of people living with HIV/AIDS reveals that unemployed individuals report more depression, anxiety, social isolation, and low self-esteem than employed individuals. Moreover, unemployment is a key factor in the contemplation of suicide among people with HIV/AIDS. Alternatively, employment among people living with HIV/AIDS is a strong indicator of improved quality of life. A finding the study investigators confirmed in a research study (PROMPT) supporting 280 members of Ottawa's low income homeless (or at-risk for homelessness) People Who Use Drugs reduce (and in some cases quit) smoking. PROMPT participants repeatedly stated that boredom and a lack of meaningful social connections and employment were major hindrances in their reduction and overall recovery from smoking and drug use. With these PROMPT findings, the investigators propose a Community-Based Participatory Action project that builds the social capital of 80 participants that identify as members of Ottawa and Toronto's low income People Who Use drugs living with or are at-risk for HIV/AIDS/HCV. The proposed multi-site project will include life-skills training, counseling, health services access (testing and treatment), and education on HIV/AIDS/HCV. Most importantly the project will include a poverty reduction intervention that connects participants with education opportunities, short-term work and volunteer opportunities. The education, work and volunteer opportunities' will be made possible with the support of local business owners and networks that support the study's poverty reduction and community building elements. The aim of project will be to demonstrate the feasibility and cost of a holistic healthcare that encourages a state of complete physical, mental, and social well-being.
More than 90% of women in substance use treatment report history of physical and/or sexual trauma, and up to 60% meet criteria for both substance use disorder (SUD) and Post Traumatic Stress Disorder (PTSD). PTSD typically precedes onset of SUD, with substances used as a means to cope with physiological, psychological, and emotional symptoms resulting from the trauma. Women with PTSD experience greater severity of addiction symptoms, readmit into treatment more frequently than women without PTSD, and tend to have poorer treatment outcomes. Due to increased risk for exacerbation of PTSD on SUD severity and treatment success, and the specific vulnerabilities and needs of women with this comorbidity, SUD treatments that target both substance use and trauma recovery are needed. However, few interventions target both SUD and PTSD concurrently, and fewer still are specific to women. Mindfulness-Based Relapse Prevention (MBRP) has been shown to decrease craving, relapse rates, and quantity/frequency of use across several substances, and has shown acceptability in diverse populations. MBRP integrates mindfulness practices with cognitive behavioral and exposure-based approaches to increase self-regulatory skills while experiencing triggers previously associated with substance use, including challenging affective states such as those common to experienced trauma. Adapting MBRP to incorporate trauma education and treatment approaches has the potential to effectively treat women with the dual vulnerabilities of trauma history and SUD. The current study is thus designed to determine feasibility, acceptability, and initial efficacy of an adapted Trauma-Informed Mindfulness-Based Relapse Prevention (TI-MBRP) intervention for women in substance use treatment settings who have PTSD. TI-MBRP integrates trauma education and treatment approaches drawn from Cognitive Processing Therapy (CPT) into the standard MBRP protocol to provide a trauma-informed approach to treating women in substance use treatment settings. The current proposal will evaluate TI-MBRP, using a randomized, pre-post design, with 100 women in residential substance abuse treatment. Participants will be randomly assigned to participate in a 4-week TI-MBRP intervention or to continue with treatment as usual (TAU). Assessments will be collected pretest, posttest, and at one-month follow-up. Data from this study will lay the groundwork for a larger scale clinical trial to determine the efficacy of TI-MBRP.
Break the Cycle is a two-session, one-on-one, in-person intervention study designed to reduce the role persons who inject drugs (PWID) play initiating non-PWID into injection drug use. Study implementation is at two sites: New York City and Tallinn, Estonia. At baseline, quantitative data are collected via a structured computer-assisted personal interview, after which the intervention is conducted. At the 6-month follow-up, a modified version of the interview is repeated. The study uses a pre- versus post- design to compare the proportion of participants who helped with first injections, and who promoted injecting among non-PWID, in the 6 months prior to baseline with the proportions at the 6-month follow-up. Based on previous research on the intervention and on the underlying theory of motivational interviewing, increases in helping and promoting behaviors between baseline and follow-up would indicate that the intervention was not effective regardless of their effect size. Accordingly, the hypotheses that the intervention will produce reductions in assisting with first injections and engaging in injection promoting behaviors will be evaluated using one-tailed statistical tests. Break the Cycle intervention follows a motivational interviewing approach to enhance current injectors' motivation and skills to avoid helping with and promoting first injections among non-PWID. The intervention's core is a discussion between an interventionist and each participant on the following eight topics: the participant's first time injecting drugs; the participant's exposures to situations where helping with others' first injections is an option, and the extent to which they have helped; PWIDs' behaviors that might encourage non-PWID to inject for the first time; the range of risks associated with injection drug use; role-playing scenarios in which the participant develops behaviors and scripts for avoiding or refusing requests to initiate others into injection drug use; role- playing talking with other PWID about not encouraging non-PWID to start injecting; imparting safer injection practices when helping with a first injection seems like the best option; and receiving training in and using Narcan to reverse overdoses.
The study is a crossover randomised controlled trial. Alcohol or cocaine dependent participants will be recruited from inpatient and outpatient psychiatric treatment centres, on the approval of their treating physician. A healthy control group will be recruited using online advertising. All participants will undergo each of three conditions in a randomised order; 1) 20 minutes of cycle ergometry at 50-60% of maximum heart rate; 2) 20 minutes of exercise at 70-80% of maximum heart rate; 3) 20 minutes of quiet reading. Immediately before and after each condition, participants will be asked to complete a computerised Stroop test, watch a film containing substance-related images, and self-report craving levels. During the Stroop test and film viewing, participants' neural activity will be measured via functional near-infrared spectroscopy
Adolescent substance use, sexual assault, and sexual risk behaviors pose a great public health concern, and subsequently there is also a great need to prevent these behaviors and experiences. This project involves the adaptation and integration of evidence-based prevention content aimed at preventing and reducing substance use, sexual assault, and sexual risk behaviors. This project uses innovative technology within primary care visits to conduct a feasibility trial of an integrated prevention program.
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.
This study will conduct an effectiveness trial of the 4-session evidence-based YMHP intervention for young men who have sex with men (YMSM) of color ages 15-29 at two CBOs in New York City, compared to usual care.
California counties are in the process of implementing a Centers for Medicare and Medicaid Services Medicaid 1115 Substance Use Disorder (SUD) demonstration. The demonstration requires that patients be assigned to addiction treatment settings and levels of care systematically, using comprehensive biopsychosocial assessments and guided by the American Society of Addiction Medicine (ASAM) patient placement criteria. RTI International, a nonprofit research institute, and University of California Los Angeles (UCLA) Integrated Substance Abuse Programs have been awarded a contract from the Patient Centered Outcomes Research Institute (PCORI) to study the effects of the ASAM implementation in California. The California 1115 SUD demonstration provides a unique opportunity to learn about the benefits and challenges resulting from system-wide implementation of ASAM criteria. The study will involve surveying patients in counties that are using the ASAM criteria and in counties that have not yet adopted the ASAM criteria. Medicaid patients receiving addiction treatment will be offered the opportunity participate in the study and to be surveyed about their experiences in treatment. The study will also analyze data from the California Outcomes Management System (CalOMS) and conduct interviews with providers, patients, and policymakers in the state. The results of the study will help inform California's efforts to continually improve its addiction treatment systems to better meet the needs of it communities. This study will also produce important and useful information to patients seeking treatment for addiction, and their providers, SUD system administrators, and payers.