Active clinical trials for "Substance-Related Disorders"

The aim of the present study is to investigate the effect of prefrontal transcranial Direct Current Stimulation (tDCS) combined with cognitive training on cognitive functions in individuals with Opioid Use Disorder (OUD). The participants will be allocated into active/sham groups (1:1) and will receive a single session of prefrontal tDCS combined with cognitive training. Outcomes of the active and sham groups will be compared.

Adolescents with substance use disorders (ASUD) in residential treatment have the most serious substance use disorders and the highest rates of psychological, motivational, behavioral, legal, environmental, and vocational problems. ASUD in residential treatment are also at high risk of relapse, with follow-up studies suggesting that 60% of ASUD will relapse within 90 days of discharge. Parenting practices have been established as a key influence on adolescents' initiation and maintenance of substance use, as well as their substance use outcomes and likelihood of relapse. However, therapists who treat ASUD have reported a myriad of systemic barriers to engaging parents in treatment. Findings such as these deem ASUD in residential treatment a high priority population and argue for the value of easily accessible parenting interventions during this critical time. The proposed study evaluates a low cost, low intensity model for delivering parenting skills to parents preparing for their adolescent's discharge from residential substance use (SU) treatment. Specifically, this project involves adapting the delivery of a computerized parenting intervention (Parenting Wisely; PW) that has preliminary evidence of efficacy in improving parenting skills and reducing youth behavior problems. This study adapts the delivery of PW for a new population (parents of ASUD) and new setting (residential treatment), and obtains initial data on its feasibility, acceptability, and effectiveness. As a first step, an open trial with 10 parents was conducted to develop and pilot an adapted version of PW that included moderate engagement strategies: in-person coaching sessions, daily text messages containing reminders of parenting skills and links to video vignettes, and an online parent forum containing two networking boards (Ask an Expert and Connect with Parents). In the current phase, a pilot randomized trial with 60 parents will compare an adapted PW plus treatment as usual (TAU) condition (PW+) versus TAU only in a residential treatment center. Both treatment conditions will be delivered by Bachelor's or Master's-level community clinicians. This small trial will provide some initial evidence regarding the utility of a low-cost, low-intensity intervention and whether a larger, fully powered trial is indicated in the future.

The long-term objective of this study is to improve women's substance use disorder (SUD) treatment. The immediate project goal is to test the efficacy of an innovative mind-body intervention, Mindful Awareness in Body-Oriented Therapy (MABT) to reduce substance use relapse among women in SUD treatment. A novel mind-body approach, MABT combines a hands-on (manual) approach with mind-body psycho-education approaches of interoceptive training and mindfulness to develop somatically-based self-care skills and to facilitate emotion regulation. A three-group, randomized clinical trial using repeated measures, this project will enroll and randomize 225 women to one of three groups, MABT + Treatment-as-usual (TAU) (n=75), TAU only (n=75), and Women's Health Education (WHE) + TAU (to control for time and attention) (n=75). Study conditions will be compared at baseline, post-intervention, and at 6 and 12 month follow-up. The primary aim is to test the hypothesis that MABT will result in reduced substance use and related health outcomes compared to TAU and to WHE+ TAU at 12 month follow-up. The second aim is to examine hypothesized underlying mechanisms of MABT. Female outpatients in two diverse community treatment facilities, serving racially diverse patients, will be recruited for study participation. This study builds on promising preliminary evidence of MABT feasibility and acceptability in substance use disorder treatment for women, and addresses the need for more clinical research aimed at improving SUD treatment outcomes for women.

Methamphetamine (MA) addiction is a public health concern that causes substantial harm to individual users, and imposes an economic burden in the U.S. totaling up to $48.3 billion annually. This study proposes to address a critical aspect of this problem: the lack of any proven, FDA-approved pharmacological treatments for MA users. The proposal combines an intervention designed to improve energy metabolism in the brain, and a neuroimaging technique capable of measuring the neurochemicals that represent cerebral bioenergetic function. The study will replicate and extend a key neuroimaging finding from the investigators recent MA studies: that MA users have decreased phosphocreatine (PCr) levels in the brain, compared to healthy volunteers. Phosphocreatine is the substrate reservoir for the creatine kinase reaction, which reversibly converts PCr into adenosine triphosphate (ATP), the brain's major energy supply, and creatine. Neuronal energy demands are met through a shift in reaction equilibrium, which is designed to maintain the concentration of ATP constant. Research results from the investigators recent study also showed that female MA users have lower brain PCr levels compared to male users. These findings join the converging lines of evidence that MA use is associated with mitochondrial dysfunction, i.e. deficient energy metabolism, in the brain. Frequently, MA users also experience depression, as well as cognitive deficits. Interestingly, both of these entities are also linked to mitochondrial dysfunction in the brain. The long-term goal of this research program is to define the alterations in brain chemistry that underlie MA use disorders, and to utilize translational magnetic resonance spectroscopy (MRS) neuroimaging to identify rational brain-based treatment targets. Once a hypothesis-driven intervention is identified, MRS can then be further employed in treatment studies, to verify that "target engagement" is achieved. The specific aims of this proposal are an example of this stepwise scientific process: the nutritional supplement creatine will be tested in a randomized, placebo-controlled study of women with MA use disorders, to investigate creatine's effect on cerebral PCr levels, depressive symptoms, and MA usage.

The purpose of the study is to determine whether adding "dual focus" mutual aid groups to formal treatment for people dually diagnosed with substance abuse and mental illness is effective in improving treatment outcomes. NO VOLUNTEERS ARE ACCEPTED. ENROLLMENT IS LIMITED TO CLIENTS OF THE PARTICIPATING TREATMENT PROGRAMS.

This study will evaluate the comparative effectiveness of Therapeutic Education System (TES), a computer-based, psychosocial treatment program, relative to standard care when offered to individuals with substance use disorders in prison settings. The study will assess the comparative effectiveness of these interventions primarily by examining changes in: (1) substance use (e.g., weeks of abstinence), (2) HIV risk behavior (evaluated as both sex-related and drug-related HIV risk behavior) and (3) reincarceration rates. The study will also examine the extent to which these interventions improve psychosocial functioning (e.g., employment, health, and psychological status) and quality of life, and promote relevant skills acquisition (e.g., improve communication skills, reduce "criminal thinking"). The investigators predict significantly better outcomes for E vs. C due to TES' research-based content and use of proven informational technologies.

This project will modify Community Reinforcement and Family Training (CRAFT; n=15) and Alanon/Naranon Facilitation (ANF; n=15) for use with parents who are concerned about an out-of-treatment adolescent. ANF was selected as a comparison because Alanon and Naranon are the most commonly available method for helping family members. The investigators will compare CRAFT for parents (CRAFT-P) (n=77) and ANF (n=77) to determine if there is a significant difference in adolescent treatment entry. Parents will attend a maximum of 18 sessions with a family specialist and also complete questionnaires periodically over a 12-month period. Parents' adolescents will have the opportunity to participate in the study by completing questionnaires at the same time points as their parent. Our primary hypothesis asks whether participants who are enrolled in the CRAFT-P condition will report more adolescent treatment entry than the ANF condition. Our secondary hypotheses examine: 1) reductions in adolescent substance use and behavior problems in the CRAFT-P group compared to the ANF condition, 2) improvements in parenting skills in the CRAFT-P group compared to the ANF condition and 3) significant pre to post treatment effects for improvements in social functioning, mood, and in parent-adolescent relationship satisfaction.

This study tests the effectiveness of Making Alcoholics Anonymous Easier (MAAEZ), a manual-guided intervention designed to help alcohol and drug dependent clients connect with individuals encountered in AA. An OFF/ON design was used (n=508). MAAEZ effectiveness was determined by comparing abstinence rates of participants recruited during ON (MAAEZ intervention) and OFF (usual care) conditions and by studying the effect of the number of MAAEZ sessions attended. Better outcomes were hypothesized for MAAEZ vs. usual care. At 12 months, more clients in the ON condition (vs. OFF) reported past 30-day abstinence from alcohol, drugs, and both alcohol and drugs. Abstinence increased for each additional MAAEZ session received. MAAEZ appeared especially effective for those with more prior AA exposure, severe psychiatric problems, and atheists/agnostics. Mechanisms of action for MAAEZ (mediators of the MAAEZ effect) include: doing service in AA/NA/CA; having a sponsor; having a social network supportive of abstinence; and comfort being in meetings. MAAEZ represents an evidence-based intervention that is easily implemented in existing treatment programs.

The aim of this research is to assess whether Contingency Management is effective in improving treatment adherence in substance use disordered (SUD) patients with comorbid PTSD. Although Prolonged Exposure therapy (PE) is the gold standard treatment for PTSD, the few studies of this treatment in substance users have shown poor adherence. Contingency Management is a well-established approach that could be used to enhance adherence to PE. From a consented sample of 125 opioid-dependent and methadone-treated patients at Addiction Treatment Services, an intent-to-treat sample of 62 patients with co-occurring current PTSD will be offered PE. Half of the 62 participants will be randomly assigned to a Prolonged Exposure with Contingency Management (PE+CM) condition that provides monetary-based incentives for attending the PE therapy sessions. The comparison condition will be assigned to a Prolonged Exposure (PE) condition without the attendance incentives intervention. The PE sessions will be scheduled once per week for 12 weeks, with a 12-week follow-up. Groups will be compared primarily on adherence to the PE schedule, improvement in PTSD symptoms, and rates of drug use (urine specimens, self-reported use). The study's three primary aims are to 1) Evaluate the efficacy of adding voucher-based attendance incentives to PE for PTSD to increase adherence in SUD patients in a methadone treatment program; 2) Evaluate the efficacy of adding voucher-based attendance incentives to PE for PTSD to reduce PTSD symptoms in SUD patients; and 3) Evaluate the effect of PE for PTSD on rates of drug use in SUD patients.

This randomized clinical trial uses a health plan's electronic medical record (EMR) alcohol screen; and examines innovative behavioral interventions, and their cost effectiveness, for hazardous drinking within a large HIV primary care clinic. We will compare Motivational Interviewing (MI) and Email Feedback (EF) to usual care; and evaluate the effect of the interventions on unhealthy drinking, comorbid drug use, enrollment in substance use treatment programs, and HIV outcomes including antiretroviral therapy adherence, HIV RNA control, and unsafe sex. Given the well-known adverse effects of unhealthy drinking on HIV care and outcomes, the proposed study has the potential to make a significant impact in the care of HIV patients.