View clinical trials related to Disease.
Filter by:The overall goal of this project is to develop initial human data on effects of novel compounds on safety (interactions with cocaine) and efficacy (subjective response to cocaine and self administration data) in non-treatment seeking cocaine use disorder subjects. The compound to be studied will be the 5-HT2CR agonist lorcaserin. Lorcaserin and other 5-HT2CR agonists have been shown to reduce cocaine self-administration and cue reactivity in rodents. In addition there is human safety data in non-cocaine using subjects for lorcaserin as it is currently FDA approved for obesity, and safety data from a cocaine interaction study in rodents , but there is no human cocaine interaction/PK data and no PD data to support potential dosages for phase II clinical trials.
This study will evaluate the safety, effectiveness and tolerance of low doses of oral naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection of VIVITROL.
Specific Aims: This study aims to assess the acceptability of asynchronous telepsychiatry (ATP) and synchronous (STP) in rural Skilled Nursing Facility (SNF) population, in a 12-month randomized controlled trial. ATP relies on video recording of a psychiatric interview, where the video is later reviewed by a psychiatrist to make a psychiatric diagnosis and treatment recommendation to the primary treatment team. STP is real-time, face-to-face psychiatric assessment using video conferencing to come up with a psychiatric recommendation. People residing in SNFs generally rely on primary and consultant physicians to visit them and rarely have outpatient psychiatrist follow-up. SNFs offer more services than what is available to primary care office, and include 24- hours skilled nursing services, physical therapy, nutritional consultation, occupational therapy, social services, wound care, and psychiatric consultation when available. SNF residents are unable to live independently due to their multiple medical comorbidities and are therefore more medically ill than patients who are typically seen in primary care settings. The present study aims to demonstrate feasibility and to collect pilot data in SNFs. This study is funded by the UC Davis Behavior Health Center of Excellence grant via the California Mental Health Services Act (Prop 63). In a larger, future study, the investigators intend to demonstrate that ATP will be no different than STP in clinical outcomes but will be more accessible and cost effective.
Ostrobothnia Depression Study (ODS) was conducted in the South Ostrobothnia hospital district of Finland during 2009-2014. ODS is a naturalistic, open label, non-randomized follow-up study on depression and related substance use disorders (SUD). The study focuses on several aspects concerning the relation of depression and SUDs, the efficacy of selected assessment and treatment protocols, characteristics and genetics of the participants and the use of related biomarkers in clinical practice. The misused substance in focus is alcohol. In this study, dual diagnosis (DD) is defined as the simultaneous presence of clinically diagnosed major depressive disorder (MDD) and alcohol use disorder (AUD). The study was approved by the local ethics committee. Written informed consent was collected from all participants.
Specialized treatment of personality disorders (PD) in youth has been neglected for a long time, because these disorders were not diagnosed before the age of 18. Since 2013 the age threshold has been dropped in the Diagnostic and Statistical Manual (DSM)-5, and such change is also announced for the International Classification of Diseases (ICD)-11. There is broad consensus from both scientific evidence and clinical experience that specialized early interventions in adolescents with PD are urgently needed. In the last decades a number of specialized psychotherapeutic treatment programs have been developed. Despite their conceptual differences, many of the treatment models have shown significant effects in the treatment of PD in adults. However, the treatment of adolescents with PD remains difficult and further enhancement and development of treatments is needed. Given the different therapeutic approaches available, the present project aims to go beyond the comparison of integral therapeutic models in the classical outcome study design. While outcome research is important to build on the evidence of the effectiveness of an intervention, it contributes little to its understanding and refinement. The aim of the present multi-center project is to compare two therapeutic methods used in routine care: - Adolescent Identity Treatment (AIT) - Dialectic Behavioral Treatment for Adolescents (DBT-A) Treatments will be performed at different study centers and compared using the same measures of outcome. The main outcome will be psychosocial functioning. Additionally, the psychotherapy process will be investigated to explore specific and unspecific mechanisms of the therapeutic process, its outcome and mediators.
Narrative Exposure Therapy (NET) is an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversity. Patients with Borderline Personality Disorder (BPD) often suffer from a comorbid Posttraumatic Stress Disorder (PTSD) caused by multiple traumatic events. Therapeutic aims are the reduction of PTSD-Symptoms in these patients via activation of associative neural networks related to traumatic experiences and habituation of fear and the placement of traumatic experiences in a reconstructed, detailed and consistent autobiography. This practice enables the processing of and coping with painful memories and the construction of clear contingencies of dangerous and safe conditions, generally leading to significant emotional recovery. The investigators assume that using NET the reduction of PTSD symptom severity is greater compared to treatment by Dialectical-Behavioral Therapy (DBT).
This study will determine the maximum tolerated dose (MTD) of arbaclofen placarbil (AP) in the treatment of subjects with Alcohol Use Disorder (AUD). For every two subjects receiving AP, one subject will receive placebo.
The purpose of this study is to understand how certain interventions help people reduce or quit their drinking and how certain interventions may help best at certain points in time in the change process.
Profound multiple disabilities also called in French polyhandicap are defined by the combination of a deep mental disability and severe motor deficit with extreme restriction of autonomy. Life in institution for people with profound multiple disabilities induces emotional and educative deficiency and often conducts to behavioral disorders. These behavioral disorders also impact on quality of life and feelings of caregivers. An intensive multimodal educative program proposed to patients with profound multiple disabilities can improve their psychic well-being, reduce chronic pain and improve also quality of life and feelings of caregivers. The intensive multimodal educative program will be compared to the usual practice of educative program.
A multi-center, open-label, long-term safety study in which approximately 600 subjects diagnosed with opioid use disorder will be enrolled. Following a screening period, all subjects will receive run in SUBOXONE sublingual film followed by an initial injection of open-label high dose (300 mg) RBP-6000. The RBP-6000 monthly injection dose can be adjusted to low dose (100 mg), and back to high dose, based on the medical judgment of the Investigator. Subjects will participate in the study for either 6 or 12 months.