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Dual Diagnosis clinical trials

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NCT ID: NCT02520271 Completed - Anxiety Disorders Clinical Trials

Ostrobothnia Depression Study (ODS). A Naturalistic Follow-up Study on Depression and Related Substance Use Disorders

ODS
Start date: October 2009
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02233738 Completed - Clinical trials for Substance-related Disorders

Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services

Start date: September 30, 2015
Phase: N/A
Study type: Interventional

Homeless Veterans with substance use disorders (SUDs) are a major group served by VA and are heavily represented in VA housing. VA recently adopted a 'Housing First' approach emphasizing rapid housing placement to initiate recovery without requiring sobriety and will necessitate SUD interventions that are efficient and easily layered onto existing services. The proposed study will investigate the effectiveness, implementation process, and cost estimate of Group Motivational Interviewing (GMI) for Veterans with SUDs in VA housing (Housing Urban Development-VA Support Housing [HUD-VASH] and Grant and per Diem [GPD]). Outcomes will be assessed at multiple time points using a multi-modal approach. The ultimate goal of this research is to establish the basis of a GMI dissemination and implementation course of action for highly vulnerable homeless Veterans in VA housing for achieving their greatest success in attaining housing stability.

NCT ID: NCT02192931 Completed - Depression Clinical Trials

A Randomized Double-Blind Controlled Trial of Creatine in Female Methamphetamine Users

Start date: September 2014
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT02082678 Completed - Bipolar Disorder Clinical Trials

Ondansetron for Bipolar Disorder and Alcohol Use Disorders

Start date: February 2014
Phase: Phase 4
Study type: Interventional

The purpose of the study is to determine if ondansetron, as an add-on therapy, is associated with reduced depressive symptoms and alcohol use in outpatients with bipolar disorder (BPD), cyclothymic disorder, schizoaffective disorder (bipolar type) and major depressive disorder (MDD) with mixed features. The investigators will also use blood samples to determine if the genotype for the serotonin transporter gene is associated with response to ondansetron.

NCT ID: NCT01964404 Completed - Schizophrenia Clinical Trials

Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment?

Start date: July 2014
Phase: Phase 1
Study type: Interventional

In this translational research proposal, based on our formulation, we seek to confirm and expand upon data obtained in our pilot study suggesting that cannabis and the cannabinoid agonist dronabinol, given in low dose to patients with schizophrenia and co-occurring cannabis use disorder, will in fact ameliorate the brain reward circuit dysregulation in these patients and, thereby, provide evidence in support of the role of cannabis as a "self-medication" agent for them.

NCT ID: NCT01639872 Completed - Schizophrenia Clinical Trials

Clozapine for Cannabis Use in Schizophrenia

CLOCS
Start date: May 1, 2013
Phase: Phase 4
Study type: Interventional

Many individuals with schizophrenia also suffer from marijuana addiction that worsens their problems related to schizophrenia. Most of the medications prescribed for schizophrenia have no effect on reducing marijuana use. Preliminary data suggests that clozapine, an atypical antipsychotic, may limit marijuana use in people diagnosed with schizophrenia, but it is not commonly used due to its side effects and is reserved for people who do not respond to other antipsychotic medications. In the proposed study, 132 individuals who are diagnosed with both schizophrenia and a cannabis use disorder will be randomized to a 12-week treatment course with either clozapine or risperidone (another commonly prescribed antipsychotic medication) to test the hypothesis that patient treated with clozapine will have decreased cannabis use as compared to patients treated with risperidone. Should this study indicate that clozapine will lessen marijuana use in persons diagnosed with schizophrenia more than risperidone, it will provide evidence needed to begin to shift clinical practice toward its use in this population.

NCT ID: NCT01514630 Completed - Depression Clinical Trials

Creatine as a Treatment Option for Depression in Methamphetamine Using Females

Start date: January 2013
Phase: Phase 4
Study type: Interventional

Methamphetamine (MA) is a psychostimulant drug with high abuse potential. MA can be smoked, snorted, injected or ingested orally to produce a release of high levels of dopamine into the brain and reduction of dopamine uptake. Its use results in feelings of pleasure, increased energy, and greater alertness lasting up to 12 hours. In 2010, the National Survey on Drug Use and Health reported that 353,000 Americans aged 12 or older reported being current MA users. Over the past decade MA use rates have fluctuated with current use rates on the decline; however, importantly, even though overall use rates are declining, use rates among males and females are approaching equal proportions. This use rate pattern is unlike other drugs of abuse, which typically demonstrate males using more than females. In some states, more females than males consider MA as their drug of choice. Namely, in a 2010 report in the state of Utah, more females were diagnosed with MA as a primary substance of abuse than males upon admission to treatment. Depression and MA use are highly comorbid. The relationship between MA use and depression is likely bidirectional, with MA use causing changes in mood and being used as a self-medicating behavior to reduce symptoms of depression. Several studies have shown that depression rates are higher in MA-using females compared to their male counterparts. It is likely that neurobiological and psychosocial mechanisms contribute to increased incidence of depressive symptoms in females. No clear treatment model exists to suggest how the comorbidity of depression and MA use is best managed. In studies of antidepressants for treatment of MA withdrawal and dependence, findings have suggested that antidepressants are ineffective for treating depressive symptoms. Creatine is an organic acid occurring naturally in vertebrates, where it takes part in energy homeostasis in tissues with fluctuating energy demands. Exogenous creatine has been shown to increase brain concentrations of PCr. Neuroimaging studies of creatine have shown increased brain phosphocreatine (PCr) content with creatine administration. Therefore, we hypothesize that oral creatine administration will increase PCr levels and reduce depressive symptoms in a sample of depressed female MA users. This hypothesis will be tested by a within subjects design by giving depressed MA using females oral creatine for eight weeks and measuring PCr pre- and post-treatment with magnetic resonance spectroscopy. Moreover, depressive symptoms will be measured by administration of the Hamilton Depression Rating Scale twice weekly during the course of creatine treatment.

NCT ID: NCT01411085 Completed - Schizophrenia Clinical Trials

Risperidone and Desipramine in Alcohol Use and Schizophrenia

RADIAUS
Start date: December 2011
Phase: Phase 2
Study type: Interventional

Note: In June 2013, the study design was changed from a randomized controlled study of risperidone + despiramine vs. risperidone vs. placebo to an open label pre-post study of risperidone (or risperidone-like drug) + desipramine. The aims of the study were revised to read: 1. To determine whether participants treated with risperidone in combination with desiprmaine have less alcohol use (fewer drinking days; fewer heavy drinking days) during the final 8 weeks on these medications as compared to pre-baseline. The primary hypothesis is that compared to pre-baseline, participants will demonstrate fewer days of drinking (per week), as well as fewer days of heavy drinking (per week) in the final eight weeks they are taking risperidone and desipramine, as recorded on the Timeline Follow-Back assessment 2. To explore changes in symptoms (of schizophrenia and of depression) in the final eight weeks of treatment with risperidone + desipramine compared to the period before baseline 3. To assess the side effect burden associated with the combination of these two medications in participants. The original aims of the study were: The purpose of this study is to determine whether participants who are treated with risperidone in combination with desipramine have less alcohol use (fewer drinking days; fewer heavy drinking days) than do participants who are treated with RISP with placebo. The primary hypothesis is that compared to treatment with risperidone, participants randomized to a combination of risperidone plus desipramine will have fewer days of drinking, as well as fewer days of heavy drinking. The study will also compare the effects of risperidone as compared to risperidone plus desipramine on participants' symptoms and side effects.

NCT ID: NCT01329393 Completed - Schizophrenia Clinical Trials

Benefits Management for People With Psychiatric Disabilities

Start date: August 2010
Phase: Phase 1
Study type: Interventional

This stage 1 clinical trial will determine pilot efficacy, develop a therapy manual, and collect qualitative data concerning a brief money management intervention for people disabled by psychiatric illnesses.

NCT ID: NCT01327586 Completed - Cocaine Dependence Clinical Trials

Abstinence-Linked Money Management Multisite

Start date: December 2009
Phase: Phase 2
Study type: Interventional

Randomized clinical trial comparing a money management-based intervention involving storage and management of client funds, substance abuse counseling, and risk reduction counseling to individualized drug counseling.