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Substance-Related Disorders clinical trials

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NCT ID: NCT01224002 Withdrawn - Dental Caries Clinical Trials

A Comparative Feasibility Study to Assess the Prevalence and Severity of Dental Caries in Incarcerated People Who Abuse Methamphetamine

Start date: September 2010
Phase: N/A
Study type: Observational

The prevalence and severity of dental caries in incarcerated people who abuse drugs are unknown but an inmate reporting to the dental clinic typically presents with myriad findings: oral signs of uncontrolled decay on the buccal smooth surfaces of the posterior teeth and interproximal surfaces of the anterior teeth, excessive tooth wear due to grinding and clenching, and gingival inflammation. The primary risk factors for the development of caries appear to be the combination of xerostomia, frequent consumption of carbonated soft drinks, high dental plaque levels and nonexistent or inadequate oral hygiene. Since some of these findings are seen in the other disease states, specifically in substance abuse cases, the diagnosis is often not clear. The objective of the project is to design a cross sectional comparative feasibility study that will estimate the prevalence, pattern, and severity of untreated dental decay for three types of inmates: methamphetamine abusers, substance abusers not identified as methamphetamine users, and non-substance abusers, focusing in on methamphetamine abusers as the highest risk group. Recruitment will be accomplished using a 2-phased process. Phase I. An invitation letter explaining the study purpose and its relevance to oral health in a correctional setting will be mailed to the inmate population at two Federal Bureau of Prisons' institutions who entered the prison system during the first half of 2009. Dublin, a female FCI located in Northern California and Butner, a male FCC located in North Carolina were the selected facilities due to the high incidence of drug abusers among their inmates. The letter, which will invite all inmates to participate in the study, will inform the inmate should they consent to participate in the study that they will have their existing dental record confirmed, Central File reviewed for DSM-IV diagnosis pertinent to the study, and that they will be given a study questionnaire. Positive responses to the invitation letters will be returned to Dr. Johnson at head quarters in Washington DC. The psychology division will code the volunteer inmates into the three study groups. Phase II. The first 30 chronologically documented volunteers in each study group category will be scheduled an appointment. A consent form will be read and explained to each inmate, in either English or Spanish as appropriate and his/her signature obtained as his/her informed consent. Each question on the study questionnaire will be read to the inmate volunteer and the Research Associate will record the answer. A retrospective comparative study will then be employed utilizing the inmate's initial dental intake exam (routinely administered by the Federal Bureau of Prisons' dental department). The dental chart will be abstracted for dental caries. The pattern of surface-specific dental caries (DFS index) will be described and analyzed. The focus will be on the levels of untreated and treated disease diagnosed in a 4-zone partition of the oral dentition, representing a modification of the zones identified in the Grainger's caries severity index scoring system as this partition allows focus on decay patterns of anterior tooth surfaces. The multivariate summary of disease levels within each zone will be derived and statistically compared across the three study groups using Hotelling's t2-test (the multivariate extension of the Student-t test). The results of the study will be used to do a preliminary assessment between methamphetamine drug abuse and oral health and determine whether a prospective clinical study is warranted.

NCT ID: NCT01217970 Completed - Substance Abuse Clinical Trials

Safety Interaction Trial Ibudilast and Methamphetamine

Start date: January 2011
Phase: Phase 1
Study type: Interventional

This study is designed to collect data to determine whether a medication, ibudilast, is safe for use as a potential treatment for methamphetamine-dependent people. For 18 years in Japan and South Korea, ibudilast has been used safely in humans as a treatment for asthma, pulmonary, and cardiovascular disease. It is not known whether ibudilast is safe to use in outpatient settings with people who have methamphetamine dependence. This would be the first study to collect this information. This study is important because individuals with methamphetamine dependence often relapse to meth use, even when in treatment; some number of individuals who participate in an outpatient study will relapse to methamphetamine while taking ibudilast. It is crucial to know whether there may be interactions between ibudilast and methamphetamine before planning an outpatient clinical trial.Ibudilast is an exciting medication candidate for treating methamphetamine dependence. When individuals become abstinent from methamphetamine during early recovery, the body starts an inflammatory process in neurons, especially glial cells. Glial cells are important in that they provide support to the nerve cells that are involved in thought, movement, and other human activities. By dampening inflammation in glial cells, ibudilast may preserve glial and other nerve cells during early abstinence, which in turn may help individuals feel better and think better during treatment. The study specific aims are to determine whether ibudilast alters: 1. blood pressure and heart rate responses to methamphetamine; 2. the ratings of craving or other drug experiences from methamphetamine; 3. the reward/reinforcing effects of methamphetamine; and 4. the metabolism of methamphetamine. Over an enrollment period of 24 months, 12 methamphetamine-dependent participants who are not looking for treatment will complete this study.

NCT ID: NCT01211106 Completed - PTSD Clinical Trials

Integrated vs Sequential Treatment for PTSD and Addiction

Start date: February 2011
Phase: N/A
Study type: Interventional

The investigators are examining different treatment strategies of helping patients with PTSD and addiction.

NCT ID: NCT01208870 Completed - Pediatric Obesity Clinical Trials

Translating Habituation Research to Interventions for Pediatric Obesity

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

The purpose of this center grant is to translate basic behavioral science on habituation theory into clinical intervention using a vertical hierarchical approach from laboratory studies to field studies to the clinical intervention to improve weight loss outcomes in pediatric obesity treatment.

NCT ID: NCT01207622 Withdrawn - Clinical trials for Attention Deficit Hyperactivity Disorder

Efficacy of Atomoxetine for ADHD in Adolescents and Young Adults With SUD

Start date: n/a
Phase: Phase 4
Study type: Interventional

The primary objective of the study is to investigate the efficacy of Atomoxetine (ATMX) in the treatments of adolescent and young adult Attention Deficit Hyperactivity Disorder (ADHD) with comorbid Substance Use Disorder (SUD). The secondary objective of the study is to determine the efficacy of ATMX in preventing SUD relapse. As previous pre-clinical work has demonstrated that ATMX has led to significant improvement in ADHD in children and lacks abuse liability, the investigators hypothesize that ATMX will be efficacious in treating ADHD in adolescents and young adults with SUD, and that ATMX will also be efficacious in preventing SUD relapse.

NCT ID: NCT01204879 Completed - Exercise Clinical Trials

Reinforcing Exercise in Substance Abusing Patients

Start date: April 2010
Phase: N/A
Study type: Interventional

This study will evaluate the efficacy of an exercise-based contingency management (CM) intervention. A total of 120 substance abusing patients in intensive outpatient treatment will be randomly assigned to one of two conditions: (a) standard care plus CM for completing goal-related activities not related to exercising (e.g., improving work, family, or transportation issues), or (b) standard care plus CM for completing exercise-related activities. Compared to those receiving goal-related CM activity contracting, it is expected that those in the exercise CM condition will participate in more physical activities and develop greater strength and flexibility, decrease drug use, reduce HIV risk behaviors, lessen depressive symptoms, and improve health indices.

NCT ID: NCT01191788 Completed - Depression Clinical Trials

Building Recovery By Improving Goals, Habits, and Thoughts

BRIGHT
Start date: August 2006
Phase: N/A
Study type: Interventional

The investigators will investigate whether group Cognitive Behavioral Therapy (CBT) for depression, with alcohol and other drug (AOD) treatment counselors leading the groups, is effective and cost effective in treating depression. If so, it could substantially increase access to appropriate mental health care. 360 clients with Beck Depression Inventory-II scores > 17 who are being treated in a single public sector AOD treatment organization will receive one of two conditions: (1) usual care residential AOD treatment (UC); (2) usual care AOD residential treatment plus a 16-session course of group CBT delivered by trained AOD counselors (CBT). Data will be analyzed using an intent-to-treat model. The investigators will collect data on the service-level costs and health effects associated with UC and CBT, and will calculate the incremental cost per unit of depression and AOD improvement, compared to UC.

NCT ID: NCT01189799 Completed - Depression Clinical Trials

Motivational Therapy for Substance Users With Depression

Aftercare
Start date: September 2007
Phase: N/A
Study type: Interventional

The primary objective of the study is to test the incremental efficacy and outcomes of an aftercare program of Cognitive Behavioral Therapy combined with motivational therapy (CBT-MT) relative to treatment as usual (TAU) in improving depression, substance use, and healthcare outcomes in a population with drug dependence and comorbid major depressive disorder (MDD). The investigators expect that among drug-dependent patients with comorbid MDD, CBT-MT will yield better clinical outcomes relative to TAU in reducing depressive symptoms and substance use and improving healthcare outcomes during treatment. Secondary Objectives: 1. Test efficacy and outcomes of CBT-MT and TAU 2. Evaluate the differential effect of CBT-MT versus TAU on HIV-risk behavior of participants, 3. To evaluate the impact of cognitive functioning on treatment retention and outcomes, and 4. To explore additional psychosocial, demographic, and diagnostic factors (e.g., age, gender, education level, motivation for change, social support) that may be associated with treatment outcome and retention in this high need population.

NCT ID: NCT01189552 Completed - Clinical trials for Substance Use Disorder

Depression Treatment for Low Income Substance Users

LET'S ACT
Start date: October 2010
Phase: N/A
Study type: Interventional

The objective of the current study is to evaluate the effects of a brief, behavioral activation treatment (the Life Enhancement Treatment for Substance Use; LET'S ACT) on long term outcomes of substance use, HIV risk behaviors and mechanisms of treatment response (depressive symptoms, environmental reward, behavioral activation).

NCT ID: NCT01189214 Completed - Substance Abuse Clinical Trials

Psychopharmacotherapy in Multiple Substances Abuse

MM opioid
Start date: March 2009
Phase: Phase 3
Study type: Interventional

Add-on of memantine or placebo treatment will proceed in a double-blinded fashion for 12 weeks after adjusted methadone dose. During the study, the investigators will evaluate treatment response and adverse effect from multiple dimensions to elucidate the therapeutic effect of add-on memantine on addictive behaviors. It will also explore the possible advantage of this treatment on social re-adaptation and psychopathogenesis of opioid dependence.