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Drug Addiction clinical trials

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NCT ID: NCT02282306 Completed - Clinical trials for Opioid-related Disorders

Phone Interview to Prevent Recurring Opioid Overdoses

TTIP-PRO
Start date: September 2014
Phase: N/A
Study type: Interventional

There has been a dramatic rise in opioid overdose (OOD) deaths in recent years. Attempts to ameliorate the problem have largely focused on increasing the accessibility of naloxone, an opioid antagonist that is effective in OOD reversal. Individuals who have experienced a non-fatal OOD are at risk for additional overdoses and yet there are no interventions that specifically target this high-risk population. To address this gap, the investigators have developed the "Tailored Telephone Intervention delivered by Peers to Prevent Recurring Opioid Overdoses" (TTIP-PRO). The overall goal of the present study is to conduct a pilot evaluation of the TTIP-PRO. The research literature suggests the need for an intervention targeting patients experiencing a non-fatal OOD.

NCT ID: NCT02258425 Completed - Drug Addiction Clinical Trials

Homeless Female Offenders Returning to the Community

FEM-CARE
Start date: January 2015
Phase: N/A
Study type: Interventional

In Phase I of this R34, the team from the University of California Los Angeles, San Francisco, and Irvine researchers plan to utilize the successful community participatory approaches to refine a gender-sensitive criminogenic needs -focused intervention program, Female Ex-Offender Mentoring in Care (FEM-CARE), with the help of a community advisory board, composed of homeless female offenders (HFOs) and addiction staff; and finalize strategies which will be validated by focus group sessions with the HFOs. In Phase 2, the research team will randomize 130 HFOs participating in one of two residential drug treatment programs to assess the impact of the FEM-CARE or a Health Promotion control program on reduction of drug and alcohol use and recidivism. This study is based upon our team's history of promoting theoretically-based, culturally sensitive nurse-led interventions that are enriched with criminal justice theoretical perspectives, and have resulted in significant reductions in drug and alcohol use among homeless persons, many of whom have had a history of incarceration. Specifically, the study aims are: AIM 1) Guided by a Community Advisory Board (CAB) made up of HFOs and addiction staff, further conceptualize our community-based program, Female Ex-Offender Mentoring in Care (FEM-CARE), to address the needs and risks of HFOs enrolled in RDT programs, and then refine the program in focus group discussions with 12 HFOs. AIM 2) Conduct a pilot RCT to assess the impact of the FEM-CARE program for 65 HFOs at six-month follow-up compared with 65 HFOs receiving a control Health Promotion (HP) program, in terms of a) self-reported and/or objective measures of drug and alcohol use; and b) prevalence of recidivism and number of days to first reincarceration. Hypothesis 2a: HFOs in the FEM-CARE program will have less drug and alcohol use at six months than HFOs in the HP control program. Hypothesis 2b: FEM-CARE HFOs will have a lower prevalence of recidivism by six months and greater number of days to first reincarceration than HP control HFOs.

NCT ID: NCT02224508 Completed - Pain Clinical Trials

Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks

CARE
Start date: September 2014
Phase: N/A
Study type: Observational

Background: Sixty million American adults suffer from moderate to severe chronic pain. Of these, 5 to 8 million currently use opioids long-term. With increased opioid prescribing for chronic pain, an epidemic of prescription opioid addiction and overdose has arisen. This necessitates action to stem opioid-related morbidity and mortality. Group Health (GH), a large nonprofit health plan, developed and implemented opioid risk reduction strategies for doctors and patients in some, but not all, of its clinics. The risk reduction initiative achieved large opioid dose reductions, near universal documentation of care plans, and marked increases in patient monitoring. Rigorous evaluation of patient outcomes resulting from the opioid risk reduction initiative, incorporating patient perspectives, is needed to guide health care improvement efforts to reduce opioid risks regionally and nationally. Research goal: The investigators will evaluate a major health plan initiative to reduce risks of long-term opioid use for chronic pain. Starting in 2008, some GH clinics reduced prescribing of high opioid doses. In 2010 the same clinics increased care planning and monitoring of chronic opioid therapy (COT) patients. Our research goal is to evaluate effects of this initiative on health and safety outcomes of COT patients. We will test whether the initiative influenced pain outcomes; patient-reported opioid benefits and problems; and opioid-related adverse events. Design and Outcomes: The investigators will assess effects of GH's opioid risk reduction initiative among COT patients using opioids long-term. The investigators will compare COT patients from clinics that implemented the initiative with COT patients from care settings that did not implement the initiative. The investigators will use survey data to assess patient-reported outcomes including pain severity, depressive symptoms, and patient perceptions of opioid benefits and problems, including validated measures of prescription opioid use disorder. They will interview and compare 800 COT patients using opioids long-term from clinics that implemented the risk reduction initiative and 800 COT patients from care settings that did not. Impact: This research will provide an urgently needed, rigorous evaluation of a major risk reduction initiative among COT patients. Evaluation results will guide efforts of health plans, clinicians and patients nationwide to ensure safe, effective and compassionate chronic pain care.

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: NCT02091284 Completed - Clinical trials for Executive Dysfunction

Bilateral Prefrontal Modulation in Alcoholism

tDCS_ALCOHOL
Start date: November 2013
Phase: N/A
Study type: Interventional

In this study, eligible alcoholic inpatients recruited from a specialized clinic for addiction treatment, filling inclusion criteria and not showing any exclusion criteria, were randomized to receive the repetitive (10 sessions, every other day) bilateral dorsolateral Prefrontal Cortex (dlPFC: cathodal left / anodal right) tDCS (2 milliamperes, 5 x 7 cm2, for 20 min) or placebo (sham-tDCS). Craving to the use of alcohol was examined before (baseline), during and after the end of the tDCS treatment. Based in our previous data, our hypothesis was that repetitive bilateral tDCS over dlPFC would favorably change craving in alcoholism and this would be a long-lasting effect.

NCT ID: NCT02091167 Completed - Clinical trials for Executive Dysfunction

Bilateral Prefrontal Modulation in Crack-cocaine Addiction

tDCS_CRACK
Start date: November 2013
Phase: Phase 2
Study type: Interventional

In this study, eligible crack-cocaine addicted inpatients recruited from specialized clinics for substance abuse disorder treatment, filling inclusion criteria and not showing any exclusion criteria, were randomized to receive the repetitive (10 sessions, every other day) bilateral dorsolateral Prefrontal Cortex (dlPFC: cathodal left / anodal right) tDCS (2 milliamperes, 3x7 cm2, for 20 min) or placebo (sham-tDCS). Craving to the use of crack-cocaine was examined before (baseline), during and after the end of the tDCS treatment. Based in our previous data, our hypothesis was that repetitive bilateral tDCS over dlPFC would favorably change clinical, cognitive and brain function in crack-cocaine addiction and these would be long-lasting effects.

NCT ID: NCT01891045 Completed - Drug Abuse Clinical Trials

Impact of Online Patient Feedback (OQ) to Therapist

Start date: July 1, 2011
Phase: N/A
Study type: Interventional

Dropout represents one of the largest problems in substance abuse treatment. International and Nordic research show that only 20 - 40 % of substance abusers complete treatment as intended. At the same time, one of the most consistent factors of favourable post-treatment outcome is treatment completion. In spite of the serious and continuous challenge dropout represents the phenomena is not well understood and there is a need to explore more of the factors that influence dropout and how it can be counteracted. As also stated: "…effective methods for reducing the problem of dropouts from treatment is one more area in need of further research" (NOU 2003:4, s 77). For the general field of mental health one of the most important innovations involves providing therapists with patient feedback about their progress. The most well-established and widely researched feedback system is the Outcome Questionnaire (OQ-45.2). The system has been shown to improve treatment outcomes, including reduced treatment dropout and length of treatment, but the system is yet to be utilized with a substance abusing patient group. The aim of the present study is to examine the usefulness of OQ-45.2 with substance abusing patients.

NCT ID: NCT01849419 Completed - Drug Addiction Clinical Trials

Effects of MDMA on Social and Emotional Processing

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

The main aim of the study is to investigate the effects of ±3,4-methylenedioxymethamphetamine (MDMA; ecstasy) on social and emotional processing in healthy humans. Ecstasy is a widely used recreational drug, with over 2 million Americans reporting use of the drug in 2006. With this number of users, and evidence that high doses of MDMA are neurotoxic in laboratory animals, the public health implications of ecstasy use may be substantial. Certain subjective effects of this drug distinguish it from other stimulants, and may contribute to its widespread use: That is, users report that ecstasy produces profound feelings of empathy and closeness to others. These so-called 'empathogenic' effects, which may reflect the distinctive neurochemical profile of action of the drug, have yet to be characterized in controlled laboratory studies. The investigators propose to characterize the effects of MDMA on measures of social and emotional processing that may contribute to this 'empathogenic' profile, including measures of emotion recognition, emotional responsiveness and sociability. The investigators will assess effects of MDMA (0, 0.75 and 1.5 mg/kg up to 125 mg) one active control drug (oxytocin: 20 IU) in 100 volunteers who report some prior ecstasy use. Oxytocin will be used because it appears to produce pro-social behavioral effects resembling those attributed to MDMA.

NCT ID: NCT01844414 Completed - HIV Clinical Trials

UCLA-Amity Parolee Health Promotion Study

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

The purpose of this study is to conduct a prospective, three-group study that randomly assigns 700 parolees, in a community residential drug treatment program, to enter one of three groups: 1) a PCPC (Parolee Comprehensive Care + Phone Coaching Program), which includes nurse case management and specialized hepatitis education sessions and the hepatitis A/B (HAV/HBV) vaccination series (to all eligible) and coach-facilitated mentoring (mostly by cell-phone); 2) a Parolee Brief Hepatitis Education + HBV vaccination + Phone Coaching (PBCP) Program, which includes brief hepatitis/HIV education, HAV/HBV vaccination and coach-facilitated mentoring; or 3) a Usual Care (UC) control program, which includes brief general health information, one-on-one coaching and the HAV/HBV vaccine.

NCT ID: NCT01722006 Completed - Drug Addiction Clinical Trials

Drug Effects on Preference and Reward

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

Classical conditioning is widely used to study motivational properties of addictive drugs in animals, but has rarely been used in humans. Here, we are establishing a procedure suitable for studying the neurobiology and individual determinants of classical conditioning in humans. Healthy volunteers are randomly assigned to four groups that received methamphetamine or placebo in the presence of distinctive environmental cues under paired or unpaired conditions. During each session, subjects perform tasks known to activate the ventral striatum in fMRI studies. The tasks are performed in the presence of a distinctive context, consisting of a screen background image of a beach or of mountains, accompanied by corresponding sounds. Separate groups of subjects carry out the tasks under high or low reward conditions. Within each of the two reward conditions, one group (paired), receives methamphetamine (20 mg, oral) or placebo consistently associated with one of the contexts, while the other (unpaired) receives drug or placebo unrelated to context. A fifth group (paired) perform the tasks with contextual cues but in the absence of monetary incentives. Before and after conditioning, participants carry out a series of forced choice tasks, and change of preference over time was analyzed.