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Drug Dependence clinical trials

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NCT ID: NCT01843023 Completed - Drug Dependence Clinical Trials

Extended Release Naltrexone for Opioid-Dependent Youth

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

The purpose of this study is to compare 6-month treatment outcomes for 15-21 year old opioid-dependent youth receiving extended release naltrexone (XR-NTX) v. Treatment as Usual (TAU).

NCT ID: NCT01550341 Completed - Clinical trials for Human Immunodeficiency Virus

HIV, Buprenorphine, and the Criminal Justice System

STRIDE
Start date: February 23, 2012
Phase: N/A
Study type: Interventional

The aims of STRIDE were changed as of July, 2014. The revised project, called STRIDE2, has a longitudinal, non-randomized, observational study design. The population under study consists of individuals living with HIV who are dependent on opioids.

NCT ID: NCT01449981 Completed - Alcohol Dependence Clinical Trials

Development and Testing of Adolescent Twelve-Step Facilitation

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

This study is the first to develop and test in a randomized experimental design the efficacy of an integrated 12-step facilitation intervention tailored for young people. In the first phase of the study, the investigators are developing and revising a preliminary manual for the two sessions individually-delivered Motivational Enhancement Therapy (MET) component and subsequent 8 session group-delivered Cognitive-Behavioral Therapy (CBT) component which will integrate Twelve-step Facilitation (TSF). Forty adolescents each will complete the preliminary integrated TSF protocol. In the second phase of the study, the investigators will compare integrated TSF (iTSF) to standard treatment (MET/CBT) in a randomized experimental design for adolescent substance use disorder with 60 adolescents. As a result, the investigators will examine potential mechanisms that may underlie the efficacy of iTSF in improving alcohol and other drug use outcomes. The investigators will test group differences on potential mechanisms of change (e.g., Alcoholics Anonymous/Narcotics Anonymous attendance and involvement) and whether these variables are associated with substance use outcomes.

NCT ID: NCT01382316 Completed - Alcohol Dependence Clinical Trials

Making Alcoholics Anonymous Easier

MAAEZ
Start date: July 2005
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT01338506 Completed - Alcohol Dependence Clinical Trials

Integrated Treatment of OEF/OIF Veterans With PTSD & Substance Use Disorders

COPE
Start date: April 2011
Phase: N/A
Study type: Interventional

In comparison to the general population, U.S. military and Veterans are at an increased risk for developing both substance use disorders (SUD) and Post Traumatic Stress Disorder (PTSD). Current research has shown that there is a high comorbidity of SUD and PTSD, and although there are a number of treatments for SUD and PTSD independently, there are very few effective methods to simultaneously treat both disorders. Because of this substantial gap in the treatment of both SUDs and PTSD, it has become essential to develop a combined treatment that would address and treat both disorders. Individuals, specifically U.S. military and Veterans, with SUD/PTSD have unique needs that require a specialized treatment approach. This designed approach would employ cognitive-behavioral therapy (CBT) to treat the SUD, in conjunction with Prolonged Exposure therapy to treat the PTSD. Prolonged Exposure (PE) is an empirically supported and evidence-based treatment that is currently regarded as the "gold standard" psychosocial treatment for PTSD. In combination with CBT, this treatment would address both disorders in hopes of reducing substance use and PTSD symptomatology.

NCT ID: NCT01246401 Completed - HIV Clinical Trials

Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations

NewHope
Start date: March 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Specific Aim: To conduct a randomized, placebo-controlled trial of extended release-naltrexone (XR-NTX) among Human Immunodeficiency Virus (HIV) infected prisoners meeting Diagnostic Statistical Manual IV (DSM-IV) criteria for opioid dependence who are transitioning from the structure of a correctional setting to the community. Hypotheses: i. XR-NTX will result in improved HIV clinical outcomes, including lower changes in HIV-1 RNA levels, higher CD4 counts and higher rates of retention in care. ii. XR-NTX will result in improved opioid treatment outcomes, including longer time to opioid relapse, lower addiction severity and lower craving for opioid. iii. XR-NTX will result in reduced drug- and sex-related HIV risk behaviors compared to the control group. iv. XR-NTX will result in decreased rates of reincarceration after 12 months of release to the community.

NCT ID: NCT01171677 Completed - Alcohol Dependence Clinical Trials

Impact of Exercise and Affirmations (IntenSati) on Addiction-related Cognitive and Psychosocial Deficits

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

Addiction to illicit and prescribed drugs, alcohol and tobacco is associated with a panoply of brain changes that contribute to structural and micro-structural deficits, altered metabolism and neurotransmission, and related cognitive deficits affecting executive function, decision-making, reward salience and motivation. Many of these deficits may act as barriers to recovery, compromising the same spectrum of cognitive processes that established interventions (motivational enhancement, cognitive behavioral therapy, therapeutic communities, etc.) depend on for successful outcomes. Even where there are medications that target a specific addiction (e.g., methadone for opiates), meaningful, sustained recovery relies on the acquisition of adaptive skills and strategies. As such, there is a need to develop interventions for substance use disorders that have the potential to improve health and cognitive and psychosocial functioning, and to be embraced by the treatment community. A growing body of basic and clinical research suggests that physical exercise may reduce drug use and improve cognitive-executive function, mood, and motivation. There is also a growing literature on the effectiveness of positive affirmation as a cognitive-behavioral intervention for depression and PTSD both of which frequently co-occur with addiction. Building on this, we hypothesize that a combined exercise and affirmation intervention (IntenSati) will lead to improved cognitive and psychosocial function. To test this, we propose to conduct a two-arm randomized clinical trial - in adult volunteers with a history of longstanding substance use and who are in treatment in a residential therapeutic community setting (Odyssey House) - to examine cognitive and psychosocial function before, during, and after randomization to either a twelve-week IntenSati intervention condition or to a twelve-week no-exercise/no-affirmations control condition. This is a pilot study intended to collect data on feasibility and effect size. The population and sample size were selected on the basis of likelihood to benefit from the intervention, likelihood for good adherence, and the realities of completing a low-cost pilot study within a one-year timeframe. Overall there were no substantial differences between IntenSati and TAU on measures of cognition, mood, and psychosocial functioning. Limitations include the small sample size, limited exercise intensity and capacity, missed exercise classes, dropout because of placement, work schedules and non-study-related medical conditions.

NCT ID: NCT01096550 Completed - Drug Dependence Clinical Trials

Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans

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

The purpose of this study is to compare the effectiveness of different levels of counseling (intensive outpatient versus standard outpatient) on treatment outcomes for African American adult patients receiving buprenorphine in 2 formerly "drug-free" programs.

NCT ID: NCT01068847 Completed - Drug Dependence Clinical Trials

Drug Discrimination in Methadone-Maintained Humans Study 3

OMDD3
Start date: February 2010
Phase: Phase 1
Study type: Interventional

This study involves giving psychoactive drugs intramuscularly (injected into the muscle of the upper arm or the hip) and/or orally, and measuring the participant's ability to tell the difference between one drug and another, as well as measuring the effects of the drugs on mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each participant will receive 2-4 of the listed interventions.

NCT ID: NCT01052675 Completed - Drug Abuse Clinical Trials

Pharmacological, Clinical and Statistical Assessment of a New Tool Available for Pharmacodependence Report Evaluation

Start date: January 3, 2008
Phase:
Study type: Observational

In France, the Afssaps is the body in charge of the evaluation of pharmacodependance. In order to fulfil its mission, the Afssaps has created a network of 11 Centres for Evaluation and Information on Pharmacodependance (CEIP), coordinated by the Drugs and Psychotropics Unit. Pharmacodependence notifications issued by professionals are collected by each Centre which evaluates them. Nantes' CEIP created an original tool to harmonize case reporting and make it possible to homogeneously evaluate the seriousness of pharmacodependence cases as each CEIP had his own way of analysing his cases. The aim of this study is to assess this tool.