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Drug Abuse clinical trials

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NCT ID: NCT00798538 Completed - HIV Clinical Trials

Integration of Buprenorphine Into HIV Clinical Settings - Primary Care Model (PCM)

BELIEVE
Start date: August 2005
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the feasibility, cost and effectiveness of interventions designed to integrate buprenorphine treatment for opioid dependence into HIV primary care in ten HIV care centers in the U.S. In the site led by Dr. Altice, we compare two models of providing HIV care and buprenorphine treatment. Assignments are based on participants' city of residence. In the onsite (integrated care) model, participants receive buprenorphine, substance abuse counseling and HIV care at one location: the Waterbury Hospital Infectious Disease Clinic. In the off-site model (non-integrated care) buprenorphine induction, substance abuse counseling, and HIV care will be provided at separate locations: the Community Health Care Van (CHCV), the Yale AIDS Program, and patients' own HIV providers, respectively. Data is collected from interviews with participants, reviews of medical records, and surveys and interviews with clinicians.

NCT ID: NCT00787423 Completed - Stress Clinical Trials

Developing Field Tools for Real-Time Assessment of Exposure to Psychosocial Stress and Drug Use in an Outpatient Treatment Population

Start date: July 14, 2009
Phase:
Study type: Observational

Background: - Researchers are interested in developing more accurate methods to assess environmental influences on psychological stress and drug use. One key to a more accurate assessment of environmental influences is minimizing the delay between exposure and reporting. Portable devices such as personal digital assistants (PDAs) and global positioning system (GPS) units may be able to provide a more real-time image of these factors. Objectives: - To assess the use of PDAs to measure stress and drug use, and GPS units to assess the effects of neighborhood environment in an outpatient treatment population. Eligibility: - Individuals from 18 to 75 years of age who are current heroin users seeking treatment for addiction and who spend most of their time in Baltimore city. - Participants must be able to visit the research and treatment center at least three times per week for regular tests. Design: - Participants will be in the study for approximately 28 weeks (7 months). - A series of three laboratory session examining responsiveness to standardized stressors will occur both early in treatment and will be repeated late in treatment. - Participants will undergo 18 weeks of daily methadone maintenance. Urine samples will be collected three times weekly. - To track drug use, stress, and geographical location (a measure of environmental risk), each participant will carry a PDA and a GPS unit for 16 of the 18 weeks. Participants will make entries (1) each time that they use a drug and (2) each time they feel overwhelmed, anxious, or stressed more than usual. Participants will also make three random-signal-triggered recordings per day and one brief (end of day) recording. - Retrospective self-report questionnaires on drug use and stress will be given regularly. - After 18 weeks of methadone maintenance, participants will discontinue carrying the PDA and GPS unit and will have the choice of transferring to a community clinic or undergoing a 10-week taper from methadone at the research clinic. Participants who stay for the taper will continue to provide urine samples, but only once a week.

NCT ID: NCT00776685 Completed - Depression Clinical Trials

Adventure: Teacher Delivered Personality-targeted Interventions for Substance Misuse

Adventure
Start date: May 2007
Phase: Phase 2/Phase 3
Study type: Interventional

Several personality factors have been shown to be associated with risk for alcohol and substance misuse, and differentiate substance abusers based on clinical profile, treatment response and susceptibility to other forms of mental illness. Personality-targeted interventions have been found to have significant preventative effects on onset and growth of drinking, binge-drinking and drinking problems in adolescents attending mainstream schools (Conrod, Castellanos & Mackie, 2008). The interventions concurrently reduced personality-specific emotional and behavioural problems (Castellanos & Conrod, 2006), and prevented the onset and escalation of drug-use over a two-year period (Conrod, Castellanos-Ryan & Strang, 2010). This cluster randomised controlled trial aims to examine whether these results can be replicated when interventions are delivered by trained educational professionals. In addition, the trial will evaluate the broader impact of the programme on cigarette smoking, school attendance, academic achievement and school-wide behaviours.

NCT ID: NCT00725608 Completed - Clinical trials for Opioid-Related Disorders

Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)

Start date: May 2008
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the acceptability and safety of switching to Suboxone® (buprenorphine plus naloxone) and the effect of the switch on medication dispensing. Subjects, for whom a therapy with Suboxone® is indicated and planned prior to study enrollment and who are willing to participate, will initiate therapy on Day 1 of the study. The dosage will be adjusted between Day 2 to 7 depending on patient's needs and determined by the treating physicians in accordance with the SmPC of Suboxone®. Data will be collected at baseline, day 1 til 7, the end of weeks 2 and 4 and monthly up to the end of Month 12.

NCT ID: NCT00723749 Completed - Clinical trials for Opioid-Related Disorders

Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)

Start date: March 2008
Phase: N/A
Study type: Observational

The aim of this post marketing surveillance study is to investigate the retention rate after 12 months of drug dependence treatment with SUBOXONE® (buprenorphine plus naloxone) of opioid dependent patients under real life conditions.

NCT ID: NCT00723697 Completed - Drug Abuse Clinical Trials

Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)

OPUS R
Start date: May 2007
Phase:
Study type: Observational

The purpose of this study is to assess the risks of abuse, misuse and adverse events related to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or its Buprenorphine High Dose (BHD) generic (Arrow Laboratories) will participate in this study. Data will be collected using physician questionnaires and self evaluation patient questionnaires at the first visit and visits at 6 and 12 months.

NCT ID: NCT00722644 Completed - HIV/AIDS Clinical Trials

Cognitive Behavioral Stress Management for HIV+ Drug Abusers

Start date: September 1999
Phase: Phase 1
Study type: Interventional

The primary purpose of this 5-year study is to determine whether a Cognitive Behavioral Stress Management (CBSM) intervention, demonstrated to be effective in reducing distress, enhancing coping, and maintaining health among HIV+ non-drug abusers (see Schneiderman and Antoni, 2000), can be effectively adapted for our target population of culturally diverse, HIV+, low-income "Recovering Drug Abusers" (RDAs). Since the late 1980s, members of our research team (i.e., Schneiderman, Antoni, Klimas, Fletcher) have been developing, refining and evaluating the effects of CBSM among HIV+ Men who have Sex with Men (MSM). In the early/mid 90s, we began to adapt and evaluate the effects of CBSM in other non-drug abusing subgroups that were emerging with increasing levels of HIV seroprevalence (e.g., pregnant women, African American and Hispanic men and women). After accumulating considerable support for the effectiveness of CBSM in these subgroups in the late 90s, our research team (i.e., Malow, Schneiderman, Antoni, Klimas, Page) turned its attention to developing the CBSM for one of the most neglected and understudied populations affected by the HIV/AIDS epidemic in this country: "inner city" minority drug abusers. With supplemental funding on two NIH grants to conduct formative stage1 pilot research, our project team has been able to develop and document the feasibility and potential promise of the CBSM approach adapted/translated for RDAs (CBSM-RDA). This application proposes to take the next logical step in continuing this work: conducting a 3, 6, 8, 10, and 12 month follow-up outcome study comparing CBSM-RDA with a matched attention, time and interest value Health Promotion Comparison (HPC) condition, in 225 male and 225 female HIV+ RDAs with respect to key biopsychosocial health endpoints: distress (i.e., depressive symptoms, and mood state), quality of life, drug abuse relapse, unsafe sex, Combination Antiretroviral Therapy (CART) medication adherence and health status indicators (e.g., Viral Load, CD4 count, physical symptoms).

NCT ID: NCT00685620 Completed - Drug Abuse Clinical Trials

Reinforcement-Based Treatment and Abstinence-Contingent Housing for Drug Abusers

CASA
Start date: August 2002
Phase: Phase 4
Study type: Interventional

Purpose of the project is to examine the effectiveness of Reinforcement-Based Treatment (RBT) on drug abuse and psychosocial outcomes of iner city opiate abusers who have recently completed a brief detoxification.

NCT ID: NCT00684073 Completed - Drug Abuse Clinical Trials

Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED)

Start date: July 2007
Phase: Phase 4
Study type: Interventional

This study is designed to determine if opioid dependent subjects who are already receiving Subutex® prefer the Suboxone® tablet over the Subutex® tablet after switching from Subutex® to Suboxone®. Subjects who are selected to participate in this study will continue their prescribed dose of Subutex® (buprenorphine 2 to 16 mg daily) for the first two days of the study (Day 1 and Day 2) then switch to and receive an equivalent dose of Suboxone® (buprenorphine 2 to 16 mg daily) for the last 3 days of the study (Day 3, Day 4 and Day 5). The Day 5 Visit will be the subject's last study visit. Upon completing the study, subjects will continue their pre-study prescribed dosage of Subutex®.

NCT ID: NCT00671632 Completed - Drug Abuse Clinical Trials

Behavioral and Subjective Efficacy of Ramelteon in Subjects With a History of Polydrug Abuse

Start date: June 2003
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the relative abuse potential of ramelteon, once daily (QD), compared to triazolam in subjects with a history of drug abuse.