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Opioid Dependence clinical trials

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NCT ID: NCT00476242 Completed - Opioid Dependence Clinical Trials

Memantine as a Supplement to Naltrexone in Treating Heroin Dependence

NAMHS
Start date: June 2008
Phase: Phase 2/Phase 3
Study type: Interventional

Prospective participants will undergo a screening process at the clinic to determine eligibility. After screening, eligible patients will complete an 8-day inpatient detoxification, followed by a 12-week outpatient phase. Patients will be randomly assigned to one of two conditions (1) Naltrexone + Placebo; (2) Naltrexone + Memantine 20 mg bid. Long-acting, injectable form of naltrexone (Vivitrol) will be administered once per month (the total of three injections) while memantine or placebo will be taken daily. In addition, patients will receive twice weekly psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. The outpatient treatment will also consist of 3 weekly visits to the clinic in which patients will receive counseling to help maintain abstinence and improve compliance with study medication.

NCT ID: NCT00447564 Completed - Opioid Dependence Clinical Trials

Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

Start date: October 2006
Phase: Phase 3
Study type: Interventional

Buprenorphine (BPN) is an approved treatment for opioid dependence, however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low. Probuphine is an implant placed just beneath the skin that contains BPN. It is designed to provide 6 months of stable BPN blood levels. This study will test the safety and efficacy of Probuphine in the treatment of patients with opioid dependence.

NCT ID: NCT00420771 Completed - Opioid Dependence Clinical Trials

Gabapentin Treatment of Benzodiazepine Abuse in Methadone Maintenance Patients

Start date: January 2007
Phase: Phase 2
Study type: Interventional

The aim of this project is to study the use of gabapentin in reducing benzodiazepine abuse in methadone maintenance patients. A second aim is to study the effects of gabapentin on craving, mood, anxiety, and sleep disturbance in methadone maintenance patients abusing benzodiazepines. The proposed protocol is a randomized, double-blind, placebo-controlled pilot outpatient trial of gabapentin in the treatment of benzodiazepine abuse in methadone maintenance patients. All subjects will receive weekly manual-guided psychotherapy directed at achieving abstinence and improving current functioning. The primary outcome measure, benzodiazepine use, will be assessed weekly by a combination of self-report (time line follow-back method) and urine toxicology. Associated psychological symptoms of craving, mood, anxiety, and sleep disturbance, will be assessed by a combination of clinician and self-rated instruments. The investigators hypothesize that individuals receiving methadone maintenance treatment who are abusing (nonprescribed use) benzodiazepines have difficulty in reducing or discontinuing benzodiazepine use because of the significant anxiety, mood, and sleep disturbance symptoms that accompany reduction in use. Gabapentin, an anticonvulsant which has anxiolytic and sedating properties, may alleviate the symptoms associated with a reduction in benzodiazepine abuse and make the achievement of abstinence more likely when administered in the setting of an active psychotherapy condition.

NCT ID: NCT00351026 Completed - Opioid Dependence Clinical Trials

Methadone Maintenance & HIV Risk in Ukraine

Start date: June 2008
Phase: Phase 3
Study type: Interventional

Treatment of opioid dependence is an important way to reduce the spread of HIV and other infectious diseases, particularly in Ukraine since intravenous opioid use is the major way these infections are being spread. This proposal will be done at the Kiev City Narcology Hospital and the City AIDS Center with collaborators from the University of Alabama and the University of Colorado. It will study the acceptability and impact of a 3-month course of methadone maintenance on 50 persons with opioid dependence, 25 who are HIV+ and 25 HIV-. The proposed work will build on a relationship that was established with the Ukrainian Co-Principal Investigator, Sergiy Dvoryak, M.D., during his Humphrey Fellowship at Johns Hopkins in 1999-2000 when he spent time with Dr. Woody and Metzger at the Penn Addiction and Treatment and Research Center. It will also extend studies of pharmacologic treatment for opioid dependence and risk reduction behavioral interventions that are being done by Drs. Woody, Schumacher and Booth in Russia and Ukraine. Primary aims are to: measure the acceptability and compliance with a 3-month course of methadone maintenance in HIV+ and HIV- patients; measure the impact of a 3-month course of methadone in reducing opioid use in HIV+ and HIV- patients; measure the impact of a 3-month course of methadone on reducing HIV risk behavior in HIV+_and HIV- patients. Secondary aims are to: assess the degree to which a 3-month course of methadone maintenance reduces illegal activities and improves employment and psychiatric symptoms; determine short-term outcome after completion of methadone treatment; and obtain pilot data on the prevalence of hepatitis B and C among study patients. This study will provide pilot data on the acceptability and efficacy of a short-term course of methadone maintenance on HIV+ and HIV- persons in a setting where this treatment has not been evaluated, on the feasibility of conducting the kind of work that is proposed, and will enhance research capabilities of Kiev investigators for future HIV prevention and treatment studies.

NCT ID: NCT00344812 Completed - Opioid Dependence Clinical Trials

Opioid Maintenance Medications Comparison Study

Start date: January 1996
Phase: Phase 2
Study type: Interventional

A 17 week, double-blind, randomized, parallel group, four arm design outpatient study comparing LAAM, buprenorphine and two dose levels of methadone for the treatment of opioid dependence.

NCT ID: NCT00292123 Completed - Opioid Dependence Clinical Trials

Combined Behavioral and Pharmacologic Treatment of Polydrug Abuse

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

The primary goal of this study is to determine how contingency management can best be combined with standard or high doses of methadone to increase simultaneous abstinence from heroin and cocaine.

NCT ID: NCT00271219 Completed - Pregnancy Clinical Trials

RCT Comparing Methadone and Buprenorphine in Pregnant Women

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

Children born to women who abuse drugs have a high risk of being born with birth defects and developmental problems. Methadone is a drug that is commonly used for treating opioid dependence. However, its use by a pregnant woman can cause severe withdrawal symptoms in a newborn because of the prenatal exposure. The purpose of this study is to evaluate the effectiveness of buprenorphine, another drug, versus methadone in reducing withdrawal symptoms in children born to opioid-dependent women.

NCT ID: NCT00268814 Completed - Opioid Dependence Clinical Trials

The German Project of Heroin Assisted Treatment of Opiate Dependent Patients

Start date: March 2002
Phase: Phase 3
Study type: Interventional

The study will test the hypotheses that heroin assisted treatment, compared to methadone maintenance treatment, is more effective with regard to - the improvement of health, - reduction of illicit drug consumption, - decrease of criminal behaviour, - rise in the accessibility and retainment, - detachment from a social drug context, - social stabilisation in the sense of new drug-free contacts, improved vocational circumstances, financial security, stabilisation of the living situation, - enrollment in subsequent treatment in the case of heroin dependent persons who could not be effectively reached or successfully treated so far, and it will check which is the optimal treatment setting with regard to these aims. The medication is injectable pure heroin (diacetylmorphine) 3x/d, or d l methadone 1x/d The study design is multicentre, open, randomised, 4 x 2 stratified. The study duration is 24 months (individual period of investigation), 1. study phase: 12 moths (protocol part B) and 2. study phase: 12 moths (part C). Patients recruited have an opiate dependency according to ICD-10, who are not being treated currently or who are in a methadone maintenance programme with an unsatisfactory course of treatment.

NCT ID: NCT00263458 Completed - HIV Clinical Trials

Integrating Buprenorphine Into the SFGH AIDS Program

BHIVES-SF
Start date: December 2005
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the feasibility, cost, and effectiveness of a model of care designed to integrate buprenorphine treatment for opioid dependence into the HIV primary care clinics at the UCSF Positive Health Program.

NCT ID: NCT00249457 Completed - Cocaine Dependence Clinical Trials

Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 2

Start date: October 1996
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether long-term exposure to the Therapeutic Workplace intervention could sustain drug abstinence over an extended period of time in heroin- and cocaine-dependent, unemployed, treatment-resistant young mothers.