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Opioid Dependence clinical trials

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NCT ID: NCT00763958 Completed - HIV Clinical Trials

Relapse Prevention to Reduce HIV Among Women Prisoners

Start date: May 2008
Phase: Phase 4
Study type: Interventional

This study is a feasibility and acceptability study assessing whether providing buprenorphine for women under criminal justice supervision leaving a controlled environment and returning to the community would prevent opioid relapse and reduce HIV risk behaviors.

NCT ID: NCT00756990 Completed - Opioid Dependence Clinical Trials

Depot Naltrexone Treatment of Opioid Dependent Parolees

Start date: November 2005
Phase: N/A
Study type: Interventional

This is an investigation involving the use of a long-acting, injectable form (depot) of naltrexone as a treatment for persons who have a history of opioid dependence, with up to 40 on parole/probation and 20 non-parolees. The test is a pilot study of up to 60 subjects treated with 6 months of depot naltrexone plus Psychosocial Treatment .

NCT ID: NCT00733239 Completed - Opioid Dependence Clinical Trials

Drug Discrimination in Methadone-Maintained Humans Study 2

OMDD2
Start date: August 2008
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 subject'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 subject will receive 2-4 of the listed interventions.

NCT ID: NCT00630201 Completed - Opioid Dependence Clinical Trials

Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

PRO-807
Start date: October 2007
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 (buprenorphine implant) 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 patient with opioid dependence. Patients who have completed 24 weeks of treatment in the Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients with Opioid Dependence, will be re-treated with Probuphine over an additional 24 weeks.

NCT ID: NCT00593125 Completed - Cocaine Dependence Clinical Trials

Levetiracetam (Keppra) Tolerability in Cocaine Abusing Methadone-maintained Patients.

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

The proposed investigation will use methadone maintained patients who have concurrent cocaine dependence in order to take advantage of the excellent (over 80%) treatment retention in this patient group and to maximize treatment compliance by daily observed medication with both methadone and levetiracetam. In the initial patients we will explore the tolerability of escalating doses of levetiracetam as well as its potential role in reducing cocaine use, as monitored by self-report and verified by three-times weekly urine toxicology testing in methadone treated patients.The specific aim of this study is to evaluate the tolerability and efficacy of levetiracetam 3 grams/day in modifying cocaine-using behavior, reducing cocaine craving and attenuating cocaine's reinforcing effect among methadone-maintained patients

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.