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Opioid Dependency clinical trials

View clinical trials related to Opioid Dependency.

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NCT ID: NCT01806389 Completed - Opioid Dependency Clinical Trials

A Study of Breastfeeding in Buprenorphine Maintained Women

Start date: February 2013
Phase: N/A
Study type: Observational

Goals: The overarching goals for this proposed research are to provide pilot data for a study to inform the FDA regarding the safety of breastfeeding infants of mothers on buprenorphine maintenance and to develop guidelines for the practitioner treating buprenorphine maintained women who wish to breastfeed. Background: There is an increase in the prevalence of illicit opiate use among women of childbearing age. Recently, a large multisite study has suggested buprenorphine as an alternative to methadone for use in this population. As a consequence, buprenorphine is likely to be delivered to larger populations of pregnant and post-partum women. The population of prenatally opioid-exposed neonates is a particularly vulnerable population. Advances in neuroscience, molecular biology and epigenetics indicate that greater attention should be given to strategies that prevent, reduce, or mitigate the consequences of significant adversity on the developing brain. Breast milk and breastfeeding offer significant health and other benefits that are particularly salient for this group. Today, there is a near complete lack of information regarding the safety of buprenorphine maintenance and lactation, making it unlikely that providers will endorse or mothers will adopt this practice. Methods: Five pregnant buprenorphine maintained breastfeeding women and their neonates will be enrolled. Subjects will selected by buprenorphine maintenance in the postpartum period and enrollment in a parent protocol and by decision to breast feed their infants. Subject will provide breast milk at times of peak maternal buprenorphine levels on days 2, 3, 4, 14 and 30 after delivery to determine buprenorphine and norbuprenorphine concentrations. Subjects will also provide plasma at times of peak buprenorphine levels for determination of buprenorphine and norbuprenorphine concentrations on the same days. Concentrations of buprenorphine and norbuprenorphine in the plasma of infants will be determined on approximately day 14 of life. The relationship between maternal dose, maternal and infant plasma concentrations, and breast milk concentrations of buprenorphine and norbuprenorphine will be determined, and ingestible infant dose calculated.

NCT ID: NCT01262261 Completed - Opioid Dependency Clinical Trials

Re-Treatment Study of Probuphine in Opioid Addiction

Start date: November 2010
Phase: Phase 3
Study type: Interventional

Probuphine (buprenorphine implant) is an investigational implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This is a 6-month, open-label, re-treatment study that will confirm the safety and efficacy of Probuphine in patients who have previously completed the 6-month PRO-806 study with either Probuphine, placebo or sublingual buprenorphine.

NCT ID: NCT01114308 Completed - Opioid Dependency Clinical Trials

A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction

Start date: April 2010
Phase: Phase 3
Study type: Interventional

Probuphine (buprenorphine implant) is an implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will confirm the efficacy of Probuphine vs. placebo and compare Probuphine treatment verses treatment with sublingual buprenorphine in the treatment of patients with opioid dependence.

NCT ID: NCT01075971 Completed - Opioid Dependency Clinical Trials

Study of Two Formulations of Buprenorphine HCl in Opioid-dependent Subjects on Buprenorphine Maintenance Therapy (Study P04451) (COMPLETED)

Start date: September 2005
Phase: Phase 2
Study type: Interventional

This is a multi-center, open-label, preference study of two sublingual formulations of buprenorphine HCl, in opioid-dependent patients on buprenorphine maintenance therapy. The objectives of this study are to evaluate the overall preference between two buprenorphine sublingual formulations, after a switch from the marketed tablet (Subutex®) to the new fast dissolving tablet (FDT), in opioid-dependent patients with buprenorphine 8 mg or 16 mg daily maintenance therapy.

NCT ID: NCT00955162 Completed - Opioid Dependency Clinical Trials

Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France ("RIME")

RIME
Start date: August 2009
Phase: Phase 4
Study type: Interventional

Patients who admit to using buprenorphine by the intravenous route will be randomized to either Subutex or Suboxone and be followed up for 3 months to determine if there is less injection with Suboxone than with Subutex based primarily on patient diaries. Patients randomized to Suboxone may continue to receive the product for a further 9 months at their request and will be monitored at 3 month intervals. Patients will receive a payment for the inconvenience of keeping a daily diary and to cover their travel expenses.

NCT ID: NCT00913484 Completed - Cocaine Dependence Clinical Trials

Disulfiram for Cocaine Abuse in Buprenorphine Treatment

Start date: October 2000
Phase: Phase 2
Study type: Interventional

The investigators are proposing a placebo-controlled clinical trial to evaluate the efficacy and potential mechanisms of action of disulfiram (versus placebo) for treating cocaine abuse in subjects with concurrent opiate dependence and cocaine abuse or dependence maintained on buprenorphine/naloxone combination.

NCT ID: NCT00877591 Completed - HIV Infections Clinical Trials

Interaction of Buprenorphine With HIV Medications and Tuberculosis Medications

Start date: April 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to examine the interactions of buprenorphine-naloxone, a medication used to treat opiate (heroin or prescription narcotic) dependence, and medications used in the treatment of HIV disease including atazanavir (Reyataz), fosamprenavir (Lexiva), didanosine (Videx), tenofovir (Viread), atazanavir (Reyataz)/ritonavir (Norvir), fosamprenavir (Lexiva)/ritonavir (Norvir), lamivudine (Epivir), or darunavir (please note that we have completed drug interaction studies for buprenorphine with atazanavir, atazanavir/ritonavir, didanosine, tenofovir and lamivudine) at the PI's previous university; for this CHR application only the studies needed to be completed at UCSF/SFGH will be discussed) or tuberculosis(TB) (rifampin or rifabutin) medications (note: supplement application currently pending). Participants are those with opioid dependence who qualify for buprenorphine/naloxone treatment or they are healthy subjects without opioid dependence who participate in pharmacokinetics studies of the antiretroviral medications. A total of 160 such individuals will be enrolled in these studies (please note that the studies have been ongoing at Virginia Commonwealth University for 3 years so that the total number of participants to be recruited at UCSF/SFGH will be about 50 protocol completers). Participants take the HIV or tuberculosis medicine(s) for up to 15 days (depending on the medication(s) administered and ability to schedule blood and urine sampling sessions).

NCT ID: NCT00772785 Terminated - Opioid Dependency Clinical Trials

Study of Probuphine in Patients With Opioid Dependence

PRO-809
Start date: September 2008
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 patients with opioid dependence. Patients who have completed at least 24 weeks of treatment in the Open-Label, Multi-Center Study of Probuphine in Patients with Opioid Dependence (PRO-807 Study), will be re-treated with Probuphine over an additional 24 weeks.

NCT ID: NCT00742170 Completed - Opioid Dependency Clinical Trials

Transdermal Electroacupuncture for Opioid Detoxification

Start date: August 2007
Phase: Phase 1/Phase 2
Study type: Interventional

This single-blind, randomized clinical trial tests whether electroacupuncture, provided as an adjunctive treatment, improves outcomes among patients receiving inpatient opioid detoxification from opioids.

NCT ID: NCT00727675 Completed - Chronic Pain Clinical Trials

Chronic Pain and Opioid Dependence Assessment and Treatment

CPODAT
Start date: August 2008
Phase: N/A
Study type: Interventional

This study involves the development of an integrated psychotherapy that addresses both chronic pain and opioid dependence(POD).