Advertisement

Topics

Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial

2014-07-24 14:17:35 | BioPortfolio

Summary

The study will assess the effectiveness of at-home vs. in-office induction for patients entering buprenorphine maintenance at Associates in Internal Medicine (AIM) primary care clinic.

Description

Buprenorphine maintenance is an effective treatment for opioid dependence, yet diffusion has been limited. Physician concern about induction is a reported barrier, primarily as buprenorphine may precipitate withdrawal due to its partial opioid agonist activity and high receptor binding affinity. To minimize risk, guidelines recommend in-office assessment and monitoring during induction. As this may not be feasible (e.g., time limitations), many patients are instructed to self-induct at home. While this may facilitate treatment entry, data on at-home induction are limited. The study will assess the effectiveness of at-home vs. in-office induction for patients entering buprenorphine maintenance at Associates in Internal Medicine (AIM) primary care clinic. Currently, patients receive buprenorphine maintenance at AIM as part of standard clinical practice and through an observational study (IRB 5258). Most patients are insured through Medicaid, which covers visit, medication (obtained through prescription from a local pharmacy), lab, and outside psychosocial treatment cost. In this demonstration project, 20 opioid dependent patients will be randomly assigned to at-home or in-office induction, and then monitored for 12 weeks. Ancillary psychosocial treatment will be encouraged but not required. After randomization, AIM clinic and NYSPI research visits will be scheduled weekly for 4 weeks, and then at weeks 8 and 12. The primary outcome will include a comparison of the proportion of patients successfully inducted one week after the initial primary care visit. Secondary outcomes will include: 1) Time to stabilization after buprenorphine initiation assessed by: a) Time until the patient is without withdrawal for two consecutive days, and b) Time until the patient is opioid free for two consecutive weeks; and 3) Retention-in-treatment at 4 and 12 weeks. Other secondary outcomes include patient satisfaction and change in addiction severity. These data will provide important information in buprenorphine initiation in primary care and enable determination of treatment effects size prior to future clinical trials.

Study Design

Time Perspective: Prospective

Conditions

Opioid-Related Disorders

Intervention

Buprenorphine

Location

Columbia University/New York State Psychiatric Institute
New York
New York
United States
10032

Status

Recruiting

Source

Columbia University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:17:35-0400

Clinical Trials [1323 Associated Clinical Trials listed on BioPortfolio]

Buprenorphine Maintenance for Opioid Addicts - 2

The purpose of this study is to evaluate varying doses of buprenorphine for opioid dependence and cocaine abuse.

Effects of Buprenorphine/Naloxone Administered in Different Ways For Treating Opioid Dependence

Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. The...

Buprenorphine Dose Alteration Study - 1

The purpose of this study is to examine the effects in buprenorphine dose alterations in opioid dependent individuals being maintained on buprenorphine.

Buprenorphine Maintenance for Opioid Addicts - 1

The purpose of this study is to evaluate the efficacy of buprenorphine and desipramine in treatment of opiate and cocaine dependence.

Abuse Potential of Buprenorphine and Naloxone in Non-Dependent Opioid Users

Buprenorphine is a medication used to treat opioid addiction, but individuals who use this drug are at risk of abusing it. A buprenorphine and naloxone combination may reduce the likelihoo...

PubMed Articles [14828 Associated PubMed Articles listed on BioPortfolio]

Interest in prescribing buprenorphine among resident and attending physicians at an urban teaching clinic.

Opioid use disorders are a major medical and public health concern. Buprenorphine is approved for the treatment of opioid use disorders; however, a shortage of physicians prescribing buprenorphine is ...

A population-based examination of trends and disparities in medication treatment for opioid use disorders among Medicaid enrollees.

Medication treatment (MT) with methadone and buprenorphine are effective treatments for opioid use disorders, but little information is available regarding the extent to which buprenorphine's approval...

Characteristics and Prescribing Practices of Clinicians Recently Waivered to Prescribe Buprenorphine for the Treatment of Opioid Use Disorder.

Expanding access to medication-assisted treatment with buprenorphine is a cornerstone of the opioid crisis response; yet, buprenorphine remains underutilized. Research has identified multiple barriers...

The OPTIMA study, buprenorphine/naloxone and methadone models of care for the treatment of prescription opioid use disorder: Study design and rationale.

Rates of non-medical use of opioids, and opioid use disorders (OUD) have been rising throughout North America. Methadone and buprenorphine/naloxone are the recommended first-line treatment options for...

The impact of buprenorphine and methadone on mortality: a primary care cohort study in the United Kingdom.

To estimate whether opioid substitution treatment (OST) with buprenorphine or methadone is associated with a greater reduction in the risk of all-cause mortality (ACM) and opioid drug-related poisonin...

Medical and Biotech [MESH] Definitions

A derivative of the opioid alkaloid THEBAINE that is a more potent and longer lasting analgesic than MORPHINE. It appears to act as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use.

A pharmaceutical preparation that combines buprenorphine, an OPIOID ANALGESIC with naloxone, a NARCOTIC ANTAGONIST to reduce the potential for NARCOTIC DEPENDENCE in the treatment of pain. It may also be used for OPIATE SUBSTITUTION THERAPY.

Disorders related or resulting from abuse or mis-use of opioids.

Medical treatment for opioid dependence using a substitute opiate such as METHADONE or BUPRENORPHINE.

These disorders are related to both SCHIZOPHRENIA SPECTRUM AND RELATED DISORDERS and DEPRESSIVE DISORDERS in terms of symptomatology, family history, and genetics. (DSM-V) .

More From BioPortfolio on "Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...


Searches Linking to this Trial