Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial
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)
Links
- Source: http://clinicaltrials.gov/show/NCT00684554
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Buprenorphine
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.
Opioid-related Disorders
Disorders related or resulting from abuse or mis-use of opioids.
Opiate Substitution Treatment
Medical treatment for opioid dependence using a substitute opiate such as METHADONE or BUPRENORPHINE.
Substance-related Disorders
Disorders related to substance abuse, the side effects of a medication, toxin exposure, and ALCOHOL-RELATED DISORDERS.
Methadone
A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Methadone is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)
Clinical Trials
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...
Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone
The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or bupr...
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.
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.
PubMed Articles
Buprenorphine (Subutex) and buprenorphine/naloxone (Suboxone) received Food and Drug Administration approval in 2002 for the treatment of opioid dependence. Introduction of these drugs expanded the av...
Buprenorphine-induced hyperalgesia in the rat.
In addition to analgesia opioids may also enhance pain sensitivity. Opioid-induced hyperalgesia, typically associated with potent mu-opioid agonists (e.g. fentanyl, morphine, and heroin), may be of cl...
Structural Determinants of Opioid and NOP Receptor Activity in Derivatives of Buprenorphine.
The unique pharmacological profile of buprenorphine has led to its considerable success as an analgesic and as a treatment agent for drug abuse. Activation of nociceptin/orphanin FQ peptide (NOP) rece...
Opioid dependence and HIV infection are associated with poor health-related quality of life (HRQOL). Buprenorphine/naloxone (bup/nx) provided in HIV care settings may improve HRQOL.
Methadone and buprenorphine are used in maintenance therapy for heroin addicts. In this study, we compared their effects on adenylate cyclase (AC) activity in human embryonic kidney (HEK) 293 cells st...
