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Biomedical subjects

David A Fiellin

Publications and source records attributed to David A Fiellin.

At least 19 recordsLinked to original sources

Systematic review: opioid treatment for chronic back pain: prevalence, efficacy, and association with addiction.

BACKGROUND: The prevalence, efficacy, and risk for addiction for persons receiving opioids for chronic back pain are unclear. PURPOSE: To determine the prevalence of opioid treatment, whether opioid medications are effective, and the prevalence of substance use disorders among patients receiving opioid medications for chronic back pain. DATA SOURCES: English-language studies from MEDLINE (1966-March 2005), EMBASE (1966-March 2005), Cochrane Central Register of Controlled Clinical Trials (to 4th quarter 2004), PsychInfo (1966-March 2005), and retrieved references. STUDY SELECTION: Articles that studied an adult, nonobstetric sample; used oral, topical, or transdermal opioids; and focused on treatment for chronic back pain. DATA EXTRACTION: Two investigators independently extracted data and determined study quality. DATA SYNTHESIS: Opioid prescribing varied by treatment setting (range, 3% to 66%). Meta-analysis of the 4 studies assessing the efficacy of opioids compared with placebo or a nonopioid control did not show reduced pain with opioids (g, -0.199 composite standardized mean difference [95% CI, -0.49 to 0.11]; P = 0.136). Meta-analysis of the 5 studies directly comparing the efficacy of different opioids demonstrated a nonsignificant reduction in pain from baseline (g, -0.93 composite standardized mean difference [CI, -1.89 to -0.03]; P = 0.055). The prevalence of lifetime substance use disorders ranged from 36% to 56%, and the estimates of the prevalence of current substance use disorders were as high as 43%. Aberrant medication-taking behaviors ranged from 5% to 24%. LIMITATIONS: Retrieval and publication biases and poor study quality. No trial evaluating the efficacy of opioids was longer than 16 weeks. CONCLUSIONS: Opioids are commonly prescribed for chronic back pain and may be efficacious for short-term pain relief. Long-term efficacy (> or =16 weeks) is unclear. Substance use disorders are common in patients taking opioids for back pain, and aberrant medication-taking behaviors occur in up to 24% of cases.

Analgesics, Opioid↗

Opioid dependence: rationale for and efficacy of existing and new treatments.

Opioid dependence is a chronic and relapsing medical disorder with a well-established neurobiological basis. Opioid agonist treatments, such as methadone and the recently approved buprenorphine, stabilize opioid receptors and the intracellular processes that lead to opioid withdrawal and craving. Both methadone and buprenorphine have been proven effective for the treatment of opioid dependence and can contribute to a decreased risk of human immunodeficiency virus (HIV) transmission. In addition, a buprenorphine/naloxone combination appears to have a decreased potential for abuse or diversion, compared with that associated with methadone. Largely because of these properties, recent legislation now affords an unprecedented opportunity for general physicians to offer opioid agonist treatment through their offices. This review focuses on the neurobiological basis of opioid dependence, the rationale for methadone and buprenorphine treatments, and issues in prescribing these medications to patients with HIV infection.

Buprenorphine↗

A trial of integrated buprenorphine/naloxone and HIV clinical care.

BACKGROUND: Untreated opioid dependence adversely affects the care of human immunodeficiency virus (HIV)-positive patients. Buprenorphine, a partial opioid agonist, is available for maintenance treatment of opioid dependence in HIV specialty settings. We investigated the feasibility and efficacy of integrating buprenorphine, along with 2 levels of counseling, into HIV clinical care. METHODS: HIV-positive, opioid-dependent patients were enrolled in a 12-week pilot study and randomized to receive daily buprenorphine/naloxone treatment along with either brief physician management or physician management combined with nurse-administered drug counseling and adherence management. Primary outcomes included treatment retention; illicit drug use, assessed by urine toxicology test and self-report; CD4 lymphocyte counts; and log(10) HIV type 1 (HIV-1) RNA levels. RESULTS: Of the 16 patients who received at least 1 dose of buprenorphine, 13 (81%) completed 12 weeks of treatment. The proportion of opioid-positive weekly urine test results decreased from 100% at baseline to 32% (month 1), 20% (month 2), and 16% (month 3). Only 4 patients reported any opioid use (in the prior 7 days) during the 12-week study. CD4 lymphocyte counts remained stable over the course of the study. The mean log(10) HIV-1 RNA level (+/- standard deviation) declined significantly, from 3.66+/-1.06 log(10) HIV-1 RNA copies/mL at baseline to 3.0+/-0.57 log(10) HIV-1 RNA copies/mL at month 3 (P<.05). No significant differences based on counseling intervention were detected. All 13 patients who completed the study continued to receive treatment in an extension phase of at least 0-15 months' duration. CONCLUSIONS: We conclude that it is feasible to integrate buprenorphine into HIV clinical care for the treatment of opioid dependence. Patients experienced good treatment retention and reductions in their opioid use. HIV biological markers remained stable or improved during buprenorphine/naloxone treatment.

Administration, Sublingual↗

Initial strategies for integrating buprenorphine into HIV care settings in the United States.

The Centers for Disease Control and Prevention's HIV Prevention Strategic Plan Through 2005 advocated for increasing the proportion of persons with human immunodeficiency virus (HIV) infection and in need of substance abuse treatment who are successfully linked to services for these 2 conditions. There is evidence that integrating care for HIV infection and substance abuse optimizes outcomes for patients with both disorders. Buprenorphine, a recently approved medication for the treatment of opioid dependence in physicians' offices, provides the opportunity to integrate the treatment of HIV infection and substance abuse in one clinical setting, yet little information exists on the models of care that will most successfully facilitate this integration. To promote the uptake of this type of integrated care, the current review provides a description of 4 recently implemented models for combining buprenorphine treatment with HIV primary care: (1) an on-site addiction/HIV specialist treatment model; (2) a HIV primary care physician model; (3) a nonphysician health professional model; and (4) a community outreach model.

Antiretroviral Therapy, Highly Active↗

Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence.

BACKGROUND: The optimal level of counseling and frequency of attendance for medication distribution has not been established for the primary care, office-based buprenorphine-naloxone treatment of opioid dependence. METHODS: We conducted a 24-week randomized, controlled clinical trial with 166 patients assigned to one of three treatments: standard medical management and either once-weekly or thrice-weekly medication dispensing or enhanced medical management and thrice-weekly medication dispensing. Standard medical management was brief, manual-guided, medically focused counseling; enhanced management was similar, but each session was extended. The primary outcomes were the self-reported frequency of illicit opioid use, the percentage of opioid-negative urine specimens, and the maximum number of consecutive weeks of abstinence from illicit opioids. RESULTS: The three treatments had similar efficacies with respect to the mean percentage of opioid-negative urine specimens (standard medical management and once-weekly medication dispensing, 44 percent; standard medical management and thrice-weekly medication dispensing, 40 percent; and enhanced medical management and thrice-weekly medication dispensing, 40 percent; P=0.82) and the maximum number of consecutive weeks during which patients were abstinent from illicit opioids. All three treatments were associated with significant reductions from baseline in the frequency of illicit opioid use, but there were no significant differences among the treatments. The proportion of patients remaining in the study at 24 weeks did not differ significantly among the patients receiving standard medical management and once-weekly medication dispensing (48 percent) or thrice-weekly medication dispensing (43 percent) or enhanced medical management and thrice-weekly medication dispensing (39 percent) (P=0.64). Adherence to buprenorphine-naloxone treatment varied; increased adherence was associated with improved treatment outcomes. CONCLUSIONS: Among patients receiving buprenorphine-naloxone in primary care for opioid dependence, the efficacy of brief weekly counseling and once-weekly medication dispensing did not differ significantly from that of extended weekly counseling and thrice-weekly dispensing. Strategies to improve buprenorphine-naloxone adherence are needed. (ClinicalTrials.gov number, NCT00023283 [ClinicalTrials.gov].).

Adult↗

The association between marijuana smoking and lung cancer: a systematic review.

BACKGROUND: The association between marijuana smoking and lung cancer is unclear, and a systematic appraisal of this relationship has yet to be performed. Our objective was to assess the impact of marijuana smoking on the development of premalignant lung changes and lung cancer. METHODS: Studies assessing the impact of marijuana smoking on lung premalignant findings and lung cancer were selected from MEDLINE, PSYCHLIT, and EMBASE databases according to the following predefined criteria: English-language studies of persons 18 years or older identified from 1966 to the second week of October 2005 were included if they were research studies (ie, not letters, reviews, editorials, or limited case studies), involved persons who smoked marijuana, and examined premalignant or cancerous changes in the lung. RESULTS: Nineteen studies met selection criteria. Studies that examined lung cancer risk factors or premalignant changes in the lung found an association of marijuana smoking with increased tar exposure, alveolar macrophage tumoricidal dysfunction, increased oxidative stress, and bronchial mucosal histopathologic abnormalities compared with tobacco smokers or nonsmoking controls. Observational studies of subjects with marijuana exposure failed to demonstrate significant associations between marijuana smoking and lung cancer after adjusting for tobacco use. The primary methodologic deficiencies noted include selection bias, small sample size, limited generalizability, overall young participant age precluding sufficient lag time for lung cancer outcome identification, and lack of adjustment for tobacco smoking. CONCLUSION: Given the prevalence of marijuana smoking and studies predominantly supporting biological plausibility of an association of marijuana smoking with lung cancer on the basis of molecular, cellular, and histopathologic findings, physicians should advise patients regarding potential adverse health outcomes until further rigorous studies are performed that permit definitive conclusions.

ErbB Receptors↗

A randomized trial of primary intensive care to reduce hospital admissions in patients with high utilization of inpatient services.

Randomized controlled trials of case management in primary care have been infrequent and contradictory. The aim of this study was to determine if a clinic-based ambulatory case management intervention, Primary Intensive Care (PIC), would reduce hospital utilization and total cost and/or improve health outcomes among primary care patients with a recent history of high use of inpatient services. Current patients with > or =2 hospital admissions per year in the 12-18 months prior to recruitment in an urban primary care clinic were enrolled in a randomized clinical trial. Patients were randomized to the PIC intervention or usual care. PIC patients underwent a comprehensive multidisciplinary assessment with the result being a team-generated plan. The PIC team nurse practitioner served as case manager for the 12 months of follow-up and provided services designed to implement the care plan for those in the experimental group. Health care use, function, and a medication adherence scale were measured at baseline and at 12 months. There were no significant differences when either comparing the number of admissions pre and post enrollment within groups or the followup results post intervention between groups. A similar result was noted for the number of emergency department visits. The number of clinic visits increased in the intervention group by 1.5 visits per year which was statistically significant when compared to the control group. Overall functional status, health outcomes, and the Mental Health Functional Status subscore did not change significantly in either group during the study. We were unable to detect a difference in hospital use or functional status, mental health function, or medication adherence among patients who require frequent hospital admissions using our intervention.

Adult↗

Alcohol problems and health care services use in human immunodeficiency virus (HIV)-infected and HIV-uninfected veterans.

BACKGROUND: Although alcohol problems are common in human immunodeficiency virus (HIV)-infected patients, their impact on health care services use in HIV-infected patients is not well understood. OBJECTIVE: We sought to examine the association between alcohol problems and health care services use in HIV-infected and HIV-uninfected patients. DESIGN, SETTING, AND SUBJECTS: We undertook a prospective analysis of 16,048 HIV-infected veterans and 32,096 age-, race-, gender-, and region-matched HIV-uninfected controls identified through the national Veterans Affairs electronic administrative medical record database. We identified subjects with alcohol problems using ICD-9-CM codes for alcohol diagnoses and/or alcohol-related complications. MAIN OUTCOME MEASURES: We measured outpatient visits, emergency department visits, and inpatient hospitalizations over 12 months of follow-up. RESULTS: In adjusted analyses, HIV-infected veterans with alcohol problems were significantly more likely than HIV-uninfected veterans without alcohol problems to have at least 1 outpatient visit and at least 1 inpatient hospitalization and, among those with any health services use, to have significantly greater rates for outpatient visits (Incidence rate ratio [IRR] 2.17; 95% confidence interval [CI] 2.06-2.28; P < 0.001), emergency department visits (IRR 1.46; 95% CI 1.35-1.58; P < 0.001), and inpatient hospitalizations (IRR 1.46; 95% CI 1.30-1.64; P < 0.001). The incidence rates for outpatient visits, mental health visits, emergency department visits, and inpatient hospitalizations were significantly higher in HIV-infected veterans with alcohol problems than in HIV-infected veterans without alcohol problems. We did not find a consistent interaction effect between alcohol problems and HIV status. CONCLUSION: Alcohol problems are associated with greater outpatient, emergency department, and inpatient health care utilization in HIV-infected and HIV-uninfected veterans. However, alcohol does not appear to have a stronger effect on health services use in HIV-infected veterans compared with HIV-uninfected veterans.

Adult↗

Quality of care for acute myocardial infarction in elderly patients with alcohol-related diagnoses.

BACKGROUND: Elderly adults with alcohol-related diagnoses represent a vulnerable population that may receive lower quality of treatment during hospitalization for acute myocardial infarction. We sought to determine whether elderly patients with alcohol-related diagnoses are less likely to receive standard indicators of quality care for acute myocardial infarction. METHODS: We conducted a retrospective cohort analysis using administrative and medical record data from the Cooperative Cardiovascular Project. Subjects were Medicare beneficiaries with a confirmed principal discharge diagnosis of acute myocardial infarction from all acute care hospitals in the United States over an 8-month period. Our primary outcome was the receipt of 7 guideline-recommended care measures among all eligible patients and patients who were ideal candidates for a given measure. RESULTS: In all, 1,284 (1%) of the 155,026 eligible patients met criteria for an alcohol-related diagnosis. Among the alcohol-related diagnoses, 1,077/1,284 (84%) were for the diagnoses of alcohol dependence or alcohol abuse. Patients with alcohol-related diagnoses were less likely than those without alcohol-related diagnoses to receive beta-blockers at the time of discharge (55% vs. 60%, p = 0.02). We found no other significant differences in performance of the quality indicators after stratifying by indication and adjustment for baseline characteristics. CONCLUSIONS: Alcohol-related diagnoses are not a barrier to receiving most quality of care measures in elderly patients hospitalized for acute myocardial infarction.

Adrenergic beta-Antagonists↗

Training HIV physicians to prescribe buprenorphine for opioid dependence.

Few HIV physicians are trained to provide buprenorphine treatment. We conducted a cross-sectional survey to assess the impact of an eight-hour course on the treatment of opioid dependence on HIV physicians' preparedness to prescribe buprenorphine. 113 of 257 trained physicians (44%) provided HIV care. Post-course, the majority of both HIV physicians and non-HIV physicians (66% vs. 67%, P = .8) planned to pursue a registration to prescribe buprenorphine. The most common reason for not planning to do so was lack of experience (9% vs. 15%, P = .19). 52 of the 113 (46%) HIV physicians had concerns about prescribing buprenorphine. 30 of the 52 (58%) indicated that interactions between buprenorphine and HAART was their primary concern. Following training, most physicians feel prepared and plan to obtain a registration to prescribe buprenorphine. HIV physicians' concerns regarding interactions between buprenorphine and HAART need to be addressed in future training efforts.

Adult↗

Evaluation of a combined online and in person training in the use of buprenorphine.

To evaluate buprenorphine training methodology, we surveyed physicians who had completed a combined online and in person buprenorphine curriculum. Of 53/70 (76%) survey respondents, 57% were psychiatrists and 40% generalists. On a scale of 1 (very poor) to 7 (superlative), the overall training rated a mean of 5.8. The online course (5.0) rated lower than in person training components (p < .001) except for material that addressed the logistics of office practice. The in person patient interview received the highest rating (mean 6.3, p < .001). The 67% of physicians who intended to prescribe buprenorphine after the training were more likely than hesitant physicians to agree that the course provided enough information (p < .05) and that telephone access to experienced providers would improve their confidence (p < .05). Physicians hesitant to prescribe cited lack of experience as the main barrier (41%), with 24% concerned about induction difficulty and reimbursement. Overall, physicians preferred in person instruction and may benefit from additional experiential training and support after curriculum participation.

Adult↗

Buprenorphine: its role in preventing HIV transmission and improving the care of HIV-infected patients with opioid dependence.

In the United States, approximately 25% of the 40,000 new human immunodeficiency virus (HIV) infections each year are secondary to injection drug use. Worldwide, there are an estimated 12.6 million injection drug users, and 10% of HIV infections (420,000 infections in 2003) are associated with this practice. Buprenorphine is a new medication used to treat opioid dependence that shows promise for reducing the rate of HIV transmission and improving the care of opioid-dependent patients with HIV infection. Although buprenorphine faces fewer clinical and regulatory barriers than does methadone, the optimal strategy for integration of office-based treatment of opioid dependence and HIV disease is an area of ongoing research. This review addresses the introduction of buprenorphine, in terms of public health, policy, and clinical implications for HIV-infected patients and for HIV care providers.

Buprenorphine↗

An evidence-based guide to writing grant proposals for clinical research.

The competition for funds to conduct clinical research is intense, and only a minority of grant proposals receive funding. In particular, funding for patient-oriented research lags behind that allocated for basic science research. Grant writing is a skill of fundamental importance to the clinical researcher, and conducting high-quality clinical research requires funds received through successful grant proposals. This article provides recommendations for the grant-writing process for clinical researchers. On the basis of observations from a National Institutes of Health study section, we describe types and sources of grant funds, provide key recommendations regarding the process of grant writing, and highlight the sections of grants that are frequently scrutinized and critiqued. We also provide specific recommendations to help grant writers improve the quality of areas commonly cited as deficient. Application of this systematic approach will make the task more manageable for anyone who writes grants.

Biomedical Research↗

The prevalence and impact of alcohol problems in major depression: a systematic review.

Major depression and alcohol problems are common in primary care, yet little is known about the prevalence of alcohol problems in patients with depression or alcohol's effect on depression outcomes. We strove to answer the following questions: How common are alcohol problems in patients with depression? Does alcohol affect the course of depression, response to antidepressant therapy, risk of suicide/death, social functioning and health care utilization? In which alcohol categories and treatment settings have patients with depression and alcohol problems been evaluated? English language studies from MEDLINE, PsychINFO, and Cochrane Controlled Trial Registry were reviewed. Studies were selected using predefined criteria if they reported on the prevalence or effects of alcohol problems in depression. Thirty-five studies met criteria and revealed a median prevalence of current or lifetime alcohol problems in depression of 16% (range 5-67%) and 30% (range 10-60%), respectively. This compares with 7% for current and 16-24% for lifetime alcohol problems in the general population. There is evidence that antidepressants improve depression outcomes in persons with alcohol dependence. Alcohol problems are associated with worse outcomes with respect to depression course, suicide/death risk, social functioning, and health care utilization. The majority of the studies, 34 of 35 (97%), evaluated alcohol abuse and dependence, and 25 of 35 (71%) were conducted in psychiatric inpatients. We conclude that alcohol problems are more common in depression than in the general population, are associated with adverse clinical and health care utilization outcomes, and that antidepressants can be effective in the presence of alcohol dependence. In addition, the literature focuses almost exclusively on patients with alcohol abuse or dependence in psychiatric inpatient settings, and excludes patients with less severe alcohol problems and primary care outpatient settings.

Alcoholism↗

The practice of office-based buprenorphine treatment of opioid dependence: is it associated with new patients entering into treatment?

Office-based buprenorphine holds the promise of bringing patients who have never received pharmacotherapy into treatment. In a cross-sectional and longitudinal analysis, we compared patients entering a clinical trial of buprenorphine in a Primary Care Clinic (PCC) and those entering a local Opioid Treatment Program (OTP) and we compared the clinical characteristics and treatment outcomes of PCC patients with no history of methadone treatment (new-to-treatment) to those with prior methadone treatment. PCC subjects (N=96) were enrolled in a 26-week randomized clinical trial of office-based buprenorphine/naloxone provided in a PCC. OTP subjects (N=94) were enrolled in methadone maintenance during the same time period. PCC subjects compared with OTP subjects were more likely to be male (77% versus 55%, p<0.01), full-time employed (46% versus 15%, p<0.001), have no history of methadone treatment (46% versus 61%, p<0.05), have fewer years of opioid dependence (10 versus 15, p<0.001), and lower rates of injection drug use (IDU) (44% versus 60%, p=0.03). The new-to-treatment PCC subjects were younger (36 years versus 41 years, p=0.001), more likely to be white (77% versus 57%, p=0.04), had fewer years of opioid dependence (7 versus 14, p<0.001), were less likely to have a history of IDU (35% versus 54%, p=0.07), and had lower rates of hepatitis C (25% versus 61%, p=0.002) than subjects with prior methadone treatment. Abstinence and treatment retention were comparable in both groups. The results suggest that office-based treatment of opioid dependence is associated with new types of patients entering into treatment. Treatment outcomes with buprenorphine in a PCC do not vary based on history of prior methadone treatment.

Adolescent↗

Primary intensive care: pilot study of a primary care-based intervention for high-utilizing patients.

This pilot study was conducted to determine whether primary care patients with perceived inappropriate high healthcare utilization would require fewer emergency or inpatient services while enrolled in a weekly multidisciplinary clinic. Seventeen high-utilizing or difficult management patients of a primary care center were referred for the special intervention, Primary Intensive Care (PIC). Although not selected for the presence of psychopathology, 16 patients had comorbid psychiatric diagnoses. Patients followed in the PIC Clinic had significantly lower inpatient and emergency department use during their enrollment in the intervention when compared to the matched pre-enrollment time period, although the total hospital cost differences did not reach statistical significance. Patient and staff satisfaction was high, although the intervention was very difficult for the providers.

Adult↗