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Biomedical subjects

P G O'Connor

Publications and source records attributed to P G O'Connor.

At least 19 recordsLinked to original sources

Methadone maintenance in primary care: a randomized controlled trial.

CONTEXT: Methadone maintenance is an effective treatment for opioid dependence, yet its use is restricted to federally licensed narcotic treatment programs (NTPs). Office-based care of stabilized methadone maintenance patients is a promising alternative but no data are available from controlled trials regarding this type of program. OBJECTIVE: To determine the feasibility and efficacy of office-based methadone maintenance by primary care physicians vs in an NTP for stable opioid-dependent patients. DESIGN: Six-month, randomized controlled open clinical trial conducted February 1999-March 2000. SETTING: Offices of 6 primary care internists and an NTP. PATIENTS: Forty-seven opioid-dependent patients who had been receiving methadone maintenance therapy in an NTP without evidence of illicit drug use for 1 year and without significant untreated psychiatric comorbidity were randomized; 1 patient refused to participate after treatment assignment to NTP. INTERVENTIONS: Patients were randomly assigned to receive office-based methadone maintenance from primary care physicians, who received specialized training in the care of opioid-dependent patients (n = 22), or usual care at an NTP (n = 24). MAIN OUTCOME MEASURES: Illicit drug use, clinical instability (persistent drug use), patient and clinician satisfaction, functional status, and use of health, legal, and social services, compared between the 2 groups. RESULTS: Eleven of 22 (50%; 95% confidence interval [CI], 29%-71%) patients in office-based care compared with 9 of 24 (38%; 95% CI, 21%-57%) of NTP patients had a self-report or urine toxicology test result indicating illicit opiate use (P =.39). Hair toxicology testing detected an additional 2 patients in each treatment group with evidence of illicit drug use, but this did not change the overall findings. Ongoing illicit drug use meeting criteria for clinical instability occurred in 4 of 22 (18%; 95% CI, 7%-39%) patients in office-based care compared with 5 of 24 (21%; 95% CI, 9%-41%) NTP patients (P =.82). Sixteen of the 22 (73%; 95% CI, 54%-92%) office-based patients compared with 3 of the 24 (13%; 95% CI, 0%-26%) NTP patients thought the quality of care was excellent (P =.001). There were no differences over time within or between groups in functional status or use of health, legal, or social services. CONCLUSIONS: Our results support the feasibility and efficacy of transferring stable opioid-dependent patients receiving methadone maintenance to primary care physicians' offices for continuing treatment and suggest guidelines for identifying patients and clinical monitoring.

Adult↗

Targeting behavioral therapies to enhance naltrexone treatment of opioid dependence: efficacy of contingency management and significant other involvement.

BACKGROUND: Contingency management (CM) and significant other involvement (SO) were evaluated as strategies to enhance treatment retention, medication compliance, and outcome for naltrexone treatment of opioid dependence. METHODS: One hundred twenty-seven recently detoxified opioid-dependent individuals were randomly assigned to 1 of 3 conditions delivered for 12 weeks: (1) standard naltrexone treatment, given 3 times a week; (2) naltrexone treatment plus contingency management (CM), with delivery of vouchers contingent on naltrexone compliance and drug-free urine specimens; or (3) naltrexone treatment, CM, plus significant other involvement (SO), where a family member was invited to participate in up to 6 family counseling sessions. Principal outcomes were retention in treatment, compliance with naltrexone therapy, and number of drug-free urine specimens. RESULTS: First, CM was associated with significant improvements in treatment retention (7.4 vs 5.6 weeks; P =.05) and in reduction in opioid use (19 vs 14 opioid-free urine specimens; P =.04) compared with standard naltrexone treatment. Second, assignment to SO did not significantly improve retention, compliance, or substance abuse outcomes compared with CM. Significant effects for the SO condition over CM on retention, compliance, and drug use outcomes were seen only for the subgroup who attended at least 1 family counseling session. The SO condition was associated with significant (P =.02) improvements in family functioning. CONCLUSION: Behavioral therapies, such as CM, can be targeted to address weaknesses of specific pharmacotherapies, such as noncompliance, and thus can play a substantial role in broadening the utility of available pharmacotherapies.

Adult↗

Outpatient management of patients with alcohol problems.

This paper addresses the clinical presentation of patients with alcohol problems including screening, diagnosis, detoxification, treatment, referral, and longitudinal follow-up. The case-based discussion focuses on the clinical management of a patient whose hazardous drinking progresses to alcohol dependence and requires coordinated care. Ways in which internists can aid patients with alcohol problems by screening, giving brief advice, and providing appropriate referrals when indicated are discussed.

Alcohol Deterrents↗

Screening for alcohol problems in primary care: a systematic review.

BACKGROUND: Primary care physicians can play a unique role in recognizing and treating patients with alcohol problems. OBJECTIVE: To evaluate the accuracy of screening methods for alcohol problems in primary care. METHODS: We performed a search of MEDLINE for years 1966 through 1998. We included studies that were in English, were performed in primary care, and reported the performance characteristics of screening methods for alcohol problems against a criterion standard. Two reviewers appraised all articles for methodological content and results. RESULTS: Thirty-eight studies were identified. Eleven screened for at-risk, hazardous, or harmful drinking; 27 screened for alcohol abuse and dependence. A variety of screening methods were evaluated. The Alcohol Use Disorders Identification Test (AUDIT) was most effective in identifying subjects with at-risk, hazardous, or harmful drinking (sensitivity, 51%-97%; specificity, 78%-96%), while the CAGE questions proved superior for detecting alcohol abuse and dependence (sensitivity, 43%-94%; specificity, 70%-97%). These 2 formal screening instruments consistently performed better than other methods, including quantity-frequency questions. The studies inconsistently adhered to methodological standards for diagnostic test research: 3 (8%) provided a full description of patient spectrum (demographics and comorbidity), 30 (79%) avoided workup bias, 12 (of 34 studies [35%]) avoided review bias, and 21 (55%) performed an analysis in pertinent clinical subgroups. CONCLUSIONS: Despite methodological limitations, the literature supports the use of formal screening instruments over other clinical measures to increase the recognition of alcohol problems in primary care. Future research in this field will benefit from increased adherence to methodological standards for diagnostic tests.

Adolescent↗

Pharmacologic treatment of heroin-dependent patients.

Patients with heroin dependence frequently present to internists and other physicians for heroin-related medical, psychiatric, and behavioral health problems and often seek help with reducing their heroin use. Thus, physicians should be familiar with the identification and diagnosis of heroin dependence in their patients and be able to initiate treatment of heroin dependence both directly and by referral. Recent research has provided much information concerning effective pharmacologically based treatment approaches for managing opioid withdrawal and helping patients to remain abstinent Methadone maintenance and newer approaches using L-alpha acetylmethadol and buprenorphine seem to be particularly effective in promoting relapse prevention. Although these treatments are currently provided in special drug treatment settings, recent and ongoing research indicates that the physician's office may be an effective alternative site for these treatments.

Analgesics, Opioid↗

New therapies for alcohol problems: application to primary care.

Primary care physicians are frequently involved in the longitudinal care of patients with alcohol problems and in helping patients to decrease their alcohol consumption. Recent clinical trials provide evidence in support of new treatment strategies for these patients. Brief interventions have been used successfully to reduce alcohol consumption in patients with hazardous and harmful drinking. Twelve-step facilitation, cognitive behavioral, and motivational enhancement therapies have produced sustained drinking reductions in patients with alcohol dependence. Pharmacologic therapies, such as naltrexone and acamprosate, have been effective in decreasing alcohol consumption when provided along with psychosocial counseling in patients with alcohol dependence. The current review highlights the application of these new therapies to primary care physicians' efforts on behalf of their patients with alcohol problems.

Acamprosate↗

HIV post-exposure therapy for drug users in treatment.

The purpose of this study was to evaluate the attitudes of drug treatment program providers concerning human immunodeficiency virus (HIV) post-exposure therapy (PET) for drug users enrolled in drug treatment. This was a cross-sectional evaluation of drug treatment program providers in four methadone maintenance programs (MMPs) in New Haven, Connecticut. Thirty-five MMP providers including: 29 MMP treatment staff (physicians, nurses, counselors) and 6 primary care provider staff (physicians, nurse practitioners, and nurses) participated in the study. The providers were presented with four case vignettes of individuals exposed to HIV through a needle stick ("stick"): a phlebotomist with occupational exposure (Case A) and three drug users with nonoccupational exposure to HIV (Cases B, C, and D). Case B had the same estimated future risk as Case A (three sticks/4 years) and the other cases had increased risk: Case C (four to six sticks/year) and Case D (monthly "sticks"). For each vignette, providers were asked whether they would offer HIV PET ("yes" or "no"). In addition, focus groups were held within each group of providers who were asked: "What role should drug treatment programs play in the implementation of PET?" All MMP staff (29/29) and primary care providers (6/6) felt that the phlebotomist with occupational exposure should be offered PET. The percent of MMP and Primary care provider staff recommending PET for the other cases were: Case B (MMP staff: 86% [25/29], PCPs: 100% [6/6]), Case C (MMP staff: 69% [20/29], PCPs: 33% [2/6]), and Case D (MMP staff: 59% [17/29], PCPs: 17% [1/6]). The "common themes" that were identified in the focus groups included: concern that MMPs lack resources to provide PET, the ethics of withholding PET, the "limit" on the number of times PET should be offered, and the role of PET in the overall HIV prevention message. Both MMP staff and PCPs felt that MMPs should have an "indirect" role in providing HIV PET by providing education and referral only. MMP staff and PCPs differed in their likelihood of offering HIV PET to drug users enrolled in MMPs. The possibility of HIV PET for drug users in treatment raises significant implementation issues for MMPs that will require further study if HIV PET becomes widely used in drug users.

Adult↗

AIDS oncology.

Kaposi's sarcoma, non-Hodgkin's lymphoma, Hodgkin's disease, and squamous cell carcinoma are among the malignancies seen with increased frequency in patients infected with HIV. The outlook for patients with these malignancies has improved significantly with the utilization of highly active antiretroviral therapy (HAART) and more aggressive cytotoxic therapies. Novel biologic therapies with lesser side effects are currently being evaluated. This article reviews the current knowledge about HIV malignancies, their epidemiology, pathogenesis, clinical manifestations, and treatment.

Antineoplastic Agents↗

Naltrexone-induced nausea in patients treated for alcohol dependence: clinical predictors and evidence for opioid-mediated effects.

Naltrexone, an opiate antagonist, is well tolerated by most alcoholic patients; however, a subset reports significant nausea that can limit the effectiveness of this therapy. The goal of this study was to identify risk factors for naltrexone-precipitated nausea to assist in the development of management strategies to maximize the overall effectiveness of naltrexone. On the basis of the hypothesis that alterations in the endogenous opioid system occur with repeated stimulation of endogenous opioids by alcohol, the authors predicted that the recency and intensity of alcohol use would be related to the risk of naltrexone-induced nausea. One hundred twenty alcohol-dependent subjects participated in an open-label trial of naltrexone. After 5 to 30 days of abstinence, subjects received an initial naltrexone dose of 25 mg followed by a dose of 50 mg daily thereafter for 10 weeks. New-onset adverse effects were rated mild, moderate, or severe after 1 week of naltrexone. Logistic regression analyses were used to predict moderate to severe nausea during the first week of therapy from pretreatment patient characteristics. Moderate to severe nausea was reported by 18 subjects (15%) and was linked to poorer medication compliance and heavier drinking during treatment. Risk of nausea was significantly predicted by age, gender, intensity of drinking, duration of abstinence, and the interaction of abstinence duration and intensity of drinking. At shorter durations of abstinence, lighter drinkers were more likely to experience nausea than heavier drinkers. However, the risk of nausea declined with longer periods of abstinence, particularly for lighter drinkers. Younger age and female gender were associated with higher rates of nausea. These results support the hypothesis that recency and intensity of alcohol use are related to opiate antagonist-precipitated nausea and suggest that long-term alcohol use may result in alterations in the endogenous opioid system. Potential strategies to minimize the risk of nausea in vulnerable individuals are discussed.

Adolescent↗

Plasma concentrations of buprenorphine 24 to 72 hours after dosing.

BACKGROUND: This study evaluated plasma buprenorphine concentrations 24-72 h following sublingual administration of a dose of buprenorphine solution, ranging from 16 mg/70 kg to 44 mg/70 kg, administered on a daily or thrice-weekly schedule. Additionally, this study evaluated the effects of different thrice-weekly buprenorphine dose schedules on opiate use and withdrawal symptoms. METHODS: Opiate dependent subjects (n = 10) were maintained in an outpatient clinic for two 3-week periods at each of three thrice-weekly buprenorphine dose schedules (providing a weekly total buprenorphine dose of 64, 84 and 112 mg) and for 1 week of a daily buprenorphine dose of 16 mg/70 kg. Plasma samples were obtained 24, 48 and 72 h following administration of buprenorphine. Urine samples were also collected and opiate withdrawal symptoms, agonist effects and the use of heroin, cocaine, alcohol and other drugs, were assessed. RESULTS: Plasma levels showed a wide range of intra- and inter-subject variability. Nonetheless, higher doses of buprenorphine resulted in higher plasma concentrations at each time point and plasma concentration decreased with time. There were no significant differences in heroin use across dosing. Rates of withdrawal symptoms were low and did not differ across dosing schedules. CONCLUSIONS: In the two highest dose schedules, plasma levels 72 h following the administration of the highest dose and at 48 h after the lower dose, were comparable to plasma concentrations at 24 h following daily administration of 16 mg/70 kg of buprenorphine.

Administration, Sublingual↗

Tuberculosis chemoprophylaxis using a liquid isoniazid-methadone admixture for drug users in methadone maintenance.

BACKGROUND: Tuberculosis is common in drug users, although compliance with therapy may be difficult in this population. OBJECTIVE: To evaluate an approach to enhancing compliance with tuberculosis chemoprophylaxis in drug users enrolled on methadone maintenance utilizing an isoniazid (INH)-methadone admixture. DESIGN: A prospective cohort study. SETTING: A drug treatment program in New Haven, Connecticut, USA. PATIENTS: Opioid-dependent drug users enrolled in methadone maintenance. INTERVENTION: Liquid isoniazid was mixed into subjects' daily dose of methadone. Vitamin B6 was given to subjects for self-administration. MEASUREMENTS AND MAIN RESULTS: Number of eligible subjects, reasons for not starting therapy, number starting therapy, proportion completing therapy and median duration of INH therapy were calculated. Thirty-nine subjects were eligible for INH chemoprophylaxis: 34 (87%) received INH mixed directly in their methadone and five (13%) had their INH consumption supervised by a nurse. Among these subjects, 72% (28/39) completed therapy. Among the 11 subjects who discontinued INH, discharge from the methadone maintenance program was the most common reason--73% (8/11). Thus, among the 31 subjects who were not discharged from methadone maintenance, 90% (28/31) successfully completed INH prophylaxis. The median duration of therapy was 182 days. CONCLUSIONS: Tuberculosis chemoprophylaxis using a liquid isoniazid-methadone admixture appears to be an effective approach to enhancing compliance with this therapy in methadone-maintained drug users.

Antitubercular Agents↗

Measurement of compliance with naltrexone in the treatment of alcohol dependence: research and clinical implications.

BACKGROUND: Medication compliance is a critical issue in pharmacotherapy. This study evaluated the clinical utility of the Medication Event Monitoring System (MEMS), a newer method for monitoring medication compliance, compared with pill count, a traditional measure, in a sample of patients treated for alcohol dependence with naltrexone. METHOD: Ninety-three outpatients meeting DSM-III-R criteria for alcohol dependence participated in a 10-week open-label study of naltrexone. They were provided with naltrexone, 50 mg daily, and concurrent counseling. Measures of medication compliance and drinking during treatment were collected every 2 weeks. RESULTS: Pill count yielded a significantly (p < .001) higher estimate of compliance (87.6%+/-18.1%) than the MEMS (80.4%+/-20.6%). However, the estimate of compliance obtained with the MEMS was more consistently correlated with treatment outcome (percentage of days abstinent, percentage of heavy drinking days, and mean alcohol amount consumed per drinking occasion) than the pill count compliance rate. In addition, classification of the sample into compliant and less compliant groups using the MEMS data yielded groups that differed more clearly on drinking outcomes than did stratification on the basis of pill count. CONCLUSION: In pharmacotherapy research, the MEMS may provide more reliable and valid information about subjects' medication compliance than pill count. Clinically, information obtained with the MEMS could be used to provide feedback to patients about their pill-taking behavior to enhance compliance and overall outcome of therapy.

Alcohol Drinking↗

Rapid and ultrarapid opioid detoxification techniques.

OBJECTIVE: To review the scientific literature on the effectiveness of rapid opioid detoxification (RD) (opioid withdrawal precipitated by naloxone hydrochloride or naltrexone) and ultrarapid opioid detoxification (URD) (opioid withdrawal precipitated by naloxone or naltrexone under anesthesia or heavy sedation) techniques. DATA SOURCES: The MEDLINE database was searched from 1966 through 1997 using the indexing terms naloxone, naltrexone, substance dependence, and substance withdrawal syndrome. Additional data sources included bibliographies of papers identified on MEDLINE and bibliographies in textbooks on substance abuse. STUDY SELECTION: Inclusion criteria were studies of RD or URD, pharmacologic protocols specified, and clinical outcomes specified and reported. Exclusion criteria were unpublished data, data not in peer-reviewed journals, abstract-only publications, and review articles. DATA EXTRACTION: The methodologic characteristics of studies were extracted by the authors and summarized according to key components of research design concerning subject characteristics, therapy allocation, and outcomes assessed. DATA SYNTHESIS: A qualitative analysis was performed on the 12 studies of RD and the 9 studies of URD identified in our search. The RD studies enrolled 641 subjects (range for individual studies, 1-162): 7 were inpatient studies, and the protocols varied considerably, as did the outcomes assessed. Three RD studies included a control group, 2 used a randomized design, and 3 reported outcomes beyond 12 days. The URD studies enrolled 424 subjects (range for individual studies, 6-300): all were inpatient studies, the detoxification and anesthesia protocols varied, 3 included a control group, 2 used a randomized design, and 2 reported outcomes for URD beyond 7 days. CONCLUSIONS: The existing literature on RD and URD is limited in terms of the number of subjects evaluated, the variation in protocols studied, lack of randomized design and use of control groups, and the short-term nature of the outcomes reported. Further research is needed using more rigorous research methods, longer-term outcomes, and comparisons with other methods of treatment for opioid dependence.

Clinical Trials as Topic↗

A randomized trial of buprenorphine maintenance for heroin dependence in a primary care clinic for substance users versus a methadone clinic.

PURPOSE: Buprenorphine is an alternative to methadone for the maintenance treatment of heroine dependence and may be effective on a thrice weekly basis. Our objective was to evaluate the effect of thrice weekly buprenorphine maintenance for the treatment of heroin dependence in a primary care clinic on retention in treatment and illicit opioid use. SUBJECTS AND METHODS: Opioid-dependent patients were randomly assigned to receive thrice weekly buprenorphine maintenance in a primary care clinic that was affiliated with a drug treatment program (n = 23) or in a traditional drug treatment program (n = 23) in a 12-week clinical trial. Primary outcomes were retention in treatment and urine toxicology for opioids; secondary outcomes were opioid withdrawal symptoms and toxicology for cocaine. RESULTS: Retention during the 12-week study was higher in the primary care setting (78%, 18 of 23) than in the drug treatment setting (52%, 12 of 23; P = 0.06). Patients admitted to primary care had lower rates of opioid use based on overall urine toxicology (63% versus 85%, P < 0.01) and were more likely to achieve 3 or more consecutive weeks of abstinence (43% versus 13%, P = 0.02). Cocaine use was similar in both settings. CONCLUSIONS: Buprenorphine maintenance is an effective treatment for heroin dependence in a primary care setting.

Adult↗