Daniel P. Alford

Systematic Review: Treatment Agreements and Urine Drug Testing to Reduce Opioid Misuse in Patients With Chronic Pain

BACKGROUND Experts recommend opioid treatment agreements and urine drug testing to reduce opioid analgesia misuse, but evidence of their effectiveness has not been systematically reviewed. PURPOSE To synthesize studies of the association of treatment agreements and urine drug testing with opioid misuse outcomes in outpatients with chronic noncancer pain. DATA SOURCES MEDLINE, PsycINFO, EMBASE, Cochrane Central Register of Controlled Clinical Trials (January 1966 to June 2009), reference lists, and expert contacts. STUDY SELECTION Original research addressing opioid medications, chronic pain, and treatment agreements or urine drug testing, with a sample size of 50 participants or more and published in English, Spanish, or French. DATA EXTRACTION Two investigators independently identified eligible studies, extracted data, and assessed study quality. The outcome of opioid misuse was defined as drug abuse, drug misuse, aberrant drug-related behavior, diversion, or addiction. DATA SYNTHESIS Of 102 eligible studies, 11 met inclusion criteria; 6 were in pain clinics and 5 were in primary care settings. Four primary care studies examined multicomponent strategies that included interdisciplinary support. All studies were observational and rated as poor to fair quality. In 4 studies with comparison groups, opioid misuse was modestly reduced (7% to 23%) after treatment agreements with or without urine drug testing. In the other 7 studies, the proportion of patients with opioid misuse after treatment agreements, urine drug testing, or both varied widely (3% to 43%). LIMITATIONS Diversity of interventions and opioid misuse measures precluded meta-analysis. Most studies evaluated combinations of interventions. CONCLUSION Relatively weak evidence supports the effectiveness of opioid treatment agreements and urine drug testing in reducing opioid misuse by patients with chronic pain. Further research on effective ways to monitor and reduce opioid misuse is needed, especially in primary care settings. PRIMARY FUNDING SOURCE Substance Abuse and Mental Health Services Administration, National Institute on Drug Abuse, and Robert Wood Johnson Foundation.

Screening and brief intervention for drug use in primary care: the ASPIRE randomized clinical trial.

IMPORTANCE The United States has invested substantially in screening and brief intervention for illicit drug use and prescription drug misuse, based in part on evidence of efficacy for unhealthy alcohol use. However, it is not a recommended universal preventive service in primary care because of lack of evidence of efficacy. OBJECTIVE To test the efficacy of 2 brief counseling interventions for unhealthy drug use (any illicit drug use or prescription drug misuse)-a brief negotiated interview (BNI) and an adaptation of motivational interviewing (MOTIV)-compared with no brief intervention. DESIGN, SETTING, AND PARTICIPANTS This 3-group randomized trial took place at an urban hospital-based primary care internal medicine practice; 528 adult primary care patients with drug use (Alcohol, Smoking, and Substance Involvement Screening Test [ASSIST] substance-specific scores of ≥4) were identified by screening between June 2009 and January 2012 in Boston, Massachusetts. INTERVENTIONS Two interventions were tested: the BNI is a 10- to 15-minute structured interview conducted by health educators; the MOTIV is a 30- to 45-minute intervention based on motivational interviewing with a 20- to 30-minute booster conducted by masters-level counselors. All study participants received a written list of substance use disorder treatment and mutual help resources. MAIN OUTCOMES AND MEASURES Primary outcome was number of days of use in the past 30 days of the self-identified main drug as determined by a validated calendar method at 6 months. Secondary outcomes included other self-reported measures of drug use, drug use according to hair testing, ASSIST scores (severity), drug use consequences, unsafe sex, mutual help meeting attendance, and health care utilization. RESULTS At baseline, 63% of participants reported their main drug was marijuana, 19% cocaine, and 17% opioids. At 6 months, 98% completed follow-up. Mean adjusted number of days using the main drug at 6 months was 12 for no brief intervention vs 11 for the BNI group (incidence rate ratio [IRR], 0.97; 95% CI, 0.77-1.22) and 12 for the MOTIV group (IRR, 1.05; 95% CI, 0.84-1.32; P = .81 for both comparisons vs no brief intervention). There were also no significant effects of BNI or MOTIV on any other outcome or in analyses stratified by main drug or drug use severity. CONCLUSIONS AND RELEVANCE Brief intervention did not have efficacy for decreasing unhealthy drug use in primary care patients identified by screening. These results do not support widespread implementation of illicit drug use and prescription drug misuse screening and brief intervention. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00876941.

Office-Based Management of Opioid Dependence with Buprenorphine: Clinical Practices and Barriers

BackgroundBuprenorphine is a safe, effective and underutilized treatment for opioid dependence that requires special credentialing, known as a waiver, to prescribe in the United States.ObjectiveTo describe buprenorphine clinical practices and barriers among office-based physicians.DesignCross-sectional survey.ParticipantsTwo hundred thirty-five office-based physicians waivered to prescribe buprenorphine in Massachusetts.MeasurementsQuestionnaires mailed to all waivered physicians in Massachusetts in October and November 2005 included questions on medical specialty, practice setting, clinical practices, and barriers to prescribing. Logistic regression analyses were used to identify factors associated with prescribing.ResultsPrescribers were 66% of respondents and prescribed to a median of ten patients. Clinical practices included mandatory counseling (79%), drug screening (82%), observed induction (57%), linkage to methadone maintenance (40%), and storing buprenorphine notes separate from other medical records (33%). Most non-prescribers (54%) reported they would prescribe if barriers were reduced. Being a primary care physician compared to a psychiatrist (AOR: 3.02; 95% CI: 1.48–6.18) and solo practice only compared to group practice (AOR: 3.01; 95% CI: 1.23–7.35) were associated with prescribing, while reporting low patient demand (AOR: 0.043, 95% CI: 0.009–0.21) and insufficient institutional support (AOR: 0.37; 95% CI: 0.15–0.89) were associated with not prescribing.ConclusionsCapacity for increased buprenorphine prescribing exists among physicians who have already obtained a waiver to prescribe. Increased efforts to link waivered physicians with opioid-dependent patients and initiatives to improve institutional support may mitigate barriers to buprenorphine treatment. Several guideline-driven practices have been widely adopted, such as adjunctive counseling and monitoring patients with drug screening.

Collaborative care of opioid-addicted patients in primary care using buprenorphine: five-year experience.

BACKGROUND Opioid addiction is a chronic disease treatable in primary care settings with buprenorphine hydrochloride, but this treatment remains underused. We describe a collaborative care model for managing opioid addiction with buprenorphine hydrochloride-naloxone hydrochloride dihydrate sublingual tablets. METHODS Ours is a cohort study of patients treated for opioid addiction using collaborative care between nurse care managers and generalist physicians in an urban academic primary care practice during a 5-year period. We examine patient characteristics, 12-month treatment success (ie, retention or taper after 6 months), and predictors of successful outcomes. RESULTS From September 1, 2003, through September 30, 2008, 408 patients with opioid addiction were treated with buprenorphine. Twenty-six patients were excluded from analysis because they left treatment owing to preexisting legal or medical conditions or a need to transfer to another buprenorphine program. At 1 year, 196 of 382 patients (51.3%) underwent successful treatment. Of patients remaining in treatment at 12 months, 154 of 169 (91.1%) were no longer using illicit opioids or cocaine based on urine drug test results. On admission, patients who were older, were employed, and used illicit buprenorphine had significantly higher odds of treatment success; those of African American or Hispanic/Latino race had significantly lower odds of treatment success. These outcomes were achieved with a model that facilitated physician involvement. CONCLUSION Collaborative care with nurse care managers in an urban primary care practice is an alternative and successful treatment method for most patients with opioid addiction that makes effective use of time for physicians who prescribe buprenorphine.

Screening and Brief Intervention for Unhealthy Drug Use in Primary Care Settings: Randomized Clinical Trials Are Needed

The efficacy of screening and brief intervention (SBI) for drug use in primary care patients is largely unknown. Because of this lack of evidence, US professional organizations do not recommend it. Yet, a strong theoretical case can be made for drug SBI. Drug use is common and associated with numerous health consequences, patients usually do not seek help for drug abuse and dependence, and SBI has proven efficacy for unhealthy alcohol use. On the other hand, the diversity of drugs of abuse and the high prevalence of abuse and dependence among those who use them raise concerns that drug SBI may have limited or no efficacy. Federal efforts to disseminate SBI for drug use are underway, and reimbursement codes to compensate clinicians for these activities have been developed. However, the discrepancies between science and policy developments underscore the need for evidence-based research regarding the efficacy of SBI for drug use. This article discusses the rationale for drug SBI and existing research on its potential to improve drug-use outcomes and makes the argument that randomized controlled trials to determine its efficacy are urgently needed to bridge the gap between research, policy, and clinical practice.

Statement of the American Society Of Addiction Medicine Consensus Panel on the use of buprenorphine in office-based treatment of opioid addiction.

Objectives:Opioid addiction affects over 2 million patients in the United States. The advent of buprenorphine and the passage of the Drug Addiction Treatment Act in 2000 have revolutionized the opioid treatment delivery system by granting physicians the ability to administer office-based opioid treatment (OBOT), thereby giving patients greater access to treatment. The purpose of this consensus panel was to synthesize the most current evidence on the use of buprenorphine in the office-based setting and to make recommendations that will enable and allow additional physicians to begin to treat opioid-addicted individuals. Methods:Literature published from 2000 to 2009 was searched using the PubMed search engine and yielded over 375 articles published in peer-reviewed journals, including some that were published guidelines. These articles were submitted to a consensus panel composed of researchers, educators, and clinicians who are leaders in the field of addiction medicine with specific expertise in the use of OBOT. The panel discussed results and agreed upon consensus recommendations for several facets of OBOT. Results:On the basis of the literature review and consensus discussions, the panel developed a series of findings, conclusions, and recommendations regarding the use of buprenorphine in office-based treatment of opioid addiction. Conclusions:Therapeutic outcomes for patients who self-select office-based treatment with buprenorphine are essentially comparable to those seen in patients treated with methadone programs. There are few absolute contraindications to the use of buprenorphine, although the experience and skill levels of treating physicians can vary considerably, as can access to the resources needed to treat comorbid medical or psychiatric conditions–-all of which affect outcomes. It is important to conduct a targeted assessment of every patient to confirm that the provider has resources available to meet the patients needs. Patients should be assessed for a broad array of biopsychosocial needs in addition to opioid use and addiction, and should be treated, referred, or both for help in meeting all their care needs, including medical care, psychiatric care, and social assistance. Current literature demonstrates promising efficacy of buprenorphine, though further research will continue to demonstrate its effectiveness for special populations, such as adolescents, pregnant women, and other vulnerable populations. Since the time of this review, several new studies have provided new data to continue to improve our understanding of the safety and efficacy of buprenorphine for special patient populations.

Effects of testosterone replacement in men with opioid-induced androgen deficiency: A randomized controlled trial

Abstract Symptomatic androgen deficiency is common in patients taking opioid analgesics, as these drugs potently suppress the hypothalamic–pituitary–gonadal axis. However, the efficacy of testosterone replacement in this setting remains unclear. The objective of this trial was to evaluate the efficacy of testosterone replacement on pain perception and other androgen-dependent outcomes in men with opioid-induced androgen deficiency. We conducted a randomized, double-blind, parallel placebo-controlled trial at an outpatient academic research center. Participants were men aged 18 to 64 years on opioid analgesics for chronic noncancer pain, and total testosterone levels were <350 ng/dL. Participants were randomly assigned to 14 weeks of daily transdermal gel that contained 5 g of testosterone or placebo. Primary outcomes were changes in self-reported clinical pain and objectively assessed pain sensitivity. Sexual function, quality of life, and body composition were also assessed. The mean age was 49 years. The median total and free testosterone levels at baseline were 243 ng/dL and 47 pg/mL and 251 ng/dL and 43 pg/mL in the testosterone and placebo arm, respectively. Of the 84 randomized participants, 65 had follow-up data on efficacy outcomes. Compared with men assigned to the placebo arm, those assigned to testosterone replacement experienced greater improvements in pressure and mechanical hyperalgesia, sexual desire, and role limitation due to emotional problems. Testosterone administration was also associated with an improvement in body composition. There were no between-group differences in changes in self-reported pain. In conclusion, in men with opioid-induced androgen deficiency, testosterone administration improved pain sensitivity, sexual desire, body composition, and aspects of quality of life.

A transitional opioid program to engage hospitalized drug users

BACKGROUNDMany opioid-dependent patients do not receive care for addiction issues when hospitalized for other medical problems. Based on 3 years of clinical practice, we report the Transitional Opioid Program (TOP) experience using hospitalization as a “reachable moment” to identify and link opioid-dependent persons to addiction treatment from medical care.METHODSA program nurse identified, assessed, and enrolled hospitalized, out-of-treatment opioid-dependent drug users based on their receipt of methadone during hospitalization. At discharge, patients transitioned to an outpatient interim opioid agonist program providing 30-day stabilization followed by 60-day taper. The nurse provided case management emphasizing HIV risk reduction, health education, counseling, and medical follow-up. Treatment outcomes included opioid agonist stabilization then taper or transfer to long-term opioid agonist treatment.RESULTSFrom January 2002 to January 2005, 362 unique hospitalized, opioid-dependent drug users were screened; 56% (n = 203) met eligibility criteria and enrolled into the program. Subsequently, 82% (167/203) presented to the program clinic post-hospital discharge; for 59% (119/203) treatment was provided, for 26% (52/203) treatment was not provided, and for 16% (32/203) treatment was not possible (pursuit of TOP objectives precluded by medical problems, psychiatric issues, or incarceration). Program patients adhered to a spectrum of medical recommendations (e.g., obtaining prescription medications, medical follow-up).CONCLUSIONSThe Transitional Opioid Program (TOP) identified at-risk hospitalized, out-of-treatment opioid-dependent drug users and, by offering a range of treatment intensity options, engaged a majority into addiction treatment. Hospitalization can be a “reachable moment” to engage and link drug users into addiction treatment.

Primary Care Patients with Drug Use Report Chronic Pain and Self-Medicate with Alcohol and Other Drugs.

Chronic pain is common among patients with drug use disorders. The prevalence of chronic pain and its consequences in primary care patients who use drugs is unknown. To examine: 1) the prevalence of chronic pain and pain-related dysfunction among primary care patients who screen positive for drug use, and 2) the prevalence of substance use to self-medicate chronic pain in this population. This was a cross-sectional analysis. This study included 589 adult patients who screened positive for any illicit drug use or prescription drug misuse, recruited from an urban, hospital-based primary care practice. Both pain and pain-related dysfunction were assessed by numeric rating scales, and grouped as: (0) none, (1–3) mild, (4–6) moderate, (7–10) severe. Questions were asked about the use of substances to treat pain. Among 589 participants, chronic pain was reported by 87 % (95 % CI: 84–90 %), with 13 % mild, 24 % moderate and 50 % severe. Pain-related dysfunction was reported by 74 % (95 % CI: 70–78 %), with 15 % mild, 23 % moderate, and 36 % severe. Of the 576 that used illicit drugs (i.e., marijuana, cocaine, and/or heroin), 51 % reported using to treat pain (95 % CI: 47–55 % ). Of the 121 with prescription drug misuse, 81 % (95 % CI: 74–88 %) used to treat pain. Of the 265 participants who reported any heavy drinking in the past 3 months, 38 % (95 % CI: 32–44 %) did so to treat pain compared to 79 % (95 % CI: 68–90 %) of the 57 high-risk alcohol users. Chronic pain and pain-related dysfunction were the norm for primary care patients who screened positive for drug use, with nearly one-third reporting both severe pain and severe pain-related dysfunction. Many patients using illicit drugs, misusing prescription drugs and using alcohol reported doing so in order to self-medicate their pain. Pain needs to be addressed when patients are counseled about their substance use.ABSTRACTBACKGROUNDChronic pain is common among patients with drug use disorders. The prevalence of chronic pain and its consequences in primary care patients who use drugs is unknown.OBJECTIVESTo examine: 1) the prevalence of chronic pain and pain-related dysfunction among primary care patients who screen positive for drug use, and 2) the prevalence of substance use to self-medicate chronic pain in this population.DESIGNThis was a cross-sectional analysis.PARTICIPANTSThis study included 589 adult patients who screened positive for any illicit drug use or prescription drug misuse, recruited from an urban, hospital-based primary care practice.MAIN MEASURESBoth pain and pain-related dysfunction were assessed by numeric rating scales, and grouped as: (0) none, (1–3) mild, (4–6) moderate, (7–10) severe. Questions were asked about the use of substances to treat pain.KEY RESULTSAmong 589 participants, chronic pain was reported by 87 % (95 % CI: 84–90 %), with 13 % mild, 24 % moderate and 50 % severe. Pain-related dysfunction was reported by 74 % (95 % CI: 70–78 %), with 15 % mild, 23 % moderate, and 36 % severe. Of the 576 that used illicit drugs (i.e., marijuana, cocaine, and/or heroin), 51 % reported using to treat pain (95 % CI: 47–55 % ). Of the 121 with prescription drug misuse, 81 % (95 % CI: 74–88 %) used to treat pain. Of the 265 participants who reported any heavy drinking in the past 3 months, 38 % (95 % CI: 32–44 %) did so to treat pain compared to 79 % (95 % CI: 68–90 %) of the 57 high-risk alcohol users.CONCLUSIONSChronic pain and pain-related dysfunction were the norm for primary care patients who screened positive for drug use, with nearly one-third reporting both severe pain and severe pain-related dysfunction. Many patients using illicit drugs, misusing prescription drugs and using alcohol reported doing so in order to self-medicate their pain. Pain needs to be addressed when patients are counseled about their substance use.

Smoking Policies in U.S. Outpatient Drug Treatment Facilities

Most drug treatment patients smoke cigarettes, and some facilities are beginning to help patients quit. Facility smoking policies can help or hinder this effort. The present study describes smoking policies in outpatient drug treatment. It is a secondary analysis of a survey on smoking cessation treatment in outpatient methadone maintenance facilities in the United States. One clinic leader (a medical director, head nurse, or clinic director) from each of the 697 U.S. facilities was invited to participate in the study. Main outcome measures included whether clinics had a written smoking policy as well as the types of indoor and outdoor policies in place for patients and staff. A total of 408 (59%) of U.S. clinics responded. Most clinics (73%) had a written smoking policy for patients, and more (82%) had written policies for staff. Over 90% banned indoor smoking by staff and patients. Few totally banned outdoor smoking. Approximately half in some way restricted where patients (48%) and staff (55%) smoke outdoors. Compared with clinics that did not treat nicotine dependence, significantly more clinics that treated nicotine dependence had written policies on smoking and restricted outdoor smoking for patients and staff. Likewise, many public clinics and those affiliated with hospitals had outdoor smoking restrictions for patients and staff. Drug treatment facilities routinely ban alcohol use and drug dealing on their grounds. Only 1 in 10 ban smoking. Outpatient facilities should restrict or ban outdoor tobacco use in order to remain consistent with their mission and avoid sabotaging clinic efforts to treat, and patient and staff efforts to stop, smoking.