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2 Treatment for Drug Dependence The most effective way for IDUs to reduce their risk for contracting HIV through contaminated injecting equipment is to stop using drugs, and if that is not possible, to stop or reduce the frequency of injecting. Drug dependence treatment is therefore a critical HIV prevention strategy. It can interrupt HIV transmission by reducing drug-related HIV risk behavior, including frequency of drug use, injecting drug use, or sharing of injecting equipment. Although not the primary goal, drug treatment programs also have the potential to reduce risk behavior associated with the sexual transmission of HIV, such as sexual activity triggered by disinhibition or other drug effects, and engaging in sex in exchange for drugs or money. Beyond its effects on HIV transmission, drug dependence treatment can reduce other adverse health and social effects of drug abuse, including deaths from overdose and other drug-related causes of excess morbidity and mortality, and serve as an entry point into health and social services, including HIV/AIDS treatment (Sorenson and Copeland, 2000). Drug dependence treatment can occur in a variety of settings, including inpatient, outpatient, and residential venues, and often blends different treatment approaches, including pharmacotherapy and psychosocial interventions. This chapter addresses the efficacy and effectiveness of pharmacotherapies—both agonist and antagonist agents for treating opioid1 depen- 1 “Opiates are a group of psychoactive substances derived from the poppy plant, that includes opium, morphine, codeine, and some others. The term ‘opiate’ is also used for the
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dence, and pharmacotherapies for treating stimulant dependence (on cocaine or amphetamine-type drugs)—as well as psychosocial interventions. This chapter also examines the extent to which drug treatment provides IDUs with links to other health and social services. The primary goal of drug abuse treatment is to reduce drug use. By doing so, it may also decrease injection drug use and other risk behaviors associated with drug use and provide a platform for providing other specific interventions directly targeting HIV transmission. Thus it may have direct, indirect, and facilitative effects on prevention of HIV transmission. As a result, the Committee first reviews the evidence regarding the effectiveness of drug treatment in reducing drug use and improving treatment-related outcomes, and then considers the impact of such treatment on HIV-related outcomes. Efficacy refers to how well a treatment works under the best of circumstances, or in controlled clinical trials. Effectiveness refers to how well the treatment works in actual clinical practice. From a public health perspective, a particular treatment will have the greatest impact on HIV transmission if it is effective in reducing drug use and drug- and sex-related HIV risk behavior, and if it attracts and retains a large-enough proportion of drug-dependent individuals. Some treatments may be efficacious in controlled clinical trials but difficult to scale up for widespread, effective use in community settings. Other treatments may be efficacious but not attractive enough to patients to gain widespread acceptance. Although clinically efficacious treatments may reduce drug use and HIV transmission among drug-dependent patients who receive the treatment, unless these treatments are sufficiently widely disseminated, accessible, and attractive to the entire population of drug-dependent individuals, even the most efficacious treatment will not substantially reduce HIV transmission and other problems resulting from drug dependence in a country. Social factors may also affect the willingness of drug-dependent patients to participate in efficacious treatments. Discrimination against patients receiving treatment for drug dependence and the stigma associated with drug dependence, as well as the monetary costs and other demands of treatment, can deter drug-dependent individuals from seeking or remaining semisynthetic drug heroin that is produced from poppy compounds. The term ‘opioids’ refers to opiates and other semisynthetic and synthetic compounds with similar properties. Opioids are dependence producing substances, which elicit their effects by activating opioid receptors in the brain. Opioids are generally consumed by injection, oral ingestion or inhalation of the fumes produced by heating. Regular use of opioids can lead to opioid dependence” (WHO et al., 2004, p. 4).
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in treatment (IOM, 1990). For drug abuse treatment to be most effective in reducing HIV transmission, it is essential that social policies encourage rather than discourage participation in treatment. In addition, consistent encouragement or even pressure to enter and remain in treatment from family members, friends, community leaders, or authorities can increase treatment engagement and contribute to successful treatment outcomes (IOM, 1990). The criminal justice system can also play an important role in getting drug users into treatment and outcomes by providing treatment as an alternative to incarceration, or as a condition of probation or parole (IOM, 1990). THE COMMITTEE’S APPROACH TO EVALUATING THE STRENGTH OF THE EVIDENCE A large number of systematic approaches to evaluating the quality and strength of scientific evidence are available. Many of these approaches, such as that used by the U.S. Preventive Services Task Force,2 rely on explicit criteria to assign a “grade” to the evidence. Others use a more qualitative approach. In evaluating the strength of the evidence on the effectiveness of HIV prevention strategies for IDUs, the Committee used a structured qualitative method based on an approach developed by the GRADE Working Group—a collaboration of researchers that aims to address problems with rating systems (GRADE Working Group, 2004). The GRADE approach takes into account strength of study design, study quality, consistency of findings across studies, directness/relevance of outcome measures, and populations. In establishing causality, this approach grades randomized trials as strong, prospective cohort and case-control studies as moderate, and other observational studies and reports as modest (e.g., serial cross-sectional, ecologic) or weak (e.g., cross-sectional) (see Box 2.1 for a description of common research study designs). The approach downgrades studies for serious limitations on quality; important inconsistencies; sparse, indirect, or imprecise data; low follow-up rates; and a high probability of reporting bias. Studies are upgraded for strong evidence of an association, consistency of effect, demonstration of dose-response, and good analytic control of confounders. Combining these elements, the approach assigns evidence to one of four quality categories: Strong: Further research is very unlikely to change confidence in the estimate of the effect. 2 The task force’s rating system for the strength of the evidence is available at: http://www.ahrq.gov/clinic/3rduspstf/ratings.htm.
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Moderate: Further research is likely to have an important impact on confidence in the estimate of effect, and may change the estimate. Modest: Further research is very likely to have an important impact on confidence in the estimate of effect, and likely to change the estimate. Weak: Further research is very likely to change the estimate, and possibly the direction of a very uncertain estimate of effect. The Committee considered other factors when rating the strength of evidence regarding an intervention. These included the total number of studies, their generalizability, the intervention’s applicability in practice, tradeoffs between benefits and harm, and acceptability to recipients. While considering all evidence as potentially policy relevant, the Committee sought to place greater weight on evidence of the highest quality in making its conclusions and recommendations. EFFICACY AND EFFECTIVENESS OF PHARMACOTHERAPIES This section first reviews evidence of effectiveness for opioid agonist therapies on (1) overall drug use and treatment-related outcomes; (2) drug-related HIV risk behavior; (3) sex-related HIV risk behavior; and (4) HIV incidence or seroconversion. The section considers factors that affect the impact of length of treatment, dosage, and adjunctive psychosocial therapy on the effectiveness of these treatments. Opioid agonist medications have two primary clinical applications: they can be used on a limited basis to facilitate opioid detoxification,3 or they can be administered over a longer-period as a maintenance treatment (IOM, 1995). This report focuses on the latter application. The section also reviews evidence of unintended consequences of opioid agonist therapy, such as misuse and diversion of treatment medications into illicit channels. The section then examines evidence on the effectiveness of opioid antago- 3 Detoxification refers to medically supervised withdrawal from a substance until the person reaches a drug-free state. Pharmacological agents are often used during detoxification to alleviate client discomfort and to reduce potential complications. Opioid agonist medications can be used to help manage withdrawal symptoms during detoxification from opioids (IOM, 1990). When used to assist with detoxification, opioid agonist medications are provided tapered doses until the patient achieves a drug-free state (IOM, 1990, 1995). Detoxification alone is not considered an effective treatment (IOM, 1990). Studies show users have high rates of relapse to drug use when detoxification is not followed by further therapeutic intervention (IOM, 1990). Several other detoxification strategies can also be used including symptomatic treatment of withdrawal effects (e.g., with clonidine), or precipitated withdrawal without medication (IOM, 1995). This report does not address the relative advantages and disadvantages of these approaches.
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BOX 2-1: Definitions of Common Research Study Designs Randomized control trial (RCT): An epidemiologic experiment in which subjects in a population are randomly allocated into groups, usually called “study” and “control” groups, to receive or not to receive an experimental preventive or therapeutic procedure, maneuver, or intervention. The results are assessed by rigorous comparison of rates of disease, death, recovery, or other appropriate outcome in the study and control groups, respectively. RCTs are generally regarded as the most scientifically rigorous method of hypothesis testing available in epidemiology. Case-control study: A study that starts with the identification of persons with the disease (or other outcome variable) of interest, and a suitable control (comparison, reference) group of persons without the disease. The relationship of an attribute to the disease is examined by comparing the diseased and non-diseased with regard to how frequently the attribute is present or, if quantitative, the levels of the attributes, in each of the groups. Cohort study: The analytic method of epidemiologic study in which subsets of a defined population can be identified who are, have been, or in the future may be exposed or not exposed, or exposed in different degrees, to a factor or factors hypothesized to influence the probability of occurrence of a given disease or other outcome. The main feature of cohort study is observation of large numbers over a long period (commonly years) with comparison of incidence rates in groups that differ in exposure levels. The alternative terms for a cohort study, i.e., follow-up, longitudinal, and prospective study, describe an essential feature of the method, which is observation of the population for a sufficient number of person-years to generate reliable incidence or mortality rates in the population subsets. This generally implies study of a large population, study for a prolonged period (years), or both. nist medication, which blocks the euphoric or rewarding effects of heroin or other opioids, and thus may help prevent resumption of opioid use. In addition, the Committee reviews the evidence of effectiveness for pharmacological treatments of stimulant dependence. In reviewing pharmacological treatments for opioid and stimulant abuse, the Committee relied partly on several recent reviews and meta-analyses by the Cochrane Collaboration.4 The Committee also relied partly 4 The Cochrane Drugs and Alcohol Review Group is part of the Cochrane Collaboration, which was developed in the United Kingdom in 1992 with the goal of producing systematic reviews of the effects of various health care interventions that clinicians can use to guide their day-to-day practice. The review group conducts systematic reviews primarily of randomized clinical trials and controlled clinical trials of prevention, treatment, and rehabilitation interventions targeting drug dependence. The review group has published more than 30 reviews and 15 protocols. These are available at: http://alcalc.oxfordjournals.org/cgi/content/full/36/2/109; http://www.cochrane.org/newslett/DrugsandAlcoholAutumn2005.pdf.
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Cross-sectional study: A study that examines the relationship between diseases (or other health-related characteristics) and other variables of interest as they exist in a defined population at one particular time. The presence or absence of disease and the presence or absence of the other variables (or, if they are quantitative, their level) are determined in each member of the study population or in a representative sample at one particular time. The relationship between a variable and the disease can be examined (1) in terms of the prevalence of disease in different population subgroups defined according to the presence or absence (or level) of the variables and (2) in terms of the presence or absence (or level) of the variables in the diseased vs. the non-diseased. Note that the disease prevalence rather than incidence is normally recorded in a cross-sectional study. The temporal sequence of cause and effect cannot necessarily be determined in a cross-sectional study. Mathematical model: A representation of a system, process, or relationship in mathematical form in which equations are used to simulate the behavior of the system or process under study. The model usually consists of two parts: the mathematical structure itself, and the particular constants or parameters associated with them. A mathematical model is deterministic if the relations between the variables involved take on values not allowing for any play of chance. A model is said to be statistical, stochastic, or random, if random variation is allowed to enter the picture. Ecological study: A study in which the units of analysis are populations or groups of people, rather than individuals. An ecological correlation is a correlation in which units studied are populations rather than individuals. Correlations found in this manner may not hold true for the individual members of these populations. SOURCE: Verbatim definitions from A Dictionary of Epidemiology (Last, 1995). on an earlier IOM report, Treating Drug Problems (1990). The Committee updated the search strategies used in the Cochrane reviews to identify critical studies published since those reviews occurred. (See Appendix B for more detail on the Committee’s review methodology.) OPIOID AGONIST MAINTENANCE PHARMACOTHERAPY Opioid agonist maintenance therapies prevent withdrawal symptoms, decrease craving, and—by creating cross-tolerance to these effects—block or diminish the effects of illicit opioid use. Use of these long-acting oral medications allows patients to stabilize physiologically so that they can reengage in normal life activities (WHO et al., 2004; IOM, 1990). Due to their long half life and resulting steady state, opioid agonists are not intoxicating and do not impair function when used at clinically appropriate and stable doses over time (IOM, 1990, 1995). This is a central phenomenon that distinguishes their therapeutic use from their misuse when injected,
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and distinguishes agonist treatment agents from other opioids, such as heroin, that are misused for their consciousness-altering properties. Many studies have examined the efficacy and effectiveness of opioid agonist maintenance therapies for treating opioid dependence. The Committee limited its review of evidence to the two most commonly used opioid agonist therapies, methadone and buprenorphine. Other pharmacological agonist agents have been used in some countries for both detoxification and maintenance therapy. Although many studies have demonstrated Levo-Alpha-Acetyl-Methadol’s (LAAM’s) effectiveness (see Clark et al., 2002) as a maintenance therapy for treating opioid dependence, reports of serious cardiac-related adverse events led to its withdrawal from the European market in 2001 (EMEA, 2001) and to extensive labeling changes for U.S. package inserts (U.S. FDA, 2001).5 Other opioid agonists, including prescription heroin (diacetylmorphine), tincture of opium, dihydrocodeine, and oral preparations of morphine, have been studied in limited settings but are not widely used (MacCoun and Reuter, 2001; WHO et al., 2004). Effects on Drug Use and Treatment-Related Outcomes A number of randomized clinical trials (RCTs) have shown the efficacy and effectiveness of methadone and buprenorphine maintenance therapies versus no opioid agonist treatment for drug and treatment-related outcomes. The evidence for each of these therapies is examined below. Methadone An extensive body of evidence spanning over three decades supports the efficacy of methadone maintenance as a treatment for opioid depen dence. In a recent Cochrane review (Mattick et al., 2003a), investigators conducted a meta-analysis of six RCTs comparing methadone maintenance treatment (MMT) with either placebo maintenance or other non-pharmacological therapy for heroin dependence.6 The six studies were conducted in diverse locations, including the United States, Sweden, Hong Kong, and Thailand. Two of the six trials were double-blinded and 5 Roxanne Laboratories, Inc., the manufacturer of ORLAAM ® (Levomethadyl hydrocholoride acetate) Oral Solution, 10 mg/mL, CII, announced that it was discontinuing sale and distribution of its product after the current inventory was depleted (Roxanne Laboratories, Inc., 2003). 6 Non-pharmacological control groups in the four non-placebo trials include those assigned to waitlist (Dole, 1969; Yancovitz, 1991), drug-free rehabilitation (Gunne and Gronbladh, 1981), or methadone detoxification (Vanichseni, 1991).
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placebo-controlled (Newman and Whitehill, 1979; Strain et al., 1993). The overall methodological quality of the studies was good. The procedures for ensuring that researchers and participants remained unaware of the randomization assignments were inadequate in one study (Dole et al., 1969), not adequately described in four studies (Gunne and Gronbladh, 1981; Newman and Whitehill, 1979; Strain et al, 1993; Vanichseni et al., 1991), and good in another (Yancovitz, 1991). Sample sizes were sometimes small, with two studies enrolling only 32 and 34 participants (Dole et al., 1969; Gunne and Gronbladh, 1981). Sample sizes for the four remaining studies ranged from 100 to 301 patients. Dosage was considered adequate in all studies. The Cochrane meta-analysis examined the impact of treatment on treatment retention, opioid drug use as measured by self-reports and urine analyses, criminal activity, and mortality. The meta-analysis showed that MMT was more effective than placebo and non-pharmacological treatments in retaining patients in treatment (3 RCTs; relative risk [RR]=3.05; 95% confidence interval [CI]: 1.75–5.35), and in reducing heroin use (3 RCTs; RR=0.32; 95% CI: 0.23–0.44). The review found a positive—although not statistically significant—effect on reducing criminal activity (3 RCTs’ RR=0.39; 95% CI: 0.12–1.25) and mortality (3 studies, 435 patients; RR=0.49; 95% CI: 0.06–4.23). One RCT of MMT (Schwartz et al., 2006), published since the Cochrane review, supported these findings. The study randomly assigned a total of 319 participants on a 3:2 basis to interim methadone maintenance (with an individually determined dose and no regularly scheduled drug counseling) for 120 days (n=199), or a waiting list for community-based methadone treatment (n=120). Some 76 percent of those assigned to the interim methadone maintenance treatment entered comprehensive methadone treatment within 4 months, compared with some 21 percent (p<0.001) assigned to the waiting list. Interim methadone participants also reported significantly fewer days of heroin use (p<0.001), and had significantly fewer heroin-positive urine tests (<0.001). Self-reported crime was also significantly lower in the treatment. The finding that MMT reduces heroin use is consistent with the findings of the Cochrane review. While RCTs have shown that MMT reduces heroin use and improves treatment retention, findings also suggest a positive effect of MMT on criminal behavior. As noted, the 2003 Cochrane review (Mattick et al., 2003a) found a positive but non-significant association between MMT and reductions in crime. Two quasi-experimental studies examining the effects of MMT program closures in California (Anglin et al., 1989; McGlothin and Anglin, 1981) found that MMT patients who were unable or unwilling to transfer to a private MMT program after a publicly funded MMT program was closed had higher rates of illicit drug use, arrest, and incarcera-
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tion than patients in other locations who continued to receive MMT. Another study that followed a sample of opioid-dependent men enrolled in MMT found—when comparing pre- and post-admission periods—that retention in methadone treatment had a small but significant effect on criminal activity (Rothbard et al., 1999). Although these studies suggest that MMT has a positive impact on reducing crime, the results must be interpreted with caution because of the strong possibility of selection bias. That is, patients who enrolled in treatment might have reduced their criminal activity in any event, while patients who did not enroll might not have reduced their criminal activity even with treatment. A number of studies have examined the impact of methadone treatment on mortality. As noted, the Cochrane review (Mattick et al., 2003a) on effectiveness of methadone maintenance found a trend suggesting that methadone had a protective effect on mortality, but it was not significant. Other non-experimental studies point to a reduction in mortality rates among people receiving opioid agonist treatment compared to out-of-treatment IDUs. For example, in a cohort study by Caplehorn et al. (1994), individuals who had left methadone maintenance treatment were three times more likely to die than those who were in treatment. Three studies by Fugelstad and colleagues (1995, 1997, 1998) found nearly all deaths of patients on methadone maintenance were due to disease already present prior to their entry to treatment (e.g., HIV), whereas the majority of heroin addicts out of treatment died as a result of overdose or violence. The significant limitation of non-experimental studies such as these is that self-selection bias could contribute to the findings of decreased mortality among people in treatment. Buprenorphine Another Cochrane review (Mattick et al., 2003b) examined the effectiveness of buprenorphine maintenance therapy vs. placebo or methadone maintenance therapy in retaining patients in treatment and reducing illicit drug use. The review considered 13 RCTs that met the inclusion criteria. All but one of the studies were double-blind, but only two were placebo-controlled (Johnson et al., 1995; Ling et al., 1998); most of the evidence came from comparing buprenorphine and methadone at varying dosage levels. The reviewers found that the methodological quality of the studies was high, except that 11 inadequately described how they concealed the allocation of treatment. The authors found that high-dose buprenorphine maintenance was more efficacious than placebo and low-dose methadone in retaining individuals in treatment and reducing heroin use. However, high-dose buprenorphine had no advantage over high-dose methadone in retaining
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patients, and was less efficacious than high-dose methadone in reducing heroin use. Three RCTs of buprenorphine have been published since the 2003 Cochrane review, and their findings are consistent with that review. The first trial (Fudala et al., 2003) tested the efficacy and safety of buprenorphine and combined buprenorphine-naloxone7 treatment in a U.S. office-based setting. In this multicenter, randomized, placebo-controlled trial, 323 opioid-dependent individuals received one of three treatments: (1) sublingual buprenorphine (16 milligrams) with naloxone (4 milligrams) (n=109); buprenorphine alone (16 milligrams) (n=105); or daily placebo for 4 weeks (n=109). The primary outcome measures were opioid-negative urine samples and patients’ self-reported craving for opiates. The researchers ended the placebo arm of the trial early because both the mono-buprenorphine tablet and the combination buprenorphine-naloxone tablet were more efficacious than placebo. The active treatment groups had higher percentages of opiate-free urine samples (17.8 percent for combined treatment and 20.7 percent for buprenorphine treatment) than the placebo group (5.8 percent; p<0.0001 for both comparisons). The active treatment groups also reported less craving for opiates than the placebo group. The later phase of the study showed that treatment was safe and well tolerated. The second study was a randomized, double-blind, placebo-controlled trial in Norway (Krook et al., 2002). This 12-week study compared interim buprenorphine maintenance treatment versus placebo in patients on a waitlist for medication-assisted rehabilitation. Participants did not receive any psychosocial treatment as part of the study. Of 106 participants, 55 were randomized to receive a daily dose of 16 milligrams of buprenorphine, and 51 to placebo. Outcome measures included treatment retention, treatment compliance, self-reported drug abuse, well-being, and mental health status. The average number of days in treatment was higher for the buprenorphine group (42 days) than the placebo group (14 days; p<0.0001). However, the attrition rate was significant for both groups, with 16 participants remaining in the buprenorphine group and 1 in the placebo group after 12 weeks. The authors attribute the retention problem to the lack of psychosocial support. The buprenorphine group also showed a larger drop in self-reported opioid use (p<0.001) and other drug and alcohol use (p<0.01), and a stronger increase in reported well-being (p<0.01) and life 7 Naloxone is an opioid antagonist similar to naltrexone. Naloxone was included to reduce or prevent potential diversion or misuse of buprenorphine by injection.
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satisfaction (p<0.05). Although these findings are consistent with those of other trials, this trial did not use urine toxicology screening to verify self-reported drug use. The third study (Kakko et al., 2003) was a randomized, placebo-controlled trial conducted in Sweden to assess the 1-year efficacy of buprenorphine combined with psychosocial therapy in treating heroin dependence. Subjects included 40 individuals who had been dependent on heroin for at least 1 year (all but one injected heroin), but who were not eligible for methadone maintenance treatment. (In Sweden at the time of the trial, individuals were eligible only after 4 years of multiple daily heroin use and more than three unsuccessful attempts at drug-free treatment.) Participants were randomly assigned (1:1) to daily buprenorphine (16 milligrams per day for 12 months, with supervised administration for 6 months and possible take-home doses after that), or to a tapered buprenorphine regimen for 6 days followed by placebo. As part of a relapse-prevention program, all patients received cognitive-behavioral group therapy and weekly individual counseling. Participants submitted urine samples for testing for illicit opiates, stimulants, cannabinoids, and benzodiazepines. The primary outcome measure was retention in treatment for 1 year. Results from Kakko et al. (2003) showed 75 percent treatment retention in the buprenorphine treatment group and 0 percent in the placebo group (p=0.0001; risk ratio: 58.7; 95% CI: 7.4–467.4). The authors attribute the high attrition rate in part to criteria that required involuntary dismissal from treatment for anyone who continued using illicit drugs. All 20 patients in the placebo group had urine tests that were positive for illicit drug use, and none remained in treatment beyond 2 months. In the buprenorphine group, four were involuntarily discharged for positive urine toxicology tests, and one voluntarily dropped out of treatment. The authors also note that withdrawal symptoms and perceived lack of suppression of craving among participants in the placebo arm could have contributed to illicit drug use and dropout. Urine samples in the buprenorphine group were 74.8 percent (standard deviation 59.6 percent) negative, on average, for substances analyzed. Mortality was substantially higher in the control group: four people (20 percent) died in the control group, and none in the buprenorphine group. The authors conclude that buprenorphine combined with psychosocial treatment is highly efficacious and safe. Based on this evidence, the Committee concludes: Conclusion 2-1: Strong and consistent evidence from well-designed, randomized, controlled trials (some double-blind, placebo-controlled) shows that opioid agonist maintenance treatment—including methadone and buprenorphine—is more effec-
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