Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries An Assessment of the Evidence (2007) / Chapter Skim
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2 Treatment for Drug Dependence
2 Treatment for Drug Dependence
Pages 74-136
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From page 74... ...
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.
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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 drugdependent individuals.
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. 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.
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drugrelated HIV risk behavior; (3) sex-related HIV risk behavior; and (4)
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In reviewing pharmacological treatments for opioid and stimulant abuse, the Committee relied partly on several recent reviews and metaanalyses by the Cochrane Collaboration.4 The Committee also relied partly 4The 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.
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(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.
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, investigators conducted a meta-analysis of six RCTs comparing methadone maintenance treatment (MMT) with either placebo maintenance or other nonpharmacological therapy for heroin dependence.6 The six studies were conducted in diverse locations, including the United States, Sweden, Hong Kong, and Thailand.
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. 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)
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(1994) , individuals who had left methadone maintenance treatment were three times more likely to die than those who were in treatment.
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. This 12-week study compared interim buprenorphine maintenance treatment versus placebo in patients on a waitlist for medication-assisted rehabilitation.
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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 treat ment -- including methadone and buprenorphine -- is more effec
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Conclusion 2-2: Moderate evidence from randomized controlled trials and quasi-experimental studies suggest that opioid agonist maintenance therapy is associated with reductions in criminal behavior. Modest evidence from studies suggest that agonist main tenance therapy lowers mortality risk for those who remain in treatment, but the possibility of self-selection bias cannot be excluded.
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Effects on HIV Risk Behavior and Seroconversion Opioid agonist treatment may reduce the risk of HIV infection in several ways. By reducing the use of opioids, such treatment may also reduce how often individuals inject, and also how often they share injecting equipment.
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Drug-Related HIV Risk Behavior Frequency of injecting: Six of the 28 studies provided the proportion of participants reporting injecting drug use before and after methadone treatment.9 Eight studies offered data on the reported frequency of injection at baseline and follow-up,10 and 2 studies11 examined both the proportion and frequency of injection. One study was an RCT (Dolan et al., 2003)
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found significant decreases in drug-related HIV risk behavior before and after MMT. The fourth study (Sees et al., 2000)
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Sex-Related HIV Risk Behavior Because opioid agonist maintenance therapy is not designed to reduce sexual risk behavior, one would not expect to see an impact on such behavior use without additional intervention. However, the Cochrane review identified a number of observational studies that have examined the impact of MMT on sex-related risk behavior, including multiple sex partners, exchange of sex for drugs or money, and unprotected sex (Gowing et al., 2004, 2005)
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. Based on this evidence, the Committee concludes: Conclusion 2-4: Because opioid agonist maintenance therapy is not designed to reduce sex-related risk behavior, one would not expect to see a substantial impact on such behavior without addi tional intervention.
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followed from 1985 to 1991, to assess the impact of MMT on HIV infection. The study included 40 cases and 40 controls.
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However, the possibility of bias in these findings from self selection cannot be ruled out: that is, patients who resist treat ment or engage in risky behaviors may leave treatment, while patients with fewer HIV risk behaviors may stay in treatment longer.
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Nor does the literature suggest that the effectiveness of opioid agonist maintenance treatment would be diminished in develop ing countries. Factors Affecting Outcomes of Opioid Agonist Treatment As noted, studies have shown that opioid agonist treatment reduces illicit opioid use, improves retention in treatment, and reduces drug-related HIV risk behavior and incidence.
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. Based on this evidence, the Committee concludes: Conclusion 2-7: Strong evidence from several large, randomized clinical trials shows that continuous agonist maintenance therapy is associated with longer treatment retention -- and reductions in illicit opioid use and relapse to opioid dependence -- than short term use of these agents.
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However, clinicians, policymakers, and regulators should consider the strong dose-response effects of opioid agonist therapies when developing guidelines, and avoid setting arbitrary dosage limits. Based on this evidence, the Committee concludes: Conclusion 2-8: Strong evidence from randomized, double-blind clinical trials, shows that buprenorphine and methadone mainte
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Combined Psychosocial and Agonist Maintenance Treatment for Opiate Dependence As noted, studies have shown the effectiveness of opioid agonist maintenance therapy in retaining patients in treatment, reducing illicit opiate use, reducing drug-related HIV risk behavior, and protecting against HIV seroconversion. Many developed countries provide MMT in conjunction with some form of psychosocial support, which may also be legally mandated.
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groups receiving agonist maintenance treatment with standard drug counseling vs. groups receiving "enhanced" psychosocial services.
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However, developing countries with plans to implement opioid agonist treatment programs can evaluate the effectiveness of adding psychosocial interventions. Furthermore, some developed countries do not require counseling along with buprenorphine maintenance treatment that is provided in office-based settings.
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HIV-related outcomes: The Committee identified some studies that examined the effect of psychosocial interventions among patients enrolled in opioid agonist treatment on HIV risk behavior. Four studies included in a meta-analysis (Prendergast et al., 2001)
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Weak evidence from several studies suggest that some psychosocial in terventions for patients enrolled in such therapy can be effective in reducing sexual and drug-related HIV risk behavior, but more research is needed. Unintended Consequences of Opioid Agonist Maintenance Therapy Despite the many benefits of opioid agonist treatments, the medications used for maintenance treatment can be abused.
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. One study examining illicit drug use and injection practices among patients enrolled in either methadone or buprenorphine maintenance treatment in France found that about 35 percent reported having used an illicit substance, 26 percent reported having injected drugs, and 15 percent reported having injected the agonist drug (buprenorphine or methadone)
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It is possible that maintenance treatment may have reduced overall injection drug use in the population treated as well as the frequency or dangers associated with injection drug use even in those who continued injection drug use while being maintained on buprenorphine. In a cross-sectional study of a sample of IDUs recruited from pharmacies, needle-exchange programs, and vending machine sites in France, 34 percent of respondents reported occasionally injecting buprenorphine, and 24 percent reported injecting only buprenorphine in the past 6 months (Obadia et al., 2001)
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Based on this evidence, the Committee concludes: Conclusion 2-11: Strategies to limit diversion of opioid agonist medications -- such as limiting the number of physicians who can prescribe the medication or directly observing patients while they ingest the medication -- may increase the costs of treatment, and the costs to and burdens on patients, and may thus limit the dissemination of opioid agonist maintenance treatment. Coun tries' policies and regulations regarding opioid agonist mainte nance treatment should balance the potentially competing goals of increasing the accessibility and utilization of opioid agonist main tenance treatment and reducing the likelihood of diversion of ago nist maintenance medications.
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. Despite strong pharmacological evidence and theoretical potential for naltrexone, evidence regarding its efficacy in controlled clinical trials is inconclusive.
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While naltrexone-treated groups had significantly fewer opioid-positive urine tests than controlled counterparts, this effect was only seen in the patient subgroup with high treatment retention. Contingency management20 (see next section on psychosocial interventions)
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The study found a decrease in HIV risk behaviors, psychiatric symptoms, and overall adjustment among patients who remained in treatment and did not relapse, although the possibility of self-selection bias cannot be excluded because follow-up was possible on only 40 percent of those who dropped out of treatment. Several studies evaluating naltrexone in special populations -- including patients on supervised probation (Cornish et al., 1997)
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Food and Drug Administration or other regulatory agencies for treatment of cocaine dependence. Several other medications, including baclofen, modafinil, tiagabine, and topiramate, have also shown initial efficacy in reducing cocaine use in controlled clinical trials of cocaine-dependent patients.
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More research is needed to further develop and define effective approaches to treat stimu lant dependence. EFFICACY AND EFFECTIVENESS OF PSYCHOSOCIAL INTERVENTIONS A second major approach to drug treatment involves psychosocial interventions, which include a broad range of psychological and behavioral strategies, used either alone or in combination with pharmacotherapies and other medical or social interventions (Mayet et al., 2004)
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These include four specific behavioral interventions (contingency management, community reinforcement approach, cognitive behavioral therapy, and motivational interviewing) as well as a collection of program models that include therapeutic communities, narcotics or drug anonymous programs (12-step programs)
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These conditions included standard cognitive behavioral therapy (CBT, n=40) , contingency management (n=42)
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The study found that a significantly higher proportion of participants in the CM conditions achieved three weeks of methamphetamine abstinence than those in the non-CM conditions. Although there is strong evidence regarding the efficacy of CM for treating cocaine dependence and moderate evidence from two RCTs of its efficacy for treating methamphetamine dependence, it has not been found to be efficacious for individuals who are addicted to opiates alone and who
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Given the efficacy of CM in treating stimulant dependence (see below) , and when combined with opioid agonist maintenance for treating co-occurring cocaine and opioid dependence, these negative findings point to the difficulty of treating opioid-dependent patients without opioid agonist maintenance treatment.
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multi-site, randomized clinical trial of psychosocial treatments for cocaine dependence promote involvement in 12-step recovery programs and utilization of the strategies, goals, and principles of these recovery groups. In the NIDA multi-site cocaine collaborative treatment study, adding individual counseling to group drug counseling improves outcomes (addiction severity index composite score and length of time abstinent)
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Based on this evidence, the Committee concludes: Conclusion 2-14: Strong evidence from a significant number of well-done randomized, controlled trials shows that CM is associ ated with longer retention in treatment and time abstinent from stimulants among individuals who are primarily dependent on stimulants, and among individuals who are dependent on both stimulants and opiates and enrolled in agonist maintenance therapy. CM has not been found to be efficacious for individuals who are addicted to opiates but who are not enrolled in agonist maintenance therapy.
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has been shown to be consistently efficacious in treating opioid dependence. Therapeutic Communities, Narcotics or Drug Anonymous Programs, and Chemical Dependency Programs The Committee also reviewed evidence regarding the effectiveness of Narcotics Anonymous (NA)
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. Consequently, data on the effectiveness of TCs are derived mainly from prospective cohort studies of patients entering TCs or other types of drug treatment.
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on the efficacy of adding psychosocial interventions targeting HIV risk reduction to drug counseling identified 18 studies comparing an intervention group and a comparison group. The results of the meta-analysis suggest that these added interventions may reduce overall HIV risk behavior and sexual risk behavior, and may increase HIV risk-reduction skills.
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The study detected no statistically significant differences between groups. Based on this evidence, the Committee concludes: Conclusion 2-18: Weak to modest evidence shows that targeted psychosocial interventions are effective in reducing sex-related HIV risk behavior among stimulant-dependent individuals.
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(2006) found that onsite primary care in drug treatment programs reduced emergency department and hospital use among patients in methadone maintenance and long-term residential programs.
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Another reason for more closely integrating ART and opioid agonist maintenance treatment is that the two sets of drugs often have serious interactions that require careful dose adjustments and monitoring. There is a significant literature documenting interactions between opioid agonist maintenance drugs and other drugs, particularly those involving metabolism by liver cytochrome P450 3A4 such as antiretroviral medications.
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These findings indicate that IDUs can benefit from integrated drug treatment, HIV care, and other health and social services. RECOMMENDATIONS Based on its review of the evidence, the Committee makes the following recommendations: Recommendation 2-1: Given the strong evidence of its effectiveness in treating opioid dependence, opioid agonist maintenance treat ment should be made widely available where feasible.
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Little research has been done to evaluate the effectiveness of naltrexone treatment or psychosocial interventions alone for reducing HIV risk behavior or HIV transmission associated with opioid dependence. Nevertheless, some patients respond to these treatments, and some will not accept or cannot access opioid agonist maintenance treatment.
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CONCLUSION In this chapter, the Committee reviewed the evidence of effectiveness of drug dependence treatment in reducing drug-use, drug- and sex-related HIV risk behaviors, and HIV seroconversion. The Committee's findings and recommendations for policymakers and clinicians are summarized as follows: For injecting opioid users seeking treatment: Opioid agonist maintenance treatment is the only consistently effective treatment for opioid dependence.
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Psychosocial interventions alone have not been shown to be consistently effective in treating opioid dependence. More research is needed on the additional benefits and cost-effectiveness of adding psychosocial interventions to opioid agonist maintenance treatment for opiate-dependent people in high-risk countries, and the relative effectiveness of those interventions in particular cultural contexts and for particular patient subgroups.
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2004. Psychosocial combined with agonist maintenance treatments versus agonist maintenance treatments alone for treatment of opioid dependence.
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1994. The privatization of methadone maintenance: Changes in risk behavior associated with cost related detoxification.
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2003. A randomized controlled trial of methadone maintenance treatment versus wait list control in an Aus tralian prison system.
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1998. Effectiveness of psychosocial interventions in preventing HIV risk behaviour in injecting drug users.
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1996. HIV risk behaviors among women in methadone maintenance treatment.
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2000. Influence of psychiatric comorbidity on HIV risk behaviors: Changes during drug abuse treatment.
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2001. Methadone maintenance as HIV risk reduction with street-recruited injecting drug users.
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2000. Adherence to HAART in French HIV-infected injecting drugs users: The contribu tion of buprenorphine drug maintenance treatment.
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2001. Meta-analysis of HIV risk reduction interventions with drug abuse treatment programs.
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1997. Buprenorphine vs metha done maintenance treatment for concurrent opioid dependence and cocaine abuse.
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1996. Methadone maintenance treatment and HIV risk-taking behaviour among injecting drug users in Berlin.
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2003. Effects of long-term, medically supervised, drug-free treatment and methadone maintenance treatment on drug users' emergency department use and hospitalization.
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