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1 results from more than 10 years (inter-) national research Peter Blanken Mexico February 2012 Central Committee on the Treatment of Heroin Addicts (CCBH) Parnassia Addiction Research Centre (PARC), Brijder Addiction Treatment

2 overview of presentation effective treatments for opioid dependence supervised heroin-assisted treatment remaining problems and potential solutions conclusions

3 effective treatments for opioid dependence

4 effective treatments for opioid dependence good medical practice: cornerstones do not harm the patient if necessary: crisis intervention intoxication and withdrawal psychiatric / medical co-morbidity 1 if possible: cure initiate abstinence prevent relapse (limit frequency and severity) 2 if cure is not possible, then: care reduce or stabilize substance use reduce harm stabilize and improve physical, mental and social functioning 3 palliation Netherlands Health Council 1995; American Psychiatric Association 2007

5 effective treatments for opioid dependence treatment goals and interventions heroin addiction type goal process medicine EBM Crisis Intervention Immediate Survival Reanimation Naloxone +++ Cure Stable Abstinence Detoxification Methadone reduction Buprenorphine reduction Clonidine/Lofexidine ++ Naltrexone (ROD/UROD) ++ Relapse prevention Naltrexone maintenance (implants/depot) ± Care Stabilization Reduction ill drug use Methadone maintenance HD +++ Buprenorphine maintenance ++ Methadone maintenance LD + Harm reduction Secondary prevention Heroin maintenance ++ Palliation Pain Relieve Provide abused drug Methadone/Heroin na van den Brink & Haasen 2006; van den Brink & Van Ree 2003; Lingford-Hughes et al. 2004, Vocci et al. 2005; O Brien 2005

6 remaining problems chronicity of dependence

7 remaining problems chronicity of dependence McLellan et al Addiction

8 remaining problems chronicity of dependence Hser et al Archives General Psychiatry

9 remaining problems 'open drug scenes': Zürich, Switzerland Rotterdam, The Netherlands public nuisance despite available and accessible MMT

10 heroin-assisted treatment in The Netherlands

11 remaining problems conference: 8 May medical social HEROIN DISPENSATION a recipe against deterioration of addicted people 1981

12 The Netherlands treatment heroin addicts in the Netherlands (1995) TOTAL N = 24,000 15% injectors, 85% smokers in treatment N = 17,000 not in treatment N=7, METHADONE MAINTENANCE N = 12,500 DRUGFREE TREATMENT N = 4, integrated N = 4,500 not integrated N = 5,000 extremely problematic N = 3,000

13 the Dutch heroin trials

14 the Dutch trials design: randomized waiting list design target group phase I 2 months randomization phase IIa 6 months phase IIb 6 months phase III 6 months 1. inhaling M (N=275) 1A (N=135) 1B (N=115) M M+H M M+H M+H (inh) appropriate no H 1A (N=135) M M 2. injecting M (N=250) 1B (N=115) M+H M+H M = oral methadone; H = heroin; inh = inhalable; iv = intravenous M+H (inj) appropriate no H M = oral methadone; H = heroin; inh = inhalable; iv = intravenous

15 the Dutch trials chronic, treatment resistant heroin addicts inclusion criteria DSM-IV heroin dep > 5 yrs registered in MMT last 12 mths >30-50 visits to MMT last 6 mths >50-60 mg meth > 4 wks last 5 yrs (nearly) daily use of heroin poor social integration and/or poor physical and/or mental health age > 25 yrs llegal resident in The Netherlands registered in area > 3 yrs willing to be randomized written informed consent exclusion criteria not meeting ALL inclusion criteria illness with high safety risk illness or behaviour likely to interfere with study completion pregnant or lactating awaiting long imprisonment other drugs dominating heroin dep short life-time expectancy voluntary abstinence > 2 mths past yr requiring > 150 mg oral methadone requiring > 1000 mg heroin participating in other study

16 the Dutch trials experimental and control treatment control treatment oral methadone < 150 mg/day standard psychosocial offer experimental treatment oral methadone < 150 mg/day standard psychosocial offer heroin inhalable or intravenous: 0-7 days/week 0-3 times/day < 400 mg/administration < 1000 mg/day dosages individually titrated no prescription other illicit drugs

17 the Dutch trials response definition 40% improvement in physical health and / or 40% improvement in mental status and / or 40% improvement in social functioning ánd no serious deterioration (40% in any domain) ánd no increase in cocaine (or other drug) use

18 the Dutch trials chronic, treatment-resistant heroin addicts patient characteristics (n = 549) age 39 years female patients 19 % Dutch/Western 86 % heroin 16 years 26 days methadone 12 years 29 days cocaine 10 years (92%) 18 days (86%) poly drug use 17 years 29 days physical problems 66 % psychiatric problems 60 % social problems 72 %

19 percentage responders heroin-assisted treatment the Dutch trials treatment response 100% 12 m onths m ethadone 12 m onths m ethadone + heroin 80% 60% = 24.3 (95%-CI: ) = 22.8 (95%-CI: ) 40% 20% % injectable heroin inhalable heroin van den Brink et al BMJ

20 MAP-HSS score number of days 0 number of days SCL-90 score 0 heroin-assisted treatment the Dutch trials number of days discontinuation completers 217 (70%) responder 115 (53%) deteriorated responders 94 (82%) 20 physical health 100 mental status 30 illegal activities ,1 11,4 4,9 no contact non-drug users ,9 cocaine use 26 69, ,1 0,3 15, ,1 11,5 20, ,4 12 = baseline = 12 months = 14 months

21 cost-effectiveness

22 cost-effectiveness cost versus benefits heroin assisted treatment per patient, per year methadone treatment heroin treatment - costs medical + psychosocial treatment - costs property crimes (damage to citizens/companies) 2,500 18,800 35,000 9,600 - costs involvement legal system 12,900 8,800 - total costs 50,400 37,200 (average) net savings per patient per year: approx. 13,000 in favor of heroin assisted treatment Dijkgraaf et al BMJ

23 long-term treatment outcome

24 long-term outcome results long-term ongoing heroin-assisted treatment 56% treatment retention after 4 years 90-92% treatment responders patients "free of problems" - no physical health problems 82% - no mental health problems 88% - no illegal activities 100% - no mainly drug scene contacts 93% - no illicit heroin use 100% - no cocaine use 53% - no excessive alcohol use 78% "complete recovery" 25% Blanken et al Addiction [see also: Güttinger et al. 2003; Verthein et al. 2008]

25 from RCT to Routine Clinical Treatment

26 Routine Clinical Treatment results randomized controlled trial versus routine clinical treatment similar patients less injectable heroin (22% versus 39%) higher methadone dosages (72 mg. versus 61 mg.) comparable 12-months treatment retention (79% versus 70%) equal effectiveness (55% versus 51% response) increased non-related fatalities (2.0% versus 0.5%) stronger reduction in cocaine use (6.1 versus 3.1 days) Blanken et al European Neuropsychopharmacology

27 current situation in The Netherlands

28 current situation in The Netherlands current situation 2006: 100 miles N = patients patients patients treatment units: treatment slots: ± (in 15 cities)

29 international situation

30 international situation heroin-assisted treatment in Europe and Canada Switzerland (Lancet, 2001) Large cohort study: feasibility HAT Netherlands (BMJ, 2003) Two RCTs: effectiveness HAT vs MMT Spain (JSAT, 2006) Small RCT: effectiveness HAT vs MMT Germany (BJP, 2007) Large RCT: effectiveness HAT vs MMT and moderation by psychotherapy Canada (NEJM, 2009) RCT: effectiveness HAT vs MMT UK (The Lancet, 2010) RCT: effectiveness HAT vs MMT iv and optimized oral MMT

31 international situation heroin-assisted treatment in Europe and Canada

32 international situation BACKGROUND: Several types of medications have been used for stabilizing heroin users: Methadone, Buprenorphine and levo-alpha-acetyl-methadol (LAAM.) The present review focuses on the prescription of heroin to heroin-dependent individuals. OBJECTIVES: To compare heroin maintenance to methadone or other substitution treatments for opioid dependence regarding: efficacy and acceptability, retaining patients in treatment, reducing the use of illicit substances, and improving health and social functioning. SEARCH METHODS: A review of the Cochrane Central Register of Trials (The Cochrane Library Issue 1, 2005), MEDLINE (1966 to november 2009), EMBASE (1980 to 2005) and CINAHL until 2005 (on OVID) was conducted. Personal communications with researchers in the field of heroin prescription identified ongoing trials. SELECTION CRITERIA: Randomised controlled trials of heroin maintenance treatment (alone or combined with methadone) compared with any other pharmacological treatment for heroin-dependent individuals. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. MAIN RESULTS: Eight studies involving 2007 patients met the inclusion criteria. Five studies compared supervised injected heroin plus flexible dosages of methadone treatment to oral methadone only and showed that heroin helps patients to remain in treatment (valid data from 4 studies, N=1388 Risk Ratio 1.44 (95%CI ) heterogeneity P=0.03), and to reduce use of illicit drugs. Maintenance with supervised injected heroin has a not statistically significant protective effect on mortality (4 studies, N=1477 Risk Ratio 0.65 (95% CI ) heterogeneity P=0.89), but it exposes at a greater risk of adverse events related to study medication (3 studies N=373 Risk Ratio (95% CI ) heterogeneity P=0.52). Results on criminal activity and incarceration were not possible to be pooled but where the outcome were measured results of single studies do provide evidence that heroin provision can reduce criminal activity and incarceration/imprisonment. Social functioning improved in all the intervention groups with heroin groups having slightly better results. If all the studies comparing heroin provision in any conditions vs any other treatment are pooled the direction of effect remain in favour of heroin. AUTHORS' CONCLUSIONS: The available evidence suggests an added value of heroin prescribed alongside flexible doses of methadone for long-term, treatment refractory, opioid users, to reach a decrease in the use of illicit substances, involvement in criminal activity and incarceration, a possible reduction in mortality, and an increase in retention in treatment. Due to the higher rate of serious adverse events, heroin prescription should remain a treatment for people who are currently or have in the past failed maintenance treatment, and it should be provided in clinical settings where proper follow-up is ensured. Ferri et al Cochrane Database Systematic Reviews

33 remaining problems potential solutions

34 psychosocial treatment

35 psychosocial interventions Prendergast et al Addiction

36 psychosocial interventions cocaine contingency management within HAT design heroin assisted treatment heroin-treatment + CM heroin-treatment alone randomisation heroin-treatment alone heroin-treatment + CM heroin-treatment Experimental group Control group Naturalistic compar. group

37 pharmacological treatment

38 cocaine pharmacological interventions rational substitution controlled and safe versus uncontrolled and harmful stabilising biology, addictive behavior, day structure motivating and supportive interventions (Shearer 2008; Grabowski et al. 2004; Herin et al. 2010) balance between effectivity versus potential harm no effect of dopamine-agonists in terms of treatment retention, cocaine use or craving (De Lima et al. 2002; Soares et al. 2003) no strong/significant effect of CNS stimulants in terms of treatment retention or cocaine use (Castells et al. 2007)... but most promising: modafinil and dex-amphetamine Herin et al Annals NY Academy Sciences; Shearer 2008 Drug Alcohol Review; Grabowski et al Addictive Behaviors; De Lima et al Addiction; Soares et al Cochrane; Castells et al Addiction

39 cocaine pharmacological interventions Cocaine Addiction Treatments to improve Control and reduce Harm 3 cities - 3 treatment centres - 3 "new" pharmacotherapies: The Hague (Brijder Verslavingszorg); Amsterdam (Jellinek-Mentrum); Rotterdam (Bouman GGZ) intervention: 12 weeks "treatment as usual" (CBT + MI), with farmacotherapeutic "add on": - Topiramate (2 n = 36) 200 mg/day - Modafinil (2 n = 36) 400 mg/day - Dexamphetamine (2 n = 36) 60 mg/day primary outcome: secondary outcome: start: late 2008 / early 2009 retention / compliance illicit cocaine use (urinalysis, self-report) Nuijten et al BMC Psychiatry

40 cocaine pharmacological interventions cocaine Hurtado-Gumucio - cocane-paste dependent individuals in Bolivia (n=50) - open study, without control group gr coca-leaves per week 1-4 gr cocaine-alkaloid - 'improved' mental, physical and social functioning: pre - 28%, post - 48% Llosa - cocaine-paste dependent individuals in Peru (n=23) - open study, without control group - 2 x per day, 2 bags coca-tea 20 mg cocaine-alkaloid - reduced craving, reduced relapse, longer abstinence duration Walsh - cocaine dependent individuals (n=8) - orally administered cocaine ( mg/day; 4-x per day; 5 weeks) - double-blind, within subjects, cross-over - reduced subjective and fysiologic reactions following intravenous cocaine ( mg) Hurtado-Gumucio 2000 Annales Médicine Interne; Llosa 1994 Substance Abuse Walsh et al Psychopharmacology

41 conclusions

42 conclusions in a comprehensive treatment system for heroin-dependent individuals who do not benefit from first choice maintenance treatment heroin-assisted treatment is a save ánd an effective treatment option (Perneger et al. 1998; Rehm et al. 2001; van den Brink et al. 2003; March et al. 2006; Haasen et al. 2007; Oviedo-Joekes et al. 2009; Strang et al. 2010) beneficial effects are linked to (long-term) treatment continuation (van den Brink et al. 2003; Güttinger et al. 2003; Verthein et al. 2008; Blanken et al. 2010) no stable predictors for treatment retention or treatment response, except for abstinence-oriented treatment (Blanken et al. 2005; Haasen et al. 2010; Nosyk et al. 2010) costly but cost-effective treatment (Frei et al. 1998/2001; Dijkgraaf et al. 2005)

43 conclusions supervised heroin-assisted treatment as routine clinical treatment is equally effective and safe strictly defined patient population well described treatment guidelines closely monitored (Blanken et al. 2010)

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