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Amphetamine Addiction in Iceland and efficacy of pharmacotherapy

Amphetamine Addiction in Iceland and efficacy of pharmacotherapy. Valgerður Rúnarsdóttir, M.D., Vogur Hospital Iceland SAA National Center of Addiction Medicine Ingunn Hansdóttir, PhD, Assistant Professor University of Iceland

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Amphetamine Addiction in Iceland and efficacy of pharmacotherapy

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  1. Amphetamine Addiction in Iceland and efficacy of pharmacotherapy Valgerður Rúnarsdóttir, M.D., Vogur Hospital Iceland SAA National Center of Addiction Medicine Ingunn Hansdóttir, PhD, Assistant Professor University of Iceland Research Counsil Member SAA National Center of Addiction Medicine Symposium on Emerging Data on Efficacy and Clinical Applications of Extended Release Naltrexone Formulations, presented at 75th Annual Meeting - College on Problems of Drug Dependence - June 15-20, 2013, San Diego, CA

  2. Disclosure of relevant financial relationships • Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland • NIDA research grant (2P50-DA012756-11) • Alkermes provided study drug Naltrexone/placebo extended release formulation

  3. Investigators Lead investigators University of Pennsylvania: • George Woody, M.D • Helen Pettinati, PhD • Charlotte Royer-Malvestuto • Biostatistician: Kevin Lynch, PhD NIDA project ManagerJamie Biswas, MD Vogur Hospital: • Thor Tyrfingsson, M.D. • Val Runarsdottir, M.D. • Ingunn Hansdottir, PhD • Data Manager: Magnus Einarsson Project co-ordinators Data analysis Other collaborators AlkermesAvani Desai, PharmD Brown University Milunka Kojic, MD

  4. Background • Amphetamine addiction is a growing problem • Number of patients seeking treatment for amphetamine addiction has almost tripled over the past two decades • Proportion of patients has risen, gone from <10% in 1984 to a current rate around 36% • Amphetamines used intravenously, increased risk of HIV and Hepatitis • Increased use among youth • No medications approved for treating amphetamine addiction • Several suggestions that Naltrexone might be effective.

  5. Swedish studies • Jayaram-Lindstrom et al Am.J. Psychiatry, 2008 • Significant effect using oral naltrexone in ramdomized, placebo-controlled 12 week trial of 80 amphetmine dependent outpatients.

  6. Rationale • Can these results be replicated with extended release formula? • Study proposed in Iceland – why Iceland?

  7. Icelandic setting • Centralized addiction treatment • Good access to treatment, free or minimal fee • Vogur hospital lynchpin in addiction trmt • Population endorses disease concept • Well trained staff • Evidence based practice

  8. Icelandic setting - Treatment as usual: Detox • Hospitalization 7-10 days Residential: • 4 weeks Intensive outpatient • 5x week for 1 mo (60 hrs) • 1x week for 3 mo (12 hrs) Outpatient follow-up • 2x week for 3 mo (24 hrs) • 1x week for 9 mo (36 hrs)

  9. Study Design -I • 100 amphetamine dependent treatment seeking patients at Vogur Hospital • Randomized, double blind trial and 6 month trmt with VIVITROL® or VIVITROL®placebo and Treatment as usual • Stratified by gender and IV status. • All participants detoxed at Vogur Hospital and consented. • Randomized before going to outpatient status.

  10. Study Design-II First study injection First study injection

  11. Screening and randomization

  12. Study design - III • Wk 24 • Repeat injections weeks 4, 8, 12, 16, 20 • Baseline assessments:Medical & social history, liver panel (wk3, 11, 23), HepC & HIV (wk24), ASI (wk 12, 24), Fagerström (wk 12, 24) RAB (wk 24), AUDIT (wk 24), Blood for genetics • Brief weekly assessments urine, alcohol breath, AE‘s, TLFB, TSR, Craving • Monthly assessmentsrelapse, pregnancy, BDI, EuroQol, • Month 12, mail-in assessment

  13. Study Design- outcomes Primary outcome • Proportion of amphetamine negative urines during weeks 1-24 of outpatient treatment Secondary outcomes Time to relapse Drug use HIV risk behavior Criminal activity Treatment retention Depression Amphetamine craving Quality of Life

  14. Inclusion criteria • Aged 18 or above. • Primary diagnosis of current amphetamine dependence as defined by DSM-IV-TR with =>10 days of amphetamine use in past month. • Successfully complete 7-10 day assessment and study baseline measures at Vogur. • Abstinent from substances for at least 7 days • Provision of contacts of 3 people • Written consent

  15. Exclusion criteria • AST or ALT >5 times the top limit of normal. • Physiologically dependent on opioids or other substances (nicotine excepted) or known concomitant or planned use of opioid analgesics, positive opioid urine drug test or positive naloxone challenge, • No severe psychiatric, cognitive, or medical problems and no known hypersensitivity to naltrexone

  16. Sample characteristics • No significant differences between treatment grps on sample characteristics. • Males 75% • Caucasian 100% • Average age 31 years • (19-30 years49%; 30-4036%; 40-5815%) • IV injecting 20 • HIV + 0 • HEP C 9

  17. Baseline demographics • No significant differences between treatment grps on baseline demographics. • Stable housing 88% • Never married 37% • Living with partner (>1year) 14% • Education completed 10th grade 59% • Not completed 13% • Employment (>11 days past mo) 12%

  18. Baseline diagnosis

  19. Baseline Placebo Treatment (N = 49) (N = 51) • Prior admissions, mean # 3 3 • BDI score 13 14 • RAB drug risk 0.8 1.5 • RAB sex risk 5.2 5.7 • Amphetamine craving 47 41(VAS 0-100)

  20. Self-reported amphetamine use 4 weeks prior to study No difference at baseline between trmt grps

  21. Missing data and retention • 53% of treatment grp provided UDS at wk 24 • 47% of placebo grp provided UDS at wk 24 • No differences in distributions of time to drop out between the trmt grps (log-rank test)

  22. RetentionNumber of subjects receiving study treatment Four or more injections: 22 treatment (29<4) 28 placebo (21<4)

  23. Negative urines;%1247 urines collected (1194-/53+) 2400 urines target

  24. % Drug Positive Urines(N=1257) • Amphetamine: 4.25 • Benzodiazepines: 8.26 • Marijuana: 6.98 • Cocaine: 1.44 • Opioids: 0.96

  25. Ampetamine Craving Scale by trmt grp

  26. Relapse • 29 subjects self-reported amphetamine relapse (3 days or more) over 6 months • Treatment group: 14 • Placebo group: 15 • 32 subjects self-reported alcohol relapse (3 days or more) over 6 months • Treatment group: 19 • Placebo group: 13

  27. SAE • 15 participants had a SAE with 20 events • 17 hospitalization due to relapse • 1 pneumothorax • 1 abdominal pain, elevated liver enzymes • 1 potential suicide attempt with relapse

  28. AE severitymild, moderate, severe

  29. Adverse Events (total) 64 subjects reported an adverse event 38 subjects reported pain/swelling injection site

  30. Secondary outcomes

  31. Conclusions • Robust response to treatment as usual for those who stayed in trmt with no additional benefit from Naltrexone. • Results did not replicate previous findings • Similarties to other studies: in regards to severity of dependence BSL and retention • Difference in amount of treatment received, start off in detox and 61% residential trmt before getting study drug. • Trend towards worse outcome for those going directly to outpatient (37% /56% +UDS res/out)

  32. Thanks for your attention • Thank you!

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