Buprenorphine Treatment of Opioid Dependence in Adolescents &Young Adults

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1 Buprenorphine Treatment of Opioid Dependence in Adolescents &Young Adults Ximena Sanchez-Samper, MD Sharon Levy, MD, MPH Adolescent Substance Abuse Program (ASAP) Center for Adolescent Substance Abuse Research (CeASAR) Children s Hospital Boston, Harvard Medical School

2 Overview 1. So what s the big deal anyway? (Epidemiology) 2. Why should treatment of adolescents/young adults be approached differently than older individuals? (Developmental considerations) 3. Why do opioid dependent adolescents/young adults benefit from pharmacologic treatment with buprenorphine? (Treatment Goals) 4. What does the research say? 5. How does Adolescent Substance Abuse Program (ASAP) approach the treatment of opioid dependent adolescents/young adults?

3 So what s the big deal anyway? (Epidemiology of opioid dependence among adolescents & young adults.)

4 Opioids Natural and synthetic substances with morphine like activity (mu receptor): Used for 6000 years (since Hippocrates) Medical use: Analgesia & Cough suppression High addiction potential: can be misused/abused Increased potency: leads to increased physical and psychological dependence Stigma prevents treatment: Brain disease NOT a moral issue!

5 Epidemiology of Opioid Dependence in the US Millions of people Americans (4.6% of the world s population) consume approximately 80% of the world s opioid supply. Americans consume 99% of the world s supply of hydrocodone (Vicodin). Substance Abuse and Mental Health Services Administration (SAMHSA) Office of Applied Studies. Substance Use Treatment Need among Adolescents: National Survey on Drug Use and Health (NSDUH) Wang J, Christo PJ. The influence of prescription monitoring programs on chronic pain management. Pain Physician. May-Jun 2009;12(3):507-15

6 Opioid use by US adolescents and young adults Non-medical opioids use was associated with the largest number of new users than any other illicit drug category Prescription meds are misused by adolescents more than any other drug except alcohol & marijuana. Approx. 1 in 8 HS seniors has used a prescription opioid recreationally/non-medical use (13.1% lifetime use) Almost half (44%) of new recreational use of prescription painkillers in 2001 was by people younger than age 18. The number of 18- to 25-year-olds admitted to treatment for prescription painkillers more than doubled between 1993 and Substance Abuse and Mental Health Services Administration (SAMHSA) Office of Applied Studies. Substance Use Treatment Need among Adolescents: National Survey on Drug Use and Health (NSDUH) 2006.

7 Reasons for Misusing Pain Meds Easy to get from medicine cabinet 62% Available everywhere 52% Not illegal 51% Easy to get through other people s prescription 50% Can claim to have a prescription if caught 49% Cheap 43% Safer to use than illegal drugs 35% Less shame attached to using 33% Easy to purchase over the Internet 32% Fewer side effects than street drugs 32% Parents don t care as much if you get caught 21% N= 7,216; grades 7th to 12th The Partnership for a Drug-Free America: The Partnership Attitude Tracking Study (PATS)

8 Reasons for Misusing Pain Meds Easy to get from medicine cabinet 62% Available everywhere 52% Not illegal 51% Easy to get through other people s prescription 50% Can claim to have a prescription if caught 49% Cheap 43% Safer to use than illegal drugs 35% Less shame attached to using 33% Easy to purchase over the Internet 32% Fewer side effects than street drugs 32% Parents don t care as much if you get caught 21% N= 7,216; grades 7th to 12th The Partnership for a Drug-Free America: The Partnership Attitude Tracking Study (PATS) 2008.

9 Reasons for Misusing Pain Meds Easy to get from medicine cabinet 62% Available everywhere 52% Not illegal 51% Easy to get through other people s prescription 50% Can claim to have a prescription if caught 49% Cheap 43% Safer to use than illegal drugs 35% Less shame attached to using 33% Easy to purchase over the Internet 32% Fewer side effects than street drugs 32% Parents don t care as much if you get caught 21% N= 7,216; grades 7th to 12th The Partnership for a Drug-Free America: The Partnership Attitude Tracking Study (PATS) 2008.

10 Reasons for Misusing Pain Meds Easy to get from medicine cabinet 62% Available everywhere 52% Not illegal 51% Easy to get through other people s prescription 50% Can claim to have a prescription if caught 49% Cheap 43% Safer to use than illegal drugs 35% Less shame attached to using 33% Easy to purchase over the Internet 32% Fewer side effects than street drugs 32% Parents don t care as much if you get caught 21% N= 7,216; grades 7th to 12th The Partnership for a Drug-Free America: The Partnership Attitude Tracking Study (PATS) 2008.

11 Consequences of Opioid Misuse Repeated exposure: neuronal changes and adaptations Tolerance, sensitization, withdrawal, craving and selfadministration (development of Addiction/Dependence) Dramatic increase in # of young heroin users: decreased price, increased purity (7% 2-3 decades ago to approx 69% today) HIV, Hepatitis B and C, Overdose/ Death Crime, Violence, Problems in Family /Workplace/School Economy ($100 billion): unemployment, missed work, criminal activities, medical care and social welfare Leshner AI., Drug abuse and addiction treatment research. The next generation. Archives of General Psychiatry 54(8):

12 Why should treatment for adolescents/young adults be approached differently than older individuals? (Developmental Considerations)

13 Adolescent Development Profound physical changes Perceived invulnerability New cognitive abilities: abstract thinking, propositional logic Social development: peer relationships assume new importance, family relationships transformed

14 Special Features of Adolescents Brain still developing Parent/guardian still assumes responsibility; need more structure than adults May be entering treatment relatively earlier in course than adult patients

15 Parental Involvement as Protective Factor Against Misuse of Prescription Opioids Teenagers who did not misuse opioids said: their parents often checked their homework they are frequently praised by their parents they perceive strong disapproval of marijuana use from their parents Sung H.E., Nonmedical use of prescription opioids among teenagers in the United States: trends and correlates. Journal 15 of Adolescent Health, 2005 Jul;37(1):44-51.; National Survey on Drug Use and Health (NSDUH) 2002.

16 Why do opioid dependent adolescents/young adults benefit from pharmacologic treatment with buprenorphine?

17 Overview of Treatment Non-pharmacologic Pharmacologic Residential treatment Detox: methadone, buprenorphine, clonidine, comfort meds Intensive outpatient/partial Opioid antagonism: naltrexone PO or IM 12 step fellowships Replacement therapy: methadone, buprenorpine Individual or group therapy Family therapy Therapeutic school/community

18 Buprenorphine formulations in the USA SUBOXONE combination tablet or film 2mg (2mg buprenorphine / 0.5mg naloxone) 8mg (8mg buprenorphine / 2mg naloxone) SUBUTEX 2mg or 8 mg

19 Buprenorphine: Treatment Goals A- Decrease risk of overdose/death B- Suppress withdrawal/dysphoria C- Block or attenuate euphoric effect ( high ) of exogenous opioids D- Minimize/eliminate craving for opioids E- Decrease diversion, IV use & risk of transmission of HBV/HCV/HIV & other infections F- Improve functional status in all spheres of life

20 Benefits of Office-Based Treatment Good first choice for adolescents & young adults Confidential, safe & effective treatment provided in a doctor s office Fits lifestyle: no daily clinic visits or out-of-town, costly residential treatment More time for school, work, family & other activities Allows for parental involvement/ support Buprenorphine approved for >16 y/o Should combine w/ psychosocial therapies & random urine testing Mattick et al., Buprenorphine versus methadone maintenance therapy: a randomized double-blind trial with 405 opioid-dependent patients., Addiction, 2003 Apr;98(4): ; Gowing, L., Buprenorphine for the management of opioid withdrawal., Cochrane Database Syst Rev. 2000;(3):CD

21 What does the research say?

22 Research on Treatment for Opioid-Dependent Adolescents Few studies in 1960 s-70 s No control groups or random assignment or focus on youth under age 18 Don t reflect characteristics of current cohort of opioid abusing youth Recent reports: Marsch, Woody, Levy

23 Marsch, L.A., et al. Comparison of pharmacological treatments for opioid-dependent adolescents: A randomized controlled trial. Archives of General Psychiatry 62(10): , Comparison of Pharmacological Treatments for Opioid-Dependent Adolescents First randomized controlled trial Double blind, double-dummy study Compare relative efficacy of buprenorphine and clonidine in detoxification of opioiddependent youth 28 day detox Participants years old, n=36

24 Marsch, L.A., et al. Comparison of pharmacological treatments for opioid-dependent adolescents: A randomized controlled trial. Archives of General Psychiatry 62(10): , Behavioral Interventions All 36 participants received multi-component behaviorally treatment program: Individual and family therapy: based on Community Reinforcement Approach Contingency Management: incentives based on results of 3x weekly urinalysis & clinic attendance Outreach component: engage adolescents in recreational & other pro-social activities

25 Post-Detoxification Interventions All adolescents provided w/ 2 months of aftercare including: Individual Counseling Urinalysis (semi-quantitative) Naltrexone (opioid antagonist) Referral to community-based treatment facility Marsch, L.A., et al. Comparison of pharmacological treatments for opioid-dependent adolescents: A randomized controlled trial. Archives of General Psychiatry 62(10): , 2005.

26 Participant retention by medication condition p<.04 Marsch, L.A., et al. Comparison of pharmacological treatments for opioid-dependent adolescents: A randomized controlled trial. Archives of General Psychiatry 62(10): , 2005.

27 Mean % of opiate-negative urinalysis results for entire treatment duration p=.01 Marsch, L.A., et al. Comparison of pharmacological treatments for opioid-dependent adolescents: A randomized controlled trial. Archives of General Psychiatry 62(10): , 2005.

28 % participants who initiated naltrexone-hcl treatment post detoxification Marsch, L.A., et al. Comparison of pharmacological treatments for opioid-dependent adolescents: A randomized controlled trial. Archives of General Psychiatry 62(10): , 2005.

29 HIV risk behavior after the 1st week of treatment Drug-related risk composite score Intake End of 1st week Buprenorphine Clonidine Marsch, L.A., et al. Comparison of pharmacological treatments for opioid-dependent adolescents: A randomized controlled trial. Archives of General Psychiatry 62(10): , 2005.

30 Summary of Findings Participants in both groups significantly decreased HIV risk factors upon trial entry Compared to clonidine, patients who received 4 weeks of buprenorphine treatment: Had fewer positive drug tests Stayed in treatment longer Were more likely to continue pharmacologic treatment after the 4 week trial period Marsch, L.A., et al. Comparison of pharmacological treatments for opioid-dependent adolescents: A randomized controlled trial. Archives of General Psychiatry 62(10): , 2005.

31 Extended vs. Short-term Buprenorphine- Naloxone for Treatment of Opioid-Addicted Youth Randomized-controlled trial 2-week detox vs 12-week treatment All patients also received 2 counseling sessions (1 individual and 1 group) for 12 weeks Participants years old, n=156 Woody, GE., et al. Extended vs. Short-term Buprenorphine-Naloxone for Treatment of Opioid-Addicted Youth. JAMA 300(17) : , 2008.

32 Opioid-Negative Urine Samples Percent of opioid (-) urines P<.05 P<.05 Detox Treatment 0 Week 4 Week 8 Week 12 Begin taper for treatment group

33 Drug test results on long term follow-up Woody, GE., et al. Extended vs. Short-term Buprenorphine-Naloxone for Treatment of Opioid-Addicted Youth. JAMA 300(17) : , 2008.

34 Summary of Findings 12-week treatment with buprenorphine-naloxone improved outcomes compared with 2-week detoxification. Further research is necessary to assess the efficacy and safety of longer-term treatment with buprenorphine for adolescents with opioid dependence. Woody, GE., et al. Extended vs. Short-term Buprenorphine-Naloxone for Treatment of Opioid-Addicted Youth. JAMA 300(17) : , 2008.

35 Buprenorphine Replacement Therapy for Adolescents in a Children s Hospital Based Outpatient Treatment Program Case series describing the unique challenges of treating opioid dependent adolescents Early diagnosis Negotiating adolescent/parent relationship Managing harm reduction in adolescents Levy S, Vaughan BL, Angulo M, Knight JR. Buprenorphine replacement therapy for adolescents with opioid dependence: J Adolesc Health; 40: , 2007

36 How does the Adolescent Substance Abuse Program at Boston Children s Hospital approach office-based treatment of opioid dependent adolescents?

37 Adolescent Substance Abuse Program (ASAP) at Children s Hospital Boston Staff Developmental-Behavioral Pediatric specialists Addiction Psychiatrists Master s level Licensed Independent Social Workers over 400 individual patients/ over 4000 visits in 2010 supported entirely by clinical revenue since 2005

38 Buprenorphine Program Encourage Abstinence Patient signs a contract committing to working towards abstinence from all substances Harm reduction used as a stepping stone towards abstinence Additional treatment recommended for patients who continue to use substances other than opioids Patients kept on buprenorphine as long as they are not using opioids

39 Buprenorphine Program Monitoring Directly observed induction All medication observed by parents Pill counts at each visit Small prescriptions, no early refills Random drug testing to monitor for medication compliance and use of illicit drugs

40 Buprenorphine Program Psychosocial Support Psychosocial support required for adolescent and parents as a condition of participating in med program Team guides level of care Several options given within level of care (individual, group, AA/NA, etc.)

41 Buprenorphine Program Ancillary Treatment On intake patients complete mental health, medical and educational/vocational screens Psychopharmacology offered in ASAP Patients given support in finding appropriate educational advocates, vocational training programs and outside counselors Consent obtained to coordinate care with all outside providers

42 Maintenance and Beyond No maximum or minimum duration of treatment Continue meds until drug-free for at least one year Slow taper Drug testing and follow-up visits continue even after Buprenorphine has been discontinued

43 Program Results 100% 99% Percent days abstinent 90% 80% 70% 60% 50% 40% 30% 20% 10% 81% 57% 84% Any substance including alcohol, marijuana and illicit drugs Illicit drugs including opioids 0% Baseline 9 Months Time of Assessment Knight et al, Unpublished data.

44 Take Home Messages Pharmacotherapy is a critical component of successful treatment of opioid dependence Treatment outcomes improve when medication is provided along with intensive behavioral therapy Psychosocial treatment should address co-occurring psychiatric disorders and age-specific issues to be effective Further research on prevention & treatment interventions are needed

45 INDIVIDUALS: Acknowledgements Wes Boyd, Frank Busconi, Camilo Chao, S. Jean Emans, Sion Harris, Sue Kiley, John Knight, Kim Knowlton-Young, Emily Leadholm, Carolyn McLaughlin, Shannon Mountain-Ray, Marianne Pugatch, Lenny Rappaport, Patricia Schram, Lon Sherritt, Shari Van Hook, Brigid Vaughan, Roger Weiss INSTITUTIONS: Children s Hospital Boston: Center for Adolescent Substance Abuse Research, Division of General Pediatrics, Division of Adolescent/Young Adult Medicine, Department of Psychiatry Harvard Medical School: Department of Pediatrics, Department of Psychiatry, Division on Addictions McLean Hospital: Department of Psychiatry

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