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Pharmacotherapy of Addictions David W. Oslin, MD University of Pennsylvania, School of Medicine And Philadelphia, VAMC Hazelden Research Co-Chair on Late Life Addictions Focus on Abuse and Dependence Participating in Specialty Care Problems / Abusive Drinking Dependent Pharmacotherapy – a real option for treatment Alcohol dependence Naltrexone Acamprosate Antabuse Opioids Buprenorphine Methadone Cocaine ? Nicotine Nicotine replacement Bupropion Varenacline Naltrexone FDA approved for the treatment of alcohol dependence Functions as an opioid receptor antagonist (mu >> delta or kappa) Development was an example of bench to bedside translational science (opioid effects on reward pathways) Randomized Placebo Controlled Naltrexone Trials Studies supporting efficacy Study Studies not supporting efficacy # Ss Notes Volpicelli et al 1992 70 None O’Malley et al 1992 97 Volpicelli et al 1997 Study # Ss Notes Oslin et al 1997 44 Older None Kranzler et al 2000 183 None 97 None Krystal et al 2001 627 VA only Kranzler et al 1998 20 Depot Lee et al 2001 (Singapore) 53 None Anton et al 1999 131 None Gastpar et al 2002 (Germ.) 171 None Chick et al 2000 (UK) 169 Adherence Kranzler et al 2004 315 Depot Monterosso et al 2001 183 None Killeen et al 2004 145 None Morris et al 2001 (Australia) 111 None Oslin et al in press 240 None Heinala et al 2001 (Finland) 121 Nonabst. Latt et al 2002 (Australia) 107 None Ahmadi and Ahmadi 2002 (Iran) 116 None Guardia et al 2002 (Spain) 202 None Balldin 2003 118 None Kiefer et al 2003 (Germany) 160 None Kranzler et al 2003 153 None Kranzler et al 2004 315 For drinking not relapse Anton et al 2004 270 None Garbutt et al 2005 627 Depot / males Acamprosate Mechanism of action is unknown – GABA vs NMDA Low rate of adverse effects Usual dose 2 gm/d divided 4 times/day SSRI’s and other serotonergic agents By all accounts serotonin is important in addictions But results from treatment trials? Some say yes, some say no, others maybe. Does the target audience matter? Treatment Algorithm Appropriate Candidates for Treatment Adults with Alcohol Dependence No Liver Failure/Active Hepatitis No Current Opioid Use Not Pregnant Naltrexone Should Be Used for Patients With: Prior treatment failure High level of interest in biomedical therapies Low level of interest in traditional psychosocial therapies Cognitive impairment In most alcohol-dependent patients Consider depot formulation for added adherence Consider Naltrexone as a Second Line Treatment in Patients Who are: Pregnant Adolescent Experiencing Active Liver Disease Experiencing Severe Medical Problems Known to be Very Non-Compliant (start on depot) Requiring Opioid Medications About to have Surgery Pretreatment Work-up Education - alcohol dependence as a disease Physical Exam Laboratory Testing Serum Transaminases Total Bilirubin Pregnancy Test Urine Toxicology Test Medical History Substance Use/Abuse History Mental Health Status Starting Naltrexone Education expected benefits goals for treatment importance of compliance adverse effects interactions with alcohol safety card Pharmacotherapy – a real option for treatment Alcohol dependence Naltrexone Acamprosate Antabuse Opioids Buprenorphine Methadone Cocaine ? Nicotine Nicotine replacement Bupropion Appropriateness for Buprenorphine Consider these factors 1. Does the patient have a diagnosis of opioid dependence? 2. Is the patient interested in buprenorphine treatment? 3. Does the patient understand the risks/benefits of buprenorphine treatment? Appropriateness for Buprenorphine Consider these factors (continued) 4. Is he/she expected to be reasonably compliant? 5. Is he/she expected to follow safety procedures? 6. Is the patient sufficiently psychiatrically stable? Appropriateness for Buprenorphine Consider these factors (continued) 7. Are the psychosocial circumstances of the patient stable and supportive? 8. Can the clinic provide the needed resources for the patient (either on or off site)? 9. Is the patient taking other medications that may interact with buprenorphine? Appropriateness for Office-based Buprenorphine Patient is less likely to be an appropriate candidate for office-based buprenorphine treatment 1. Dependence on high doses of benzodiazepines, alcohol, or other CNS depressants 2. Significant psychiatric co-morbidity 3. Active or chronic suicidal or homicidal ideation or attempts Appropriateness for Office-based Buprenorphine Patient is less likely to be an appropriate candidate for office-based buprenorphine treatment (continued) 4. Multiple previous treatments and relapses 5. Non-response to buprenorphine in the past 6. Patient needs cannot be addressed with existing office-based resources Appropriateness for Office-based Buprenorphine Patient is less likely to be an appropriate candidate for office-based buprenorphine treatment (continued) 7. High risk for relapse 8. Pregnancy 9. Current medical condition(s) that could complicate treatment 10. Poor support systems Preparation for Induction Are all necessary assessments completed? H&P ECG Labs Psychosocial assessment Consent for treatment and, If necessary, treatment contract Is patient education for induction completed? Preparation for Induction Determine when, how and where you will start medication Advise patient not to use opioids for an appropriate amount of time prior to first dose Ensure that patient has arranged for transportation home from appointment for first dose Other contingency preparations? Summary Buprenorphine and buprenorphine/naloxone are effective for the treatment of opiate dependence in the office setting. Physicians can easily become qualified to prescribe buprenorphine. Managing patients within the office setting can be done with existing resources and minimal difficulty. Administrative Issues Availability of physician Clinic Directive Malpractice Availability of lab support Monitoring (psychosocial platform)
