Case Studies in the Use of Suboxone 2 nd Adriatic Drug Addiction Conference Kranjska Gora May 19, 2005 Melinda Campopiano, M.D. Baron Edmond de Rothschild Chemical Dependency Institute

Suboxone Buprenorphine formulated with naloxone as a sublingual tablet Buprenorphine is absorbed sublingually Naloxone is minimally absorbed and not biologically available If the tablet is dissolved and injected the user will experience acute withdrawal

What is buprenorphine? Receptor Affinity: Partial antagonist –High receptor affinity and receptor occupancy: 95% occupancy at 16 mg (Greenwald et al, 2003) –Blockade or attenuate effect of other opioids –Rapid onset of action Intrinsic Activity: Partial receptor agonist –Lower physical dependence –Limited development of tolerance –Ceiling effect on respiratory depression Slow dissociation –Long duration of action –Milder withdrawal

Duration of Action Duration of action is dose related –4-8 mg: 4-12 h –8-16mg: +/- 24 h –16-24mg:2-3 d Elimination half life h Steady state equilibrium achieved in 3-7d Strive for once daily dosing

Breakdown of buprenorphine Hepatic metabolism: –CYP450 3A4 (little effect on enzyme activity) –N-dealkylation to norbuprenorphine –Glucuronidation Excretion: –30% urine –60% feces

My Protocol Initial history and physical –45 minutes to an hour Follow-up phone call in 24 hours Follow-up visit in one week –Usually 30 minutes Monthly evaluation for refill

The Medical Assessment Drug use history –Current and past drug use –Quantity, frequency, duration, All drug classes –Assessment of dependence – DSM IV Treatment history –Motivation(s) and patient goals –Previous attempts Psychiatric history and mental status exam –Psychosocial circumstances –Family history Discussion of treatment options –Risks and benefits of treatment –Verbal Consent Medical history and physical exam –Clinical lab tests (especially LFT and HCV testing)

Buprenorphine Therapy Cases Case 1 KB Case 2 JM Case 3 TR Case 4 PT Case 5 MW

Case 1: KB October year old who has heard I might help him get off heroin. History of alcohol and cocaine use and abuse for 30 years.

Case 1: KB October year old who has heard I might help him get off heroin. History of alcohol and cocaine use and abuse for 30 years. Ten years of heroin use with 3 years of injecting. Now has to skin pop. Uses 8 to 10 bags a day.

Case 1: KB October year old who has heard I might help him get off heroin. History of alcohol and cocaine use and abuse for 30 years. Ten years of heroin use with 3 years of injecting. Now has to skin pop. Uses 8 to 10 bags a day. Lives with his wife of 23 years in the home of his frail mother-in-law. Has a 21 year old daughter in college and a 16 year old son.

Case 1: KB October year old who has heard I might help him get off heroin. History of alcohol and cocaine use and abuse for 30 years. Ten years of heroin use with 3 years of injecting. Now has to skin pop. Uses 8 to 10 bags a day. Lives with his wife of 23 years in the home of his frail mother-in-law. Has a 21 year old daughter in college and a 16 year old son. Has done several inpatient detox and rehab stays. Has attended both NA and AA. Once detoxed with pharmacist compounded lozenges of buprenorphine.

Case 1: KB October year old who has heard I might help him get off heroin. History of alcohol and cocaine use and abuse for 30 years. Ten years of heroin use with 3 years of injecting. Now has to skin pop. Uses 8 to 10 bags a day. Lives with his wife of 23 years in the home of his frail mother-in-law. Has a 21 year old daughter in college and a 16 year old son. Has done several inpatient detox and rehab stays. Has attended both NA and AA. Once detoxed with pharmacist compounded lozenges of buprenorphine. Physical exam: unremarkable

KB Today Fall 2002 makes 4 separate attempts to detox with clonodine, tramadol and chlordiazepoxide under my supervision. Began antidepressants.

KB Today Fall 2002 makes 4 separate attempts to detox with clonodine, tramadol and chlordiazepoxide under my supervision. Began antidepressants. Attempted detox using buprenorphine lozenges 12/02 and 1/03. Agreed to maintenance but could only afford about 6 lozenges per day (1mg each).

KB Today Fall 2002 makes 4 separate attempts to detox with clonodine, tramadol and chlordiazepoxide under my supervision. Began antidepressants. Attempted detox using buprenorphine lozenges 12/02 and 1/03. Agreed to maintenance but could only afford about 6 lozenges per day (1mg each). 3/03 Subutex becomes available and he stabilizes on 8mg per day.

KB Today Fall 2002 makes 4 separate attempts to detox with clonodine, tramadol and chlordiazepoxide under my supervision. Began antidepressants. Attempted detox using buprenorphine lozenges 12/02 and 1/03. Agreed to maintenance but could only afford about 6 lozenges per day (1mg each). 3/03 Subutex becomes available and he stabilizes on 8mg per day. Winter uses cocaine regularly but stops without further intervention spring 2004.

KB Today Fall 2002 makes 4 separate attempts to detox with clonodine, tramadol and chlordiazepoxide under my supervision. Began antidepressants. Attempted detox using buprenorphine lozenges 12/02 and 1/03. Agreed to maintenance but could only afford about 6 lozenges per day (1mg each). 3/03 Subutex becomes available and he stabilizes on 8mg per day. Winter uses cocaine regularly but stops without further intervention spring intermittent cocaine use.

KB Today Fall 2002 makes 4 separate attempts to detox with clonodine, tramadol and chlordiazepoxide under my supervision. Began antidepressants. Attempted detox using buprenorphine lozenges 12/02 and 1/03. Agreed to maintenance but could only afford about 6 lozenges per day (1mg each). 3/03 Subutex becomes available and he stabilizes on 8mg per day. Winter uses cocaine regularly but stops without further intervention spring intermittent cocaine use. Constructive dialogue with his teenage son about his own early use of alcohol

Case 2: JM June year old female with about 10 years of opioid use and abuse starting with hydrocodone then methadone then heroin. Also uses marijuana and cocaine. Injects 15 to 20 bags a day and has done so for the last 2.5 years.

Case 2: JM June year old female with about 10 years of opioid use and abuse starting with hydrocodone then methadone then heroin. Also uses marijuana and cocaine. Injects 15 to 20 bags a day and has done so for the last 2.5 years. Did 30 days of rehab Feb/03 and resumed drug use upon discharge.

Case 2: JM June year old female with about 10 years of opioid use and abuse starting with hydrocodone then methadone then heroin. Also uses marijuana and cocaine. Injects 15 to 20 bags a day and has done so for the last 2.5 years. Did 30 days of rehab Feb/03 and resumed drug use upon discharge. 17 year old son lives at her apartment while she lives elsewhere with a male friend. 11 year old daughter lives with the maternal grandmother. Is here with the male friend who is offering to pay for her treatment. Has supported herself as a prostitute. Lost her home and cleaning business.

Case 2: JM June year old female with about 10 years of opioid use and abuse starting with hydrocodone then methadone then heroin. Also uses marijuana and cocaine. Injects 15 to 20 bags a day and has done so for the last 2.5 years. Did 30 days of rehab Feb/03 and resumed drug use upon discharge. 17 year old son lives at her apartment while she lives elsewhere with a male friend. 11 year old daughter lives with the maternal grandmother. Is here with the male friend who is offering to pay for her treatment. Has supported herself as a prostitute. Lost her home and cleaning business. Used this morning and expects to begin feeling sick this evening. Worst withdrawal symptom is leg cramps. Sluggish pupils, tearful.

JM Today Now has medical assistance and has tested negative for Hep C and HIV. Had a normal GYN exam.

JM Today Now has medical assistance and has tested negative for Hep C and HIV. Had a normal GYN exam. Works a part-time job and is doing community service. Working on her GED. Lives in her own apartment with her son and sees her daughter regularly. Last cocaine or marijuana use about 6 months ago.

JM Today Now has medical assistance and has tested negative for Hep C and HIV. Had a normal GYN exam. Works a part-time job and is doing community service. Working on her GED. Lives in her own apartment with her son and sees her daughter regularly. Last cocaine or marijuana use about 6 months ago. Injected one bag of heroin in March. The day prior manager of her apartment complex told her she would have to get rid of the pet bird she’d had for 20 years. Woke in the am and didn’t take her Suboxone so she could use if she decided to. Thought about it all day and injected around 6pm. Now very upset and tearful. Requests a note to be allowed to keep her bird for medical reasons.

Case 3: TR 12/03 24 year old brother of another patient with opioid dependence beginning with a back injury in Initially used oxycontin.

Case 3: TR 12/03 24 year old brother of another patient with opioid dependence beginning with a back injury in Initially used oxycontin. Attended NA for a while but in 2000 began snorting and injecting heroin. Currently using 10 to 20 bags a day. Did 30 day rehab with methadone taper summer 2003 and stayed clean 17 days after discharge. Tested negative for Hep C and HIV while there.

Case 3: TR 12/03 24 year old brother of another patient with opioid dependence beginning with a back injury in Initially used oxycontin. Attended NA for a while but in 2000 began snorting and injecting heroin. Currently using 10 to 20 bags a day. Did 30 day rehab with methadone taper summer 2003 and stayed clean 17 days after discharge. Tested negative for Hep C and HIV while there. Reports last drug use was 7 am when he used 3 bags. Feels hot and has stomach upset presently.

Case 3: TR 12/03 24 year old brother of another patient with opioid dependence beginning with a back injury in Initially used oxycontin. Attended NA for a while but in 2000 began snorting and injecting heroin. Currently using 10 to 20 bags a day. Did 30 day rehab with methadone taper summer 2003 and stayed clean 17 days after discharge. Tested negative for Hep C and HIV while there. Reports last drug use was 7 am when he used 3 bags. Feels hot and has stomach upset presently. Physical Exam: sluggish pupils, wheezing, phlebitis of left arm.

TR Today January 04 ran out of meds and injected daily for a week before coming in.

TR Today January 04 ran out of meds and injected daily for a week before coming in. Spring 04 stopped meds and resumed drug use after friend had stillborn baby.

TR Today January 04 ran out of meds and injected daily for a week before coming in. Spring 04 stopped meds and resumed drug use after friend had stillborn baby. Fall 04 incarcerated for check fraud. Tested for Hep C and HIV at syringe exchange both negative

TR Today January 04 ran out of meds and injected daily for a week before coming in. Spring 04 stopped meds and resumed drug use after friend had stillborn baby. Fall 04 incarcerated for check fraud. Tested for Hep C and HIV at syringe exchange both negative January 05 requests resumption of suboxone. Released from prison 12/13/04. Completed 30 day rehab and returned to his parents home under house arrest 2 weeks ago. Now taking remeron and seroquel for anxiety. Has cravings but has not used since 10/1/04.

TR Today January 04 ran out of meds and injected daily for a week before coming in. Spring 04 stopped meds and resumed drug use after friend had stillborn baby. Fall 04 incarcerated for check fraud. Tested for Hep C and HIV at syringe exchange both negative January 05 requests resumption of suboxone. Released from prison 12/13/04. Completed 30 day rehab and returned to his parents home under house arrest 2 weeks ago. Now taking remeron and seroquel for anxiety. Has cravings but has not used since 10/1/04. Now is Hep C positive

Case 4: PT 9/03 59 year old who presents to the office to meet his new PCP and complains of right groin pain. Discloses he snorts 2-3 bags of heroin a day for 10 years. His only past period of abstinence was while incarcerated. He has hypertension.

Case 4: PT 9/03 59 year old who presents to the office to meet his new PCP and complains of right groin pain. Discloses he snorts 2-3 bags of heroin a day for about 10 years. His only past period of abstinence was while incarcerated. He has hypertension. Physical exam: He is pleasant and talkative but disheveled. He has a right inguinal hernia; can’t flex his right hip greater than 90 degrees; sluggish pupils; and no track marks.

PT today Right hip replaced 2/04

PT today Right hip replaced 2/04 Hernia repaired 8/04

PT today Right hip replaced 2/04 Hernia repaired 8/04 Began Suboxone 8mg sl qd upon discharge from hospital

PT today Right hip replaced 2/04 Hernia repaired 8/04 Began Suboxone 8mg sl qd upon discharge from hospital Keeps monthly appointments but frequently runs out of both Suboxone and anti-hypertensives. Uses heroin about 2 days per month.

Case 5 MW 2/05 51 year old physician with a history of abuse of prescription opioids from the late 1980s through 1995.

Case 5 MW 2/05 51 year old physician with a history of abuse of prescription opioids from the late 1980s through Had right knee replacement 6 weeks prior and is taking about 120mg of long acting oxycodone a day. Yesterday had 100mg. Today has had 40mg.

Case 5 MW 2/05 51 year old physician with a history of abuse of prescription opioids from the late 1980s through Had right knee replacement 6 weeks prior and is taking about 120mg of long acting oxycodone a day. Yesterday had 100mg. Today has had 40mg. Withdrawal consists of dysphoria, GI distress, body aches and profound fatique.

Case 5 MW 2/05 51 year old physician with a history of abuse of prescription opioids from the late 1980s through Had right knee replacement 6 weeks prior and is taking about 120mg of long acting oxycodone a day. Yesterday had 100mg. Today has had 40mg. Withdrawal consists of dysphoria, GI distress, body aches and profound fatique. Unremarkable physical exam.

Case 5 MW 2/05 51 year old physician with a history of abuse of prescription opioids from the late 1980s through Had right knee replacement 6 weeks prior and is taking about 120mg of long acting oxycodone a day. Yesterday had 100mg. Today has had 40mg. Withdrawal consists of dysphoria, GI distress, body aches and profound fatique. Unremarkable physical exam. Participates in a monitoring program which prohibits maintenance with any opioid agonist.

MW today Tapered with Suboxone 2mg tablets –3 tabs every 6 hours for 2 days –2 tabs every 6 hours for 2 days –2 tabs every 8 hours for 2 days –1 tab every 8 hours for 2 days –1 tab every 12 hours for 2 days –1 tab a day for 2 days

MW today Tapered with Suboxone 2mg tablets –3 tabs every 6 hours for 2 days –2 tabs every 6 hours for 2 days –2 tabs every 8 hours for 2 days –1 tab every 8 hours for 2 days –1 tab every 12 hours for 2 days –1 tab a day for 2 days Seen day 7 of taper. Withdrawal symptoms absent.

MW today Tapered with Suboxone 2mg tablets –3 tabs every 6 hours for 2 days –2 tabs every 6 hours for 2 days –2 tabs every 8 hours for 2 days –1 tab every 8 hours for 2 days –1 tab every 12 hours for 2 days –1 tab a day for 2 days Seen day 7 of taper. Withdrawal symptoms absent. Day 11 has 3 tabs left. Support group encourages no maintenance and he reluctantly agreed. Plan monthly visits for now.

Harm Reduction in Practice If at first you don’t succeed, redefine success. Meet them where they’re at –Work on what’s bothering them rather than what’s bothering me Have low threshold access –Same day and walk-in appointments Dana Davis, Allegheny General Hospital Positive Health Center, Pittsburgh, PA