Office-based Opioid Dependence Treatment with Buprenorphine

Office-based Opioid Dependence Treatment with Buprenorphine Boyde J. Harrison, M.D., MRO Chairman Alabama Board of Medical Examiners July 10, 2015 2 1

Substance Use Disorder Addiction A Chronic Brain Disease The Anti Reward Brain System 4 2

Temp 3 degrees Dx-Pneumonia Smoking 3 cigarettes 5 6 3

Buprenorphine OBOT and Beyond Office Based Opioid Treatment What it is and What it Ain t 7 Full Agonists Bind to and activate receptor site As dose is increased, effect is increased until a maximum response is attained Examples: Heroin Oxycodone Methadone 4

Antagonists Bind to the receptor without causing activity An antagonist can block the receptor from being activated by partial or full agonist Examples: Naloxone Naltrexone Partial Agonists Bind to receptor and excite the receptor Activity reaches a plateau at which an increase in dose does not result in increased activity Examples: Buprenorphine (also a kappa antagonist) Pentazocine 5

Comparative Efficacies Conceptual Representation of Opioid Effect Versus Log Dose for Opioid Full Agonists, Partial Agonists, and Antagonists Full Agonist (Methadone) Opioid Effect Partial Agonist (Buprenorphine) Antagonist (Naloxone) Log Dose 6

6/5/2015 Buprenorphine: A Guide for Nurses To read the text of DATA 2000, to view what is required of qualifying physicians under the act, or to find out more about buprenorphine and DATA 2000, follow this link. http://www.buprenorphine.samhsa.gov/bwns_locator/aboutphysician.htm How buprenorphine works is explained at http://www.naabt.org/education/images/receptors_hires.jpg 14 7

Buprenorphine OBOT and Beyond This is a federally approved treatment for opioid dependence and addiction This is NOT a methadone clinic This is a way to help people who want help Rarely will you have a more appreciative patient than one you help get their life back These patients do take a little more time 15 16 8

17 9

10

11

12

Predisposition & Progression Substance Use 1.) Substance Use / 2.) Substance Abuse( Patterns Develops) Initiation Use Heavy Use Substance Use Disorders 3.)Substance Use Disorders / Addiction Genetics / Environment 13

14

Desire Corresponds with Drug Use 50% 0f US population DOES NOT USE any alcohol/drugs Liking Non-problematic Use 50% Wanting Use 89% Craving Addiction 11% Stages of the Addiction Cycle 15

Addiction creates a powerless state because of where and how the brain is altered Pathways include projections from the ventral tegmental area (VTA) of the brain, through the median forebrain bundle (MFB), and terminating in the nucleus accumbens (Nuc Acc), in which dopamine neurons are prominent These centers near the brainstem and hypothalamus areas are not very responsive to the cerebral cortex 32 16

33 17

18

19

20

21

22

46 23

24

25

Cost of Various forms Haleyville Dose mg Pharm 1 Pharm 2 Chain Generic 8/2 tabs 8/2 10.00 6.29 8.12 Subutex 8mg tabs 8 5.00 2.30 4.25 Suboxone film 8/2 10.00 8.56 9.66 Zubsolv 5.7/1.4 10.00 8.58 9.66 Bunavail 4.2/0.7 10.00 8.57 9.66 51 Opioid Addiction Pharmacotherapy Enhances Treatment Outcomes Medical Withdrawal: Remove the opioid from the body and remain free of future opioid use Maintenance Therapy: Use a substitute opioid (agonist), satisfy narcotic hunger, eliminate craving Buprenorphine approved for both approaches 26

Pharmacology of Opioids Affinity: The strength with which a drug binds to its receptor Dissociation: The speed at which a drug uncouples from its receptor Efficacy: The percent of maximal response that a drug generates when it binds to the receptor Titrate to Stability Intoxication Withdrawal Insufficient Opioid Withdrawal Intoxication Withdrawal Intoxication Excessive Opioid Stabilization 27

Tolerant User - But Not Physically Dependent 7 Arbitrary Scale 6 5 4 3 2 1 0 High Tolerance Threshold Normal Heroin Hours 0 1 2 3 4 5 6 Tolerant and Physically Dependent Heroin User Arbitrary Scale 7 6 5 4 3 2 1 0 High Tolerance Threshold Normal Withdrawal Threshold Sick Heroin Hours 0 1 2 3 4 5 6 28

Pharmacokinetic Distinctions Methadone Slowly absorbed from the gut reaching peak blood level in 45 to 90 minutes Half-life in maintenance patient is 24 hours Allows once-daily dosing Buprenorphine Sublingual tablets must be held under the tongue for 4 to 8 minutes for absorption Peak blood level in 60 minutes Half-life is 32 hours Allows once-daily or everyother-day dosing Chiang CN, Hawks RL. Pharmacokinetics of the combination tablet of buprenorphine and naloxone. Drug Alcohol Depend. 2003;70(suppl 2):S39-S47. Other Distinctions Buprenorphine has greater opioid receptor affinity and slower receptor dissociation than methadone Buprenorphine will displace a full agonist (methadone) and dock at the receptor, thus blocking other full agonists from attaching there Patients switching from methadone to buprenorphine may experience withdrawal distress and are advised to complete a reduction process before starting buprenorphine 29

Induction Dosing Guidelines: Buprenorphine for Non-Methadone Patients Give the first dose after discontinuing opioids and some withdrawal symptoms are evident Precipitated withdrawal is avoided by giving the first dose of buprenorphine after withdrawal symptoms are displayed Clinical Trials Dosing Sublingual buprenorphine daily doses of 8 to16 mg has been shown to be equally effective to oral methadone daily doses of 80 to 120 mg Buprenorphine maintenance is ideal for people abusing illegal opiates and for those who want to switch from methadone to buprenorphine Protocols for treatment can be found in the manual Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction: a Treatment Improvement Protocol (TIP) 40. Available at: www.samhsa.gov/centers/csat/csat.html 30

Drug Interactions Benzodiazepines respiratory depression and cardiovascular collapse are possible when high doses are taken of both drugs. Patients must be closely monitored Other depressants produce additive effects on the CNS and may create interactive effects for patients operating motor vehicles or heavy machinery Buprenorphine given to tolerant physically dependent opiate addicts may produce withdrawal symptoms Buprenorphine is metabolized by the cytochrome p450 3A4 pathway. Drugs metabolized by the same pathway could result in higher than normal levels of either drug. Patients who are on both buprenorphine and one of these drugs need to be monitored closely Buprenorphine/Naloxone Combination and Buprenorphine Alone Dosages: Buprenorphine 2 mg with naloxone 0.5 mg Buprenorphine 4 mg with naloxone 1mg Buprenorphine 8 mg with naloxone 2 mg Buprenorphine 12 mg with naloxone 3mg Two dosages: Buprenorphine 2 mg Buprenorphine 8 mg Tablet(s) or film should be held under the tongue until completely dissolved. 31

Buprenorphine and Adolescent Brain Few studies available: Woody,G.et al.,extended vs Short-term Buprenorphine-Naloxone for Treatment of Opioid-Addicted Youth, JAMA, Nov 5 2008,vol300,No.17 FDA Approved Criteria for Adolescent patients who meet the following criteria are considered good candidates for buprenorphine treatment: Age 16 or older Meet the criteria for opioid dependence Two documented, failed prior treatment attempts At least a 1-year history of opioid dependence Before treating adolescent patients, verify federal, state, or insurance provider regulations that may require parental consent or notification prior to treatment. More than half of states allow patients under age 18 to consent for their own substance use disorder treatment (i.e. parental consent is NOT required). 6/5/2015 Buprenorphine 6/5/2015 32

Extended Abstinence is Predictive of Sustained Recovery After 5 years if you are sober, you probably will stay that way. It takes a year of abstinence before less than half relapse Dennis et al, Eval Rev, 2007 Cravings Craving: memory of rewarding aspects of drug use superimposed on a negative emotional state Compels drug-seeking in dependent individuals 3 Types of Cravings Withdrawal induced Cue-induced Drug-induced 33

Three Stages of Addiction Binge/intoxication Reward Brain Withdrawal/negative affect Anti-reward Brain Preoccupation/ anticipation/ craving Addiction- Craving Brain Factors Contributing to Vulnerability to Develop a Specific Addiction use of the drug of abuse essential (100%) Genetic (25-50%) DNA SNPs other polymorphisms Environmental (very high) prenatal postnatal contemporary cues comorbidity mrna levels peptides proteomics Drug-Induced Effects (very high) neurochemistry behaviors Kreek et al., 2000 34

Legalities Only specifically licensed programs / physicians can detoxify opioid addicts using opioid medications! Any physician who can prescribe controlled substances can taper them when they are no longer needed/effective if there is a legitimate pain diagnosis. Heit HA, Covington EC, Good P.M.. Pain Medicine 2004;5(3):303 Note: PDR recommendations support this stance 69 Symptoms of Opioid Withdrawal Dilated pupils, rhinorrhea (runny nose) Tachycardia, hypertension Nausea, vomiting, diarrhea, abdominal cramps Goose bumps, sweats, muscle/bone/joint aches. Insomnia, anxiety, headache 70 35

Avoid Common Pitfalls But I really, really need opioids. Don t you trust me? I thought we had a good relationship / I thought you cared about me? If you don t give them to me, I will drink / use drugs / hurt myself. Can you just give me enough to find a new doc? 71 Rules to Prescribe By If you can t fly, don t take off If you can t land, don t take over If you can t get out, don t get in If you can t say no, don t say yes 72 36

Rules to Prescribe By NO. The above is a complete sentence. Let s all practice 73 74 37

38

Preparing Your Office for OBOT Preparing Your Office for OBOT Fina l Ste p A final step should be preparing your office, including staff members, to begin OBOT. These tasks should include: Establishing billing pro to co ls: Decide if you will accept insurance or Medicaid coverage, run as a fee-for-service practice only, or a combination of both. Determine fees and payment plans and policies. Determ ine your recordkeeping practices: Determine how you will store buprenorphine prescribing records, both for your own use as well as in case of a DEA site visit. Remember that these records should be stored at your DEA registered address. Train staff: Both clinical and administrative staff will need to be trained on various aspects of OBOT. non-physician clinicians may benefit from taking a buprenorphine training program, even though they can not prescribe buprenorphine. Assemble practice and patient education forms: There are a number of existing forms, many of which have been included in this program, which you can use in practice. Visit our Resource Center (http://www.buppractice.com/resources) to review or access all of these forms. Re la t e d Re so urce s: PCSS-MAT Guidance: Billing for OBOT Description: This clinical guidance from the PCSS-MAT provides a list of commonly used CPT codes for buprenorphine induction and maintenance. Information is includes for both psychiatrists and non-psychiatrist physicians. So urce: PCSS-MAT Office-Based Treatment: Training Your Staff Description: Your staff will be assisting you with many of the tasks essential to conducting in-office buprenorphine treatment. Therefore, staff members need a firm grasp of the principles of addiction treatment and corresponding clinical skills and an attitude conducive to working with this patient population. The staff's attitudes will affect the way they treat patients, thus influencing the outcome of treatment. Before starting office-based buprenorphine treatment, you may wish to conduct formal training with your staff. The brief guidelines below can help you structure your training. Info rm atio n to Co nvey In the course of your staff trainings, try to cover the following topics: Addiction is a chronic medical illness, not a character flaw or weakness of will, and can be treated successfully The treatment philosophy your practice espouses Substance abuse screening skills Proper record keeping and compliance with confidentiality legislation Appropriate interaction with patients and how to handle negative situations that m ay arise Knowledge of other services and referral options Principles of Staff Training The setting and tone of the trainings and the methods of information delivery will influence learning. Keep the following principles in mind: Design hands-on activities that stress experience. Focus on skills by using role-playing, for example. This will be more effectiv e for staff than simply being lectured. Start the training with a participatory activity and intersperse these activities throughout the training to keep attention levels high. Notice how the staff members learn, and try to do more things that enhance their learning. Provide additional resources so that learning can continue after training is complete. Buprenorphine Treatment: Training for Multidisciplinary Addiction Professionals Description: This is a training package developed by the Buprenorphine Awareness Blending Team to create awareness about buprenorphine among non-physician addiction professionals. So urce: National Institute on Drug Abuse (NIDA) and The Addiction Technology Transfer Center (ATTC) 39

40

Rough Morning 81 41

83 42

85 86 43

87 88 44

89 90 45

91 92 46

93 94 47

95 96 48

97 98 49

Buprenorphine: A Guide for Nurses 7. Medications are an important element of treatment for many patients, especially when combined with counseling and other behavioral therapies. Opioid replacement therapy can be very effective in helping individuals stabilize their lives and reduce their drug use. Both behavioral treatments and medications can be critically important, especially for patients with mental disorders. 8. Addicted or drug-abusing individuals with coexisting mental disorders should have both disorders treated in an integrated way. Substance use disorders (SUDs) and mental disorders often co-occur; Patients presenting for either condition should be assessed and treated for the co-occurrence of the other type of disorder. 9. Medical detoxification is only the first stage of addiction treatment and by itself does little to change long-term drug use. Detox safely manages acute physical symptoms of withdrawal; Detox alone is rarely sufficient to achieve long-term abstinence; Strongly indicated precursor to effective drug addiction treatment for some individuals. 10.Treatment does not need to be voluntary to be effective. Strong motivation can facilitate the treatment process; Sanctions or enticements in the family, employment setting, or criminal justice system can increase significantly: Treatment entry and retention rates; and Success of drug treatment interventions. 11.Possible drug use during treatment must be monitored continuously. It is not unusual for lapses to occur during treatment. Objective monitoring (urinalysis/other tests) helps patients withstand urges to use. Monitoring can provide early evidence of drug use so that the treatment plan can be adjusted. Feedback to patients who test positive for illicit drug use is an important element of monitoring. 12.Treatment providers should assess and counsel individuals about HIV/AIDS, hepatitis B and C, tuberculosis, and other infectious diseases. Counsel to avoid high-risk behavior. Counsel to help people who are already infected manage their illness. 13.Recovery from drug addiction can be a long-term process and frequently requires multiple episodes of treatment. As with other chronic illnesses, relapses can occur during or after successful treatment episodes. Individuals may require prolonged treatment and multiple episodes of treatment to achieve long-term abstinence and fully restored functioning. Participation in self-help support programs during and following treatment often is helpful in maintaining abstinence. 99 100 50

102 51

103 104 52

105 106 53