Experiences of Assessing Misuse, Abuse and Opioid Use Disorders in Patients with Pain on Opioid Therapy

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1 Experiences of Assessing Misuse, Abuse and Opioid Use Disorders in Patients with Pain on Opioid Therapy Martin D. Cheatle, PhD Center for Studies of Addiction Perelman School of Medicine University of Pennsylvania 1

2 Incidence of Prescription Opioid Abuse in Chronic Non-Cancer Pain Patients 3% 62% of CPPs on opioid therapy exhibit problematic opioidtaking behaviors. Martell et al., 2007; Chabal et al., 1997; Fishbain, 1996; Katz & Fanciullo 2002; Michna et al, 2007; Ballantyne & Laforge Reported rate of substance use disorder in CPPs ranges from 1 %< 40% Fishbain et al., 1992; Reid et al., 2002; Katz & Fanciullo 2002; Ives et al., 2006; Fishbain et al,

3 Misuse, Abuse, Addiction Definitions of misuse, abuse and addiction are inconsistent across studies and behaviors evaluated vary in seriousness Poorly standardized methods to detect these outcomes Data from efficacy trials underestimate risks 3

4 Diagnostic Conundrum Defining, measuring, diagnosing opioid misuse, abuse and opioid use disorders in CPP is complex Diagnostically, these patients have multiple impediments to their functionality because of their illness, not necessarily due to medication issues Patients who are on chronic opioid therapy who take their opioids as prescribed are likely to show tolerance and withdrawal symptoms if a dose is skipped and be mistaken as displaying evidence of addiction (O Brien et al, 2006) 4

5 Substance Dependence (Addiction) DSM-IV Tolerance Physical dependence/withdrawal Used in greater amounts or longer than intended Unsuccessful attempts to cut down or discontinue Much time spent pursuing or recovering from use Important activities reduced or given up Continued use despite knowledge of persistent physical or psychological harm 3/7 required for diagnosis 5/7 common in non-addicted pain patients 5

6 DSM-5 Opioid-Use Disorder A maladaptive pattern of substance use leading to clinically significant impairment or distress, as manifested by 2 (or more) of the following, occurring within a 12-month period: Recurrent substance use resulting in a failure to fulfill major role obligations Recurrent substance use in situations in which it is physically hazardous Continued substance use despite having persistent or recurrent social or interpersonal problems Tolerance, as defined by either of the following: A need for markedly increased amounts of the substance to achieve intoxication or desired effect Markedly diminished effect with continued use of the same amount of the substance (Note: tolerance is not counted for those taking medications under medical supervision such as analgesics, antidepressants, anti-anxiety medications or beta-blockers) Withdrawal, as manifested by either of the following: The characteristic withdrawal syndrome for the substance (refer to Criteria A and B of the criteria set Withdrawal from the specific substances) The same (or a closely related) substance is taken to relieve or avoid withdrawal symptoms (Note: Withdrawal is not counted for those taking medications under medical supervision such as analgesics, antidepressants, anti-anxiety medications or beta-blockers) The substance is often taken in larger amounts or over a longer period than was intended There is a persistent desire or unsuccessful efforts to cut down or control substance use A great deal of time is spent in activities necessary to obtain the substance, use the substance, or recover from its effects Important social, occupational or recreational activities are given up or reduced because of substance use The substance use is continued despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance Craving or a strong desire to urge to use a specific substance 6

7 Prevalence of opioid addiction in chronic pain population Boscarino JA, Rukstalis MR, Hoffman SN, Han JJ, Erlich PM, Ross S, Gerhard GS, Stewart WF. Prevalence of prescription opioid-use disorder among chronic pain patients: comparison of the DSM-5 vs. DSM-4 diagnostic criteria. J Addict Dis Jul-Sep;30(3): patients receiving chronic opioid therapy for chronic pain were identified Prevalence of prescription opioid use disorder in chronic pain patients was assessed comparing DSM-IV-TR and DSM-5 diagnostic criteria Prevalence of lifetime opioid use disorder (OUD) based on DSM-5 criteria was 34.9% which was similar to the prevalence of opioid dependence using DSM-IV- TR criteria (35.5%) Kappa value between DSM-5 and DSM-IV was significant (Kappa = 0.87) Based on DSM-5 criteria, 21.7% of this patient population met criteria for moderate OUD and 13.2% met criteria for severe OUD Based on DSM-IV-TR criteria and the more sensitive proposed DSM-5 criteria, this study suggests that OUD may be more prevalent in patients with chronic non-cancer pain receiving opioid therapy than expected 7

8 Aberrant Drug-taking Behaviors Probably more predictive Selling prescription drugs Stealing or borrowing another patient s drugs Prescription forgery Injecting oral formulation Obtaining prescription drugs from non-medical sources Concurrent abuse of related illicit drugs Multiple unsanctioned dose escalations Recurrent prescription losses Probably less predictive Aggressive complaining about need for higher doses Drug hoarding during periods of reduced symptoms Requesting specific drugs Acquisition of similar drugs from other medical sources Unsanctioned dose escalation 1-2 times Unapproved use of the drug to treat another symptom Reporting psychic effects not intended by the clinician Frequent phone calls to clinic Multiple pain sites Jaffe, 1992 Passik and Portenoy, 1997 Cheatle et al,

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10 Differential Diagnosis of Aberrant Drug- Taking Attitudes and Behavior Addiction (out of control, compulsive drug use) Inadequate analgesia Other psychiatric diagnosis Encephalopathy Personality Disorder Depression/Anxiety Criminal Intent (diversion) Self-medication of mood /sleep disorders Kirsh et al,2002 Savage,

11 Risk Assessment Tools: Examples Tool Patients considered for long-term opioid therapy: # of items Administered ORT Opioid Risk Tool 5 By patient SOAPP Screener & Opioid Assessment for Patients w/ Pain 24, 14, & 5 By patient DIRE Diagnosis, Intractability, Risk, & Efficacy Score 7 By clinician Characterize misuse once opioid treatments begins: PMQ Pain Medication Questionnaire 26 By patient COMM Current Opioid Misuse Measure 17 By patient PDUQ Prescription Drug Use Questionnaire 40 By clinician Not specific to pain populations: CAGE-AID Cut Down, Annoyed, Guilty, Eye-Opener Tool, Adjusted to Include Drugs 4 By clinician RAFFT Relax, Alone, Friends, Family, Trouble 5 By patient DAST Drug Abuse Screening Test 28 By patient SBIRT Screening, Brief Intervention, & Referral to Treatment Varies By clinician 11

12 The risk of producing an opioid use disorder by prescribing opioids to patients with chronic noncancer pain Martin D. Cheatle, Rollin M. Gallagher, Charles P. O Brien NIH/NIDA 5-P60-DA (in preparation for submission) Design: Longitudinal, prospective study assessed the extent of pain and functional impairment (BPI), illegal substance use (UDS), ADRB (chart review), opioid use disorder (DSM-IV), and psychiatric disorders (MINI, PHQ, BAI) in a cohort of patients with CNCP who were initiating a new course of opioid therapy prescribed by community-based primary care physicians. Results: 180 patients were enrolled and followed 12 months. Over the 12 month follow up period the subjects displayed minimal ADRBs (0-9 scalerange of.31 to.46) and UDM revealed a low percentage of illicit drug use (cannabis range 4.3% to 9.7%, cocaine range 0% to 1.7%). The average daily dose of opioids was less than 20 mgs MS equiv (ER/LA only 9%). At 12 months fewer than 5% of the study population met DSM-IV of any type of substance use disorder. Discussion: Important to collect various sources of data to accurately assess misuse, abuse and OUD 12

13 Clinical and Genetic Characteristics of Opioid Addiction in Chronic Pain Martin D. Cheatle, PhD Charles P. O Brien, MD, PhD Wade Berrettini, MD, PhD University of Pennsylvania Dennis Turk, PhD University of Washington Lynn Webster, MD Lifetree Clinical Research and Pain Clinic Grant 1RO1DA from the National Institute on Drug Abuse, National Institutes of Health 13

14 Specific Aims a) Collect phenotypic measures and blood samples of 2000 patients, with a history of CNCP who have undergone treatment for addiction to prescription opioids and 2000 patients with CNCP who are receiving COT but who have not displayed any aberrant behaviors suggestive of opioid addiction. b) Conduct genetic analysis of samples from all 4000 subjects. c) Perform comprehensive statistical analyses of the phenotypic and genotypic results to examine potential markers of OA 14

15 Conclusions Diagnosing misuse, abuse and OUD in patients with pain is complex Current screening tools do not diagnose abuse or OUD but only misuse and not intent DSM-5 is an improvement over the DSM-IV as it is recognized that tolerance and withdrawal in patients being prescribed an opioid are natural and predictable conditions not necessarily reflective of an OUD Like the DSM-IV some of the other DSM-5 criteria may not necessarily indicate that a patient with pain on COT is developing an OUD. Even reaching criteria for a mild OUD should alert the clinician to the possibility of misuse, abuse or OUD and prompt a discussion and further examination of information (ADRB, PMDP, UDM) to form a differential diagnosis (under treatment of pain, abuse, OUD). Assessing risk of abuse and OUD in patients receiving COT is a dynamic, ongoing process There is a need for additional longitudinal studies to further refine our definitions of misuse, abuse and SUD 15

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