1. Opioid Therapy, Pain and Addiction at the Crossroads
Steven D. Passik, PhD
Director of Clinical Addiction Research and Education
Millennium Laboratories
San Diego, CA

2. Addiction Medicine and Pain Management
The Opioid Pendulum
Opiophobia
Opiophilia
Balance of
Addiction Medicine and Pain Management
Principles 2

3. Nearly 20 years of expanded opioid prescribing
What have we learned?
Something fundamental about the clinical use of opioids? OR
Something fundamental about what our health care system is bad at?

4. What is our health care system bad at?
Chronicity
Complexity
Conditions with big motivational/psychiatric component
Communication amongst professionals
Ongoing risk assessment
Conditions that intersect badly with SES
When patients don’t deal with us in good faith

5. Go to drugs…
PPI
Opioids

6. Pushing the Pendulum Toward Opiophilia
Drinking the
Trivialization of Risk and Overstatement of Benefits
To individual patients
To society
Pain management is easy
Pain patients vs. addicts
The delivery system will deliver us
What is functional improvement

7. Base Rates of Addiction/Abuse
6-10% Illicit drugs
15% Alcohol
25% Nicotine
33% Have experimented with illicit drugs at least once
50%
(Colliver & Kopstein, 1991; Gfroerer et al, 1992; Regier et al, 1984)

8. Color by (treating) numbers
Pain
Blood Pressure

9. Poor Scholarship: The Misapplication of Pseudo-addiction
Weissman and Haddox
Passik, Kirsh and Webster
N of 1 case study
Inpatient
Became surly and uncooperative
Pain management improved, behavior improved
Failures to demonstrate it empirically
Use of illegal drugs covered?
Overuse of prescribed medications by outpatients covered?
Primary vs. secondary alcoholism as a better model

10. AIDS Patients and Aberrant Behaviors
Adequate Analgesia
(n=49)
Inadequate Analgesia
(n=24)
Total # aberrant behaviors
305
(6.2)
152
(6.3)
Aberrant behaviors “probably less predictive of addiction”
239
(78%)
116
(74%)
Aberrant behaviors “probably more predictive of addiction” 66
(22%) 40
(26%)

11. Use of Psychotherapeutic Agents
2,500
2,000
1,500
1,000
600
Pain
Relievers
Annual numbers of new users of psychotherapeutics,
Thousands of New Users
Tranquilizers
Stimulants
Sedatives
NHSDA, 2002.

12. New Illicit Drug Use in the United States: 2005
2500
2193
2114
2000
1500
1286
Numbers in Thousands
1000
877
872
647
615
500
NSDUH 2005 Results Survey. The category “Pain Relievers” included:
Darvocet, Darvon, or Tylenol with codeine
Percocet, Percodan, or Tylox
Vicodin, Lortab, or Lorcet/Lorcet Plus
Codeine
Demerol
Dilaudid
Fioricet
Fiorinal
Hydrocodone
Methadon
Morphine
OxyContin
Phanaphen with Codeine
Propoxyphene
SK-65
Stadol
Talacen
Talwin
Talwin NX
Tramadol
Ultram
247
243
108 77
Marijuana
Inhalants
Stimulants
Sedatives
Heroin
Pain Relievers*
Tranquilizers
Cocaine
Ecstasy
LSD
PCP
*526,000 new nonmedical users of OxyContin®.
SAMHSA. Results From the 2005 National Survey on Drug Use and Health. DHHS Publication No. SMA , 2006.

13. Doctors on Trial: Pain Docs or Drug Dealers?

14. What Makes News? This?
Diversion and abuse of pharmaceuticals is a billion dollar illicit market operating in the US
At least 70% of the DEA’s enforcement cases involve pharmaceuticals
Since 1995 the nonmedical use of prescription drugs exceeded that of all illicit substances except marijuana and hashish.
75% of abused drugs reported from DAWN data are pharmaceuticals 14

15. This?

16. Or This?

17. What constitutes functional improvement, anyway?
Slowing the rate of decline?

18. Pushing the Pendulum Toward Opiophobia
Just say no
Opioid strawman
Addiction lives in drugs
Hyperalgesia

19. The Opioid Strawman

20. Where does addiction live?

21. Addiction is not simply a disease of exposure
Burroughs was wrong
Exposure is necessary not sufficient
Exposure to Drug
Vulnerable Person
Vulnerable Time

22. Does drug selection matter?

23. Long acting vs. short acting opioids
Oatmeal
French fries

24. Hyperalgesia Easy to demonstrate in:
Rats
Humans on opioids in acute pain
Chronic pain????
Undeniable that some people are better off, off opioids
Is this
Hyperalgesia?
Hypogonadism?
Psychological/existential distress?
Having normal bowel movements?

25. Can we catch the pendulum?
Screening & risk stratification
Use of PMP data
Compliance monitoring
Urine screening
Pill/patch counts
Education re drug storage & sharing
Psychotherapy & highly “structured” approaches
Abuse-deterrent formulations 25

26. Population of Rx Opioid Users Is Heterogeneous
“Self-Treaters”
“Recreational users”
“Adherent”
“Chemical copers”
“Substance abusers”
“Substance abusers”
“Addicted” (SUD)
“Addicted” (SUD)
Nonmedical Users
Pain Patients

27. Assessment of Addiction Risk
Measures for screening for addiction risk
STAR/SISAP
CAGE AIDD
Opioid Risk Tool (Emerging Solutions in Pain)
SOAPP (see painedu.org)
Psychiatric interview assessment of risk
Chemical
Psychiatric
Social/Familial
Genetic
Spiritual 27

28. How Do Different Risk Measures Compare?
A recent study at a pain practice in Tennessee
A retrospective study of discharged patients
N= 48
Risk rating of each patient with all four measures:
Clinical semi-structured interview by a psychologist
DIRE (Belgrade et al, 2006)
ORT (Webster & Webster, 2005)
SOAPP (Butler et al, 2004)
“Medium” or “High” risk rating = Accurate prediction
This assesses measure sensitivity (not specificity)
Moore, et al 2008

29. Accuracy in Predicting Discharge (Aberrant Drug-Related Behaviors)
Measure % Accuracy Rate
Interview %
SOAPP %
ORT %
DIRE %
Moore, et al 2008

30. State PMP Status, 2003
Operating Programs
No PMP

31. State PMP Status, September 2010
Recent Legislation
No PMP
PMP Pending
PMP Operating

32. Aberrant Behaviors Versus Urine Toxicology Testing
Yes No
Total
Positive
10 (8%)
26 (21%)
36 (29%)
Negative
17 (14%)
69 (57%)
86 (71%)
27 (22%)
95 (78%)
122
53/122 (43%) of patients had “problems” (positive urine screen or behavioral issues)
Katz N, Fanciullo GJ. Clin J Pain. 2002;18:S76-S82.

33. Teaching About Medication Storage and Sharing
Sharing prescription meds seen as safe by “self-treaters”
Need to educate patients about medication storage
New devices being developed to help only the patient have access and on a schedule programmed in by the MD or RN

34. EMBEDA™: Pivotal Trial
Phase III double-blind, randomized, placebo-controlled, 12-wk, multicenter trial
>500 OA (hip/knee) pts moderate-severe pain
Primary endpoint: significant pain relief (P<.05)
NDA filed February 2008
EMBEDA
Alpharma Press Releases. Oct 15, 2007; Nov 29, 2007; Feb 28, ClinicalTrials.gov: NCT 34

35. Opioid Renewal Clinic Procedure Strategy Opioid Treatment Agreement
Consult from PCP
Elligibilty
Workup & pain dx
Opioid Treatment Agreement
Baseline urine drug test
PCP CONTINUES TO BE RESPONSIBLE TO PRESCRIBE OPIOIDS
Procedure
Opioid Treatment Agreement
Second Chance Agreement
Frequent visits
Prescribing opioids on short-term basis
ie, weekly or bi-weekly
Random UDT
Pill counts
Co-management with addiction services
Strategy
Weidemer and Gallagher et al. Pain Med 35

36. Aberrant-Behavior Categories (n=171)
No aberrant behavior =164
Weidemer and Gallagher. Pain Med 36

37. NIDA Study: Adherence Therapy for Opioid Abusing Pain Patients
40 pain patients at 2 sites in Virginia & New York
Evidence of opioid efficacy for diagnosis
>6 mo duration, constant, moderate-severe intensity (VAS >7 despite daily opioids)
Substance abuse co-morbidity
Opioid abuse or dependence, >2 on “problems with pain meds”, no current substance dependence, & lifetime dependence or current abuse permissible
Psychiatric co-morbidity
No unstable major psychiatric disorders, current suicidal/ homicidal ideation, or medication dose considerations
Medical co-morbidity
No unstable/severe medical conditions or planned surgery within study period; no meds that interact with methadone
Haller D. Adherence therapy for opioid abusing patients. “PROJECT PAIN.” NIDA (Grant #R01DA1369). Presented at 2006 CPDD Conference. 37

38. NIDA Study: Adherence Therapy for Opioid Abusing Pain Patients
Haller D. Adherence therapy for opioid abusing patients. “PROJECT PAIN.” NIDA (Grant #R01DA1369). Presented at 2006 CPDD Conference. 1 38

39. When things go wrong

40. Aberrant Behaviors (n = 388) (Passik, Kirsh et al, 2005)
Patients Exhibiting Behaviors (%)
(n = 33)
(n = 26)
(n = 16)
Number of Behaviors Reported

41. Aberrant Behaviors in Cancer and AIDS (Passik, Kirsh et al, 2005)
Percent of Sample
Percent of Aberrant Behaviors

42. Differential Diagnosis: Aberrant Drug-Taking Attitudes & Behavior
Addiction
Compton
Fleming
Pseudo-addiction
Elander
Other psychiatric diagnosis
Organic mental syndrome
Personality disorder
Chemical coping
Depression/anxiety/situational stressors
Butler
Criminal intent
Katz
Jung & Reidenberg 42

43. We are all stakeholders
Patients
Professionals
Law enforcement
Media
3rd Party Payors

44. 3rd Party Payors: Their share of the blame
Frequent visits
Urine screens
Psychological care
Abuse deterrent opioids
Less drug per prescription

45. Conclusions