Attitudes and risk of addiction in Patients Suffering from Chronic Pain and Treated with Long-Term Opioid Therapy

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Attitudes and risk of addiction in Patients Suffering from Chronic Pain and Treated with Long-Term Opioid Therapy Dr. Grisell Vargas-Schaffer Pain center at CHUM University of Montreal Canada

Conflict of interest Astra Zeneca Research funds Conferences Services: travel expenses, accommodation Bayer X x x Medical Advisory Jansen-Ortho x x x Lille x X Merck Frosst x x Pfizer Purdue Pharma x x x x

Moral commitment If, in my presentation I suggested off-label for a drug, I agree to inform the audience. I agree to use as far as possible, the pharmacologic terminology instead of brand names.

Changes in the Treatment of Chronic Pain Tremendous progress has been made in the study and treatment of pain in the past 2 decades. Efforts have been undertaken to make pain assessment and treatment a priority of medical care and to use all of the weapons in our arsenal to bring relief to the millions of people with chronic pain. However, this progress has been somewhat tempered by the souring of the regulatory climate and the growth of prescription drug abuse.

Changes in the Treatment of Chronic Pain Despite these setbacks, the use of long-term opioid therapy to treat chronic non-cancer pain is growing, based in part on evidence from clinical trials and a growing consensus among pain specialists. The appropriate use of these drugs requires skill in the prescription of opioids, knowledge of the issues related to addiction, and a commitment to performing and documenting a comprehensive assessment repeatedly over time.

Equipoise We are neither opiophobic nor opiophilic we are supportive of an adequate pain treatment for our patients.

3A-CP Study Attitude Addiction Alexithymia In Chronic Pain Patients with long-term opioid therapy.

3A-CP Study How many of you believe that patients with chronic pain have a negative attitude towards opioids? How many of you believe that chronic pain patients have a high risk addiction?

Original Hypotheses 1. We hypothesized that patients attending the chronic pain center would have high pain scores, a highly negative attitude towards taking opioids 2. We also wished to evaluate the level of risk of addiction in patients with long-term opioid therapy.

Study Overview University based chronic pain center. The protocol was approved by the university hospital ethics committee. Patients received an invitation to participate in the mail and completed the questionnaires over the phone. We used French language validated questionnaires. Data analysis was carried out by Montreal Heart Institute Coordinating Center (MHICC).

Study exclusion criteria Patients do not take any opioids. Patients with less than 12 month of treatment with opioids. Patients do not speak French. Patients excluded for hospitalisation. Patients who died. Patients-unreachable (tried to reach to at least 3 times with no response)

Study inclusion criteria Patients signed the inform consent. Patients with more than one year of treatment with opioids.

Study Population 303 patients

Study Population (N=303) 63% 36.9% Age Mean age 59.6 years Age range 26 to 91 years Under 65 years 74%

Level of Education (N=303) Level of Education N Percent Elementary school 29 9.6 High school 98 32.3 College 76 25.1 University 89 29.3 54.4% N/D 11 3.6

Job Status (N=303) Job status Workman's compensation or similar Frequency Percent 113 37.3 Retired 89 29.4 Working (full or partial time) 55 18.1 Unemployed 37 12.2 Others (housework, N/D) 9 3.0 66.6%

Types of Pain (N=303)

Type of pain (N=303) Type of pain Frequency Percent Spinal pain 143 47.2 Musculoskeletal pain 34 11.2 Neuropathic pain 31 10.2 Fibromyalgia 21 6.9 CRPS 17 5.7 Abdominal pain 17 5.7 Arthritis, arthrosis pain 14 4.6 Chest pain 10 3.3 Others 16 5.2 75.5%

Mean Pain Intensity (N= 303) NRS (0-10) 5.5 Level of pain at time of questionnaire 95% CI 5.2 5.7 6.1 Average pain in the last 7 days 5.8 6. 3 8.0 Worst pain in last 7 days 7.8 8.2

Time Course of Suffering, Treatment and Medication (N=303) Mean (years) 10.9 Length of time suffering from chronic pain 95% CI 10.0-11.8 6.0 Length of time taking opioids 5.8 6.3 4.9 Length of follow-up time in our pain clinic 4.5 5.4

Morphine Equivalents (mg per day) (N=303) Opioids used for treatment N Median (mg) Q1 Q2 Codeine 18 3.7 3.7 7.5 Tramadol 44 15.6 9.3 39.8 Buprenorphine 6 11.5 11.5 69 Morphine 38 32.5 10.0 130.0 Oxycodone 84 48.0 20.0 96.0 Hydromorphone 89 40.0 15.0 90.0 Fentanyl 62 180.0 90.0 270.0 Methadone 36 300.0 100.0 675.0

Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain Recommendations: Chronic non-cancer pain can be managed effectively in most patients with dosages at or below 200 mg/day of morphine or the equivalent. Consideration of a higher dosage requires careful reassessment of the pain and of the risk for misuse, and frequent monitoring for evidence of improved patient outcomes. Canadian Medical Association Journal (vol. 182, no. 13, pp. 923-930). 2010 http://nationalpaincentre.mcmaster.ca/opioid/.

Median Number of Morphine Equivalents Per Day for Patients Taking Several Opioids Concurrently (N=291) Number of opioids N Median Q1 Q2 1 196 48.0 14.5-128 2 83 151.0 53.0-310.0 3 12 289.0 109.5-574.6

Cannabis Morphine equivalents not available. 5 patients taking cannabis and another opioid. 7 patients taking only synthetic cannabis.

The Drug Attitude Inventory (DAI)

Attitudes Towards Medications A multitude of factors play a role in a patient's decision as to whether or not to take medication. Attitudes and beliefs about health and illness have been consistently identified as the major factors in such decisions. A patient s attitudes towards drugs that have a social stigma may play an important role in whether or not they commit to a treatment.

The Drug Attitude Inventory (DAI) The aim of this questionnaire is to gain some understanding of what people think about medications and their experiences while taking them. It was designed to identify the subjective responses of patients with schizophrenia taking neuroleptic drugs and their attitude towards disease and treatment. Howan, Awad Psychological Med. 1983

Similarities Between the Patients with Chronic Pain and Patients with Schizophrenia The chronic use of medication. The social stigma attached to these medications. The need to take these drugs to be functional.

Creating the DAI-M Using this questionnaire for patients in a pain clinic required a few small wording changes. We contacted Dr. Awad (DAI author) who approved the changes. The French validated version was used.

The Drug Attitude Inventory DAI-10 Modified with Author's Permission Questions T F 1) For me, the good things about medication outweigh the bad 2) I feel strange, "doped up", on medication 3) I take medications of my own free choice 4) Medications make me feel more relaxed 5) Medication makes me feel tired and sluggish 6) I feel more normal on medication 7) I take medication only when I feel pain* 8) It is unnatural for my mind and body to be controlled by medications 9) My thoughts are clearer on medication 10) Taking medication will prevent me from having crises of pain ** * I take medication only when I feel ill ** Taking medication will prevent me from having a breakdown Howan, Awad Psychological Med. 1983

Results of the DAI-M DAI-M N Percent Positive Attitude 103 33.99 Negative Attitude 116 38.28 Neutral Attitude 73 24.09 Incomplete 11 3.63

Questions to Assess Feelings of Dependence and Stigma We created five additional questions to assess the following items: Feelings of dependence Sense of stigmatism while taking opioids

The Dependence and Stigma Questions (N=303) Questions 1) I feel dependent on painkillers to be functional 2) I'm afraid of the medication, but I take it because it decreases the intensity of pain. 3) I take medication without telling my family that they are opioids 4) I feel dependent on my medication to relieve pain 5) I feel criticized by my family and/or my friends when I take opioids for pain relief. T F

The Dependence and Stigma Questions (N=303) Questions 1 and 4 were added to assess feelings of dependence. Questions 3 and 5 were added to assess the potential sense of stigma that patients may experience when taking opioids for chronic pain management. Question 2 is a measure of the presence of fear.

Questions Regarding Feelings of Dependence (N=303) Questions I feel dependent on opioids to be functional 67.0* 33.0 I feel dependent on my medication to relieve pain 77.8* 21.4 T % F %

Questions Regarding Feelings of Stigma (N=303) Questions I take medication without telling my family that they are opioids 10.8* 88.4 I feel criticized by my family and/or my friends when I take opioids for pain relief. T % F % 23.1* 76.5

Question Regarding Fear of Taking Opioids (N=303) Question I'm afraid of the medication, but I take it because it decreases the intensity of pain. T % F % 41.6* 58.4

3A-CP Study Attitude Addiction In Chronic Pain Patients with long-term opioid therapy

Addiction in Patients with Chronic Pain We used two questionnaires to assess the risk of addiction in patients treated with long-term opioid therapy (LtOT). The Opioid Risk Tool (ORT). The Screening Tool for Addiction Risk (STAR).

Opioid Risk Tool (ORT) 5-item questionnaire with yes or no answers. Designed to predict the probability of patients displaying aberrant drug behavior when opioids are prescribed for chronic pain. Recommended tool both nationally and provincially for the safe and effective use of opioids for non-cancer pain. Webster Pain Med 2005 Collège des Médecins du Québec 2009 Canadian Medical Association Journal 2010

Opioids Risk Tool (ORT) Webster Pain Med 2005

History of Substance Abuse (N=303) Family history Alcohol Illegal drugs 35.3% yes Prescriptions drugs 10.2% yes 11.5% yes 57% 17% 6% Personal history Alcohol Illegal drugs 10.8% yes Prescriptions drugs 5.9% yes 9.2% yes 21% 14% 18%

History of other Relevant Risk Factors History of preadolescent sexual abuse 15.1% yes 26% Age 45 13.3 % yes 56% ADD Psychological disease OCD Bipolar 6.2% yes 22% Schizophrenia Depression 54.4% yes 65%

Opioid Risk Tool (ORT) Low risk: 0-3 Unlikely to abuse opioids Moderate risk: 4-7 As likely will as won t abuse opioids High risk: >=8 Likely to abuse opioids

Results of ORT Low risk Addiction 88.0% Moderate risk Addiction 11.2% Low risk: 0-3 Moderate risk: 4-7 High risk: >=8 High risk Addiction 0.6%

The Screening Tool for Addiction Risk (STAR) The STAR questionnaire was reported for the first time in 2003. 14-item (yes/no) questionnaire. It was developed to identify the cases of substance abuse in patients with chronic pain and long-term opioid treatment. Freidman 2003

The Screening Tool for Addiction Risk (STAR) Questions T F 1. Have you felt depressed or anxious over the last 6 months? 68.6 31.4 2. Have you noticed frequent mood swings over the last 6 months? 64.6 35.4 3. Are you currently employed? 81.6 18.4 4. Do you smoke cigarettes? 34.3 65.7 5. Do you feel that you smoke too much? 21.4 78.6 6. Do you drink more than three alcohol drinks/day? 2.3 97.7 7. Have you used recreational drugs during the last year? 11.8 88.2 8. Have you ever been treated in a drug or alcohol rehabilitation facility? 6.9 93.1 9. Do you get pain medicine from more than one doctor? 16.8 83.2 10. Have you been to a pain clinic before? 98.4 1.6 11. Have you visited an emergency room for pain treatment in the past year? 26.7 73.3 12. Has anyone in your family (relatives you don t live with) had problems with drug or alcohol abuse? 13. Has anyone in your household (partner, children) had problems with drug or alcohol abuse? 39.0 61.0 5.6 94.4 14. Did any family member physically or verbally abuse you when you were a child? 25.7 74.3 Freidman 2003

The Screening Tool for Addiction Risk (STAR) Logistic regression showed that history of treatment in a drug or alcohol rehabilitation facility was a significant predictor of addiction with a positive predictive value of 93% and a negative predictive value of 5.9%. Factor analysis revealed that questions relating to tobacco abuse and prior treatment for drug and alcohol abuse distinguished between patients with addiction and pain from patients with chronic pain and long-term opioid therapy. Freidman 2003

The Screening Tool for Addiction Risk (STAR) Do you smoke cigarettes? Yes % No % Do you feel that you smoke too much? 4.2% 95.8% Have you ever been treated in a drug or alcohol rehabilitation facility?

Level of Addiction in Our Population We had no idea what the risk of addiction would be in our population, The generally held opinion is that risk of addiction in patients with long-term opioid therapy is high, We expected to find high levels such as those sited by Friedman of 27%. We found that the level of risk of addiction in our population is extremely low. ORT: 0.6 % and STAR 4.2%.

Conclusion (1) Attitude 38.2 % of patients had a negative attitude towards taking opioids. Patients taking long-term opioid therapy do not feel stigmatized. Addiction ORT: 11.8% with a moderate or high risk of addiction. STAR: 4.2% were found to be at risk for addiction.

Conclusion (2) We suggest for the evaluation of risk of addiction: complete the ORT add the 3 relevant questions from STAR This may increase the power to detect patients who are at higher risk for abuse or addiction.

Conclusion (3) Because patients do not suffer from the stigma related to long-term opioid therapy, and have a low risk of addiction we can go further in relieving pain by adequately prescribing and adjusting medication.

Conclusion (4) Main study limitation: Our results are specific to a tertiary care pain center population therefore may not be easily generalizable to the primary care setting. This study concerns patients with an average of 6 years of LtOT and 5 years of follow-up therefore it is likely that patients with a high risk of addiction have undergone a natural attrition from the pain clinic.

Take home message Despite public opinion to the contrary, patients in chronic pain treatment programs are not addicts. We need to listen to our patients, believe their descriptions of their pain and treat them accordingly. We have the opportunity to encourage our patients to be more pro-active in their treatment.

Take home message How can we do this? By educating patients and practitioners. By treating patients and not blaming them.

Thanks for your attention Questions?...

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