IHS 331: Research Methods

September 18, 2014

Journal #4
1. Birnbaum, H. G., White, A. G., Schiller, M., Waldman, T., Cleveland, J. M., & Roland, C.
L. (2011). Societal Costs of Prescription Opioid Abuse, Dependence, and Misuse in the United
States. Pain Medicine, 12(4), 657-667. doi:10.1111/j.1526-4637.2011.01075.x
-The purpose of this study was to estimate the societal costs of prescription opioid abuse in the
US in 2007. This research updates and expands on previous research by also including the
burden on caregivers, additional criminal justice and lost productivity components. Results
aggregated into three primary categories: health care, criminal justice, and lost workplace
productivity.
Health Care costs: estimated using apportionment method (identifying total expenditures on
substance abuse treatment, prevention, and research) and multiplying by the proportion
associated with opioids. Excess medical and drug costs for Medicare and uninsured opioid
abuse patients and their caregivers were estimated by applying national Medicaid-to-Medicare
spending ratio and a privately insured-to-uninsured ratio. Total: $25 billion (excess medical and
drug costs ~ $23.7 billion). Criminal justice costs: apportionment method used to estimate
spending associated with opioid abuse on police protection, legal and adjudication, correctional
facilities, and property lost due to crime. Total: $5.1 billion (correctional facilities ~ $2.3
billion). Lost workplace productivity cost: includes lost productivity due to incarceration,
premature death, absenteeism, and presenteeism. Total: $25.6 billion (premature death ~ $11.2
billion).
-Gaps: need to assess other components of societal costs that are directly linked to or caused by
prescription opioid abuse not considered here (ex automobile accidents, insurance fraud). Also
near to analyze the costs of undertreating pain, which can result from practitioners concerns
about addiction and abuse.
2. Barth, K. S., Maria, M., Lawson, K., Shaftman, S., Brady, K. T., & Back, S. E. (2013). Pain
and motives for use among non-treatment seeking individuals with prescription opioid
dependence. American Journal On Addictions, 22(5), 486-491. doi:10.1111/j.15210391.2013.12038.x
-This study describes pain prevalence, location, severity, and functional interference in a
sample of non-treatment seeking prescription opioid-dependent individuals. The study closes
gaps in literature that did not adequately address the presence and role of pain in individuals
with prescription opioid dependence with the intended goal of informing screening and
treatment interventions.
-The study finds that the large majority of prescription opioid-dependent individuals in this
study were reported being introduced to opioid analgesics by a physician (91.3%) by a
physician.

-Gaps: A future study that can differentiate whether prescription opioid-dependent individuals
had a primary substance use disorder and then developed prescription-opioid dependence or
whether they developed substance use problems after they were introduced to prescriptionopioids would be beneficial for evaluating the current practice of screening for current
substance use patterns when prescribing prescription opioids.
3. Prescription opioid abuse, chronic pain, and primary care: A Co-Occurring Disorders Clinic
in the chronic disease model (Journal of Substance Abuse Treatment 43 (2012) 446-450
-This study evaluates the effectiveness of the sublingual preparation of buprenorphine in
patients with co-occurring chronic non-cancer pain (CNCP) and opioid addiction.
Buprenorphine has a more favorable safety profile in overdose, making the drug an attractive
alternative for the comorbid treatment of CNCP and opioid dependence.
-A major barrier to using buprenorphine to treat CNCP and opioid dependence is inadequate
pain control.
-Data from the study shows that 65% of patients induced on buprenorphine continued on the
medication, and 65% of those patients were on the medication for over six months. Of the
patients no longer prescribed BUP/NLX, 14% were no longer taking any opioid. Those who
continued to require opioid agonists to maintain their chronic pain condition were using lower
doses than prior to the study. Surprisingly, average pain scores did not increase after the switch
to BUP/NLX.
-Gaps: This is a retrospective review not a prospective research project. Future studies must
be completed to confirm these results. Future studies must further limit the variables present in
the current study (such as limiting the other prescription drugs prescribed to the patient) in
order to confirm that the modest improvements observed in this study are attributed to
BUP/NLX and not another factor.
4.Substance misuse treatment for high-risk chronic pain patients on opioid therapy: A
randomized trial. (International Association for the Study of Pain; doi:
10.1016/j.pain.2010.02.033
-Summary: This purpose of this study was to see if close monitoring and cognitive behavioral
substance misuse counseling could increase overall compliance with opioids for chronic pain
patients. 42 patients meeting criteria for high-risk opioid misuse were randomized to either
standard control or experimental compliance treatment consisting of monthly urine tests,
compliance checklists, and individual and group motivational counseling. Twenty patients who
met criteria indicating low potential for misuse were recruited to a low-risk control group.
Patients were followed for six months and completed pre and post study questionnaires and
monthly journal entries. Participants who were labeled as high-risk at the beginning of the
study were found to have fewer signs of opioid misuse (as demonstrated by a positive Drug
Misuse Index) than high-risk subjects in the control condition.

-The study provides support for the benefits of brief behavioral interventions in the
management of opioid compliance among chronic pain patients at high-risk for prescription
opioid abuse (specifically chronic back pain patients).
Gaps: Although this study was a good introductory study, it must be repeated with a greater
number of subjects in each cell and with a longer follow-up (> 6 months). Future studies must
also compare the respective effectiveness of each of the treatments in improving compliance
with opioids among chronic pain patients. Further studies will help determine individual
difference factors (gender, age, etc.) and what interventions are most useful.
5. An Opioid Screening Instrument: Long-Term Evaluation of the Utility of the Pain
Medication Questionnaire.
-This study sought to expand upon an earlier study that showed a positive relationship between
higher Pain Medication Questionnaire (PMQ) scores and concurrent measures of substance
abuse, psychopathology, and life functioning. The current study used a larger sample size and
examined the relationship between PMQ scores and various treatment outcomes. The study
administered the PMQ to 271 newly evaluated chronic pain patients. These patients were reevaluated immediately post-treatment and six months after discharge. Subjects with the highest
PMQ scores (test group) were 2.6 times more likely to have a known substance-abuse problem,
3.2 times more likely to request early refills of prescription meds, and 2.3 times more likely to
drop out of treatment, when compared to the lowest PMQ scores (control group). Also, patients
who completed the program experienced a significant decrease in PMQ scores over time in
comparison to patients who either dropped out or were involuntarily discharged from the
program. These findings support the clinical utility of the PMQ for screening patients with a
greater likelihood of misusing prescription opioids.
-Gaps: The PMQ still requires further validation. Future studies are required to identify
strong/weak items on the PMQ and validate the predictive capability of the PMQ by following
a larger sample of patients for a longer period of time (> 6 months).
6. Weiss, Roger D. Sharpe Potter, Jennifer Adjunctive Counseling During Brief and
Extended Buprenorphine-Naloxone Treatment for Prescription Opioid Dependence. Arch Gen
Psychiatry. 2011; 68 (12): 1238-1246. doi:10.1001/archgenpsychiatry.2011.121
-The purpose of this study is to determine if subjects addicted to prescription painkillers may
reduce their opioid abuse when given sustained treatment with the medication buprenorphine
plus naloxone (Suboxone). The study is the first large scale randomized clinical trial using a
medication for the treatment of prescription opioid abuse. Phase 1 of the trial includes a brief 2
week buprenorphine-naloxone stabilization, a 2-week taper, and 8-week postmedication
follow-up. Patients with successful outcomes exited the study following phase 1. Unsuccessful
patients entered phase 2, an addition 12-week extended naloxone treatment, 4-week taper, and
8-week postmedication follow-up.

-The study demonstrated that the addition of intensive opioid dependence counseling provided
no additional benefit. This suggests that patients addicted to prescription opioids may be
effectively treated in primary care settings, although there is a strong proclivity towards relapse
after the medication is discontinued.
-Gaps: As mentioned above, there was a strong tendency towards relapse after the drug was
discontinued. Future studies need to determine how to sustain recovery among this patient
group. Also, the length of buprenorphine-naloxone treatment that will lead to better outcomes
after a taper (when the patient is taken off the drug) must be determined in future studies.
7. Characteristics of Opioid-Users Whose Death Was Related to Opioid-Toxicity: A
Population-Based Study in Ontario Canada.
-This study analyzed all drug-related deaths in Ontario from 2006 to 2008, and identified
opioid-related deaths. Out of 2330 drug-related deaths during this time period in Ontario, 58%
were attributed in some way to opioids. Oxycodone was involved in approximately 1/3 of
these opioid-related deaths.
-In this study there was an overrepresentation of individuals with a history of drug abuse. This
study identified several vulnerable subpopulation of opioid users, including those involved in
the correctional system, those with a prior history of suicide, those whose physicians had
recently changed their opioid medication, and those involved in a methadone program.
8. Prescription Opioid Abuse in Chronic Pain: A Review of Opioid Abuse Predictors and
Strategies to Curb Opioid Abuse. (Seghal, Nalini MD) Pain Physician 2012; 15:ES67-ES92.
iSSN: 2150-1149
-Although this article is technically a literature review, it was extremely helpful in organizing
the current state of knowledge regarding opioid abuse and misuse, known risk factors, and
methods for assessing and monitoring prescribed patients.
-Risk factors for opioid abuse and misuse include demographic factors and genetic factors.
Studies have shown that there is a significant link with young, white males and prescription
drug abuse. Studies have also found linkages between younger aged subjects, those with
serious mental illness, and/or cigarette smoking. Certain genes (such as 118G allele, OPRK1
and OPRD1 receptor genes) have been associated with increased risk for opiate addiction.
Future studies are required to replicate association data and understand the role these genes
play in drug dependency and treatment.
-The study also evaluated Opioid Assessment Screening Tools, including urine drug testing,
prescription monitoring programs, opioid treatment agreements, universal precautions, patient
and provider education, behavioral interventions, and emerging treatments. The study
particularly advocates the use of cognitive, behavioral, and interventional techniques to
optimize outcomes.
9. Conversion from Full-Opioid Agonists to Sublingual Buprenorphine, Pain Physician 2012.

-This objective of this study was to determine the effectiveness of converting patients from
traditional full agonist opioid medications to sublingual buprenorphine and identify patient
subgroups most likely to benefit from this therapy.
-Using clinical records compiled from 104 de-identified chronic pain patients who had been
treated with opioid-agonist drugs and were converted to SL buprenorphine during the study.
-The study reported that patients who continued SL buprenorphine therapy for more than 60
days reported a significant decrease in pain (2.3 points on a Quality of Life score). Patients on
lower doses of opioid medication had greater decreases in pain after conversion to
buprenorphine SL than patients on the highest doses (> 400 mg morphine equivalent). The
study concluded that sublingual buprenorphine (in tablet form) is effective in high-risk patients
who have failed or become tolerant to traditional opioids for chronic pain.
Gaps: further research is needed to identify which demographic groups are most likely to
benefit from conversion from traditional opioid drugs to buprenorphine SL. Future studies
investigating change in patient quality of life during sublingual buprenorphine therapy and
corresponding effect on family relationships, mental health and clarity, and physical
functioning.
10. Chang, Yu-Ping and Compton, Peggy (2013). Management of chronic pain with chronic
opioid therapy in patients with substance use disorders. Addiction Science & Clinical Practice
(8:21).
-This study addresses the overlapping presentation of addiction and chronic pain, as well as the
insufficient management of both conditions. The purpose of the paper is to assess the
prevalence of substance use disorders in chronic pain patients, evaluate risk factors and
stratification for addiction, as well as make recommendations for treating patients with chronic
opioid therapy.
-The study notes that chronic pain patients receiving COT have a tendency to hide addictive
behaviors due to a fear of losing access to the prescription medications. The study suggests that
a relapse contract be developed with the patient in early treatment may lead to more positive
outcomes. Future studies should investigate the effectiveness of measures such as relapse
contracts in chronic pain patients receiving COT.

Summary of all articles

These articles confirm that prescription opioid abuse and dependence is a substantial public
health and policy concern. Despite the enormous toll that this issue takes on society (from the
extensive costs, overdose fatalities, lack or workplace productivity, to the inundation of the
criminal justice system), relatively little research has been done in opioid dependence treatment
programs. Most of the research done has been conducted with heroin-dependent patients
receiving methadone, despite the fact that the use of prescription opioids for nonmedical
reasons in 20 times more common than heroin use.

Although several screening strategies have been introduced in the past few years, there is not a
single mode/test that can accurately (and consistently) predict patients who are not suitable for
opioid therapy or those who need increased monitoring during therapy. These articles suggest
that a future large-scale, clinical study measuring the comparative effectiveness of preventative
measures for limiting prescription opioid misuse and subsequent relapse will be of substantial
clinical benefit.