Download Topic 10: “Treatment Options for Opioid Substance Abuse”

Topic 10: “Treatment Options for Opioid Substance Abuse”
Comparative effectiveness of medication regimens, intensive counseling, and combined
modalities for treatment of opioid substance abuse.
Criteria
Introduction
Overview/ definition of
topic
Relevance to patient­
centered outcomes
Burden on Society
Recent incidence and
prevalence in
populations and sub­
populations
Brief Description
DESCRIPTION OF CONDITION
Opioid dependence occurs when patients are unable to stop using opioids
(substances derived from the opium poppy or synthetic versions such as
morphine, heroin, and oxycodone).
Dependence can be related to use of illicit or prescribed drugs.
Opioid prescription painkillers were involved in almost 15,000 deaths in 2008. 1
TREATMENTS
Medication Assisted Treatment (MAT) involves the use of drugs that are longer­
acting, but induce less euphoria. This treatment has been shown to be effective in
randomized control trials and meta­analyses.2­5 Replacement medications include:
o Methadone
Used to reduce diversion, it is only available in Narcotic Treatment
Programs subject to specific licensing and regulations (not available in
doctor’s offices)
o Buprenorphine
Used to reduce diversion and available via doctor’s prescription as long as
physician meets specific requirements to dispense
Use is FDA approved only in combination with naloxone
Naltrexone, though used more often for alcohol dependence, is prescribed for
relapse prevention to block the effects of opioids.
Counseling is also used to teach skills to reduce cravings, prevent relapse and
address related issues (e.g., mental and physical health, socioeconomics, and
relationships).4
Combination MAT and counseling/sober support groups are another option
Fewer than 10% of people dependent on opioids in the U.S. receive MAT
treatment4 due to lack of access.
Detoxification programs are not covered in this brief.4
The most relevant patient­centered outcome is quality of life. New research that
identified the most effective ways to allow access to treatments for opioid addiction, with
minimal relapse rates, could drastically improve the quality of life for addicts as well as
their families, employers, and society as a whole.6
PREVALENCE AND SUB­POPULATIONS
About 4.5% of US adults (14.1 million) reported non­medical use of prescription
opioids in the past year in a national survey; of these, about 13% (1.84 million)
met the criteria for opioid dependence. 7
Some sub­populations are at increased risk:
PCORI Topic Brief: Assessment of Prevention, Diagnosis, and Treatment Options
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Criteria
Brief Description
People with low incomes8
People on Medicaid (in Washington State, one study found 45% of people who
died from prescription painkiller overdoses were enrolled in Medicaid) 9
o People with mental illness and/or addiction to other substances (e.g., alcohol) 8
o Residents of the Southwestern U.S. and the Appalachian region 1
INCIDENCE
o
o
initiating use of nonmedical prescription pain relievers, but by 2011, this had risen
to 11.1 million.10
Effects on patients’
quality of life,
productivity,
functional capacity,
mortality, and use of
health services
QUALITY OF LIFE/FUNCTIONAL CAPACITY/MORTALITY
A recent meta­analysis found that 32% of people using opioids for nonmedical
reasons had comorbid mental health symptoms.11
o 17% had comorbid depression
o 16% had comorbid anxiety
o 48% reported chronic pain
Patients with opioid addictions are generally unable to maintain employment and
personal relationships.12
Opioid­related fatalities have increased dramatically in past ten years; 13 in 2008,
opioids contributed to approximately 5 out of 100,000 deaths in the U.S. 14
Opioid overdose is the second leading cause of accidental death in U.S. 4
USE OF HEALTH SERVICES/PRODUCTIVITY
Recent study found that healthcare utilization costs in opioid users were >5 times
higher than non­users ($2138/month vs. $408/month) 15
Societal costs were estimated to be $55.7 billion in 2007. 12
o $25.6 billion from lost earnings from reduced productivity/early death
o $25.0 billion from health care costs (medical/prescription costs)
o $5.1 billion from criminal justice costs (prison/police costs)
How strongly does the
overall societal
burden suggest that
CER on alternative
approaches to this
problem should be
given high priority?
FACTORS IN FAVOR
Moderate to high number of Americans affected (n=1.84 million) 7
Chronic/long­term condition
High economic burden, especially for serious patient outcomes (e.g., overdose) 12
Many patients have chronic pain
FACTOR AGAINST
Even if most effective treatment methods identified, lack of access to treatment might
limit use
Social stigma against persons with substance­abuse problems
Options for Addressing the Issue
Based on recent
Many (approximately 18) Cochrane reviews synthesize evidence for various treatments
systematic reviews,
for opioid addiction.
what is known about
Three Cochrane Systematic Reviews16­18 and an American Society of Addiction
the relative benefits
Medicine19 consensus panel concluded psychosocial counseling in addition to
and harms of
pharmacological treatments is the most effective way to treat opioid dependence.
available
o Psychosocial counseling alone was not effective. 16­18
management
One systematic review found that buprenorphine can be used for maintenance
PCORI Topic Brief: Assessment of Prevention, Diagnosis, and Treatment Options
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Criteria
options?
What could new
research contribute
to achieving better
patient­centered
outcomes?
Have recent
innovations made
research on this topic
especially
compelling?
How widely does care
now vary?
Brief Description
treatment due to its lower abuse potential,20 but three Cochrane reviews
suggested it may be less effective than methadone delivered at adequate
dosages;2,21,22 the National Institute for Health and Care Excellence (NICE)
guidelines recommend use of methadone as a first choice. 23
A recent meta­analysis of 18 randomized control trials concluded that doses >60
mg/day and individualized doses of methadone are associated with better
retention compared to doses <60 mg/day or fixed­dose strategies.24
The U.S. Department of Veteran’s Affairs/U.S. Department of Defense and the
World Federation of Societies of Biological Psychiatry recommend methadone or a
combination of buprenorphine and naloxone as first­line treatment. 25,26
A Cochrane review found that heavy sedation upon commencement of naltrexone
maintenance treatment does not confer additional benefits compared to light
sedation and might lead to life threatening adverse effects and greater costs.27
Another recent Cochrane review suggested that prescribing heroin along with
flexible doses of methadone could decrease heroin use among long­term,
treatment refractory opioid users compared to methadone alone. 28
o Evidence shows heroin prescriptions might reduce involvement in criminal
activity, incarceration, mortality, and increase retention in treatment
programs.28
Two Cochrane reviews found insufficient evidence on effectiveness of
detoxification and maintenance treatments for adolescents who were dependent
on opioids.29,30
Three other Cochrane reviews found insufficient evidence regarding the
effectiveness of sustained­release naltrexone, 31 oral naltrexone, 32 and oral
morphine.33
Comparative effectiveness of long­term outcomes of MAT.
Comparative effectiveness of long­term maintenance therapy plus different types
of psychosocial therapy (e.g., cognitive behavioral therapy, 12­step programs,
group therapy, family therapy)
Comparative effectiveness of different maintenance therapies in terms of
treatment of non­cancer chronic pain in patients with opioid addictions.
Comparative effectiveness of different treatment plans among adolescents
addicted to opioids.
Patient preferences for alternative treatment strategies including site of care (i.e.,
clinic vs. doctors office)
Use of clonidine off­label (currently used to mitigate withdrawal symptoms) for
maintenance therapy
Because of high prevalence of relapse, most patients require many episodes of treatment
or ongoing treatment
Type of treatment depends on many factors, including prior treatment history, medical
and /or mental health co­morbidities, co­occurring alcohol and/or other drug use,
PCORI Topic Brief: Assessment of Prevention, Diagnosis, and Treatment Options
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Criteria
What is the pace of
other research on this
topic as indicated by
recent publications
and ongoing trials?
Brief Description
socioeconomic status, and access to treatment.
Care varies greatly and is dependent upon the availability of Narcotic Treatment
Programs, insurance status, and other factors.
Clinicaltrials.gov :
NIH Reporter (search: opioid abuse):
Search: Opioid abuse
Projects: 494
Ongoing trials: 102
Publications: 156
Completed trials: 315
One ongoing study plans to present long­term outcomes (1.5, 2.5, and 3.5 years)
comparing drug counseling plus buprenorphine to standard medical management
CER that identified sub­populations that would benefit from certain treatment regimens
would improve clinical decision­making.
CER that improved access to treatment and reduced relapse rates would also provide
valuable information that would impact clinical decisions.
How likely is it that new
CER on this topic
would provide better
information to guide
clinical decision
making?
Potential for New Information to Improve Care and Patient­Centered Outcomes
What are the
BARRIERS
facilitators and
Access to treatment is limited.
barriers that would
o Methadone, regulated by the Drug Enforcement Administration, is only available
affect the
in federal and state­licensed Narcotic Treatment Programs, so not available
implementation of
through general practitioners in the U.S. as it is in Canada and many other
new findings in
countries.4
practice?
o Physicians who want to prescribe buprenorphine must meet requirements
outlined in Drug Abuse Treatment Act of 2000 or take 8­hour training course; also
physicians are limited to 30 buprenorphine patients in their first year and 100
patients in subsequent years.34
Insurance coverage:
o Medicare Part A pays for inpatient substance abuse care.
o Medicare Part B pays for outpatient substance abuse treatment services,
but methadone is not covered when delivered on an outpatient basis.
FACILITATORS
Under the Affordable Care Act, all health insurance plans sold on Health Insurance
Exchanges or provided by Medicaid must include services for substance abuse. However,
for states that are opting out of Medicaid expansion, people with incomes <133% of
federal poverty level will not have access to treatment.
Private insurance generally covers treatment.
Medicaid generally covers treatment.
In some counties, public health departments provide vouchers for entry into MAT
programs.
How likely is it that the
results of new
research on this topic
would be
implemented right
Somewhat likely that new research would be implemented right away; however, the
major issue is access to treatment
Research on novel drug regimens or novel uses for existing drugs will take time to reach
patients, given the need for FDA approval and the typical pace of diffusion for
PCORI Topic Brief: Assessment of Prevention, Diagnosis, and Treatment Options
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Criteria
away?
Brief Description
pharmaceuticals.
Research on improved access to care and retention in treatment would likely be readily
implemented.
Would new information
New information from CER on opioid dependence would likely remain current for several
from CER on this topic
years.
remain current for
several years or
would it be rendered
obsolete quickly by
subsequent studies?
CER = comparative effectiveness research; FDA = U.S. Food and Drug Administration; MAT = medication assisted treatment; NICE = National
Institute for Health and Care Excellence
PCORI Topic Brief: Assessment of Prevention, Diagnosis, and Treatment Options
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