medication for opioid use disorder… · • in 1947, approved in us as analgesic and antitussive...
TRANSCRIPT
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Medication for Opioid Use Disorder
Melissa B. Weimer, DO, MCR, FASAM Assistant Professor of Medicine
Medical Director, Yale Addiction Medicine Consult Service
Yale University School of Medicine
1
2
Melissa Weimer Disclosures
• Dr. Weimer has received monetary honorarium on one occasion from Indivior related to speaking about opioid dependence and pain only.
The contents of this activity may include discussion of off label or investigative drug uses. The faculty is aware that is their responsibility to disclose this information.
3
Target Audience
• The overarching goal of PCSS-MAT is to make
available the most effective medication treatments
to serve patients in a variety of settings, including
primary care, psychiatric care, and pain
management settings.
4
Educational Objectives
• At the conclusion of this activity participants should be able to:
Identify the rationale for using medications to treat opioid use disorder
Describe effective medications for treating opioid use disorder
Explain the unique properties of methadone, buprenorphine, and naltrexone
5
Case
• Jane is a 23 year old female with chronic low back pain from a motor vehicle accident at
age 16 who presents to your office asking for help to stop using IV heroin.
• She has been using opioids daily for about 4 years. She started using illicit prescription
opioids, then switched to IV heroin daily about 2 years ago when she could no longer
afford illicit opioid pills.
• She has attempted non-medication-based addiction treatment in the past and quickly
relapsed.
• She also drinks approximately 14 alcoholic drinks per week, but has never had alcohol
withdrawal symptoms when she stops drinking. She feels that she could easily stop
drinking alcohol. She denies other drug use.
• She denies other mental health or medical issues, but has had two opioid overdoses in
the past year.
• She lives with her parents who are supportive of her. She is on probation for possession
of opioids.
• She reports opioid withdrawal symptoms including anxiety, restlessness, nausea,
stomach cramping, and diarrhea. Her vital signs and physical exam are normal except
for gooseflesh, dilated pupils, and bilateral upper extremity track marks.
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Case Questions
• Is medication for opioid use disorder (OUD) indicated for this
patient?
• What additional work up or evaluation is needed to decide
upon medication for this patient?
• Which medication to treat OUD is most appropriate for this
patient?
• How will you address the concomitant alcohol use?
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Substance Use Disorder:
A Chronic Relapsing Disorder
McLellan, Lewis, O’Brien & Kleber (2000) JAMA, 284: 1689-1695.
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Stages of the Addiction Cycle
Volkow, et al, NEJM. 2016
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Substance Use Disorder: DSM-5
(>2 items in 12 month period)
1. Failure to fulfill responsibilities ✓
2. Use in physically hazardous situations ✓
3. Legal problems was in DSM-IV but it was replaced with Craving in DSM-5.
4. Social/interpersonal problems ✓
5. Use larger amounts/longer than intended ✓
6. Cannot cut down ✓
7. ↑ time spent to get, use, and recover ✓
8. Give up or ↓ other important parts of life ✓
9. Ongoing use despite problems ✓
10. Tolerance* ✓
11. Withdrawal* ✓
Mild=2-3
Mod=4-5
Severe=6+
DS
M-I
V A
bu
se
D
SM
-IV
: D
ep
en
de
nce
*10 and 11 do
not count if opioid
is prescribed
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Purpose of Medication for OUD
• Allow reestablishment of homeostasis of the reward pathways in the brain away from substances
• Restore emotional and decision-making capacities
• Control symptoms of opioid withdrawal
• Suppress opioid cravings
• Block the reinforcing effects of ongoing opioid use
• Promote and facilitate patient engagement in recovery-oriented activities
• Coupled with behavioral interventions
Enhance the salience of natural, healthy rewards
Reduce stress reactivity and negative emotional state
Improve self-regulation
Increase avoidance of relapse triggers
Volkow, et al, NEJM. 2016
ASAM National Practice Guideline, June 1, 2015.
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Goals of Medication for OUD
• Reduce mortality
All cause and drug-related
• Reduce associated morbidity
Transmission of blood-borne viruses
Infectious complications from IV drug use
• Reduce and/or discontinue opioid use
• Increase retention in addiction treatment
• Improve general health and well-being
• Reduce drug-related crime
Volkow, et al, NEJM. 2016
12
Access to medication remains a key barrier
to reduction in mortality from opioid use
Williams, Bisaga. Health Affairs, 2017.
13
Opioid Maintenance
Treatment and Mortality
Adjusting for heroin purity
and the number of
methadone patients, there
was a statistically
significant inverse
relationship between
heroin overdose deaths
and patients treated with
buprenorphine (P = .002).
Schwartz et al AJPH 2013
14
Medication for OUD
• Methadone
Opioid Treatment Program
• Buprenorphine
Office-Based
Opioid Treatment Program
• Naltrexone
Office-Based
Opioid Treatment Program
• Counseling mandatory for methadone; ability to refer to counseling
necessary for buprenorphine; optional for naltrexone but encouraged.
• All medical modalities require medication management
Opioid (mu) Receptor Activity for Medications
treating Opioid Use Disorder
no drug high dose
Medication Dose
low dose
% Mu
Receptor
Intrinsic
Activity
0
10
20
30
40
50
60
70
80
90
100
Full Agonist: Methadone
Antagonist: Naltrexone
Partial Agonist: Buprenorphine
16
Medication Efficacy for
Opioid Use Disorder
All cause
Mortality
Treatment
Retention
Any Opioid
Use
HIV or HCV
Transmission
Criminal
Activity
Methadone
(n=4)a,c
(n=6)a
(n=6)a
(n=34)b
(n=2)a
Buprenorphine
(n=2)a,c
(n=4)a
(n=2)a
(n=6)b
(n=2)a
Oral
Naltrexone
No data
(n=3)d
(n=3)d No data
(n=2)d
Extended
Release
Naltrexone
(n=1)e
(n=6)e-j
(n=6)e-j No data
(n=1)g
aMattick RP, et al. Cochrane Database Syst Rev 2014; bGowing, L et al. Cochrane Database Syst Rev 2011 cSordo, et al. BMJ 2017 dMinozzi S, et al. Cochrane Database Syst Rev 2011; eReece, AS. J Addict Dise 2010 fKrupitsky E et al. Lancet. 2011,
gComer SD et al. Arch Gen Psychiatry 2006, hLee J et al, NEJM, 2016. iTanum L et al. JAMA Psych, 2017
jLee, et al. X:BOT. Lancet, 2018
(n = number of studies)
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Methadone
• Developed in 1930s during WWII as an alternative to
morphine
• In 1947, approved in US as analgesic and antitussive
• In 1960s, first utilization as medication to treat OUD by
Dr. Vincent Dole of Rockefeller University
• 1971, first federal program for methadone maintenance
treatment
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Methadone
• Full opioid agonist indicated to treat opioid use disorder
• Long and variable elimination half-life
15-150 hours
• Federal regulation requires dispensing in a licensed
opioid treatment program (OTP)
Exceptions: hospitals
• OTPs integrate counseling into the treatment paradigm
• Specific Eligibility Criteria
• Typical effective dose range is 60-100mg per day, may
need to be higher in some patients
Mattick Cochrane Rev 2013
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Methadone
• >40 years of data support 1,2
Safety
Sustained opioid abstinence
Treatment retention
Reduced IV Drug Use risk behaviors
Reduced transmission of HIV and HCV
• But…
Requires careful monitoring
Increased risk of mortality in first 2 weeks of treatment due to unique and complex pharmacokinetics
Prolongs QTc3,4
− 23% of patients by 16 weeks of treatment4
Multiple drug-drug interactions5
1 Kreek Addict Dis 2010 2 Mattick Cochrane Rev 2014 3 Chou, J Pain 2014 4 Wedam Arch Intern Med 2007 5 McCance-Katz Am J Addict 2009
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Mortality Risk During and After
Methadone Treatment
0
5
10
15
20
25
30
35
40
Methadone - all cause mortality Methadone - overdose risk
Mortality rates/1000 person years (95% CI)
In treatment Out of treatment
Sordo, et al. BMJ 2017.
21
Methadone:
Contraindications and Precautions
Contraindications Precautions
Hypersensitivity
Concurrent use of other CNS depressants
including alcohol, other opioids,
benzodiazepines
Respiratory depression (e.g.
severe COPD, severe OSA, etc) Liver disease
Hypercapnia
Drug interactions with medications
metabolized by cytochrome p450
-CYP34A, CYP2B6, CYP2C19, CTY2C9,
CYP2D6
Paralytic ileus Electrocardiogram (ECG) QTc > 450ms*
ECG QTc > 500ms*
*Pretreatment and annual ECG screening recommended
Chou, J Pain 2014
ASAM National Practice Guideline, June 1, 2015.
22
Buprenorphine/Naloxone Film or Tablet
(4:1 combination)
• First FDA approval in 2002 for OUD treatment
• Partial opioid agonist, Schedule 3
• Transmucosal film or tablet
• Dosing
Once daily
Alternative dosing: every other day or thrice weekly also effective
Off label: twice daily or three times daily
• 24mg/day usually the highest effective dose
• Ceiling Effect* with lower opioid overdose risk
• Office based prescribing by MDs, DOs, PAs, or NPs with DEA waiver or “X license”
Treat up to 30 patients the first year, then up to 100 patients
Can apply to prescribe up to 275 patients if certain requirements met
*Ceiling effect does not apply to children where unintentional exposure can lead to death
SAMHSA TIP 63: https://store.samhsa.gov/system/files/sma18-5063pt3.pdf
23
Rationale for Buprenorphine/Naloxone
Combination
• Naloxone present in attempt to decrease misuse or
diversion
• Naloxone is mostly inactive unless injected
Very low bioavailability of naloxone when medication
used sublingually
If patient opioid dependent and not in opioid withdrawal,
injection of buprenorphine/naloxone can precipitate
withdrawal
If patient in opioid withdrawal, injection of
buprenorphine/naloxone can have euphorogenic or
opioid withdrawal relieving effects
SAMHSA TIP 63: https://store.samhsa.gov/system/files/sma18-5063pt3.pdf
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Commercially Available Transmucosal
Buprenorphine Formulations for the
Treatment of OUD
Buprenorphine/
Naloxone Suboxone® Buprenorphine Zubsolv® Bunavail®
Formulation SL Tablets SL Film SL Tablets SL Tablets
Mucous
Membrane
Film
Dosages
Available
2/0.5mg
8/2mg
2/0.5mg
4/1mg
8/2mg
12/3mg
2mg
8mg
1.4/0.36mg
2.9/0.71mg
5.7/1.4mg
8.6/2.1mg
11.4/2.9mg
2.1/0.3mg
4.2/0.7mg
6.3/1mg
Concomitant
Naloxone Yes Yes No Yes Yes
SL = Sublingual
Belbuca®, Buprenex®, and Butrans® are not indicated for treatment of opioid dependence or opioid use disorder
Fudin, J, 2016
25
Buprenorphine:
Contraindications and Precautions
Contraindications Precautions
Hypersensitivity
Concurrent use of other CNS
depressants including alcohol, other
opioids, benzodiazepines
Patient not already on
buprenorphine and undergoing
a procedure where full agonist
treatment is needed*
Precipitated withdrawal due to full
agonist opioid use
Severe liver impairment
*Patients can have acute pain addressed while on buprenorphine treatment. Refer to PCSS Core
Pain Curriculum for more information.
ASAM National Practice Guideline, June 1, 2015.
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Buprenorphine Implant
(Probuphine®)
• FDA approved in 2016
• Indication: Treatment of OUD in patients who have been clinically
stabilized on transmucosal buprenorphine 8 mg/day or less.
• Medication consists of 4 implants (80mg/implant) surgically inserted
into the subdermal region of the upper arm that release
buprenorphine for 6 months.
• At steady state (after 4 weeks), comparable to trough
buprenorphine plasma levels produced by daily sublingual
buprenorphine doses of 8mg or less.
• To prescribe, insert or remove medication, providers must complete
a live training program.
SAMHSA TIP 63: https://store.samhsa.gov/system/files/sma18-5063pt3.pdf
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Buprenorphine Implant
Probuphine®
Responder Rate Implant SL B/X P Value NNT
Primary Analysis
• 4 of 6 month
without illicit
opioid use
81/84 (96.4%) 78/89 (87.6%) <0.001 11.4
Secondary Analysis
• 6 month illicit
opioid abstinence 72/84 (85.7%) 64/89 (71.9%) 0.03 7.3
• 177 randomized; 166 completed (93.8% retention)
Rosenthal, Lofwall et al. JAMA. 2016. 316(3):282-290
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Buprenorphine Depot Injection
(Sublocade®)
• FDA approval obtained November 2017
Moderate to severe OUD treatment
• Monthly subcutaneous abdominal injection
Minimum 7 days of transmucosal buprenorphine treatment first
• Two doses
300mg/1.5mL and 100mg/0.5mL
• Two dosing options based on current evidence
300mg/1.5mL x 6 months
300mg/1.5mL x 2 months, followed by 100mg/0.5mL x 4 months
• Peak buprenorphine concentrations occur ~24 hrs after injection
• Steady state achieved in 4 to 6 months
• After discontinuation, patients may have detectable plasma levels for 12 months or longer
SAMHSA TIP 63: https://store.samhsa.gov/system/files/sma18-5063pt3.pdf
29
Buprenorphine Depot Injection
(Sublocade®)
• One Phase 3 trial completed1
• Low proportion of people with significant adverse effects
• Primary endpoint = mean % abstinence1
41-43% treatment arm vs 5% for placebo (p<0.0001)
• Secondary endpoint = treatment success (80% urine
samples free of opioids) 1
28-29% treatment arm vs 2% placebo (p<0.0001)
1Late-Breaking Research Oral Session at CPDD 79th
Annual Scientific Meeting 2017. http://cpdd.org/meetings/2017-meeting-information/
30 Treatment duration (days)
Re
ma
inin
g in
tre
atm
en
t (
nr)
0
5
10
15
20
0 50 100 150 200 250 300 350
Treatment Retention: Buprenorphine Detoxification vs. Maintenance
Maintenance: 75% Abstinent at 1 year
0% mortality
HR = 58.7, p .0001
Kakko, Lancet 2003
Detoxification: 0% Abstinent at 1 year
20% mortality
Mortality Risk During and After
Buprenorphine Treatment
0
2
4
6
8
10
12
Buprenorphine - all cause mortality Buprenorphine - overdose risk
Mortality rates/1000 person years (95% CI)
In treatment Out of treatment
Sordo, et al. BMJ 2017.
Buprenorphine vs. Methadone Treatment Retention
Perc
ent
Reta
ined
0
20
40
60
80
100
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17
20% Low dose
methadone (20mg)
58% Buprenorphine
73% High dose
methadone (60-
100mg)
Study Week Johnson NEMJ 2000
Buprenorphine vs. Methadone Opiate Urine Results
Mean %
Negative
Study Week
40% Buprenorphine
80
1 3 5 7 9 11 13 15 17
0
20
40
60
100
19% Low dose
methadone
39% High dose
methadone
Johnson NEMJ 2000
34
Oral Naltrexone
• Opioid antagonist: blocks all opioid receptors
• Two formulations: Oral and Intramuscular
• Oral Naltrexone FDA approved in 1984 for blockade of effects of administered opioids
Dose is 50mg daily
Alternative dosing = dose three times a week with two 100mg-doses followed by 150mg dose
Not widely used to treat OUD because low rates of patient acceptance, difficulty with initiation, and high rates of medication nonadherence
Cochrane Review did not find oral naltrexone superior to placebo or no medication in treatment retention and illicit opioid use
SAMHSA TIP 63: https://store.samhsa.gov/system/files/sma18-5063pt3.pdf
Minozzi S, et al. Cochrane Database Syst Rev 2011
35
Extended-Release (XR)
Naltrexone: Intramuscular Injection
• FDA approved 2010 for treatment of opioid use disorder following medically supervised withdrawal
• 380mg administered intramuscularly once every 4 weeks
Some people may metabolize quickly and need injection in 21 days
• Consider in
Patients who have failed agonist treatment
Patients confined to environments that do not allow for medication treatments
Patients who do not have access to agonist treatment
Patients with high risk of diversion
Patients who are highly motivated and willing to taper off opioid agonists
Patients who do not want to be treated with an agonist
Patients with concomitant opioid and alcohol use disorder
Comer, S, Cunningham, C, et al. (2015)
ASAM The National Practice Guideline For the Use of
Medications in the Treatment of Addiction Involving Opioid Use.
36
XR-Naltrexone
• Requires patient to be fully abstinent from opioids
Short acting opioids = 5-7 days abstinent
Long acting opioids = 7-10 days abstinent
Confirm opioid abstinence with urine drug test and/or naloxone
challenge*
• Few drug-drug interactions
• Induction delays and non-adherence may reduce overall effectiveness
Comer, S, Cunningham, C, et al. (2015)
ASAM The National Practice Guideline For the Use of
Medications in the Treatment of Addiction Involving Opioid Use.
*Naloxone Challenge:
Use to assess lack of physical opioid dependence
Usually involves injection (IV, IM, or SQ) of
Short-acting NALOXONE to test opioid abstinence
See TIP 63 for more information
37
XR-Naltrexone
• Efficacious for opioid abstinence compared to placebo
Comer: 60 U.S. people who use heroin at 8 weeks1
Krupitsky: 250 Russian people who use heroin at 24
wks2
− % Opioid Abstinent XR-Naltrexone 45 (35.7%) vs
Placebo 25 (22.8%)
− RR 1.58, 95% CI (1.06 – 2.36), p = 0.0224
− NNT 7.8
− Fair quality study, high attrition, young white males
only
1 Comer Arch Gen Psych 2006 2 Krupitsky Lancet 2011
38
XR-Naltrexone to Prevent Opioid
Relapse in Criminal Justice Offenders
• Open-label, randomized, controlled effectiveness trial
• Compared six monthly injections of XR-NTX with usual treatment (brief counseling and referrals for community treatment programs)
• Study population: adult ex-prisoners who had a history of opioid dependence
• Primary endpoint: opioid relapse
Lee JD et al. N Engl J Med 2016;374:1232-1242
39
After 6 months
Time to relapse:
10.5 weeks Naltrexone
5.0 weeks Usual
Treatment
Opioid Relapse Event:
43% Naltrexone
64% Usual Treatment
Overdoses:
0 Naltrexone
7 Usual Treatment
Lee JD et al. N Engl J Med 2016;374:1232-1242
Kaplan–Meier Curves for Relapse-free Survival
XR-Naltrexone to Prevent Opioid
Relapse in Criminal Justice Offenders
40
XR-Naltrexone:
Contraindications and Precautions
Contraindications Precautions
Hypersensitivity Vulnerability to overdose
Patient currently physically
dependent on opioids – will
develop severe precipitated opioid
withdrawal
Injection site reactions associated with
injectable naltrexone
Patient receiving opioid analgesics Risk of hepatotoxicity
Patients in acute opioid withdrawal Monitor for development of depression
and suicidality
Thrombocytopenia or coagulation
disorder – injection bleeding risk
ASAM National Practice Guideline, June 1, 2015.
41
XR-Naltrexone Compared to
Buprenorphine
• Tanum, et al, 2017: Open label RCT
159 patients randomized / 105 completed study
Inpatient detox setting
12 weeks follow up
Primary Outcomes: retention in treatment, group proportion of opioid-negative UDTs, days of use of heroin or other opioids
XR-NRT non-inferior to buprenorphine (relatively low dose) for treatment retention and decreasing opioid use at 12 weeks
− Lower use of heroin or other opioids in XR-NRT group
• Secondary outcomes: XR-NRT superior to buprenorphine on reduction in heroin craving, reduction of insomnia, satisfaction with treatment, life satisfaction, and reduction of pain. No difference in anxiety or depression
Tanum L et al. JAMA Psych, 2017
42
X:BOT Trial (XR-Naltrexone
Compared to Buprenorphine)
• Lee, et al, 2018: Comparative Effectiveness RCT
570 patients randomized / 474 completed
8 INpatient detoxification/residential treatment programs
around the US
− Sites utilizing non-opioid detox had better success with
XR-NRT induction
24 weeks of follow up
Primary outcome: “time to relapse”
− 7 consecutive use days
− 4 consecutive use weeks
− Beginning no earlier than 21 days post-randomization
Lee, et al. X:BOT. Lancet, 2018
43
X:BOT Trial (XR-Naltrexone
Compared to Buprenorphine)
• Patients were less likely to be inducted on XR-NTX, less likely to relapse if they received buprenorphine.
• Once started on medication, a statistically significant difference was not observed btw medications.
Lee, et al. X:BOT. Lancet, 2018
Outcome XR-NXT (n=283) BUP-NX (n=287) Treatment Effect*
Number of patients
Inducted to study
medication (ITT)
204 (72%) 270 (94%) OR 0.61, 0.09-0.28
P<0.0001
Weeks Relapse-free
survival (ITT) 8.4 (3-23.4) 14.4 (5.1-23.4)
HR 1.36, 1.10-1.68
P=0.0040
24-week relapse rates
(ITT) 65% 57%
OR=1.44, 1.02-2.01
P=0.04
XR-NRT (n=204) BUP-NX (n=270)
Weeks Relapse-free
survival Per-protocol 20.4 (5.4-23.4) 15.2 (5.7-23.4)
HR 0.92, 0.71-1.18
P=0.49
24-week relapse rates
per-protocol 52% 56%
OR=0.87, 0.60-1.25
P=0.44
44
Models of Care Treating
Patients with OUD
• Office-based buprenorphine
therapy
• Buprenorphine HIV
evaluation and support
collaborative model
• One-stop shop model
• Integrated prenatal care and
MAT
• Hub and spoke model
• Medicaid health home model
• Project ECHO
• Collaborative opioid
prescribing model
• Nurse care manager model
• ED initiation of buprenorphine
• Inpatient initiation of MAT
• Southern Oregon model
Chou R, et al. Agency for Healthcare Research and Quality (US); 2016
Dec. (Technical Briefs, No. 28.) Report No.: 16(17)-EHC039-EF.
Korthuis, et al. Annals of Internal Medicine, 2017.
45
What is Medication Management?
• Treatment of opioid withdrawal
• Medication initiation
• Evaluation for safety and effectiveness
• Confirmation of adherence
Urine drug testing, pill counts, patient report
• Evaluating treatment plan based on patient need and adherence
• Referral for or treatment of mental illness, if needed
• Also involves
Psychosocial needs assessment
Supportive counseling
Case management
Links to existing family supports
Referral to community services
ASAM National Practice Guideline, 2015
46
Role of Counseling
• Purpose:1
Modify behaviors that maintain or reinforce drug use
Develop coping strategies
Encourage medication adherence
Treat or identify concomitant mental illness that can
complicate SUD or trigger relapse
• Some evidence shows that psychosocial treatment
improves adherence and retention in treatment2-3, but
findings are mixed4-7
1 ASAM National Practice Guideline, 2015 2 Brigham GS, et al, Drug Alcohol Dependence 2014 3 Ruetsch C, et al, Addict Behav, 2012 4 Fiellin, DA, et al, Am J Med 2013 5 Fiellin DA, et al, NEJM 2006 6 Tetrault JM et al, K Subst Abuse Treat 2012 7 Weiss RD et al, Arch Gen Psych 2011
47
Effective Counseling Modalities
• Relationship building
• Cognitive behavioral therapies
• Contingency management
• Relapse prevention
• Motivational interviewing
Dutra, et al. Am J Psychiatry, 2008
48
Case
• Jane is a 23 year old female with chronic low back pain from a motor vehicle accident at
age 16 who presents to your office asking for help to stop using IV heroin.
• She has been using opioids daily for about 4 years. She started using illicit prescription
opioids, then switched to IV heroin daily about 2 years ago when she could no longer afford
illicit opioid pills.
• She has attempted non-medication-based addiction treatment in the past and quickly
relapsed.
• She also drinks approximately 14 alcoholic drinks per week, but has never had alcohol
withdrawal symptoms when she stops drinking. She feels that she could easily stop drinking
alcohol. She denies other drug use.
• She denies other mental health or medical issues, but has had two opioid overdoses in the
past year.
• She lives with her parents who are supportive of her. She is on probation for possession of
opioids.
• She reports opioid withdrawal symptoms including anxiety, restlessness, nausea, stomach
cramping, and diarrhea. Her vital signs and physical exam are normal except for
gooseflesh, dilated pupils, and bilateral upper extremity track marks.
49
Case Questions
• Is medication indicated for this patient?
Yes
• What additional work up or evaluation is needed to decide upon medication for this patient?
Urine drug screen and pregnancy test
DSM-5 evaluation
General medical evaluation
• How will you address the concomitant alcohol use?
May need to consider medically supervised withdrawal
Structure care to monitor this closely
50
Pros and Cons of Each Medication
Medication Pros Cons
Buprenorphine
• Quick stabilization of
withdrawal
• May also treat concomitant
pain
• Possible overdose risk with
concomitant alcohol use
Methadone
• Quick stabilization of
withdrawal
• May be more effective to
treat concomitant pain
• Possible overdose risk with
concomitant alcohol use
XR-Naltrexone
• Will treat concomitant
alcohol use disorder
• No risk of withdrawal if
patient is incarcerated
• More severe withdrawal
• Delay in initiation of
treatment
Ultimate choice of medication should be based on patient choice, but access to treatment
program, insurance coverage, and medication access will also likely guide decision.
51
More Information on
Medication Treatments
https://store.samhsa.gov/
Substance Abuse and Mental Health Services Administration. Medications for Opioid Use Disorder.
Treatment Improvement Protocol (TIP) Series 63, Executive Summary.
HHS Publication No. (SMA) 18-5063EXSUMM. Rockville, MD:
Substance Abuse and Mental Health Services Administration, 2018.
52
• Brigham GS, Slesnick N, et al. (2014) A randomized pilot clinical trial to evaluate the efficacy of Community Reinforcement and Family Training
for Treatment Retention (CRAFT-T) for improving outcomes for patients completing opioid detoxification. Drug Alcohol Depend;138:240–243.
• Chou, R, et al. (2014) Methadone Safety: A Clinical Practice Guideline From the American Pain Society and College on Problems of Drug
Dependence, in Collaboration With the Heart Rhythm Society. The Journal of Pain, 15 (4): 321 – 337
• Chou R, et al. (2016) Medication-assisted treatment models of care for opioid use disorder in primary care settings [internet]. Rockville, MD:
Agency for Healthcare Research and Quality (US); (Technical Briefs, No. 28.) Report No.: 16(17)-EHC039-EF.
• Comer, S, Cunningham, C, et al. (2015) ASAM The National Practice Guideline For the Use of Medications in the Treatment of Addiction
Involving Opioid Use.
• Comer S, Sullivan, MA. (2006) Injectable, sustained-release naltrexone for the treatment of opioid dependence: a randomized, placebo-
controlled trial. Arch Gen Psychiatry, 63 (2): 210-8.
• Dutra L, Stathopoulou G, et al. (2008) A meta-analytic review of psychosocial interventions for substance use disorders. Am J Psychiatry 165:
179-187.
• Fiellin DA, Barry DT, et al. (2013) A randomized trial of cognitive behavioral therapy in primary care-based buprenorphine. Am J Med.
126:74.e11–74.e17.
• Fiellin DA, Pantalon MV, et al. (2006) Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence. N Engl J
Med;355:365–374.
• Fudin, J. (2016) A Brief Review of Buprenorphine Products. Pharmacy Times.
• Gowing, L, Farrell, M, et al. (2011) Oral substitution treatment of injecting opioid users for prevention of HIV infection. Cochrane Database of
Systematic Reviews (8): CD004145
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References
PCSS Mentor Program
• PCSS Mentor Program is designed to offer general information to
clinicians about evidence-based clinical practices in prescribing
medications for opioid addiction.
• PCSS mentors are a national network of providers with expertise in
addictions, pain, evidence-based treatment including medication-
assisted treatment.
• 3-tiered approach allows every mentor/mentee relationship to be unique
and catered to the specific needs of the mentee.
• No cost.
For more information visit:
pcssNOW.org/clinical-coaching
55
Funding for this initiative was made possible (in part) by grant nos. 5U79TI026556-02 and 3U79TI026556-02S1 from SAMHSA. The
views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the
official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or
organizations imply endorsement by the U.S. Government.
PCSS-MAT is a collaborative effort led by the American Academy of Addiction Psychiatry (AAAP) in
partnership with the: Addiction Technology Transfer Center (ATTC); American Academy of Family
Physicians (AAFP); American Academy of Neurology (AAN); American Academy of Pain Medicine (AAPM);
American Academy of Pediatrics (AAP); American College of Emergency Physicians (ACEP); American
College of Physicians (ACP); American Dental Association (ADA); American Medical Association (AMA);
American Osteopathic Academy of Addiction Medicine (AOAAM); American Psychiatric Association (APA);
American Psychiatric Nurses Association (APNA); American Society of Addiction Medicine (ASAM);
American Society for Pain Management Nursing (ASPMN); Association for Medical Education and
Research in Substance Abuse (AMERSA); International Nurses Society on Addictions (IntNSA); National
Association of Community Health Centers (NACHC); National Association of Drug Court Professionals
(NADCP), and the Southeast Consortium for Substance Abuse Training (SECSAT).
For more information: www.pcssNOW.org
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