Download Vivitrol Workshop Posted - Los Angeles County Evaluation System

Implementation of Antagonist
Medication into
SUD Treatment System
Desirée A. Crèvecoeur-MacPhail, PhD
Sarah J. Cousins, MPH
Kira Jeter, MPH
UCLA Integrated Substance Abuse Program
Los Angeles CA
Department of Health Care Services
Substance Use Disorders Statewide Conference
Costa Mesa, CA
August 2014
1
Disclosures
• No part of this research was funded by
Alkermes who manufactures Vivitrol
• This project was funded solely by the Los
Angeles County Department of Public
Health Substance Abuse Prevention and
Control
2
Learning Objectives
1. Define medically assisted treatment
2. Identify at least one benefit of using
medically assisted treatments, such as
XR-NTX, among alcohol or opioid users
3. Identify disparities in access to XR-NTX
4. Describe at least one association
between gender and subsequent doses
of XR-NTX for alcohol use disorders
3
Learning Objective #1
DEFINE MEDICALLY
ASSISTED TREATMENT
4
What is Medically Assisted
Treatment (MAT)?
• According to SAMHSA
– MAT is the use of medications, in combination
with counseling and behavioral therapies, to
provide a whole-patient approach to the
treatment of substance use disorders
– Research shows that when treating
substance-use disorders, a combination of
medication and behavioral therapies is most
successful
5
Partial/Full Agonist, Antagonist,
What’s the Difference?
6
Agonist Medications
• Similar structure and bind to same
receptor sites as drug of abuse
• Full activation at receptor site
• Synthetic opioid that binds to receptors
activated by heroin and other opioids
• If taken as prescribed, user does not
experience euphoria or intoxication
• Example: Methadone
7
Partial Agonist Medications
•
•
•
•
•
•
•
Similar structure and bind to same
receptor sites as drug of abuse
Provide partial activation at site
Relief from craving & withdrawal
Degree of activation less than full agonist
Block full agonists from binding
Limit drug’s effect if substance is
subsequently used
Example: Buprenorphine
8
Antagonist Medications
•
•
•
•
•
•
Decrease pleasure and reward
Have similar structure and bind to same
receptor sites as drug of abuse
Provide no activation
Block full and partial agonists from binding
at receptor sites
May induce withdrawal symptoms
Example: Naltrexone
9
No opioid
effect
Full MU Agonist:
Partial MU Agonist:
Full MU Antagonist:
Methadone
Buprenorphine
Naltrexone
•Naltrexone has the highest receptor BINDING AFFINITY, then buprenorphine, then
methadone
10
Agonist/Antagonist Medications
• Best of all worlds?
• Provides some relief from withdrawal but
also binds with the site so that patients
cannot abuse the agonist
Suboxone= Buprenorphine + Naloxone is an
agonist/antagonist combo
• Naloxone is a powerful opioid receptor
antagonist that will displace other opioids
and precipitate withdrawal
11
What is XR-NTX (Vivitrol)?
• Injectable extended release naltrexone
(XR-NTX) was FDA approved in 2006, for
the treatment of alcoholism
– In 2010, the FDA approved Vivitrol for the
opioid use relapse prevention
• An antagonist - blocks the mu-opioid
receptors in the brain
– Mu-opioid receptors are responsible for the
“high” or “buzz”
12
Naltrexone/Vivitrol for Opioid and
Alcohol Dependence
• Full MU opioid receptor ANTAGONIST
No opioid
effect
13
XR-NTX (Vivitrol)
• Monthly intramuscular
injection
• Given by nurse, PA, MD,
other
• Non-narcotic, prescribed by
MD/DO/NP
• Not for use if:
– Pregnancy
– Severe liver disease
– Chronic pain requiring opioids
14
Audience?
• How many of you work with medications in
your treatment programs?
• How has your experience been with XRNTX (Vivitrol)?
• What are the issues you would like to
discuss in today’s workshop?
15
Learning Objective #2
IDENTIFY AT LEAST ONE
BENEFIT OF USING MAT
16
Evaluation Design
•
Treatment Outcome Data
– Los Angeles County Participant Reporting
System (LACPRS)
•
Patient Response to Vivitrol
– Medically Assisted Treatment Survey
(MATS)
– Urge to Drink Scale (UDS)
•
Counselor Attitudes
17
Results and Conclusions
Results Significant at
p<.05 or better
18
Limited Side Effects
Proportion Reporting Side Effect for Weeks 1 – 4 After First Dose
19
Participant Characteristics
Categorical
Variable
Gender (Female)
Race/Ethnicity
White
African American
Latino
Other
Criminal Justice Involvement (yes)
Homeless status (yes)
Employment Activities (yes)
Program Type (Outpatient)
Mental Illness* (yes)
Vivitrol
Group
(% yes)
55.3%
Post-hoc
TAU Group
(% yes)
56.8%
41.1%
13.2%
41.1%
4.7%
31.6%
40.5%
10%
35.3%
44.7%
43.7%
12.1%
40%
4.2%
33.2%
35.3%
14.2%
34.7%
32.1%
Statistic
X2 = 0.096
X2 = 0.323
X2 = .108
X2 = 1.118
X2 = 1.583
X2 = .012
X2 = 6.407
*Lifetime report of mental illness differed between groups; p<.01
20
Participant Characteristics
Vivitrol Group
Post-hoc
TAU Group
Mean (sd)
Mean (sd)
Age at Admission
37.2 (9.5)
36.8 (10.7)
t(374) = -.469
Age at First Use
17.1 (6.3)
17 (6.1)
t(378) = -.173
Days of Primary Drug in the
Last 30
8.2 (9.5)
10.2 (11.3)
t(378) = 1.877
# of Prior Treatment Episodes
2.2 (3.7)
2 (6)
t(378) = -.463
Days on Wait List*
7.2 (13.6)
3.7 (10.5)
t(378) = -2.826
Age at Admission
37.2 (9.5)
36.8 (10.7)
t(374) = -.469
Age at First Use
17.1 (6.3)
17 (6.1)
t(378) = -.173
Continuous
Variable
Test
Statistic
*Days spent on the wait list significantly differed between the groups p<.001.
21
Engagement & Completion Rates for
Vivitrol and Post Hoc (TAU) Clients
Engagement and Completion Rates of Vivitrol Treatment Clients vs. TAU
Treatment Clients
22
XR-NTX & Engagement
• Engagement = In treatment for 30+ days
• Predictors included
– XR-NTX (p < .001)
• OR (95% CI) = 12.609 (5.178-30.706)
– Age at first use (p < .05)
• OR (95% CI) = 1.066 (1.009-1.126)
23
XR-NTX & Retention
• Retention = In treatment for 90+ days
• Predictors included
– XR-NTX (p < .001)
• OR (95% CI) = 3.868 (2.352 – 6.361)
– Race (African American vs. White) (p < .05)
• OR (95% CI) = .380 (.175 - .826)
– Mental illness diagnosis (p <.01)
• OR (95% CI) = 2.415 (1.370 – 4.258)
24
XR-NTX & Pos Compliance
• Positive Compliance = Discharge status
– Vivitrol group (78.4%)
– Comparison group (60%)
• Predictors included
– XR-NTX (p < .001)
• OR (95% CI) = 2.766 (1.665 – 4.595)
– Age at first use (p < .01)
• OR (95% CI) = 1.062 (1.018 - 1.109)
– Employment activities (p < .01)
• OR (95% CI) = .318 (.134 - .755)
25
Audience?
• Have you tried implementing an MAT?
– If yes:
• What barriers did you experience?
• What successes did you have?
– If no:
• What barriers do you expect to experience?
• What successes do you hope to have?
• What do you think promotes/inhibits an individual
seeking MAT at a treatment center?
26
Learning Objective #2
IDENTIFY DISPARITIES IN
ACCESS TO MAT
27
What is a Health Disparity?
•
Population-specific differences in
–
–
–
–
•
the presence of disease
outcome of disease
quality of health care
access to health care services
Commonly viewed through the lens of race and
ethnicity, but also includes SES, age,
geographic location, gender, disability status,
and sexual orientation
(HRSA, 2014; Kaiser Family Foundation, 2008)
Health Disparities & Race/Ethnicity
Compared to the non-Hispanic whites, racial/ethnic
minority populations:
• Lower prevalence of SUD, anxiety, mood disorders but an
anxiety and mood disorder that persists for a longer duration
(SAMHSA, 2012; Breslau et al., 2005.)
• Less satisfied with SUD treatment services (Marsh et al, 2009;
Niv et al, 2009)
• Less likely to complete SUD treatment (Bluthenthal et al, 2007;
Guerrero et al, 2013)
• Experience more medical and social consequences from
substance use (NIDA, 2008)
• May receive less innovative evidence based treatments such
as MATs (Knudsen & Roman, 2009)
Treatment Access & Gender
Did not seek help
100%
Sought help
80%
72
69.5
60%
76
40%
20%
28
30.5
24
0%
Total
Men
Women
Bottom line:
Women with
SUD have
lower levels of
help-seeking
compared to
men.
Source: Grella & Stein, 2013. NESARC Wave I sample with past-year alcohol or other drug
dependence; refers to any type of help received in lifetime; N = 1,262; p < .001
Treatment Outcomes & Gender
 It is unclear if gender predicts SUD Tx outcomes
 Characteristics associated with gender may have a
greater impact on women’s treatment outcomes:




Co-occurring psychiatric disorders
History of abuse or trauma
Socioeconomic status, employment
Parenting and childcare responsibilities
Source: Grella & Stein, 2013. NESARC Wave I sample with past-year alcohol or other drug
dependence; refers to any type of help received in lifetime; N = 1,262; p < .001
What causes a Health Disparity?
• The way the healthcare systems are
organized and operate can contribute to
differences
• Patients attitudes and behaviors
• Health care providers’ biases, prejudices
and uncertainties when treating minority
groups
Institute of Medicine, 2002
So what?
• Inequities in the health care system result
in lost productivity or use of services at a
later stage of illness, there are health and
social costs that affect us all
Kaiser Family Foundation, 2008
Disparities in MAT utilization
Less likely to provide MATs:
• Publically-funded SUD Tx programs
– Use of XR-NTX: 8% public vs. 18% private
• Outpatient-only treatment settings
• Programs that receive a large proportion of CJ
referrals
• Lack of knowledge, recovery status, and
counselor credential predict MAT utilization
Abraham, Kundsen, Reickmann, Roman, 2013; Knudsenm Abraham, Oser, 2012;
Roman, Abraham, Knudesen, 2011
Addressing Barriers
• LA County increased availability of XR-NTX as a
treatment option
• Obtained a grant for drug court patients
• Medication hubs linked with referring agencies to
provide medical screenings and provide XR-NTX
doses
• Transportation to/from Tx and the medication
hub was coordinated
• Education sessions to increase knowledge of
MAT among Tx providers
Disparities in Access to XR-NTX?
1. Are XR-NTX recipients different from the
“average” patient seeking Opioid or Alcohol
treatment services in LA County?
2. Were there any disparities in access to XR-NTX
recipients by racial/ethnic or gender groups?
Methods
•
•
Used 2010-2013 admission records to compare
XR-NTX patients to LA County patients seeking
treatment for alcohol or opioids
Examined differences in treatment modality,
race/ethnicity, SUD history and gender
Use of XR-NTX in LA County
100%
Treatment Modality
XR-NTX Patients
80%
LAC Patients
67%
60%
40%
49%
32%
17%
20%
19% 16%
0%
Outpatient
p < 0.05
Residential
Detoxification
Use of XR-NTX in LA County
100%
Substance of Use
80%
XR-NTX Patients
74%
LAC Patients
63%
60%
40%
30%
18%
20%
8%
7%
0%
Alcohol
p < 0.05
Heroin
Other Opiates
Use of XR-NTX in LA County
(M + SD)
XR-NTX
Alcohol
(N = 438)
LAC
Alcohol
(N = 31,554)
XR-NTX
Opioid
(N = 171)
LAC
Opioid
(N = 18,177)
Age
40.5 (9.836)
38.6 (14.347) 36.1 (11.587) 40.3 (13.474)
Age First used
16.7 (5.993)
17.7 (6.708)
21.8 (9.667)
Days Used Past Mo
13.5 (11.850)
9.8 (11.157)
11.1 (12.426) 20.6 (12.054)
2.4 (5.632)
1.2 (3.378)
# of Prior Tx Episodes
4.2 (5.393)
22.1 (8.833)
2.7 (4.036)
All findings significant at p < .01
Bottom line: XR-NTX recipients appear to have a more substantive
SUD history as compared to the typical patient in LA County.
Use of XR-NTX in LA County
XR-NTX
Alcohol
(N = 438)
LAC
Alcohol
(N = 31,554)
XR-NTX
Opioid
(N = 171)
LAC
Opioid
(N =18,177)
Non-Hispanic White
45.9%
26.3%
66.1%
54.9%
Black or African American
11.6%
27.9%
3.5%
8.3%
Latino / Hispanic
36.3%
39.8%
23.4%
31.9%
Asian/Pacific Islanderi
0.9%
2.4%
1.2%
1.2%
American Indian/Alaska Nativei
0.7%
1.2%
0.6%
0.8%
Other/Mixedi
4.6%
2.4%
5.3%
2.9%
Race
i Due to small sample sizes, a chi-square was conducted on a collapsed “Other Race/Ethnicity” category. This Race/Ethnic
group contained individuals who identified as either American Indian, Asian/Pacific Islander or Other/Mixed Race. Analysis
resulted in “Other Race/Ethnicity” comprising of 6.2% Vivitrol Alcohol vs. 6% LAC Alcohol as well as 8.3% Vivitrol Opioid
vs. 4.9% LAC Opoids. p < 0.01
Bottom line: Racial/ethnic minorities were under-represented among
Vivitrol recipients.
Use of XR-NTX in LA County
100%
Gender by patients seeking Alcohol Tx
80%
XR-NTX Patients
LAC Patients
61%
60%
52%
48%
40%
40%
20%
0%
p < 0.05
Men
Women
Use of XR-NTX in LA County
100%
Gender by patients seeking Opioid Tx
80%
68%
60%
XR-NTX Patients
LAC Patients
54%
46%
40%
32%
20%
0%
p < 0.05
Men
Women
Summary of Findings
• Treatment providers may have promoted XRNTX to the patients with more severe SUD
histories
• Men and racial/ethnic minorities were
underrepresented among XR-NTX recipients
• Further research is warranted to examine if
geographic area or organizational characteristics
predicts access to XR-NTX
Bottom Line: Not only is it important to provide evidence based
practices, like MAT, but it is also important to ensure equal
access for all patients.
44
Learning Objective #3
DESCRIBE AT LEAST ONE
ASSOCIATION BETWEEN
GENDER AND SUBSEQUENT
VIVITROL DOSES
45
Studies on Gender and NTX
• Results of studies on effectiveness of oral
NTX by gender are mixed
• Hernandez-Avila et al (2006) suggests that
oral NTX may be more effective in men
than women
• Baros et al (2008) and Greenfield et al
(2010) both found that NTX was effective
in both men and women
46
Studies on Gender and Oral NTX cont.
• O’Malley et al (2000) found that women were
more likely to report nausea led to low
adherence and discontinuation
• Suh et al (2008) found that women more likely to
discontinue oral NTX treatment with prior severe
psychiatric disorder or nausea
47
Participant Demographics by Gender
Total
(N=465)
Male
(N=223)
Female
(N=242)
%
45.9
9.7
36.7
7.7
%
43.5
7.2
37.8
11.5
%
48.1
11.9
35.7
4.3
37.7 (10.2)
38.2 (10.4)
37.0 (9.9)
Parent of child <age 18**
55.1
42.3
65.1
Homeless at treatment admission
38.1
37.5
38.7
Under criminal justice supervision*
34.5
38.9
29.8
Mental illness diagnosis*
46.3
33.2
57.9
31.6
20.2
41.7
Variable
Race/Ethnicity*
White
African American
Latino
Othera
Age at treatment admission
Prescribed medication for MI**
*p<.05; **p<.01
aOther
race/ethnicity includes multi-racial, Native American & Asian
48
SUD Characteristics by Gender
Total
(N=465)
Male
(N=223)
Female
(N=242)
Alcohol problems
75.1
73.5
76.4
Opiate problems
24.9
26.5
23.6
Primary substance of use **
Alcohol
Opiates
Other
50.6
20.7
28.8
54.3
26.2
19.5
47.2
15.7
37.0
Secondary substance of use **
Alcohol
Opiates
Other
18.0
7.4
74.6
14.8
3.8
81.4
20.9
10.6
68.5
Variable
Prescribed XR-NTX for:
*p<.05; **p<.01.
49
Treatment Characteristics by Gender
Total
(N=465)
Male
(N=223)
Female
(N=242)
Outpatient
33.1
26.7
38.9
Residential
61.5
67.1
56.4
Detoxification
5.4
6.2
4.7
Days on SUD b treatment waiting list
8.2 (14.8)
8.4 (12.2)
8.0 (16.9)
Average XR-NTX doses received
2.5 (1.7)
2.5 (1.6)
2.5 (1.8)
Variable
Treatment modality *
*p<.05; **p<.01 b SUD=substance use disorder.
50
Clinical Characteristics by Gender (1)
Total
(N=220)
Male
(N=110)
Female
(N=110)
Week 1
2.1 (1.3)
1.9 (1.4)
2.2 (1.3)
Week 2*
1.1 (1.2)
0.9 (1.1)
1.3 (1.2)
Week 1**
85.5
79.0
92.0
Week 2**
57.2
46.4
68.0
Week 1
39.5
36.0
43.0
Week 2**
28.9
19.6
38.1
Side Effects Reported
Average number of side effects
Any side effects
Headache
*p<.05; **p<.01
51
Clinical Characteristics by Gender (2)
Total
(N=220)
Male
(N=110)
Female
(N=110)
Week 1
55.9
49.0
61.0
Week 2
27.3
23.7
30.7
Injection site reaction
Week1
Week 2
34.0
14.9
31.0
11.3
37.0
18.6
Nausea
Week 1
Week 2
46.5
20.6
44.0
17.5
49.0
23.7
Side Effects Reported
Fatigue
*p<.05; **p<.01
52
Reduced Urge to Drink/Use by Gender
30
Women
Men
25
20
15
19.2
18.7
A score of 10 or more indicates danger of relapse.
10
8.9
7.3
5
6.2
0
Week 0
Week 1
Week 2
Based on the Urge to Drink/Use Scale, which is scored from 0 to 30.
53
Qualitative Findings
Total
Male
Female
Percent who had questions or concerns
about XR-NTX in week 1, 2 or 3
(e.g., regarding adverse events, liver
concerns, efficacy of XR-NTX; medication
interactions)
18.9%
21.2%
16.8%
Percent reporting positive response to XRNTX
(i.e., reduced cravings for substances
including nicotine)
12.0%
11.7%
12.2%
Respondents were asked
“Have you noticed any other changes from using Vivitrol”?
”Do you have any questions or concerns about Vivitrol?”
No statistically significant differences between men and women
54
Qualitative Findings
Concerns/Problems
Mild and/or transient
Severe
No Severity
“trouble sleeping on the second day”
“slight redness at injection site”
“unable to get out of bed”
“pain at injection site that went on forever”
“I’ve been eating more, not as satisfied with food; adding more
salt and pepper to food”
“appetite decreased”
Related to Abstinence?
“irritable”, “moody”, “shakiness”
Not attributed to Vivitrol
“I’ve been jittery, but don’t think it’s because of the Vivitrol”
Respondents were asked
“Have you noticed any other changes from using Vivitrol”?
”Do you have any questions or concerns about Vivitrol?”
55
Summary of Findings on Gender
– Based on the findings, women may have a greater
need for SUD treatment that addresses co-occurring
mental health problems as well as parenting needs
– Women may also have a greater need for additional
support in managing early side effects
– No differences in the total number of injections
received
– Despite quantitative findings that women had more
side effects, there were no differences in the number
of doses obtained by gender.
– Qualitative findings seem to suggest similar
experiences with XR-NTX
56
Put Your Collaborative Thinking
Caps On!
57
To Discuss
• Would MAT work in your facility?
• What MATs could work for your program
and treatment population?
• What if you implemented MAT and
noticed…
– More men compared to women were
receiving MAT?
– A large proportion of some race/ethnic group
were not receiving MAT?
58
Conclusions
• Although no causal conclusions can
be made, Vivitrol was associated with
increases in
– Treatment engagement
– Treatment retention
– Positive compliance in treatment
– Reductions in use were noted
59
Policy Changes
• Substantial work done to reduce time
required to get approval from Medi-Cal
– Down from almost 3 months to 3-5 days
• Given results from first pilot, doses are
capped at 3; but client may acquire
additional doses if
– Request made to Medical Director at SAPC
– Urges remain high
– Client remains in treatment
60
Acknowledgements
• Could not have done this work without:
– Loretta L. Denering, MS
– Diane Herbeck, MA
– Eva Vasquez
– Reham Abdel Maksoud, MBBS
– Stefanie Weimann, MA
– Dave Bennett, BA
– Mary-Lynn Brecht, PhD
– Richard A. Rawson, PhD
61
Thank You!
Desiree A. Crevecoeur-MacPhail, Ph.D.
(310) 267-5207
email: [email protected]
62