Transcript PPT- Desiree Crevecoeur-MacPhail, Ph.D.

Medication Assisted Treatment for
SUD: Extended Release Naltrexone
Improves Treatment Outcome
Desirée A. Crèvecoeur-MacPhail, PhD
UCLA Integrated Substance Abuse Program
Los Angeles CA
California SUD/Health Care
Integration Learning Collaborative (ILC)
September 24, 2014
1
Disclosures
• No part of this research was funded by
Alkermes who manufactures XR-NTX
• This project was funded solely by the Los
Angeles County Department of Public
Health Substance Abuse Prevention and
Control
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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
3
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
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Naltrexone/XR-NTX for Opioid and
Alcohol Dependence
• Full MU opioid receptor ANTAGONIST
No opioid
effect
5
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
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The LA County Project:
Evaluation Background
Evaluation Questions
1. Will patients take multiple doses?
2. How did the Urge to Drink/Use score
change?
3. Compared to the Post-hoc group, what
proportion of the XR-NTX group:
• Engaged in treatment (LOS 30+ days)?
• Retained in treatment (LOS 90+ days)?
Evaluation Design: Scales & Tools
•
Treatment Outcome Data
– Los Angeles County Participant Reporting
System (LACPRS)
•
Patient Response to XR-NTX
– Medically Assisted Treatment Survey
(MATS)
– Urge to Drink Scale (UDS)
•
Counselor Attitudes
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Evaluation Design
• The three medication hubs:
– Tarzana Treatment Center (main hub)
– Behavioral Health Services
– Prototypes
• Selection criteria:
– Infrastructure (staff, examination room, refrigerated and
locked location for medication storage) to administer
medications
– Long-standing histories of providing quality substance
abuse treatment to a broad range of clients
Evaluation Design: Procedures
• Three medication hubs were selected based on
existing infrastructure.
• Counselors attended a training.
• Patients were offered the opportunity to utilize XRNTX once per month.
• Data were collected on participants’ urge to use,
medication side effects and days of use.
• Data was collected at weeks 0, 1, 2, 3 post
injection and then monthly thereafter.
Evaluation Design
• No random assignment
• The three medication hubs
– Clients went to hubs for medication and
returned to their treatment agency for
psychosocial treatment
• Hub selection criteria:
– Infrastructure to administer medications
– Long-standing histories of providing quality
substance abuse treatment
Overall Results
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XR-NTX Doses in LA County
Among LAC XR-NTX Patients(N=609)
Alcohol
(N = 438)
Doses
Mean (SD)
Median
Maximum
Total Doses
Total Injections Received+
One Dose Only, % (n)
Two Doses Only, % (n)
Three Doses Only, % (n)
Four Doses Only, % (n)
Five or More Doses, % (n)
+p
Opioid
(N = 171)
Total
(N = 609)
2.81 (2.310)
2
16
1,232
2.41 (1.593) 2.70 (2.140)
2
2
9
16
412
1,644
33.8% (148)
24% (105)
16% (70)
11.2% (49)
15.1% (66)
40.9% (70)
19.3% (33)
14.6% (25)
16.4% (28)
8.8% (15)
35.8% (218)
22.7% (138)
15.6% (95)
12.6% (77)
13.3% (81)
< .06
Bottom line: Patients received two to three doses of XR-NTX,
regardless of substance use disorder.
Clinical Characteristics
Comparison of LAC XR-NTX Patients(N=609)
(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.
Patient Demographics by Gender
Among UCLA XR-NTX Participants (N=465)
Total
(N=465)
Male
(N=223)
Female
(N=242)
%
45.9
9.7
36.7
7.7
37.7 (10.2)
%
43.5
7.2
37.8
11.5
38.2 (10.4)
%
48.1
11.9
35.7
4.3
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*
Prescribed medication for MI**
46.3
31.6
33.2
20.2
57.9
41.7
Variable
Race/Ethnicity*
White
African American
Latino
Othera
Age at treatment admission
*p<.05; **p<.01
aOther race/ethnicity includes multi-racial, Native American & Asian
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Reduced Urge to Drink/Use
30
Among UCLA Phase 2 XR-NTX Participants (N=220)
25
20
19
A score of 10 or more indicates danger of relapse.
15
10
8.1
5
6.3
6.1
Week 2
Week 3
0
Week 0
Week 1
Based on the Urge to Drink/Use Scale, which is scored from 0 to 30.
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Reduced Urge to Drink/Use by Gender
30
Among UCLA Phase 2 XR-NTX Participants (N=220)
Women
Men
25
20
15
19.2
18.8
A score of 10 or more indicates danger of relapse.
10
9.1
7.2
5
6.4
6.4
5.9
6.1
0
Week 0
Week 1
Week 2
Week 3
Based on the Urge to Drink/Use Scale, which is scored from 0 to 30.
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Limited Side Effects
Among UCLA Phase 2 Participants (N=220)
100%
90%
Fatigue
Reporting “Yes”
80%
Injection Site Reaction
70%
Nausea
60%
Headache
50%
40%
30%
56%
48%
40%
35%
28% 29%
20%
21%
20%
17%
10%
15%
9%
0%
Week 1
Week 2
Week 3
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Clinical Characteristics by Gender
Among UCLA Phase 2 XR-NTX Evaluation Participants (N=220)
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
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Comparison Results
Results Significant at
p<.05 or better
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Two Groups
• XR-NTX (n = 190)
– Received at least one dose of medication
– No random assignment – wanted medication,
got medication
• Post-hoc Comparison (TAU) (n = 190)
– Did not receive medication
– Demographics matched to XR-NTX group
– Calculated propensity scores
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)
XR-NTX
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%
Test
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
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Participant Characteristics
Continuous
Variable
XR-NTX
Group
Post-hoc
TAU Group
Age at Admission
Mean (sd)
37.2 (9.5)
Mean (sd)
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
Test
Statistic
*Days spent on the wait list significantly differed between the groups p<.001.
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Engagement & Completion Rates for
XR-NTX and Post Hoc (TAU) Clients
Engagement and Completion Rates of XR-NTX Treatment Clients vs. TAU
Treatment Clients
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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)
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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)
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ADDITIONAL FINDINGS
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Examine Access to Prevent Disparity
• Treatment providers may have promoted XRNTX to the patients with more severe SUD
histories
• Men and some racial/ethnic minorities may be
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.
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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
Summary of Findings on Gender
• No differences in the total number of
doses (not shown) by gender
• Women may have a greater need for SUD
treatment that addresses co-occurring MH
and parenting needs
• Women may need support in managing
side effects
• Qualitative findings (not shown) suggest
similar experiences with XR-NTX
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What about:
TREATMENT INTEGRATION?
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Expansion of Availability of MAT
• Number of SUD
treatment programs
with patients taking
XR-NTX before LA
County Study:
1 program
• Number of SUD
treatment programs
with patients taking
XR-NTX after LA
County Study:
32 programs
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Expansion to Other Areas of CA?
• Many other counties and jurisdictions in
CA using the medication:
– Orange County: starts in jail, also used by
probation
– Santa Cruz County: similar to OC program
– San Mateo County: DD clients with AUD
– Sacramento: small, but very successful – no
crime, tx compliant, clean urines
– San Francisco: VA using with Homeless
Veteran project
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Use of Medication Requires
Collaboration
• In all counties, some collaboration needed
between (some or all of) offices below
– Substance Use Treatment
– Primary Healthcare
– Sheriff’s Department
– Probation Department
– Behavior Health
• Funding varied – Medi-Cal (not Drug),
AB109, Gov grants
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Conclusions
• Although no causal conclusions can
be made, XR-NTX was associated with
increases in
– Treatment engagement
– Treatment retention
– Positive compliance in treatment
– Reductions in use were noted
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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
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45-year-old, Latina female who has been trying to stop
drinking for 15 years. She has been in “over 20 detoxes”
and this is her fifth time in residential treatment.
This is the first time, thanks to XR-NTX, that she
has lost the craving for alcohol since she began
drinking as an adolescent.
52-year-old, Caucasian male who has been drinking
since 14 years of age. He tried to stop drinking for 25
years on his own or through 12-step programs. He never
achieved more than 3-4 months of sobriety at a time. This
is his 2nd Tx program; in his first program he lasted two
months – “thinking about drinking every single day. I
couldn’t get it out of my head, so I left.” Currently, he has
received 2 XR-NTX injections and has “been able to
concentrate on the counseling work” since the third day
after his first injection. He was on a pass last week and
passed the liquor store where he has been “keeping a tab”
for 15 years and “didn’t even realize I went by it until I was
three blocks away. XR-NTX is fantastic!”
36-year-old, American Indian male with a 20-year history
of alcohol and methamphetamine abuse and a co
occurring diagnosis of bipolar disorder. He has been in
treatment 4 times since he began trying to stop using 8 years
ago. While he did manage to stop using meth 4 years ago,
his daily drinking has been steadily getting worse over the last
two years, most often leading to blackouts. He has received 4
XR-NTX injections so far and says he has not had any urges
to drink since “a couple of days after the first shot.”
Acknowledgements
•
•
•
•
•
Sarah J. Cousins, MPH
Kira Jeter, MA
Diane Herbeck, MA
Eva Vasquez
Reham Abdel Maksoud,
MBBS
•
•
•
•
Stefanie Weimann, MA
Dave Bennett, BA
Mary-Lynn Brecht, PhD
Richard A. Rawson,
PhD
• Loretta L. Denering,
MS
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Thank You!
Desiree A. Crevecoeur-MacPhail, Ph.D.
(310) 267-5207
email: [email protected]
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