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Medication Assisted Treatment for SUD: Extended Release Naltrexone

Improves Treatment Outcome

Desirée A. Crèvecoeur-MacPhail, PhDUCLA Integrated Substance Abuse Program

Los Angeles CA

California SUD/Health CareIntegration Learning Collaborative (ILC)

September 24, 2014

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

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• 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

Antagonist Medications

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Naltrexone/XR-NTX for Opioid and Alcohol Dependence

• Full MU opioid receptor ANTAGONIST

No opioid effect

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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

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)?

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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

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 XR-

NTX 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

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Overall Results

Alcohol(N = 438)

Opioid(N = 171)

Total(N = 609)

 

Doses  

Mean (SD) 2.81 (2.310) 2.41 (1.593) 2.70 (2.140)  

Median 2 2 2  

Maximum 16 9 16  

Total Doses 1,232 412 1,644  

Total Injections Received+  

One Dose Only, % (n) 33.8% (148) 40.9% (70) 35.8% (218)  

Two Doses Only, % (n) 24% (105) 19.3% (33) 22.7% (138)  

Three Doses Only, % (n) 16% (70) 14.6% (25) 15.6% (95)  

Four Doses Only, % (n) 11.2% (49) 16.4% (28) 12.6% (77)  

Five or More Doses, % (n) 15.1% (66) 8.8% (15) 13.3% (81)  + p < .06

Bottom line: Patients received two to three doses of XR-NTX, regardless of substance use disorder.

XR-NTX Doses in LA CountyAmong LAC XR-NTX Patients(N=609)

Clinical Characteristics 

(M + SD)

XR-NTXAlcohol

(N = 438)

LACAlcohol

(N = 31,554)

XR-NTXOpioid

(N = 171)

LACOpioid

(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) 22.1 (8.833)  

Days Used Past Mo 13.5 (11.850) 9.8 (11.157) 11.1 (12.426) 20.6 (12.054)  

# of Prior Tx Episodes 2.4 (5.632) 1.2 (3.378) 4.2 (5.393) 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.

Comparison of LAC XR-NTX Patients(N=609)

Patient Demographics by Gender

VariableTotal

(N=465)Male

(N=223)Female(N=242)

Race/Ethnicity* White African American Latino Othera

%45.99.7

36.77.7

%43.57.237.811.5

%48.111.935.74.3

Age at treatment admission 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 Prescribed medication for MI** 31.6 20.2 41.7

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*p<.05; **p<.01aOther race/ethnicity includes multi-racial, Native American & Asian

Among UCLA XR-NTX Participants (N=465)

Week 0 Week 1 Week 2 Week 30

5

10

15

20

25

30

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8.1

6.3 6.1

Reduced Urge to Drink/Use

Based on the Urge to Drink/Use Scale, which is scored from 0 to 30.

A score of 10 or more indicates danger of relapse.

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Among UCLA Phase 2 XR-NTX Participants (N=220)

Week 0 Week 1 Week 2 Week 30

5

10

15

20

25

30

19.2

7.26.1 5.9

18.8

9.1 6.46.4

WomenMen

Reduced Urge to Drink/Use by Gender

Based on the Urge to Drink/Use Scale, which is scored from 0 to 30.

A score of 10 or more indicates danger of relapse.

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Among UCLA Phase 2 XR-NTX Participants (N=220)

Week 1 Week 2 Week 30%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

56%

28%

20%

35%

15% 9%

48%

21%17%

40%

29%

17%

Fatigue

Injection Site Reaction

Nausea

Headache

Re

po

rtin

g “

Ye

s”

Limited Side Effects

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Among UCLA Phase 2 Participants (N=220)

Clinical Characteristics by Gender

Side Effects ReportedTotal

(N=220)Male

(N=110)Female(N=110)

Average number of side effects

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)

Any side effects

Week 1** 85.5 79.0 92.0

Week 2** 57.2 46.4 68.0

Headache

Week 1 39.5 36.0 43.0

Week 2** 28.9 19.6 38.1

*p<.05; **p<.01

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Among UCLA Phase 2 XR-NTX Evaluation Participants (N=220)

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Comparison Results

Results Significant at

p<.05 or better

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

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Participant Characteristics

Categorical Variable

XR-NTX Group(% yes)

Post-hocTAU Group

(% yes)Test

StatisticGender (Female) 55.3% 56.8% X2 = 0.096Race/Ethnicity White African American Latino Other

41.1%13.2%41.1%4.7%

43.7%12.1%40%4.2%

X2 = 0.323

Criminal Justice Involvement (yes) 31.6% 33.2% X2 = .108Homeless status (yes) 40.5% 35.3% X2 = 1.118Employment Activities (yes) 10% 14.2% X2 = 1.583Program Type (Outpatient) 35.3% 34.7% X2 = .012Mental Illness* (yes) 44.7% 32.1% X2 = 6.407

*Lifetime report of mental illness differed between groups; p<.01

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Participant Characteristics

*Days spent on the wait list significantly differed between the groups p<.001.

ContinuousVariable

XR-NTX Group

Mean (sd)

Post-hocTAU Group

Mean (sd)

TestStatistic

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

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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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• Treatment providers may have promoted XR-NTX 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.

Examine Access to Prevent Disparity

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

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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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TREATMENT INTEGRATION?

What about:

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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

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: desireec@ucla.edu