Transcript The CSAT Methamphetamine Treatment Project

The CSAT
Methamphetamine
Treatment Project
A Multi-site Trial of a Manualized Psychosocial
Protocol for the Treatment of Methamphetamine
Dependence
Richard Rawson Ph.D.
U.C.L.A. Integrated Substance Abuse Programs (I.S.A.P.)
The MTP Site Investigators
Funded by the Center for Substance Abuse Treatment
What Is Methamphetamine?
•
Powerfully addictive stimulant
that dramatically affects the
central nervous system
•
Made easily in clandestine labs
with OTC ingredients
How Is Methamphetamine Taken?
Methamphetamine comes in many forms
and can be:
•
Smoked
•
Snorted
•
Orally Ingested
•
Injected
Scope of the Methamphetamine Problem Worldwide


According to surveys and estimates by WHO
and UNDCP, methamphetamine is the most
widely used illicit drug in the world except for
cannabis.
World wide it is estimated there are over 35
million regular users of methamphetamine, as
compared to approximately 15 million heroin
users and 10 million cocaine users
Scope of Methamphetamine Use in the United
States


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
Methamphetamine abuse, long reported as the dominant drug
problem in Honolulu, Hawaii and San Diego, CA, has become a
substantial drug problem in other sections of the West, Midwest &
Southwest, as well.
Indications that it is spreading to rural and urban sections of the
South and East coast.
Once traditionally associated with white, male, blue-collar workers.
Now is being used by more diverse population groups that change
over time and differ by geographic area.
Groups with High Rates of Meth Use

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Women
Residents in Western/Midwestern Rural
Areas and Small/Medium Cities
Predominantly Caucasian, Increasing
Numbers of Hispanics
Gay Men
CSAT MTP Project Goals:
To study the clinical effectiveness of the Matrix Model
To compare the effectiveness of the Matrix model to
other locally available outpatient treatments
To establish the cost and cost effectiveness of the Matrix
model compared to other outpatient treatments
To explore the replicability of the Matrix model and
challenges involved in technology transfer
Manuals in Psychosocial Treatment





Reduce therapist
differences
Ensure uniform set of
services
Can more easily be
evaluated
Enhance training
capabilities
Facilitate research to
practice
Matrix Model of
Outpatient Treatment
Organizing Principles of Matrix Treatment

Program components based upon scientific
literature on promotion of behavior change.

Program elements and schedule selected based on
empirical support in literature and application.

Program focus is on current behavior change in the
present and not underlying “causes” or presumed
“psychopathology”.

Matrix “treatment” is a process of “coaching”,
educating, supporting and reinforcing positive
behavior change.
Matrix Model of
Outpatient Treatment

Organizing Principles of Matrix Treatment
Non-judgemental, non-confrontational relationship
between therapist and patient creates positive
bond which promotes program participation.
Therapist as a “coach”

Positive reinforcement used extensively to promote
treatment engagement and retention.
Verbal praise, group support and encouragement
other incentives and reinforcers.
Matrix Model of
Outpatient Treatment
Organizing Principles of Matrix Treatment

Accurate, understandable, scientific information
used to educate patient and family members
Effects of drugs and alcohol
Addiction as a “brain disease”
Critical issues in “recovering” from addiction
Matrix Model of
Outpatient Treatment
Organizing Principles of Matrix Treatment

Behavioral strategies used to promote cessation of
drug use and behavior change


Scheduling time to create “structure”

Promoting and reinforcing participation in nondrug-related activities
Educating and reinforcing abstinence from all
drugs and alcohol
Matrix Model of
Outpatient Treatment
Organizing Principles of Matrix Treatment

Cognitive-Behavioral strategies used to promote
cessation of drug use and prevention of relapse.
 Teaching the avoidance of “high risk” situations
 Educating about “triggers” and “craving”
 Training in “thought stopping” technique
 Teaching about the “abstinence violation effect”
 Reinforcing application of principles with verbal
praise by therapist and peers
Matrix Model of
Outpatient Treatment
Organizing Principles of Matrix Treatment


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Encourage participation in self-help meetings

Social support activities to maintain abstinence
Involvement of family members to support recovery.
Urine testing to monitor drug use and reinforce
abstinence
Matrix Model
An Integrated, Empirically-based, Manualized Treatment Program
Relapse Prevention
Family and Group
Therapy
Motivational
Interviewing
12- Step Involvement
Psychoeducation
Social Support
Elements of the Matrix Model



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Engagement/Retention
Structure
Information
Relapse Prevention
Family Involvement
Self Help Involvement
Urinalysis/Breath Testing
The Matrix Model
Monday
Early Recovery Skills
Wednesday
Family/education
Weeks1-4
Friday
Early Recovery Skills
Weeks1-4
Weeks 1-12

Relapse Prevention
Social Support
Relapse Prevention
Weeks 1-16
Weeks 13-16
Weeks 1-16
Urine or breath alcohol tests once per week, weeks 1-16
Table 1. Sites participating in the MTP (from Herrell et al, 2000)
Coordinating Center
University of California at
Los Angeles (UCLA)
Integrated Substance
Abuse Programs (ISAP)
Grantee / Site*
Principal Investigators
M. Douglas Anglin, Ph.D.
Richard A. Rawson, Ph.D.
Principal Investigator
Directors
Patricia Marinelli-Casey, Ph.D.
, Project Director
Jeanne Obert, MFT, Clinical
Alice Huber, Ph.D. Research
Chris Reiber, Ph.D. Statistics
Lead Evaluator
County of San Mateo,
Belmont, CA:
Two sites: ODASA and
Pyramid
Yvonne Frazier, Ph.D.
County of San Mateo, Alcohol and
Drug Services; Belmont, CA
Joseph Guydish, Ph.D.
University of California at San
Francisco; San Francisco, CA
East Bay Community
Recovery Project,
Hayward, CA
Joan Zweben, Ph.D.
East Bay Community Recovery
Project; Hayward, CA
Judith Cohen, Ph.D., M.P.H.
East Bay Community Recovery
Project; Hayward, CA
Matrix Institute, Costa
Mesa, CA
Michael McCann, M.A.
Matrix Institute; Costa Mesa, CA
Vikas Gulati, B.S.
Matrix Institute; Costa Mesa, CA
New Leaf Treatment
Center, Lafayette, CA
Gantt Galloway, Pharm.D.
New Leaf Treatment Center;
Lafayette, CA
Janice Stalcup, Ph.D.
New Leaf Treatment Center;
Lafayette, CA
San Diego Association of
Governments, San
Diego, CA
Susan Pennell, M.A.
San Diego Association of
Governments; San Diego, CA
Cynthia Burke, Ph.D.
San Diego Association of
Governments; San Diego, CA
South Central Regional
Mental Health Center,
Billings, MT
Denna Vandersloot, B.S.
South Central Regional Mental
Health Center; Billings, MT
Russell H. Lord, Ph.D.
Montana State University; Billings,
MT
St. Francis Medical
Center, Honolulu, HI
A lice Dickow, B.A.
St. Francis Women’s Addiction
Treatment Center, Hawaii;
Honolulu, HI
Ewa Stamper, Ph.D.
St. Francis Women’s Addiction
Treatment Center, Hawaii;
Honolulu, HI
Table 2. Treatment-As-Usual: Elements of Treatment
Site
Duration of
Treatment Intensive
Phase
Individual
Sessions
Group Sessions
12-Step Program
Involvement
Site 1
8 wks
1x/wk x 4-8 wks,
30-50 min each
4x/wk x 4-8 wks,
3hr each, families
attend 1x/wk
required;
1x/wk x 4-8 wks
Site 2
12 wks
1x/wk x 12 wks,
1 hr each
5x/wk x 2wk,
3x/wk x 2wks,
2x/wk x 8 wks
Site 3
12 wks
1x/wk x 12 wks,
1 hr each
none
recommended
Site 4
16 wks
1x/wk x 16 wks,
10-15 min each
3x/wk x 16 wks,
1 hr each
required;
3x/wk x 16 wks
Site 5
12 wks
1x/wk x 12 wks,
30-60 min each
3x/wk x 12 wks,
90 min each and
2x/wk x 12 wks, 6090 min each
required;
1x/wk x 12 wks
Site 6
12 wks
1x/wk – 2x/mo x
12 wks, 1 hr each
2x/wk x 12 wks,
90 min each,
families attend
1x/2 wks
Site 7
16 wks
1x/wk x 16 wks,
1 hr each
2x/wk x 16 wks,
2 hrs each
recommended
Site 8
12 wks
2x/wk x 12 wks,
1 hr each
1x/wk x 12 wks,
2 hrs each
required;
6 meetings
recommended
recommended
Table 3. Enrollment in the MTP by Site and Treatment Condition
Site
TAU (n)
Matrix 16-week (n)
Total
Site 1
69
73
142
Site 2
78
77
155
Site 3
77
76
153
Site 4
50
57
107
Site 5
61
63
124
Site 6
73
70
143
Site 7
24
22
46
Site 8
54
54
108
Overall TOTAL
486
492
978
Table 4. MTP Participant Characteristics (taken from baseline ASI)
Characteristic
% Male
Summary
45
Age (Yrs.), mean (sd)
32.8 (8.0)
Ethnicity (%)
Caucasian
60
African-American
2
American Indian
3
Asian/Pacific Islander
17
Hispanic
18
Educational Attainment Level (yrs.), mean (sd)
12.2 (1.7)
% Employed
69
% Married (and not separated)
16
Overall Substance Use Patterns-Lifetime (yrs.), mean (sd)
Methamphetamine
7.54 (6)
Alcohol
7.6 (8.5)
Cocaine
1.75 (3.5)
Cannabis
7.15 (8)
Overall Substance Use Patterns—Days in Past 30, mean (sd)
Methamphetamine
11.53 (9.6)
Alcohol
4.72 (7.3)
Cocaine
0.21 (1)
Cannabis
4.38 (8.3)
Preferred Route of Administration of MA (%)
Oral
0
Nasal
11
Smoked
65
IV- injection
24
Sample Description
Baseline Demographics
Participants Served (n)
1016
Age (mean)
32.8 years
Education (mean)
12.2 years
Methamphetamine Use (mean)
7.5 years
Marijuana Use (mean)
7.2 years
Alcohol Use (mean)
7.6 years
Gender Distribution of Participants
60
55
Percent
50
45
40
30
20
10
0
female
male
Gender
Ethnic Identification of Participants
60
60
Percent
50
40
30
17
20
10
2
3
0
Ethnic Identification
18
caucasian
african amer
native amer
asian/pac isl
hispanic
Marital Status of Participants
50
50
Percent
40
33
married/remar.
separated/div.
single/widowed
30
20
16
10
0
Marital Status
Employment Status of Participants
80
69
70
Percent
60
FT/PT
50
Retired/Disable
40
Unemployed
23
30
20
10
Student/Control Env.
6
2
0
Employment Status
Route of Methamphetamine
Administration
64
Percent Using by Route
70
60
50
40
30
20
24
11
10
0
Route of Administration
nasal
smoke
iv
Changes from Baseline to
Treatment-end
Days Paid for Work in Past 30
Mean Days Paid
12
10
10.4
8.2
8
6
4
2
0
BL
Tx end
Possible is 0-30; tpaired=6.01; p-value<0.000 (highly sig.)
Total Income (Past 30 days)
of Participants
Mean Total Income ($)
1400
1211
1200
1096
1000
BL
Tx end
tpaired=2.34; p-value=0.02 (sig.)
Mean Composite Score
ASI Composite Scores
0.6
0.53
0.49
BL
Tx end
0.5
0.4
0.3
0.26
0.24
0.21
0.21
0.21
0.19
0.15
0.2
0.11
0.08
0.23
0.22
0.10
0.1
0.0
P
M
FA
SY
C
**
C
*
O
*
L*
*
Y*
**
H
S
A
G
U
G
LE
R
**
O
PL
D
LC
E
M
D
A
E
M
Possible is 0-1;
Higher : worse problem
tpaired: *p-value<0.03 (sig.),
**p-value<0.000 (highly sig.)
Days of Methamphetamine Use in Past
30 (ASI)
Mean Days Use
12
11.5
10
8
6
4.4
4
2
0
BL
Tx end
Possible is 0-30; tpaired=20.90; p-value<0.000 (highly sig.)
Days of Marijuana Use in Past 30 (ASI)
Mean Days Use
12
10
8
6
4.5
4
2.4
2
0
BL
Tx end
Possible is 0-30; tpaired=8.02; p-value<0.000 (highly sig.)
Mean Days Use
Days
12 of Alcohol Use in Past 30 (ASI)
10
8
6
4.8
3.3
4
2
0
BL
Tx end
Possible is 0-30; tpaired=6.47; p-value<0.000 (highly sig.)
Beck Depression Inventory (BDI) Total
Scores
Mean Total Score
20
15.4
15
9.9
10
5
0
BL
Tx end
Possible is 0-63; tpaired=16.87; p-value<0.000 (highly sig.)
BSI Scores (mean)
BL1
Tx-end
Paired t
Somatization
0.7
0.5
7.67
Obsessive-Compulsive
1.2
0.9
11.40
Interpersonal Sensitivity
1.0
0.7
11.40
Depression
1.2
0.8
11.98
Anxiety
0.9
0.6
11.24
Hostility
0.8
0.6
9.39
Phobic Anxiety
0.6
0.4
8.47
Paranoid Ideation
1.1
0.7
11.49
Psychoticism
0.9
0.6
10.70
1Possible,
*
all scores, is 0-4; *all p-values<0.000 (highly sig.)
Mean # symptoms
Positive Symptom Total (PST) from Brief
30
26
Symptom
Inventory
(BSI)
18
20
10
0
BL
Tx end
Possible is 0-53; tpaired=14.33; p-value<0.000 (highly sig.)
Table 5. Summary of the number of clinical contacts made by participants,
by treatment group and site
Site (TAU length,
wks.)
Site 1 (8)
TAU
Mean
SD
Matrix 16-week
Mean
SD
17.2
25.2
21.7
26.1
6.3
28.4
22.8
31.5
15.4
25.7
2.1
25.2
13.8
35.4
3.9
22.2
12.7
26.8
Site 2 (12)
Site 3 (12)
Site 4 (16)
Site 5 (12)
Site 6 (12)
Site 7 (16)
Site 8 (12)
Overall
summary
Figure 3. Participant retention throughout treatment, by site and treatment group
Table 7. Comparison of retention between groups within sites, with Matrix truncated to the
length of TAU at each site
Site
TAU length (wks.)
Log-rank
Chi-square
p
Site 1
8
-20.07
33.17
<0.0001
Site 2
12
-9.49
4.98
0.026
Site 3
12
-8.39
3.68
0.055
Site 4
16
1.64
0.26
0.610
Site 5
12
-22.30
28.74
<0.0001
Site 6
12
-17.46
17.87
<0.0001
Site 7
16
-5.01
3.34
0.067
Site 8
12
-10.59
7.99
0.005
Figure 4. Percent completing treatment, by group
Matrix 16
TAU
Completer
40.85
34.16
Not Completer
59.15
65.84
x2=4.68, p=0.031
Figure 5. Mean number of MA-free urine samples, by treatment length and treatment group
(Matrix group data truncated to the length of TAU)
10
Matrix16
mean number of MA-free
urines
8.04
7.28
8
6
4
3.75
4.29
3.38
2
0
*
3.29
Site 4 (court) &
Site 7 (small n)
All Other Sites
Only Site 1
8-wk
12-wk
Tx-Length Group
*Statis tic ally signific ant two-group t-tes t, p<0.05.
16-wk
TAU
Table 8. Summary of the number of MA-free urine samples provided by participants, by
treatment group and site
Raw Data
Site (TAU
length,
wks.)
Matrix16
mean
SD
Truncated Data
TAU
mean
Matrix16
SD
mean
SD
TAU
mean
Site 1 (8)
6.23
3.38
3.75
3.38
4.86
4.19
Site 2 (12)
6.25
4.19
Site 3 (12)
5.75
3.62
4.61
8.6
8.44
1.72
4.30
1.72
3.3
3.27
7.0
4.54
Site 6 (12)
4.24
3.27
Site 7 (16)
7.0
4.54
Site 8 (12)
5.39
3.30
4.28
-0.76
0.45
-0.94
0.35
-1.52
0.13
0.13
0.89
-3.70
0.0003
-0.04
0.97
-1.50
0.14
-1.23
0.22
SD
8.6
Site 5 (12)
5.19
p
3.62
Site 4 (16)
8.44
t
3.30
Table 9. Longest MA abstinent period by treatment group and site
Raw Data
Site (TAU
length,
wks.)
Matrix16
mean
SD
Truncated Data
TAU
mean
Matrix16
SD
mean
SD
TAU
mean
t
p
SD
Site 1 (8)
3.575
2.754
2.877
2.754
0.982
0.328
Site 2 (12)
3.753
2.474
3.377
2.474
-1.47
0.144
Site 3 (12)
3.197
1.805
3.013
1.805
-2.16
0.033
Site 4 (16)
6.140
5.560
6.140
5.560
0.546
0.586
0.001
Site 5 (12)
3.889
1.279
3.429
1.279
3.393
Site 6 (12)
2.429
2.342
2.314
2.342
0.2
0.841
Site 7 (16)
4.682
2.542
4.682
2.542
1.586
0.121
2.130
0.551
0.583
Site 8 (12)
2.833
2.130
2.519
Figure 2. Mean number of weekly data visits attended, by treatment length and treatment group
(Matrix group data truncated to the length of TAU)
12
10.62
mean number of visits
10
*
8
6
4.04
Site 4 (court) &
Site 7 (small n)
All Other Sites
Only Site 1
0
8-wk
12-wk
Tx-Length Group
*Statistically significant two-group t-test, p<0.05.
Matrix16
TAU
*
5.15
5.11
4
2
6.41
9.7
16-wk
Discharge UA Result
by Attendance During Treatment
and Group
100%
100%
80%
80%
60%
60%
40%
40%
20%
20%
0%
0%
0
10
00
<1
0
<9
0
<8
0
<7
0
<6
0
<5
0
<4
0
<3
0
<2
0
<1
0
0
10
0
0
<1
0
<9
0
<8
0
<7
0
<6
0
<5
0
<4
0
<3
0
<2
0
<1
0
Percent of Data Visits Attended During Treatment
Percent of Data Visits Attended During Treatment
Matrix 16
clean
TAU
missing
dirty
Figure 1. Overall participant follow-up by treatment condition and time point
number of participants
492
486
401
421
397
420
Baseline
Discharge
6-month FU
Matrix 16-wk.
TAU
6-mos. F.U. UA Result
by Attendance During Treatment and Group
100%
100%
80%
80%
60%
60%
40%
40%
20%
20%
0%
0%
0
10
00
<1
0
<9
0
<8
0
<7
0
<6
0
<5
0
<4
0
<3
0
<2
0
<1
0
0
10
0
0
<1
0
<9
0
<8
0
<7
0
<6
0
<5
0
<4
0
<3
0
<2
0
<1
0
Percent of Data Visits Attended During Treatment
Percent of Data Visits Attended During Treatment
TAU
Matrix 16
MA-
missing
MA+
Figure 5. Urinalysis Results: %Meth Negative
Matrix 16
TAU
Discharge
69%
66%
6 Month
Follow-up
66%
68%
x2=4.68, p=0.031
Figure 6. Participant self-report of MA use (number of days during the past 30) at enrollment,
discharge, and 6-month follow-up, by treatment condition
12
11.3
11.8
Baseline
Discharge
6-month FU
meannumber of daysof MAuse
10
8
6
4.3
4.4
4.4
4
2
0
Matrix 16-wk.
TAU
4.0
MTP Study Conclusions




A multisite evaluation of a research-based intervention
can be conducted in community sites during a 3 year
period.
Six research-naïve sites and 2 experienced sites
successfully were trained and conducted all necessary
research activities for a complex clinical trial.
A complex psychosocial treatment protocol was
successfully replicated at 8 sites over a 3 year period.
Over 1000 MA-Users received free treatment.
MTP Study Conclusions
Treatment for MA dependence associated with
improvements in many domains including drug
use, mj use, mood, Income
 Matrix treatment results in longer retention,
more sessions attended, more treatment
completers, more MA-negative Uas, longer
periods of MA abstinence
* Except for drug court site

MTP Study Conclusions


Outcomes at discharge and follow-up
demonstrated comparable results between
Matrix and TAU
Program compliance associated with superior
urinalysis results at discharge and follow-up
MTP Study Conclusions

The design of multi-site studies has to carefully
consider priorities among the following issues:
–
–
Priority of testing the null hypothesis of the primary
study outcomes
Flexibility to accommodate all investigators
individual site priorities and site program variability