Transcript Carroll and Weiss Plenary 2015

 Is buprenorphine that good?
 Is medical management (MM) that good?
 Is counseling that ineffective for this population?
 Have the studies been designed properly?
 What are the minimal requirements for counseling
and good enough outcomes?
Why would
everything we’ve
learned about treating
opioid dependence
not apply to
buprenorphine?
60
50
40
30
20
10
0
A
B
C
D
E
F
Why would everything we’ve learned about treating
opioid dependence not apply to buprenorphine?
McLellan et al 1993
Figure 3. Opioid Use and Treatment:
Randomized to Methadone versus Buprenorphine
(N = 795)
Randomized to Buprenorphine and Methadone
(N = 795)
Buprenorphine
100
Methadone
Opioid Use for Bup (N = 464)
Opioid Use for Met (N = 331)
Treatment for Bup (N = 464)
Treatment for Met (N = 331)
80
15
Percent
Days of Opioid Use
20
Figure 2. Days of Opioid Use:
10
60
40
5
20
0
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 54 56 58 60
0
Months since randomization date
Hser et al., under review
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 49 51 53 55 57 59 61
Months since randomization date
% drug free urines by medication and
condition-CM versus feedback
60
50
40
30
20
10
0
Meth+CM
Meth+Feedback
Bup+CM
Bup+Feedback
• Treatments that retain less than 50% over 6 months have
significant room for improvement
Randomized
Protective transfer or MMP
Missed visits
Retained/success at 24 weeks (12
weeks after CBT stopped)
MM
MM
71
MM+CBT
MM+CBT
70
28 (39%)
11
45%
19 (27%)
24
39%
*6/12 sessions attended
Supervision, no fidelity testing
Urine confirmed weeks abstinent from all drugs
8
Weeks abstinent from all drugs
7
6
5
4
3
2
1
0
PO MM
PO MM + CBT
Heroin MM
Heroin MM + CBT
Randomized
Completed
treatment phase 16
weeks
CBT
53
37/53=69%
CM
49
35/49=71%
CBT+CM
49
34/49=69%
NT
51
28/51=54%
26/53=49%
28/49=57%
24/49=49%
22/51=43%
CBT and CM stop
Complete
medication phase
(32 weeks)
**Payments for assessments, including urines, CM reinforcement for opioid-negative
urines only, no data on CBT fidelity, 73% compliance
Randomized
Success Phase 1 (12 weeks)
Start phase 2
Success Phase 2 (24 weeks)
Success at post taper followup
MM
MM + Counseling
324
329
24 (7%)
19 (6%)
180
180
84 (47%)
93 (52%)
13 (7%)
18 (10%)
% drug free urines
60
50
40
30
20
10
0
Meth+CM
Meth+Feedback
Bup+CM
Bup+Feedback
Randomized
Retained/success at 12
weeks
MM+ CM
MM+CM+TES
78
92
64%
80%
** No follow-up reported
Why were these outcomes so much better?
Bup + Standard care
Randomized
Retained at 24
weeks
Negative urines
(opioids and
cocaine)
Bup + Therapist CRA
Bup + Computer CRA
(TES)
45
58%
45
53%
45
62%
57%
73%
70%
Why were these outcomes so much better?
Reason
%
Discharge involuntarily/conflict with staff
24%
Discharge for missing too many days
17%
Program conflicts with other obligations (work,
home)
17%
Sought another provider
14%
Discharged due to too many positive urines
9%
Incarcerated
7%
Did not like buprenorphine
4%
Financial
4%
Wanted to keep using drugs
4%
Finished treatment successfully
4%
• Patients seeking bup often don’t want extra visits/counseling,
especially not in standard specialty programs or methadone
programs
Anxiety
Pain
Cocaine
• Standardized delivery of low cost, accessible
evidence based interventions
Core principles:
CBT4CBT development
Demo at CBT4CBT.com
Overview: CBT4CBT methadone trial
higher levels psychiatric comorbidity (29% depressive
disorder, 30% anxiety disorder), multiple other substance
use
Carroll et al., Am J Psych. 2014
CBT4CBT trial
Carroll et al., AJP, 2014
Better response
6
5
CBT4CBT
TAU
4
3
Baseline
End of tx-8 wks
Follow-up 20
weeks
Kiluk et al, Addiction, 2010
Adherence
Attendance
Abstinence
Alternate activities
Accessing support
√
√
√
√
√
√
Is medical management (MM) that good?
•
•
•
•
Compared to nothing, of course
Moderate response, high attrition, high relapse implies
significant room for improvement (floor, not ceiling effects)
MM not scalable, nor representative of usual care in many
settings
Many providers new to addiction may be uncomfortable
providing MM, access to addiction expertise seen as significant
barrier
Is counseling ineffective for this population?
•
•
•
No behavioral therapy yet tested without MM
Tests of CM, CBT not done in accordance with current with
methodological standards (targeting compliance, cocaine,
other behaviors)
Different models need to be considered
• Stepped models
• Technology based models
• Treating to success
Have the studies been designed properly?
•
•
•
•
Highly unusual for CM not to be effective
Cannot conclude counseling not effective for bup without
significant MM
Consider outcomes other than ‘retention = success’
What are the minimal requirements for counseling and
good enough outcomes?
Supported by NIDA P50 DA09241, R37 DA15969, U10
DA015831, R01 DA035058, R01 DA03069 & NIAAA
AA021405
Psychotherapy Development Center website (training videos
and resources, manuals, datasets): pdc.yale.edu
CBT4CBT demo, etc at: CBT4CBT.com
[email protected]