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Adaptive Treatment Strategies in the Addictions: Current Examples and Future Directions. James R. McKay, Ph.D. Professor of Psychology in Psychiatry University of Pennsylvania CTN Meeting 3.22.07. Overview of Presentation.

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adaptive treatment strategies in the addictions current examples and future directions

Adaptive Treatment Strategies in the Addictions:Current Examples and Future Directions

James R. McKay, Ph.D.

Professor of Psychology in Psychiatry

University of Pennsylvania

CTN Meeting


overview of presentation
Overview of Presentation
  • Major problems in providing addiction treatment and how we’ve tried to address them
  • Adaptive treatment models and how they are developed
  • Examples of adaptive treatment in specialty care
  • Examples of adaptive treatment in other treatment settings
  • Challenges in designing and implementing adaptive treatment protocols
problems in addiction treatment
Problems in Addiction Treatment
  • High rates of dropout and continued alcohol and drug use
    • In community-based programs
    • In research protocols
  • Even with evidence-based treatments, considerable response heterogeneity
attempts to address nonresponse
Attempts to Address Nonresponse?
  • Improve existing treatments
  • Develop new treatments
  • Tailoring, or “matching” treatments to subgroups of patients


still left with variable response
Still left with variable response…..
  • Even when treatment delivery is standardized and high adherence to manual is achieved, some patients do well and others do not.
  • Very hard to predict who will do well in a particular treatment
  • Some patients do well at first, but then deteriorate
  • Nonresponse often blamed on the patient, but that is likely not the whole story.
in adaptive treatment protocols
In Adaptive Treatment Protocols…
  • Treatment is tailored or modified on the basis of measures of response (e.g., symptoms, status, or functioning) obtained at regular intervals during treatment
  • Goal is to deliver the treatment that is mosteffective for a particular patient at a particular time.
  • Rules for changing treatment are clearly operationalized and described…..


  • Temporal issues important– when has sufficient time elapsed to indicate “non-response”?
experimental design for developing adaptive protocols
Experimental Design for Developing Adaptive Protocols
  • Use randomization to develop optimal adaptive treatment strategies
    • Example: What to do with early non-responders?
      • Switch treatment?
      • Augment treatment?
  • Determine the set of decision rules and interventions that produce the highest percentage of responders


  • Compare the optimal adaptive protocol to TAU or other treatments in standard RCT
the alternative approach
The alternative approach….
  • Devise adaptive protocol on the basis of:
    • Expert clinical judgment
    • Feedback from patients
    • Prior research findings
    • Face validity
  • Compare that adaptive protocol to TAU or other treatment in standard RCT
  • Pros and Cons: Faster than experimental approach, but protocol may be flawed
recovery management checkups
Recovery Management Checkups
  • Protocol developed by Dennis, Scott et al.
    • Interview patients every quarter for 2 years
    • If patient reports any of the following……
      • Use of alcohol or drugs on > 2 weeks
      • Being drunk or high all day on any days
      • Alcohol/drug use led to not meeting responsibilities
      • Alcohol/drug use caused other problems
      • Withdrawal symptoms

….. ….Patient transferred to linkage manager

  • Linkage Manager provides the following:
    • Personalized feedback
    • Explore possibility of returning to treatment
    • Address barriers to returning to treatment
    • Schedule an intake assessment
    • Reminder cards, transportation, and escort to intake appointment
results rmc vs tau
Results: RMC vs. TAU
  • Time to return to treatment

376 vs. 600 days (p< .05)

  • Total days of treatment

62 vs. 40 days (p< .05)

  • In need of treatment at 24 months

43% vs. 56% (p< .01)

  • In need of treatment in at least 5 quarters

23% vs. 32% (p< .05)

Dennis et al. (2003) Evaluation and Program Planning, 26, 339-352

adaptive methadone treatment
Adaptive Methadone Treatment
  • Brooner & Kidorf (2002) protocol
    • Methadone patients start in low intensity psychosocial condition
    • Missed session or dirty/missing urine leads to increases in psychosocial counseling
    • Providing additional contingencies for participation further improves outcomes
      • More/less convenient dosing times
      • Methdone taper and possible discharge
penn telephone continuing care study
Penn Telephone Continuing Care Study
  • Patients:
    • 359 graduates of 4-week IOP programs
    • Cocaine (75%) and/or alcohol (75%) dependent
  • Continuing care treatment conditions (12 weeks):
    • Standard group counseling (STND)
    • Individualized relapse prevention (RP)
    • brief telephone-based counseling (TEL)

McKay et al., 2004, Journal of Consulting and Clinical Psychology

continuing care conditions
Continuing Care Conditions
  • Telephone Monitoring and Counseling
    • Weeks 1-4, patients make a 15 minute call and attend a “transition” group (1x/week @)
    • Weeks 5-12, patients have telephone contact only (1x/week)
    • During calls, patients report results of self-monitoring and progress toward 1-2 goals, and plan goals for next week
    • Patients use a workbook that structures intervention for each week.
    • Total minutes of contact with therapist 50% of minutes in other conditions
total abstinence rates
Total Abstinence Rates

Tx Main Effect


p< .05

McKay et al., 2005, Archives of General Psychiatry

Adaptive Treatment Strategy:Using Progress in Initial Phase of Treatment to Select OptimalContinuing Care Models
7 item composite risk indicator
7-Item Composite Risk Indicator
  • Failure to achieve key goals while in IOP:
    • Any alcohol use in prior 30 days
    • Any cocaine use in prior 30 days
    • Attendance at < 12 self-help meetings in prior 30 days
    • Social support < median for the sample
    • Does not have goal of absolute abstinence
    • Self-efficacy < 80%
  • Current dependence on both alcohol and cocaine

(each item: yes=1, no=0)

McKay et al., 2005, Addiction, Archives of General Psychiatry

  • Patients: Cocaine dependent IOP participants recruited after achieving early engagement
  • Treatment conditions:
    • Treatment as usual (TAU)
    • TAU plus adaptive protocol (24 mo.)
    • TAU plus adaptive protocol (24 mo.), plus incentives for participation and cocaine-free urines (12 mo)
  • Outcomes assessed over 24 months
the telephone calls
The Telephone Calls
  • Frequency: weekly at first, titrated to bimonthly
  • Each call starts with a brief “risk assessment” that assesses negative and positive factors and yields overall risk score (low, moderate, high)
  • Similar protocol to prior study for telephone counseling:
    • Provide feedback on risk level
    • Review progress/goals from last call

3. Identify upcoming high-risk situations

4. Select target for remainder of call

5. Brief problem-solving regarding target concern(s)

6. Set goal(s) for interval before next call

7. Suggest change in level of care if warranted

adaptive protocol
Adaptive Protocol
  • Increases in services triggered when risk reaches moderate level
    • First: increase frequency of phone calls
    • Second: bring patient in for 1-2 face-to-face evaluation and motivational interviewing (MI) sessions
    • Third: provide 8 CBT relapse prevention sessions
    • Fourth: refer back to IOP
adaptive primary care protocols for heavy drinkers
Adaptive Primary Care Protocols for Heavy Drinkers
  • Kristenson et al. (1983, 2003)
    • Patients randomized to visits with a nurse (every month) and physician (every 3 months), vs. TAU
    • Both provided for up to 4 years
    • GGT levels monitored, and treatment/drinking goals modified on basis of scores
    • Results: fewer sick days, fewer hospital days, lower mortality over 6 and 16 years than TAU
adaptive continuing care naltrexone protocol
Adaptive Continuing Care Naltrexone Protocol
  • O’Malley et al. (2003) study of NTX treatment comparing primary care (PC) and specialty care (CBT) approaches
  • First, pts given NTX and randomized to PC or CBT for 10 weeks
  • Responders (57%) further randomized:
    • PC plus extended NTX vs. placebo (24 wks)
    • CBT plus extended NTX vs. placebo (24 wks)
alcohol use results and interpretations
Alcohol Use Results and Interpretations
  • Findings:
    • Initiation phase: PC=CBT
    • Extended PC phase: NTX > placebo
    • Extended CBT phase: NTX= placebo
  • Resulting treatment algorithm
    • If patient responds to PC and NTX in first 10 weeks, continue both for at least 24 more weeks
    • If patient responds to CBT and NTX in first 10 weeks, continue CBT but stop NTX
  • Note: no guidance regarding nonresponders
adaptive naltrexone study david oslin pi
Adaptive Naltrexone Study(David Oslin, PI)
  • Experimental design to determine optimal algorithms for naltrexone responders and nonresponders
  • All patients begin with 8 week trial of open label naltrexone, plus weekly medication management session
  • During the 8 week trial, patients self-select into Responder and Non-responder groups
  • First randomization: Different definitions of “non-response”
    • More than 1 heavy drinking day
    • More than 4 heavy drinking days
adaptive naltrexone cont
Adaptive Naltrexone, cont.

Second Randomization

  • Nonresponders:
    • Add CBI and drop NAL (i.e., “switch”)
    • Add CBI and continue NAL (i.e., augment”)
  • Responders:
    • NAL script plus no further care
    • NAL script plus telephone disease management
summary of possible adaptations
Summary of Possible Adaptations
  • Non-responders
    • Step up (e.g., OP to IOP or residential)
    • Lateral move (e.g., CBT to TSF)
    • Modality change (e.g., CBT to medication)
    • Step down (e.g., IOP to telephone monitoring)
  • Responders
    • Reduce frequency of intervention (e.g., IOP to OP)
    • Change to lower burden intervention (e.g., OP to periodic check-ups, or e-treatment)
adaptive treatment and the ctn difficult problems but big opportunities and potential benefits
Adaptive Treatment and the CTN:Difficult Problems………….. But Big Opportunitiesand Potential Benefits
challenges in adaptive treatment
Challenges in Adaptive Treatment


  • Keeping patients engaged, especially when deterioration occurs
  • Increasing compliance with adaptive changes, especially “step ups”
  • Identifying alternative treatments for non-responders
    • Lack of a variety of effective medications
    • Are different types of “talk” therapy really different enough?
    • How important is patient preference/choice?
challenges cont
Challenges, cont.


  • Incorporating choice in algorithms
    • Comparing heterogeneous condition to other interventions
  • Sequential randomization designs
    • Randomizing patients 2+ times
    • Analytic issues (first decision)
  • Power
    • Primary vs. secondary comparisons
    • New methods under development
focus of efforts in treatment development
Focus of Efforts in Treatment Development
  • Emphasis in field has been on improving efficacy and adherence to manuals, and coming up with more cost-effective approaches.
  • Shift emphasis to making participation more attractive to the patients to improve retention:
    • Greater weight to patient choice– at intake, and for non-responders
    • Use of more convenient forms of care whenever possible
    • Incentives for participation?
possible research designs
Possible Research Designs
  • Adaptive strategies to address early dropout
    • Test providing a menu of treatment options vs. efforts to re-engage in standard care

“So you don’t like IOP. How about…….?”

  • Adaptive medication algorithms
    • Start with promising med– augment with or switch to additional medication for nonresponders
research designs cont
Research Designs, cont.
  • Adaptive studies that combine behavioral and pharmacological interventions:
    • Start with medication and low intensity behavioral treatment, step up to more intensive treatment if no response
    • Offer non-responders sequential package that first involves switching meds, but then includes augmentation with stepped up behavioral treatment if response still not achieved.
  • Colleagues:
    • NIDA CTN algorithms group
    • Dave Oslin, Kevin Lynch, Tom TenHave
    • Susan Murphy, Linda Collins
  • Grant support:
    • NIDA: K02-DA00361, R01-DA14059, R01-DA20623
    • NIAAA: R01AA14850