Understanding Drug Abuse Treatment Outcomes
Condition: Drug Abuse/Dependence
MeSH terms: Substance-Related Disorders
Study type: Observational

Summary: 
      Background:

      Although some treatments for substance abuse are considered effective for some people who are
      drug dependent, many others do not benefit as much over time. Researchers are working to find
      out what characteristics predict treatment response. They also want to determine how to
      design treatments that are more effective for a greater number of substance abusers. This
      pilot study involves providing drug addicts with cognitive behavioral therapy (CBT), a
      treatment considered to be one of the most effective in reducing substance-abuse, to identify
      ways in which the brain works that may predict and explain treatment effects. A comparison
      group will be included that receives only standard psychotherapy or talk therapy. This
      approach will enable researchers to determine what factors might be interfering with
      favorable treatment outcomes and how to refine or develop new treatments that work well for
      more people.

      Objectives:

      - To identify individual characteristics which predict and explain the effects of CBT in
      people with opiate dependence.

      Eligibility:

        -  Males between 18 and 60 years of age who are dependent on opioids (such as heroin).

        -  Participants must be willing to take buprenorphine and receive substance abuse
           counseling.

      Design:

        -  Participants will be screened with a physical exam and medical history.

        -  Researchers will ask questions about participants ability to cope in certain situations,
           along with questions about drug use and lifestyle issues. These questions will be asked
           twice, before and after completing treatment.

        -  Participants will be placed into one of two groups. One group will have CBT twice a week
           for 8 weeks. The other group will have standard counseling twice per week. Both groups
           will take buprenorphine as part of the drug abuse treatment.

        -  Participants will have other tests during this study. They will have imaging studies to
           look at brain function. These studies will test thinking and decision making.
    

Detailed description: 
      OBJECTIVE:

      The primary objective of this pilot study is to collect data for a NIH RO1 grant submission
      that aims to elucidate cognitive, emotional regulatory and neurobiological mechanisms that
      both moderate and mediate effects of cognitive behavioral therapy (CBT) in individuals with
      opiate dependence. CBT has proven moderately effective in treating substance abuse; however,
      significant variability in treatment outcomes remains. CBT curricula teach adaptive decision
      making and cognitive reappraisal skills to down-regulate emotional responses to drug-related
      cues, thereby promoting avoidance of drug use situations. A certain level of cognitive and
      emotion regulatory functioning is, however, required for assimilating and executing these
      skills which is often deficient in substance abusers. Consequently, many addicts cannot
      effectively process and act on CBT curriculum, leading to poor treatment outcomes. Tailoring
      interventions requires systematic investigation of neurobiological indicators that interfere
      with or promote favorable treatment responsivity.

      The small pilot study outlined below will provide the feasibility and supportive data for a
      larger effort.

      Aim 1: Moderation. Identify baseline ECF and emotion regulatory functions and their neural
      substrates that predict treatment variability in the form of: (a) program responsivity (e.g.,
      treatment engagement, motivation, social competences) and (b) posttreatment outcomes (e.g.,
      substance use frequency, days of continuous abstinence). Functional magnetic resonance
      imaging (fMRI) will be used during performance of tasks that measure ECF (decision-making;
      inhibitory control) and cognitive reappraisal of emotional cues to investigate the
      neuromodulatory role of PFC regions (e.g., OFC, ACC) on emotion (e.g., amygdala) and reward
      (e.g., ventral striatum) structures and autonomic activity.

      Aim 2: Mediation. Determine whether change in these neurocognitive functions in response to
      CBT mediate intervention effects. Evidence suggests that CBT alters PFC and limbic function;
      such changes are associated with clinical outcomes in depression and anxiety. Similarly, in
      drug abusers, we predict treatment response will be associated with changes in neural
      activation patterns, ECF, and emotional regulation, and that little to no change will occur
      in those with relatively poorer outcomes.

      Study Population: Participants will be 18 primary opioid dependent individuals between the
      ages of 18 and 60. These individuals will either be enrolled in NIDA Protocol 09-DA-N020,
      (Dr. Kenzie Preston, PI) or patients at the University of Maryland Medical Center outpatient
      substance abuse clinics (i.e., Alcohol and Drug Abuse Program (ADAP) or Outpatient Addiction
      Treatment Service (OATS) and are receiving buprenorphine.

      DESIGN:

      Study participants visit their treatment facility daily for buprenorphine and receive
      standard counseling as part of Protocol 09-DA-N020 or their treatment protocol at ADAP or

      OATS. They will be screened by MMG for eligibility into the present study then randomly
      assigned to a TAU control group or a CBT group. This study consists of 3 assessment time
      points (baseline, midway, post-treatment) and 16 bi-weekly counseling visits (CBT or standard
      TAU counseling). Baseline assessments will consist of functional magnetic resonance imaging
      (fMRI) during performance of decision making, inhibitory control and emotional regulatory
      tasks. Questionnaires will be used to evaluate historical and current drug use, background
      and psychological traits, and other relevant factors. Those in the TAU group visit their
      treatment facility routinely for buprenorphine and standard counseling but will not receive
      CBT. The CBT group participants will undergo 8 weeks of CBT in the

      Archway Clinic twice a week provided by a CBT clinician from Mountain Manor Treatment

      Center who will be supervised by Dr. Marc Fishman, treatment director at MMTC; this CBT
      counseling will be in place of the TAU counseling they would be receiving as part of the
      parent protocol. Midway through CBT/TAU counseling, participants in this pilot study will be
      evaluated outside the scanner with the same cognitive tasks used in the scanner and
      questionnaires from baseline. After treatment completion, they will receive a post-treatment
      fMRI scan where they will perform the same tasks and questionnaires. Also, we will
      preliminarily assess mediation by examining variability in level of responsivity within the
      treatment group to determine whether this outcome is related to functional baseline
      characteristics and change over time. Expectations are that baseline features will predict
      intervention response and that these same characteristics will change over time in response
      to intervention in those with favorable outcomes.

      OUTCOME MEASURES:

      The focus of our outcome evaluation will be use of opioid (e.g., frequency, days of
      continuous abstinence, etc.), coping strategies, and change in lifestyle measures (e.g.,
      employment, relationships, behavioral problems, treatment engagement).
    

Time perspective: Other
Keywords: Drug Abuse/Dependence