Drug Abuse/Dependence Clinical Trial
Official title:
Neural Mechanistic Explanations for Differential Drug Abuse Treatment Outcomes
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.
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).
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