Clinical trial NCT01320748: fMRI Study of a Dual Process Treatment Protocol With Substance Dependent Adults
Official title: fMRI Study of a Dual Process Treatment Protocol With Substance Dependent Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Substance Dependence
Alcohol Abuse
Drug Use
Relapse
Keywords: Abstinence from alcohol
Substance Abuse and Mental Health Services
Social Support
Psychosocial Support Systems
Psychological support
Cognitive Support
Emotional Support
Mental Support
Psychosocial Support
Intervention Studies
Prevention & control
Preventive therapy
Treatment
Therapy
Magnetic Resonance Imaging
fMRI
Imaging
Magnetic Resonance Imaging, Functional
MRI Scans
MRI, Functional
Clinical Protocols
Protocols, Treatment
Drug Abuse Treatment Center
Substance Abuse Treatment Center
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
Collaborators: name: George Mason University
name: Georgetown University
First posted: 2011-03-22
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether drug-dependent adults who participate in a dual processing relapse prevention treatment protocol that allows for sensory-based exposure experiences over 10-weeks in outpatient treatment will show significant brain change related to diminished cue reactivity, and greater improvement in self-efficacy, anxiety, somatization, and treatment retention, as compared to the standard care patients in a relapse prevention program.

Detailed description: The substance abuse literature consistently shows that negative emotional states and subjective stress are highly predictive of relapse and significantly influence behavioral motivation. From a neurobiological perspective, stress associated with withdrawal and substance abuse experiences stimulates chemical and hormonal changes in the brain creating a protracted hyperaroused state. Further, cognitive control resources (i.e., cognitive coping skills/relapse prevention training) have been shown to exert minimal impact on behavioral decision-making in the presence of intense affective material. Thus, implicit cognitive processes play a significant role in drug use behavior, decreasing self regulation capacities and increasing risk of. Specifically, high levels of stress can compromise prefrontal cortex functioning, with the nucleus accumbens, orbitofrontal cortex and amygdala functional changes related to increased cue reactivity.

Taken together, the current literature strongly suggests that verbally-based therapies may have limited utility as a singular form of treatment in early substance abuse recovery, as the brain may not be functionally ready for executive level processing. Instead, the multidisciplinary substance abuse literature suggests that psychosocial treatment methods need to include a range of learning approaches that allow for visual-sensory processing, in addition to traditional verbal-based processing. Integrated multi-modal interventions are needed to offer opportunities for activation of these different brain regions to facilitate cognitive-affective balance in behavioral decision-making.

Eligibility criteria: Study Inclusion Criteria:

* Age \< 18 years old
* Signed informed consent for this study
* History of chemical dependency
* Meets Inova CATS Relapse Prevention admission criteria
* Must have at least 60 days of sobriety prior to admission with documentation of negative drug and alcohol screening
* Documentation of HIV negative test result (completed in the past year)
* Willing and able to attend an out-patient drug treatment group for two hours twice a week for 10 weeks
* Willing to complete study-required evaluations (including assessments, questionnaires, drug/alcohol testing, week 8 qualitative interview)
* A score \< 25 on the MoCA (Montreal Cognitive Assessment)

Study Exclusion Criteria:

* History of taking "anti-craving" medication in the past 90 days
* Other medical illness or florid psychiatric symptoms that would render the participant inappropriate for study participation
* History of receiving treatment for addictions other than substance use (i.e. food, gambling, sex)
* Clinical determination of dementia or organic brain syndrome
* History of major head injury
* Incapable of consenting for themselves due to cognitive impairment
* Enrollment in another study that might interfere with analysis of this study

Additional Inclusion Criteria for fMRI sub-study:

* Willing and able to participate in the fMRI arm of the study
* If of childbearing capacity, must have negative screening urine pregnancy test and be willing to use birth control as specified in the consent document

Additional Exclusion Criteria for fMRI sub-study:

* Left-handed
* Cardiac pacemakers or other body metals
* Other criteria identified on the "MRI Screening Form" that would indicate that having an MRI would be unsafe
* Pregnancy
* Claustrophobia (for the fMRI testing)
* Muscular or back problems that would prevent participant from being able to lie in the scanner for 90 minutes

Primary outcomes:
measure: fMRI blood-oxygenation-level-dependent (BOLD) signal change as a measure of emotional reactivity related to the visual presentation of drug-imagery.
timeFrame: 10 weeks
Secondary outcomes:
measure: Heart rate during MRI scanning as a measure of emotional reactivity related to the visual presentation of drug-imagery.
timeFrame: 10 weeks
measure: Quality of Life Inventory (QOLI) as a measure of the subject's quality of life.
timeFrame: 10 weeks
measure: Brief Symptoms Inventory (BSI), as a measure of subjective craving, anxiety, and somatization
timeFrame: 10 weeks
measure: Hamilton - Depression Inventory (HAM-D) as a measure of depression.
timeFrame: 10 weeks
measure: Urine specimen toxicology analysis as a measure of treatment retention.
timeFrame: Weekly for 10 weeks
measure: Blood Alcohol Level analysis as a measure of treatment retention.
timeFrame: Weekly for 10 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown Center for Functional And Molecular Imaging, Georgetown University Medical Center
state: District of Columbia
city: Falls Church
country: United States
facility: Inova Heath Services Comprehensive Addictions Treatment Services (ICATS)
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University, School of Social Work
name: Holly C Matto, PhD
role: PRINCIPAL_INVESTIGATOR
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