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| Name | Class |
|---|---|
| George Mason University | OTHER |
| Georgetown University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual Processing | Experimental |
| |
| Relapse Prevention | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual Processing | Behavioral | A 10-week, 20-session program, which meets two times per week for 2 hours each time. It is a psychosocial intervention that combines a visual processing (structured drawing activities to engage in sensory-based cue exposure) and a verbal processing component (structured cognitive-behavioral therapy). The treatment focuses on sensory-based emotional expression and cognitive reappraisal and containment strategies that facilitate emotional regulation around a patient's drug and alcohol use experiences. |
| Measure | Description | Time Frame |
|---|---|---|
| fMRI blood-oxygenation-level-dependent (BOLD) signal change as a measure of emotional reactivity related to the visual presentation of drug-imagery. | In a subset of approximately 26 subjects, fMRI technology will be employed to examine brain structure and function change (pre-treatment and post-treatment) in the amygdaloid region, orbitofrontal cortex, in the anterior cingluate cortex (structure implicated in drug cue attention); in medial prefrontal cortex and right dorsolateral prefrontal cortex (associated with effective behavioral decision-making in substance abusers). | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate during MRI scanning as a measure of emotional reactivity related to the visual presentation of drug-imagery. | Changes in heart rate related to the visual presentation of drug-imagery during MRI scanning, to assess cue reactivity differences across the treatment and control groups at two time-points (pre-intervention and post-intervention). | 10 weeks |
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Study Inclusion Criteria:
Study Exclusion Criteria:
Additional Inclusion Criteria for fMRI sub-study:
Additional Exclusion Criteria for fMRI sub-study:
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| Name | Affiliation | Role |
|---|---|---|
| Holly C Matto, PhD | Virginia Commonwealth University, School of Social Work | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown Center for Functional And Molecular Imaging, Georgetown University Medical Center | Washington D.C. | District of Columbia | 22057 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17719013 | Background | Brewer JA, Potenza MN. The neurobiology and genetics of impulse control disorders: relationships to drug addictions. Biochem Pharmacol. 2008 Jan 1;75(1):63-75. doi: 10.1016/j.bcp.2007.06.043. Epub 2007 Jul 3. | |
| 11280338 | Background | Brewin CR. A cognitive neuroscience account of posttraumatic stress disorder and its treatment. Behav Res Ther. 2001 Apr;39(4):373-93. doi: 10.1016/s0005-7967(00)00087-5. |
| Label | URL |
|---|---|
| Inova Health System, Comprehensive Addiction Treatment Services (CATS) | View source |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D000437 | Alcoholism |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D019973 | Alcohol-Related Disorders |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D011615 | Psychotherapy, Group |
| D055502 | Secondary Prevention |
| ID | Term |
|---|---|
| D012960 | Socioenvironmental Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D013812 | Therapeutics |
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|
| Relapse Prevention | Behavioral | The program's standard care outpatient program is a Relapse Prevention 10-week, 20-session, psychosocial intervention program, which meets two times per week for 2 hours each time. This RP program is based on Gorski's Relapse Prevention model and is a primarily didactic approach. |
|
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| Quality of Life Inventory (QOLI) as a measure of the subject's quality of life. | Questionnaire completed by subjects at baseline and at the end of the study. We will measure changes in Overall QOLI score and Weighted Satisfaction Profile score at the two time-points (pre-intervention and post-intervention). | 10 weeks |
| Brief Symptoms Inventory (BSI), as a measure of subjective craving, anxiety, and somatization | Questionnaire completed by subjects at baseline and at the end of the study. We will measure changes in Nonpatient T Score and Percentile in the 12 domains at the two time-points (pre-intervention and post-intervention). | 10 weeks |
| Hamilton - Depression Inventory (HAM-D) as a measure of depression. | Questionnaire completed by subjects at baseline and at the end of the study. We will measure changes in the total Hamilton depression scale score at the two time-points (pre-intervention and post-intervention). | 10 weeks |
| Urine specimen toxicology analysis as a measure of treatment retention. | Urine specimen collection and analysis to track patient drug use on a weekly basis during the 10 weeks in treatment. | Weekly for 10 weeks |
| Blood Alcohol Level analysis as a measure of treatment retention. | Breathalizer test for alcohol to track patient alcohol use on a weekly basis during the 10 weeks in treatment. | Weekly for 10 weeks |
| Inova Heath Services Comprehensive Addictions Treatment Services (ICATS) | Falls Church | Virginia | 22042 | United States |
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| 17509899 | Background | Goldstein M, Brendel G, Tuescher O, Pan H, Epstein J, Beutel M, Yang Y, Thomas K, Levy K, Silverman M, Clarkin J, Posner M, Kernberg O, Stern E, Silbersweig D. Neural substrates of the interaction of emotional stimulus processing and motor inhibitory control: an emotional linguistic go/no-go fMRI study. Neuroimage. 2007 Jul 1;36(3):1026-40. doi: 10.1016/j.neuroimage.2007.01.056. Epub 2007 Mar 12. |
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| National Institute on Drug Abuse | View source |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |