fMRI Study of a Dual Process Treatment Protocol With Substance Dependent Adults
- Conditions
- Substance DependenceAlcohol AbuseDrug UseSubstance AbuseRelapse
- Interventions
- Behavioral: Relapse PreventionBehavioral: Dual Processing
- Registration Number
- NCT01320748
- Lead Sponsor
- Inova Health Care Services
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Relapse Prevention Relapse Prevention - Dual Processing Dual Processing -
- Primary Outcome Measures
Name Time Method fMRI blood-oxygenation-level-dependent (BOLD) signal change as a measure of emotional reactivity related to the visual presentation of drug-imagery. 10 weeks 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).
- Secondary Outcome Measures
Name Time Method Urine specimen toxicology analysis as a measure of treatment retention. Weekly for 10 weeks Urine specimen collection and analysis to track patient drug use on a weekly basis during the 10 weeks in treatment.
Quality of Life Inventory (QOLI) as a measure of the subject's quality of life. 10 weeks 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).
Heart rate during MRI scanning as a measure of emotional reactivity related to the visual presentation of drug-imagery. 10 weeks 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).
Brief Symptoms Inventory (BSI), as a measure of subjective craving, anxiety, and somatization 10 weeks 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).
Hamilton - Depression Inventory (HAM-D) as a measure of depression. 10 weeks 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).
Blood Alcohol Level analysis as a measure of treatment retention. Weekly for 10 weeks Breathalizer test for alcohol to track patient alcohol use on a weekly basis during the 10 weeks in treatment.
Trial Locations
- Locations (2)
Georgetown Center for Functional And Molecular Imaging, Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Inova Heath Services Comprehensive Addictions Treatment Services (ICATS)
🇺🇸Falls Church, Virginia, United States