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fMRI Study of a Dual Process Treatment Protocol With Substance Dependent Adults

Information source: Inova Health Care Services
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Substance Abuse; Substance Dependence; Alcohol Abuse; Drug Use; Relapse

Intervention: Dual Processing (Behavioral); Relapse Prevention (Behavioral)

Phase: N/A

Status: Completed

Sponsored by: Inova Health Care Services

Official(s) and/or principal investigator(s):
Holly C Matto, PhD, Principal Investigator, Affiliation: Virginia Commonwealth University, School of Social Work

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.

Clinical Details

Official title: fMRI Study of a Dual Process Treatment Protocol With Substance Dependent Adults

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: fMRI blood-oxygenation-level-dependent (BOLD) signal change as a measure of emotional reactivity related to the visual presentation of drug-imagery.

Secondary outcome:

Heart rate during MRI scanning as a measure of emotional reactivity related to the visual presentation of drug-imagery.

Quality of Life Inventory (QOLI) as a measure of the subject's quality of life.

Brief Symptoms Inventory (BSI), as a measure of subjective craving, anxiety, and somatization

Hamilton - Depression Inventory (HAM-D) as a measure of depression.

Urine specimen toxicology analysis as a measure of treatment retention.

Blood Alcohol Level analysis as a measure of treatment retention.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Georgetown Center for Functional And Molecular Imaging, Georgetown University Medical Center, Washington, District of Columbia 22057, United States

Inova Heath Services Comprehensive Addictions Treatment Services (ICATS), Falls Church, Virginia 22042, United States

Additional Information

Inova Health System, Comprehensive Addiction Treatment Services (CATS)

Substance Abuse and Mental Health Services Administration

National Institute on Drug Abuse

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Starting date: February 2011
Last updated: January 29, 2013

Page last updated: August 23, 2015

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