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

Primary Purpose

Substance Abuse, Substance Dependence, Alcohol Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dual Processing
Relapse Prevention
Sponsored by
Inova Health Care Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Georgetown Center for Functional And Molecular Imaging, Georgetown University Medical Center
  • Inova Heath Services Comprehensive Addictions Treatment Services (ICATS)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dual Processing

Relapse Prevention

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).
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).
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.
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.

Full Information

First Posted
March 7, 2011
Last Updated
November 28, 2018
Sponsor
Inova Health Care Services
Collaborators
George Mason University, Georgetown University
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1. Study Identification

Unique Protocol Identification Number
NCT01320748
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inova Health Care Services
Collaborators
George Mason University, Georgetown University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dual Processing
Arm Type
Experimental
Arm Title
Relapse Prevention
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Dual Processing
Other Intervention Name(s)
Group Therapy, DP
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Relapse Prevention
Other Intervention Name(s)
Group Therapy, RP
Intervention Description
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.
Primary Outcome Measure Information:
Title
fMRI blood-oxygenation-level-dependent (BOLD) signal change as a measure of emotional reactivity related to the visual presentation of drug-imagery.
Description
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).
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Heart rate during MRI scanning as a measure of emotional reactivity related to the visual presentation of drug-imagery.
Description
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).
Time Frame
10 weeks
Title
Quality of Life Inventory (QOLI) as a measure of the subject's quality of life.
Description
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).
Time Frame
10 weeks
Title
Brief Symptoms Inventory (BSI), as a measure of subjective craving, anxiety, and somatization
Description
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).
Time Frame
10 weeks
Title
Hamilton - Depression Inventory (HAM-D) as a measure of depression.
Description
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).
Time Frame
10 weeks
Title
Urine specimen toxicology analysis as a measure of treatment retention.
Description
Urine specimen collection and analysis to track patient drug use on a weekly basis during the 10 weeks in treatment.
Time Frame
Weekly for 10 weeks
Title
Blood Alcohol Level analysis as a measure of treatment retention.
Description
Breathalizer test for alcohol to track patient alcohol use on a weekly basis during the 10 weeks in treatment.
Time Frame
Weekly for 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly C Matto, PhD
Organizational Affiliation
Virginia Commonwealth University, School of Social Work
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown Center for Functional And Molecular Imaging, Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
22057
Country
United States
Facility Name
Inova Heath Services Comprehensive Addictions Treatment Services (ICATS)
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States

12. IPD Sharing Statement

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Links:
URL
http://inova.org/cats
Description
Inova Health System, Comprehensive Addiction Treatment Services (CATS)
URL
http://www.samhsa.gov/
Description
Substance Abuse and Mental Health Services Administration
URL
http://www.nida.nih.gov/NIDAHome.html
Description
National Institute on Drug Abuse

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

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