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

November 28, 2018 updated by: Maria Hadjiyane, Inova Health Care Services
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 22057
        • Georgetown Center for Functional And Molecular Imaging, Georgetown University Medical Center
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Heath Services Comprehensive Addictions Treatment Services (ICATS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dual Processing
Behavioral: Dual Processing
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.
Other Names:
  • DP
  • Group Therapy
Active Comparator: Relapse Prevention
Behavioral: Relapse Prevention
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.
Other Names:
  • RP
  • Group Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 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).
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate during MRI scanning as a measure of emotional reactivity related to the visual presentation of drug-imagery.
Time Frame: 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).
10 weeks
Quality of Life Inventory (QOLI) as a measure of the subject's quality of life.
Time Frame: 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).
10 weeks
Brief Symptoms Inventory (BSI), as a measure of subjective craving, anxiety, and somatization
Time Frame: 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).
10 weeks
Hamilton - Depression Inventory (HAM-D) as a measure of depression.
Time Frame: 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).
10 weeks
Urine specimen toxicology analysis as a measure of treatment retention.
Time Frame: Weekly for 10 weeks
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.
Time Frame: Weekly for 10 weeks
Breathalizer test for alcohol to track patient alcohol use on a weekly basis during the 10 weeks in treatment.
Weekly for 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inova Health Care Services

Collaborators

Georgetown University
George Mason University

Investigators

  • Principal Investigator: Holly C Matto, PhD, Virginia Commonwealth University, School of Social Work

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

March 7, 2011

First Submitted That Met QC Criteria

March 21, 2011

First Posted (Estimate)

March 22, 2011

Study Record Updates

Last Update Posted (Actual)

November 30, 2018

Last Update Submitted That Met QC Criteria

November 28, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IHS 11-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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