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

This study has been completed.
Sponsor:
Collaborators:
Inova CATS
George Mason University
Georgetown University
Information provided by (Responsible Party):
Mitch Kost, Inova Health Care Services
ClinicalTrials.gov Identifier:
NCT01320748
First received: March 7, 2011
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Substance Abuse
Substance Dependence
Alcohol Abuse
Drug Use
Relapse
Behavioral: Dual Processing
Behavioral: Relapse Prevention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: fMRI Study of a Dual Process Treatment Protocol With Substance Dependent Adults

Resource links provided by NLM:


Further study details as provided by Inova Health Care Services:

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. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: Weekly for 10 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: Weekly for 10 weeks ] [ Designated as safety issue: No ]
    Breathalizer test for alcohol to track patient alcohol use on a weekly basis during the 10 weeks in treatment.


Enrollment: 29
Study Start Date: February 2011
Study Completion Date: January 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Group Therapy
  • DP
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:
  • Group Therapy
  • RP

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320748

Locations
United States, District of Columbia
Georgetown Center for Functional And Molecular Imaging, Georgetown University Medical Center
Washington, District of Columbia, United States, 22057
United States, Virginia
Inova Heath Services Comprehensive Addictions Treatment Services (ICATS)
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Inova Health Care Services
Inova CATS
George Mason University
Georgetown University
Investigators
Principal Investigator: Holly C Matto, PhD Virginia Commonwealth University, School of Social Work
  More Information

Additional Information:
Publications:

Responsible Party: Mitch Kost, Holly C. Matto, PhD, LCSW-C, Associate Professor, Study Principal Investigator, School of Social Work, Virginia Commonwealth University., Inova Health Care Services
ClinicalTrials.gov Identifier: NCT01320748     History of Changes
Other Study ID Numbers: IHS 11-001
Study First Received: March 7, 2011
Last Updated: January 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Inova Health Care Services:
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

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 23, 2014