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

NCT01320748 | Completed

• 1 other identifier: IHS 11-001
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

  10 weeks

Secondary Outcomes (6)

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

  10 weeks

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

  10 weeks

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

  10 weeks

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

  10 weeks

• Urine specimen toxicology analysis as a measure of treatment retention.

  Weekly for 10 weeks

Study Arms (2)

Dual Processing

EXPERIMENTAL

Behavioral: Dual Processing

Relapse Prevention

ACTIVE COMPARATOR

Behavioral: Relapse Prevention

Interventions

Dual Processing BEHAVIORAL

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.

Also known as: Group Therapy, DP

Dual Processing

Relapse Prevention BEHAVIORAL

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.

Also known as: Group Therapy, RP

Relapse Prevention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Inova Health Care Services: lead
• George Mason University: collaborator
• Georgetown University: collaborator

Study Sites (2)

Georgetown Center for Functional And Molecular Imaging, Georgetown University Medical Center

Washington D.C., District of Columbia, 22057, United States

Location

Inova Heath Services Comprehensive Addictions Treatment Services (ICATS)

Falls Church, Virginia, 22042, United States

Location

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Related Links

• Inova Health System, Comprehensive Addiction Treatment Services (CATS)
• National Institute on Drug Abuse

MeSH Terms

Conditions

Substance-Related Disorders; Alcoholism; Recurrence

Interventions

Psychotherapy, Group; Secondary Prevention

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities; Therapeutics; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Holly C Matto, PhD

  Virginia Commonwealth University, School of Social Work

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Director Behavioral Health Adult Ambulatory Services

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 22, 2011
• Study Start: February 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: January 1, 2013
• Last Updated: November 30, 2018

Record last verified: 2018-11

Locations

US (2)