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

Substance Abuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320748
• Other study ID #: IHS 11-001
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: January 2013

Study information

• Verified date: November 2018
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Drug Use
• Relapse
• Substance Abuse
• Substance Dependence
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Inova Health Care Services	George Mason University, Georgetown University

Country where clinical trial is conducted

United States, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	10 weeks
Secondary	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).	10 weeks
Secondary	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).	10 weeks
Secondary	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).	10 weeks
Secondary	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.	Weekly for 10 weeks
Secondary	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.	Weekly for 10 weeks

External Links

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