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

Sponsor

Inova Health Care Services (Other)

Overall Status

Completed

CT.gov ID

NCT01320748

Collaborator

George Mason University (Other), Georgetown University (Other)

Enrollment

Locations

Arms

Duration (Months)

14.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Substance Abuse Substance Dependence Alcohol Abuse Drug Use Relapse	Behavioral: Dual Processing Behavioral: Relapse Prevention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

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: 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

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:

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:

Group Therapy

Outcome Measures

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. [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).

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Georgetown Center for Functional And Molecular Imaging, Georgetown University Medical Center	Washington	District of Columbia	United States	22057
2	Inova Heath Services Comprehensive Addictions Treatment Services (ICATS)	Falls Church	Virginia	United States	22042