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Substance AbuseNCT01320748

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

A study testing Dual Processing and Relapse Prevention in people with Substance Abuse and Substance Dependence, run by Inova Health Care Services at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dual Processing and Relapse Prevention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
2 sitesUnited States
Study dates
Feb 2011to Jan 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Inova Heath Services Comprehensive Addictions Treatment Services (ICATS)

    Falls Church, Virginia, 22042

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

    Washington D.C., District of Columbia, 22057

Other trials in United States

About this study

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.

Read the 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.

Being tested
Dual Processing, Relapse Prevention
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
Medical subject headings
Substance-Related Disorders, Alcoholism, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dual ProcessingBehavioural

    Also called Group Therapy, DP

    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 PreventionBehavioural

    Also called Group Therapy, RP

    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.

Study groups in NCT01320748
Study groupRoleWhat they receive
Dual ProcessingExperimentalNot described
Receives: Behavioral: Dual Processing
Relapse PreventionActive comparatorNot described
Receives: Behavioral: Relapse Prevention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 10 weeks

Secondary outcomes (6)

  1. 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).

    Measured: 10 weeks

  2. 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).

    Measured: 10 weeks

  3. 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).

    Measured: 10 weeks

  4. 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).

    Measured: 10 weeks

  5. 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.

    Measured: Weekly for 10 weeks

  6. 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.

    Measured: Weekly for 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionMar 2012
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01320748
Sponsor's protocol ID
IHS 11-001
Status last verified
Nov 2018
First submitted
7 Mar 2011
Last updated
30 Nov 2018
Results posted
No
Data monitoring committee
No

Publications

  • Brewer JA, Potenza MN. The neurobiology and genetics of impulse control disorders: relationships to drug addictions. Biochem Pharmacol. 2008 Jan 1;75(1):63-75. doi: 10.1016/j.bcp.2007.06.043. Epub 2007 Jul 3.

    PubMed 17719013

  • Brewin CR. A cognitive neuroscience account of posttraumatic stress disorder and its treatment. Behav Res Ther. 2001 Apr;39(4):373-93. doi: 10.1016/s0005-7967(00)00087-5.

    PubMed 11280338

  • Brewin CR, Dalgleish T, Joseph S. A dual representation theory of posttraumatic stress disorder. Psychol Rev. 1996 Oct;103(4):670-86. doi: 10.1037/0033-295x.103.4.670.

    PubMed 8888651

  • Charney DS. Psychobiological mechanisms of resilience and vulnerability: implications for successful adaptation to extreme stress. Am J Psychiatry. 2004 Feb;161(2):195-216. doi: 10.1176/appi.ajp.161.2.195.

    PubMed 14754765

  • Chee MW, Sriram N, Soon CS, Lee KM. Dorsolateral prefrontal cortex and the implicit association of concepts and attributes. Neuroreport. 2000 Jan 17;11(1):135-40. doi: 10.1097/00001756-200001170-00027.

    PubMed 10683845

  • Childress AR, Ehrman RN, Wang Z, Li Y, Sciortino N, Hakun J, Jens W, Suh J, Listerud J, Marquez K, Franklin T, Langleben D, Detre J, O'Brien CP. Prelude to passion: limbic activation by "unseen" drug and sexual cues. PLoS One. 2008 Jan 30;3(1):e1506. doi: 10.1371/journal.pone.0001506.

    PubMed 18231593

  • Coffey SF, Stasiewicz PR, Hughes PM, Brimo ML. Trauma-focused imaginal exposure for individuals with comorbid posttraumatic stress disorder and alcohol dependence: revealing mechanisms of alcohol craving in a cue reactivity paradigm. Psychol Addict Behav. 2006 Dec;20(4):425-35. doi: 10.1037/0893-164X.20.4.425.

    PubMed 17176177

  • Fein G, Di Sclafani V, Meyerhoff DJ. Prefrontal cortical volume reduction associated with frontal cortex function deficit in 6-week abstinent crack-cocaine dependent men. Drug Alcohol Depend. 2002 Sep 1;68(1):87-93. doi: 10.1016/s0376-8716(02)00110-2.

    PubMed 12167554

  • Goldin PR, McRae K, Ramel W, Gross JJ. The neural bases of emotion regulation: reappraisal and suppression of negative emotion. Biol Psychiatry. 2008 Mar 15;63(6):577-86. doi: 10.1016/j.biopsych.2007.05.031. Epub 2007 Sep 21.

    PubMed 17888411

  • Goldstein M, Brendel G, Tuescher O, Pan H, Epstein J, Beutel M, Yang Y, Thomas K, Levy K, Silverman M, Clarkin J, Posner M, Kernberg O, Stern E, Silbersweig D. Neural substrates of the interaction of emotional stimulus processing and motor inhibitory control: an emotional linguistic go/no-go fMRI study. Neuroimage. 2007 Jul 1;36(3):1026-40. doi: 10.1016/j.neuroimage.2007.01.056. Epub 2007 Mar 12.

    PubMed 17509899

  • Goodman A. Neurobiology of addiction. An integrative review. Biochem Pharmacol. 2008 Jan 1;75(1):266-322. doi: 10.1016/j.bcp.2007.07.030. Epub 2007 Jul 27.

    PubMed 17764663

  • Houben K, Schoenmakers TM, Wiers RW. I didn't feel like drinking but I don't know why: the effects of evaluative conditioning on alcohol-related attitudes, craving and behavior. Addict Behav. 2010 Dec;35(12):1161-3. doi: 10.1016/j.addbeh.2010.08.012. Epub 2010 Aug 11.

    PubMed 20810220

  • Koob GF. The neurobiology of addiction: a neuroadaptational view relevant for diagnosis. Addiction. 2006 Sep;101 Suppl 1:23-30. doi: 10.1111/j.1360-0443.2006.01586.x.

    PubMed 16930158

  • Matto HC, Strolin-Goltzman J. Integrating social neuroscience and social work: innovations for advancing practice-based research. Soc Work. 2010 Apr;55(2):147-56. doi: 10.1093/sw/55.2.147.

    PubMed 20408356

  • Matto HC, Strolin JS, Mogro-Wilson C. A pilot study of a dual processing substance user treatment intervention with adults. Subst Use Misuse. 2008;43(3-4):285-94. doi: 10.1080/00952990701202848.

    PubMed 18365931

Questions about this trial

What is this clinical trial studying?

A study testing Dual Processing and Relapse Prevention in people with Substance Abuse and Substance Dependence, run by Inova Health Care Services at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01320748, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2018.

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