fMRI Study of a Dual Process Treatment Protocol With Substance Dependent Adults
NCT ID: NCT01320748
Last Updated: 2018-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
29 participants
INTERVENTIONAL
2011-02-28
2013-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Predicting Dropout and Outcome From Neuropsychological Functions in SUD Patients
NCT03220373
Real-Time fMRI to Enhance Interventions That Change Delay Discounting
NCT04828577
Effectiveness of Cognitive Therapy for Suicide Attempters With Drug Dependence Disorder
NCT00218725
Severe Alcohol-use Disorder: a tDCS and Response Inhibition Training Intervention
NCT03447054
Neurofeedback Training of Metacognition in Subjects With Alcohol Use Disorder. Disorder Induces Neural Modifications: an Event-related Potentials Study
NCT05913518
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dual Processing
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
George Mason University
OTHER
Georgetown University
OTHER
Inova Health Care Services
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Maria Hadjiyane
Senior Director Behavioral Health Adult Ambulatory Services
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Holly C Matto, PhD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University, School of Social Work
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Georgetown Center for Functional And Molecular Imaging, Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Inova Heath Services Comprehensive Addictions Treatment Services (ICATS)
Falls Church, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Matto H. A bio-behavioral model of addiction treatment: applying dual representation theory to craving management and relapse prevention. Subst Use Misuse. 2005;40(4):529-41. doi: 10.1081/ja-200030707.
Moeller SJ, Maloney T, Parvaz MA, Dunning JP, Alia-Klein N, Woicik PA, Hajcak G, Telang F, Wang GJ, Volkow ND, Goldstein RZ. Enhanced choice for viewing cocaine pictures in cocaine addiction. Biol Psychiatry. 2009 Jul 15;66(2):169-76. doi: 10.1016/j.biopsych.2009.02.015. Epub 2009 Apr 9.
Ochsner KN, Ray RD, Cooper JC, Robertson ER, Chopra S, Gabrieli JD, Gross JJ. For better or for worse: neural systems supporting the cognitive down- and up-regulation of negative emotion. Neuroimage. 2004 Oct;23(2):483-99. doi: 10.1016/j.neuroimage.2004.06.030.
Phan KL, Wager T, Taylor SF, Liberzon I. Functional neuroanatomy of emotion: a meta-analysis of emotion activation studies in PET and fMRI. Neuroimage. 2002 Jun;16(2):331-48. doi: 10.1006/nimg.2002.1087.
Schneider F, Habel U, Wagner M, Franke P, Salloum JB, Shah NJ, Toni I, Sulzbach C, Honig K, Maier W, Gaebel W, Zilles K. Subcortical correlates of craving in recently abstinent alcoholic patients. Am J Psychiatry. 2001 Jul;158(7):1075-83. doi: 10.1176/appi.ajp.158.7.1075.
Shaham Y, Erb S, Stewart J. Stress-induced relapse to heroin and cocaine seeking in rats: a review. Brain Res Brain Res Rev. 2000 Aug;33(1):13-33. doi: 10.1016/s0165-0173(00)00024-2.
Tanabe J, Tregellas JR, Dalwani M, Thompson L, Owens E, Crowley T, Banich M. Medial orbitofrontal cortex gray matter is reduced in abstinent substance-dependent individuals. Biol Psychiatry. 2009 Jan 15;65(2):160-4. doi: 10.1016/j.biopsych.2008.07.030. Epub 2008 Sep 18.
Uhl GR, Drgon T, Johnson C, Fatusin OO, Liu QR, Contoreggi C, Li CY, Buck K, Crabbe J. "Higher order" addiction molecular genetics: convergent data from genome-wide association in humans and mice. Biochem Pharmacol. 2008 Jan 1;75(1):98-111. doi: 10.1016/j.bcp.2007.06.042. Epub 2007 Jul 25.
van Reekum CM, Johnstone T, Urry HL, Thurow ME, Schaefer HS, Alexander AL, Davidson RJ. Gaze fixations predict brain activation during the voluntary regulation of picture-induced negative affect. Neuroimage. 2007 Jul 1;36(3):1041-55. doi: 10.1016/j.neuroimage.2007.03.052. Epub 2007 Apr 6.
Related Links
Access external resources that provide additional context or updates about the study.
Inova Health System, Comprehensive Addiction Treatment Services (CATS)
National Institute on Drug Abuse
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IHS 11-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.