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Neurocognitive and Neurobehavioral Mechanisms of Change Following Psychological Treatment for Alcohol Use Disorder (ABQ TREAT)

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ClinicalTrials.gov Identifier: NCT03842670
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
The Mind Research Network
Information provided by (Responsible Party):
Barbara S McCrady, PhD, University of New Mexico

Brief Summary:

Alcohol Use Disorder (AUD) is a significant public health problem, with prevalence rates of 13.9% for current and 29.1% for lifetime diagnosis (Grant et al., 2015). AUD creates harm at the individual, familial, and societal level, with an estimated societal cost of $249 billion (Sacks et al., 2015) per year. The course of AUD typically is characterized by periods of relapse to problematic drinking (Maisto et al., 2014), signaling a need for better treatments and understanding of mechanisms of behavior change.

The goal of this research is to conduct a randomized clinical trial with 140 participants who have an Alcohol Use Disorder (AUD). Each participant will complete behavioral assessments, self-report surveys and brain imaging before and after receiving psychotherapy treatment to change their drinking behaviors. Various aspects of behavior change will be looked at to better understand changes in brain function and emotional reactivity when someone changes their patterns of alcohol use. The two treatment used in this study have been found to be helpful in reducing alcohol use. Participants will be randomly assigned to either Mindfulness-Based Relapse Prevention (MBRP) or Cognitive Behavior Therapy (CBT) that will be completed in 12 weekly therapy sessions.

It is anticipated that there will be numerous changes in brain function that are found when someone reduces or stops their alcohol use after the completion of 12 weeks of treatment.


Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Alcohol Abuse Alcohol Drinking Alcohol Dependence Behavioral: Cognitive Behavior Therapy Behavioral: Mindfulness Based Relapse Prevention Not Applicable

Detailed Description:
Although pharmacological and psychosocial treatments for alcohol use disorders (AUDs) exist that improve outcomes over natural recovery (Finney et al., 2013), outcomes are still modest. Identifying mechanisms of behavior change (MOBCs) that lead to successful outcomes may be critical for efforts to improve existing treatments or to better match patients with particular treatments. The goal of the proposed research is to conduct a randomized clinical trial to systematically examine pretreatment neurocognitive and behavioral characteristics and changes in brain function over time during two empirically supported treatments for AUD. One hundred forty treatment-seeking individuals with an AUD will be randomized to receive either 8 weeks of Cognitive Behavioral Treatment (CBT) or Mindfulness Based Treatment (MBT) after receiving 4 weeks of a platform treatment that focuses on enhancing motivation to change. Neurocognitive and behavioral characteristics will be measured using neuroimaging, comprehensive behavioral assessments, and patient self-reports. To establish the temporal relationship between changes in drinking and changes in these MOBCs, patients will be assessed at: (a) baseline; (b) four weeks into treatment; (c) immediately post-treatment; and (d) 9- and 15-months post-baseline. Self-report measures and behavioral tasks will be administered at monthly intervals during treatment; and fMRI will be collected at baseline, and at 3, and 9-months post baseline. The primary aim of the study is to examine the effects of the treatments on three hypothesized mechanisms: craving/regulation of craving, cognitive and behavioral control, and regulation of affect/arousal. The secondary aim will identify neurocognitive and behavioral baseline characteristics predictive of reductions in drinking over time and differential patterns of response to CBT or MBT.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Neurocognitive and Neurobehavioral Mechanisms of Change Following Psychological
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Active Comparator: Cognitive-Behavior Therapy
The CBT condition will include 8 weekly, 60-minute sessions, and will be delivered according to the Epstein & McCrady (2009) cognitive-behavioral treatment manual, excluding material provided in the platform treatment. The treatment manual and accompanying client workbook provide detailed therapist instructions for each session, client exercises, worksheets, and homework assignments. The treatment focuses on cognitive and behavioral coping skills training, and emphasizes problem-solving as an overall approach to dealing with drinking.
Behavioral: Cognitive Behavior Therapy
The CBT condition will include 8 weekly, 60-minute sessions, and will be delivered according to the Epstein & McCrady (2009) cognitive-behavioral treatment manual, excluding material provided in the platform treatment. The treatment manual and accompanying client workbook provide detailed therapist instructions for each session, client exercises, worksheets, and homework assignments. The treatment focuses on cognitive and behavioral coping skills training, and emphasizes problem-solving as an overall approach to dealing with drinking. Treatment sessions may be audio-recorded for supervision and to ensure that the treatment is being delivered as intended.

Active Comparator: Mindfulness Based Relapse Prevention
The MBT condition will be adapted from the 8-week version of the mindfulness-based relapse prevention (MBRP) manual (Bowen et al., 2011; Witkiewitz et al., 2005). The main adaptation will be to eliminate the relapse prevention/CBT components and focus attention on mindfulness practices. The mindfulness practices in MBT are designed to increase awareness of triggers and decrease reactivity to distress or discomfort in the presence of triggers (Witkiewitz & Bowen, 2010). The relevant worksheets and homework assignments focusing on mindfulness tools will be maintained from the MBRP manual.
Behavioral: Mindfulness Based Relapse Prevention
The MBT condition will be adapted from the 8-week version of the mindfulness-based relapse prevention (MBRP) manual (Bowen et al., 2011; Witkiewitz et al., 2005). The main adaptation will be to eliminate the relapse prevention/CBT components and focus attention on mindfulness practices. The mindfulness practices in MBT are designed to increase awareness of triggers and decrease reactivity to distress or discomfort in the presence of triggers (Witkiewitz & Bowen, 2010). The relevant worksheets and homework assignments focusing on mindfulness tools will be maintained from the MBRP manual. Treatment sessions may be audio-recorded for supervision and to ensure that the treatment is being delivered as intended.




Primary Outcome Measures :
  1. MOBC: Craving - self report [ Time Frame: Up to 15 months ]
    Penn Alcohol Craving Scale will be used to examine changes in craving that occur during and after treatment.

  2. MOBC: Craving - neuroimaging [ Time Frame: Up to 9 months ]
    The difference in percent signal change during alcohol vs. neutral picture cues in ventral striatum will be assessed using a cue task while participants are scanned using functional magnetic resonance imaging

  3. MOBC: Cognitive and Behavioral Control - self report impulsivity [ Time Frame: Up to 15 months ]
    The UPPS-P Impulsivity Questionnaire will be used to examine changes in impulsivity that occur during and after treatment.

  4. MOBC: Cognitive and Behavioral Control - behavior [ Time Frame: Up to 15 months ]
    The Monetary Choice Questionnaire will be used to determine the degree to which impulsive choice changes during and after treatment. A discounting rate (k) will be computed for each administration.

  5. MOBC: Cognitive and Behavioral Control - neuroimaging inhibition [ Time Frame: Up to 9 months ]
    The difference in percent signal change during successful inhibition of responses vs. successful non-inhibition trials in right inferior frontal cortex will be assessed using a stop signal task while participants are scanned using functional magnetic resonance imaging.

  6. MOBC: Cognitive and Behavioral Control - neuroimaging errors [ Time Frame: Up to 9 months ]
    The difference in percent signal change during unsuccessful inhibition of responses vs. successful non-inhibition trials in dorsal anterior cingulate cortex will be assessed using a stop signal task while participants are scanned using functional magnetic resonance imaging.

  7. MOBC: Regulation of Affect/Arousal - neuroimaging [ Time Frame: Up to 9 months ]
    The difference in percent signal change during negative vs. neutral picture cues in amygdala will be assessed using a cue task while participants are scanned using functional magnetic resonance imaging.

  8. MOBC: Regulation of Affect/Arousal - negative affect self-report [ Time Frame: Up to 15 months ]
    The Negative Affect Summary score from the NIH toolbox will be used to assess overall negative affect changes during and after treatment.


Secondary Outcome Measures :
  1. Percent drinking days [ Time Frame: Baseline, 4-week within treatment visit, 8-week within treatment visit, and 3-month follow-up, 9-month follow-up, and 15-month follow-up ]
    The Form 90 will be used to derive estimates of the outcome percent drinking days.

  2. Drinks per drinking day [ Time Frame: Baseline, 4-week within treatment visit, 8-week within treatment visit, and 3-month follow-up, 9-month follow-up, and 15-month follow-up ]
    The Form 90 will be used to derive estimates of the outcome: drinks (standard drink=14 grams of pure alcohol) per drinking day.

  3. Percent heavy drinking days [ Time Frame: Baseline, 4-week within treatment visit, 8-week within treatment visit, and 3-month follow-up, 9-month follow-up, and 15-month follow-up ]
    The Form 90 will be used to derive estimates of the outcome: percent heavy drinking days, where heavy drinking is defined as 4+ drinks per occasion for women and 5+ drinks per occasion for men.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 22-55 years
  2. Self-identify as a heavy/binge/weekly drinker
  3. Engage in "hazardous and harmful alcohol use" (Babor et al., 2001) based on an AUDIT score > 8 for men and > 7 for women
  4. Breath alcohol level of 0.00 at in-person screening
  5. Right handed
  6. Explicitly be seeking help for their drinking
  7. Alcohol use during the past 30 days

Exclusion Criteria:

  1. History of brain injury or neurological diagnoses
  2. Evidence of current psychosis
  3. Past-year substance dependence other than nicotine or marijuana
  4. Evidence of recent illicit drug (other than marijuana) use on a urine screen
  5. Contraindications for MRI (e.g., medical devices in the body)
  6. Female participants who think they may be pregnant must pass a urine pregnancy screen prior to each MRI scanning session
  7. Estimated IQ < 80
  8. Unable to read or speak English fluently
  9. History of major alcohol withdrawal
  10. Currently in treatment for alcohol use (or within the past 6 months)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03842670


Contacts
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Contact: Barbara McCrady, PhD 505-925-2833 bmccrady@unm.edu
Contact: Eric Claus, PhD eclaus@mrn.org

Locations
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United States, New Mexico
The Mind Research Network Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Stefan Klimaj, BS       sklimaj@mrn.org   
Principal Investigator: Eric Claus, PhD         
The University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Alicia R Shiver, MA       astevens@unm.edu   
Contact: Roberta Chavez, MA       robertac@unm.edu   
Principal Investigator: Barbara McCrady, PhD         
Sub-Investigator: Katie Witkiewitz, PhD         
Sponsors and Collaborators
University of New Mexico
The Mind Research Network
Investigators
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Principal Investigator: Barbara McCrady, PhD The University of New Mexico

Publications:
Aiken, L. S., West, S. G., & Reno, R. R. (1991). Multiple regression: Testing and interpreting interactions. Sage.
Babor, T., Higgins-Biddle, J. C., Saunders, J. B., & Monteiro, M. G. (2001). AUDIT: The Alcohol Use Disorders Identification Test: Guidelines for use in primary care, Second edition. Department of Mental Health and Substance Dependence, World Health Organization.
Claus, E.D., Littlewood, R.A., Feldstein Ewing, S.W., Aranella, P., Bogenschutz, M.P., Hutchison, K.E. (unpublished). BOLD response as a potential biomarker predicting treatment response to olanzapine in alcohol dependence.
Epstein, E. E. & McCrady, B. S. (2009a). A cognitive-behavioral treatment program for overcoming alcohol use problems: Therapist guide. New York: Oxford University Press.
Epstein, E. E. & McCrady, B. S. (2009b). A cognitive-behavioral treatment program for overcoming alcohol use problems: Client workbook. New York: Oxford University Press.
Finney, J. W., Moos, R. H., & Timko, C. (2013). The course of treated and untreated substance use disorders: Remission and resolution, relapse and mortality. In: B. S. McCrady & E. e. Epstein (Eds.), Addiction: A comprehensive guidebook, 2nd edition (pp. 108-134). NY: Oxford University Press.
First, M. B., William, J. B. W., Karg, R. S., Spitzer, R. L. (2015). User's Guide for the Structured Clinical Interview for DSM-5 Disorders, Research Version (SCID-5-RV). Arlington, VA: American Psychiatric Association.
Friston, K. J., Ashburner, J., Frith, C. D., Poline, J. B., & Frackowiak, R. S. J. (1995). Spatial registration and normalization of images. Human Brain Mapping, 3, 165-189.
Friston, K. J., Holmes, A. P., Worsley, K. J., Poline, J. P., Frith, C. D., & Frackowiak, R. S.J. (1995). Statistical parametric maps in functional imaging: a general linear approach. Human Brain Mapping, 2, 189-210.
Herault, J., & Jutten, C. (1986). Space or time adaptive signal processing by neural network models. American Institute for Physics Conference Proceedings, 151, 206
Jutten, C., & Herault, J. (1991). Blind separation of sources, part I: An adaptive algorithm based on neuromimetic architecture. Signal Processing, 24, 1-10.
Koob, G. F. (2013). Neuroscience of addiction. In: B. S. McCrady & E. E. Epstein (Eds.), Addiction: A comprehensive guidebook, 2nd edition (pp. 17-354). NY: Oxford University Press.
Lang, P. J., Bradley, M. M., & Cuthbert, B. N. (1997). International affective picture system (IAPS): Technical manual and affective ratings. NIMH Center for the Study of Emotion and Attention, 39-58.
McCrady, B. S. (2071). Mechanisms of change and the treatment of alcohol use disorders. In: D. McKay, J. Abramowitz, & E. Storch (Eds.), Mechanisms of syndromes and treatment for psychological problems. NY: Wiley Press.
Miller, W. R. (1996). Form 90: A structured assessment interview for drinking and related behaviors, test manual. Project MATCH Monograph Series, Vol 5. Bethesda, MD: National Institute of Alcohol Abuse and Alcoholism.
Miller, W. R., Mattson, M. E., Arciniega, L. T., Arroyo, J...Zweben, A. (2004). COMBINE behavioral intervention manual. A clinical research guide for therapists treatment people with alcohol abuse and dependence. DHHS Publication No. (NIH) 04-5288. Bethesda, MD: National Institute on Alcohol Abuse and Alcoholism.
Miller, W. R. & Rollnick, S. (2013). Motivational interviewing: Helping people change, 3rd edition. NY: Guilford Press.
Miller, W.R., Tonigan, J.S. & Longabaugh, R. (1995). The Drinker Inventory of Consequences (DrInC): An instrument for assessing adverse consequences of alcohol abuse. Project MATCH Monograph Series, Vol. 4. DHHS Publication No. 95-3911. Rockville MD: NIAAA.
Wechsler, D. (1999). Abbreviated Scale of Intelligence (WASI). San Antonio, Tx.: Harcourt.
Whiteside, S. P., Lynam, D. R., Miller, J. D., & Reynolds, S. K. (2005). Validation of the UPPS impulsive behaviour scale: a four‐factor model of impulsivity. European Journal of Personality, 19(7), 559-574.

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Responsible Party: Barbara S McCrady, PhD, Distinguished Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT03842670     History of Changes
Other Study ID Numbers: 1240557-4
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Barbara S McCrady, PhD, University of New Mexico:
Alcohol Use Disorder
Behavioral Treatment
Mechanisms of behavior change
Neuroimaging

Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders