Clinical trial NCT03842670: Neurocognitive and Neurobehavioral Mechanisms of Change Following Psychological Treatment for Alcohol Use Disorder
Official title: Neurocognitive and Neurobehavioral Mechanisms of Change Following Psychological
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Alcohol Abuse
Alcohol Drinking
Alcohol Dependence
Keywords: Alcohol Use Disorder
Behavioral Treatment
Mechanisms of behavior change
Neuroimaging
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: The Mind Research Network
First posted: 2019-02-15
Enrollment: 110
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age 22-85 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)

Primary outcomes:
measure: Percent heavy drinking days
timeFrame: 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
Secondary outcomes:
measure: Percent drinking days
timeFrame: 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
measure: MOBC: Craving - self report
timeFrame: Up to 15 months
measure: MOBC: Regulation of Affect/Arousal - negative affect self-report
timeFrame: Up to 15 months
measure: MOBC: Regulation of Affect/Arousal - neuroimaging
timeFrame: Up to 9 months
measure: MOBC: Cognitive and Behavioral Control - neuroimaging errors
timeFrame: Up to 9 months
measure: MOBC: Cognitive and Behavioral Control - neuroimaging inhibition
timeFrame: Up to 9 months
measure: MOBC: Cognitive and Behavioral Control - behavior
timeFrame: Up to 15 months
measure: MOBC: Cognitive and Behavioral Control - self report impulsivity
timeFrame: Up to 15 months
measure: MOBC: Craving - neuroimaging
timeFrame: Up to 9 months
measure: Drinks per drinking day
timeFrame: 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
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: The Mind Research Network
state: New Mexico
city: Albuquerque
country: United States
facility: The University of New Mexico
state: New Mexico
Study officials:
affiliation: The University of New Mexico
name: Barbara McCrady, PhD
role: PRINCIPAL_INVESTIGATOR
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