The Role of Neural Systems for Emotion Regulation in Coping With Alcohol Craving
FRAME
1 other identifier
interventional
36
1 country
1
Brief Summary
Cognitive Behavioral Coping Skills Therapy (CBCST) is a commonly utilized, evidence-based psychosocial therapy (talk therapy) for alcohol dependence. By identifying the neural mechanisms through which CBCST changes drinking behavior, it may be possible to improve its efficacy. CBCST promotes abstinence by teaching "coping skills" for managing alcohol-related thoughts and emotions. In this pilot study, the investigators examine the neural systems that play a role in the learning of coping skills through CBCST, specifically focusing on the role of emotion regulation systems.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 10, 2014
CompletedFirst Posted
Study publicly available on registry
December 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedJuly 2, 2021
July 1, 2021
6.1 years
December 10, 2014
July 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent heavy drinking days
Assessed during the weekly CBCST treatment
12 weeks
Study Arms (1)
Cognitive Behavioral Coping Skills
EXPERIMENTALCognitive Behavioral Coping Skills Therapy is an individual psychotherapy for alcohol use disorders that has been previously shown to reduce drinking. The focus of this treatment is the teaching of coping skills for managing alcohol craving and negative emotions as a way to reduce drinking behavior.
Interventions
Cognitive Behavioral Coping Skills Therapy (CBCST) is an individual psychotherapy for alcohol dependence that helps individuals to reduce drinking by addressing the ability to regulate, or "cope" with alcohol cravings and other emotions that promote alcohol use.
Eligibility Criteria
You may qualify if:
- Right-handed
- Meets DSM-V criteria for current Alcohol Use Disorder
- Currently drinking \>5/4 or more drinks/day for men/women in the last 28 day, on average, at the time of initial screening visit.
- Current goal of moderating or abstaining from drinking alcohol
- Seeking treatment for Alcohol Use Disorder
- Agree to not seek additional treatment, apart from Alcoholics Anonymous
- English-speaking and able to provide informed consent and comply with study procedures
- Willing to abstain from alcohol completely for 24 hours on 3 separate occasions
You may not qualify if:
- Any current Moderate or Severe substance use disorder, other than alcohol, nicotine or caffeine use disorders.
- Lifetime history of Bipolar Disorder, Schizophrenia or Schizoaffective Disorder
- A diagnosis of any current psychiatric disorder other than Alcohol Use Disorder (e.g. Major Depressive Disorder, Generalized Anxiety Disorder) that in the investigator's judgment might require intervention with either pharmacological or non-pharmacological therapy over the course of the study.
- History of severe alcohol withdrawal (e.g. seizure, delirium tremens, multiple detoxifications or ER visits for alcohol withdrawal)
- Significant risk for suicide or violence
- Legally mandated to receive treatment
- Sufficiently socially unstable as to preclude study participation (e.g. homeless).
- Currently taking any psychotropic medications.
- Significant cognitive impairment
- Neurological or medical conditions that would interfere with MRI scanning (e.g. history of stroke, seizure, brain tumor, brain infection, multiple sclerosis, metal device in body, pregnancy, claustrophobia)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYPInstitute
New York, New York, 10032, United States
Related Publications (1)
Srivastava AB, Sanchez-Pena J, Levin FR, Mariani JJ, Patel GH, Naqvi NH. Drinking reduction during cognitive behavioral therapy for alcohol use disorder is associated with a reduction in anterior insula-bed nucleus of the stria terminalis resting-state functional connectivity. Alcohol Clin Exp Res. 2021 Aug;45(8):1596-1606. doi: 10.1111/acer.14661. Epub 2021 Aug 2.
PMID: 34342012DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nasir H. Naqvi, MD, PhD
Assistant Professor of Pscyhiatry
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- research psychiatrist
Study Record Dates
First Submitted
December 10, 2014
First Posted
December 15, 2014
Study Start
December 1, 2014
Primary Completion
January 1, 2021
Study Completion
January 1, 2021
Last Updated
July 2, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share