Clinical trial NCT02316574: The Role of Neural Systems for Emotion Regulation in Coping With Alcohol Craving
Official title: The Role of Neural Systems for Emotion Regulation in Coping With Alcohol Craving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholism
Keywords: Alcohol dependence
Cognitive Behavioral Therapy
Functional neuroimaging
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2014-12-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Detailed description: The study combines 1) a 12-week clinical trial of CBCST in currently drinking alcohol dependent patients (target N=25) who are seeking treatment to reduce their drinking with 2) functional magnetic resonance imaging (fMRI) experiments that probe neural activity related to the utilization of copings skills taught in CBCST. The fMRI studies will be performed both before and after treatment with CBCST, with the goal of determining 1) the pattern of neural activity that is related to coping skills utilization prior to undergoing CBCST, with particular focus on neural systems known to play a role in emotion regulation; 2) how CBCST changes this pattern of neural activity; and 3) how these changes in neural activity predict changes in alcohol use during CBCST.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Percent heavy drinking days
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYPInstitute
state: New York
Study officials:
affiliation: Assistant Professor of Pscyhiatry
name: Nasir H. Naqvi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.