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The Role of Neural Systems for Emotion Regulation in Coping With Alcohol Craving (FRAME)

Primary Purpose

Alcoholism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Coping Skills Therapy
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcoholism focused on measuring Alcohol dependence, Cognitive Behavioral Therapy, Functional neuroimaging

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • NYPInstitute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive Behavioral Coping Skills

Arm Description

Cognitive 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.

Outcomes

Primary Outcome Measures

Percent heavy drinking days
Assessed during the weekly CBCST treatment

Secondary Outcome Measures

Full Information

First Posted
December 10, 2014
Last Updated
July 1, 2021
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02316574
Brief Title
The Role of Neural Systems for Emotion Regulation in Coping With Alcohol Craving
Acronym
FRAME
Official Title
The Role of Neural Systems for Emotion Regulation in Coping With Alcohol Craving
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
January 2021 (Actual)
Study Completion Date
January 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
Alcohol dependence, Cognitive Behavioral Therapy, Functional neuroimaging

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Coping Skills
Arm Type
Experimental
Arm Description
Cognitive 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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Coping Skills Therapy
Other Intervention Name(s)
Cognitive Behavioral Therapy, Relapse Prevention Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent heavy drinking days
Description
Assessed during the weekly CBCST treatment
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasir H. Naqvi, MD, PhD
Organizational Affiliation
Assistant Professor of Pscyhiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYPInstitute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34342012
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. Erratum In: Alcohol Clin Exp Res (Hoboken). 2023 Jul;47(7):1423-1424.
Results Reference
derived

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The Role of Neural Systems for Emotion Regulation in Coping With Alcohol Craving

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