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

July 1, 2021 updated by: Nasir Naqvi, New York State Psychiatric Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • NYPInstitute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Behavioral Coping Skills
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.
Behavioral: Cognitive Behavioral Coping Skills Therapy
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.
Other Names:
  • Cognitive Behavioral Therapy
  • Relapse Prevention Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent heavy drinking days
Time Frame: 12 weeks
Assessed during the weekly CBCST treatment
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Investigators

  • Principal Investigator: Nasir H. Naqvi, MD, PhD, Assistant Professor of Pscyhiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

December 10, 2014

First Submitted That Met QC Criteria

December 12, 2014

First Posted (Estimate)

December 15, 2014

Study Record Updates

Last Update Posted (Actual)

July 2, 2021

Last Update Submitted That Met QC Criteria

July 1, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #6859

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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