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

This study is currently recruiting participants.
Verified October 2017 by New York State Psychiatric Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02316574
First Posted: December 15, 2014
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
New York State Psychiatric Institute
  Purpose
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.

Condition Intervention
Alcoholism Behavioral: Cognitive Behavioral Coping Skills Therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Role of Neural Systems for Emotion Regulation in Coping With Alcohol Craving

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Percent heavy drinking days [ Time Frame: 12 weeks ]
    Assessed during the weekly CBCST treatment


Estimated Enrollment: 40
Study Start Date: December 2014
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316574


Contacts
Contact: Nasir H. Naqvi, MD, PhD 212-923-3031

Locations
United States, New York
NYPInstitute Recruiting
New York, New York, United States, 10032
Contact: Nasir H. Naqvi, MD, PhD    212-923-3031    nhn2102@columbia.edu   
Principal Investigator: Nasir H. Naqvi, MD, PhD         
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Nasir H. Naqvi, MD, PhD Assistant Professor of Pscyhiatry
  More Information

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02316574     History of Changes
Other Study ID Numbers: #6859
First Submitted: December 10, 2014
First Posted: December 15, 2014
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by New York State Psychiatric Institute:
Alcohol dependence
Cognitive Behavioral Therapy
Functional neuroimaging

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs