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

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02316574
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arm: 1
• Actual Duration (Months): 73
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholism	Behavioral: Cognitive Behavioral Coping Skills Therapy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: N/A
• 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
• Actual Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Jan 1, 2021
• Actual Study Completion Date: Jan 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percent heavy drinking days [12 weeks]

   Assessed during the weekly CBCST treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	NYPInstitute	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nasir Naqvi, research psychiatrist, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT02316574
• Other Study ID Numbers: #6859
• First Posted: Dec 15, 2014
• Last Update Posted: Jul 2, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Nasir Naqvi, research psychiatrist, New York State Psychiatric Institute: Alcohol dependence; Cognitive Behavioral Therapy; Functional neuroimaging
• Additional relevant MeSH terms: Alcoholism

Study Results

No Results Posted as of Jul 2, 2021