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

NCT ID: NCT02316574

Last Updated: 2021-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2021-01-31

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.

Conditions

Alcoholism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive Behavioral Coping Skills Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Cognitive Behavioral Therapy; Relapse Prevention Therapy

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Nasir Naqvi

research psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nasir H. Naqvi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Pscyhiatry

Locations

NYPInstitute

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34342012 (View on PubMed)

Other Identifiers

#6859

Identifier Type: -

Identifier Source: org_study_id