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Completed

NCT Number: NCT02316574

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYPInstitute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cognitive Behavioral Coping Skills Therapy

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.

Other names: Cognitive Behavioral Therapy, Relapse Prevention Therapy

Primary outcomes

  1. Percent heavy drinking days

    Time frame: 12 weeks

    Assessed during the weekly CBCST treatment

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Registry information

Acronym: FRAME

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Dec 15, 2014
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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