New York, New York 10032


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.


Study summary:

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.


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)


Study is Available At:


Original ID:

#6859


NCT ID:

NCT02316574


Secondary ID:


Study Acronym:

FRAME


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

New York State Psychiatric Institute


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Nasir H. Naqvi, MD, PhD
Principal Investigator
Assistant Professor of Pscyhiatry
Primary Contact:Nasir H. Naqvi, MD, PhD
212-923-3031

Study Dates

Start Date:December 2014
Completion Date:January 2020
Completion Type:Anticipated
Primary Completion Date:January 2020
Primary Completion Type:Anticipated
Verification Date:March 2019
Last Changed Date:March 5, 2019
First Received Date:December 10, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:Percent heavy drinking days
Time Frame:12 weeks
Safety Issues:False
Description:Assessed during the weekly CBCST treatment

Study Interventions

Intervention Type:Behavioral
Name:Cognitive Behavioral Coping Skills Therapy
Description: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.
Arm Name:Cognitive Behavioral Coping Skills
Other Name:Cognitive Behavioral Therapy

Study Arms

Study Arm Type:Experimental
Arm Name:Cognitive Behavioral Coping Skills
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:New York State Psychiatric Institute

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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