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Clinical Trials/NCT03457077
NCT03457077
Completed
Not Applicable

Neural and Mobile Assessment OF Behavior Change Among Problem Drinkers

New York State Psychiatric Institute1 site in 1 country164 target enrollmentFebruary 27, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alcohol Use Disorder
Sponsor
New York State Psychiatric Institute
Enrollment
164
Locations
1
Primary Endpoint
Drinking
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This study will examine the neural mechanisms underlying both spontaneous behavior change and behavior change in response to a brief intervention among problem drinkers.

Detailed Description

Although problem drinkers (PD) are a less severe, highly prevalent sub-type of alcohol use disorder (AUD) who are more likely to undergo reductions in alcohol use, compared to more severe AUD, the underlying mechanisms that maintain PD, as well as the mechanisms that underlie both spontaneous and treatment- related behavior change in this population, are not well understood. This proposal takes a lab to life approach by combining functional neuroimaging (fMRI), ecological momentary assessment (EMA), and brief interventions (BI) in non-treatment seeking PD to test whether heightened incentive salience (reactivity) to alcohol cues and impaired ability to regulate cue-induce craving are the mechanisms that characterize PD, and play a role in behavior change vs. persistence of behavior. Identifying these mechanisms is critical for testing and understanding treatments and uncovering who is most likely to respond to interventions.

Registry
clinicaltrials.gov
Start Date
February 27, 2018
End Date
December 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nasir Naqvi

research psychiatrist

New York State Psychiatric Institute

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Past or current severe AUD as defined by DSM- V
  • Currently seeking treatment or attempting to stop drinking
  • Past or current alcohol withdrawal symptoms
  • Current DSM-V diagnosis of substance use disorder (other than nicotine or caffeine).
  • Regular use (more than 1-2 times weekly) of recreational drugs.
  • Psychotic Disorder or Bipolar disorder
  • Severe depression (Patient Health Questionnaire score \> 19) or anxiety (Beck Anxiety Inventory \> 25)
  • Substantial risk of suicide or violence
  • MRI contraindications (e.g., metallic implants, pacemaker, weight \> 350 lbs, waist \> 55")
  • Hearing impaired/hearing aids, unable to read newspaper at arm's length with corrective

Outcomes

Primary Outcomes

Drinking

Time Frame: 6 months

Heavy drinking days

Study Sites (1)

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