Neural and Mobile Assessment OF Behavior Change Among Problem Drinkers

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

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Behavioral: Brief intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • NYPInstitute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria (Problem Drinkers):

• Age 21-55
• English language fluency
• Over the last 28 days ,Have an average weekly consumption of greater than 14 standard drinks for women, and greater than 24 standard drinks for men.
• Current DSM-V mild or moderate alcohol use disorder (AUD) diagnosis
• Own a smartphone with data plan

Inclusion Criteria (Healthy Controls):

• Age 21-55
• English language fluency
• Have an average weekly consumption of less than </=14 standard drinks for women and less than/equal to 24 standard drinks for men and up to 2 heavy drinking days (>4/5 standard drinks for a woman/man)
• No lifetime diagnosis of AUD
• owns smartphone with a data plan

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
• Objective cognitive impairment
• Current or recent (evidence of disease x 5 years) non-skin neoplastic disease or melanoma. - Active hepatic disease (not a history of hepatitis) or primary renal disease requiring dialysis, primary untreated endocrine diseases, e.g., Cushing's disease or primary hypothalamic failure or insulin dependent diabetes (Type I or II). Well-treated hypothyroidism will not be excluded.
• Pregnant, lactating (participation allowed 3 months after ceasing lactation), or currently intending to become pregnant
• Any history of ECT
• Brain disorder such as stroke, tumor, infection, epilepsy, multiple sclerosis, degenerative diseases, head injury (LOC > 5 minutes), mental retardation
• Diagnosed learning disability, dyslexia, or ADHD
• For women: Current pregnancy or intention to be pregnant in the near future

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief Intervention; Participants will receive a brief intervention at week 0	Behavioral: Brief intervention; A brief motivational intervention with feedback about drinking levels compared to norms
Other: Delayed Intervention; Participants will receive a brief intervention at 6 months	Behavioral: Brief intervention; A brief motivational intervention with feedback about drinking levels compared to norms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drinking	Heavy drinking days	6 months

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: Northwell Health
• Investigators: Principal Investigator: Nasir Naqvi, MD, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: fMRI; brief intervention
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: 7390

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No