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Neural and Mobile Assessment OF Behavior Change Among Problem Drinkers

Primary Purpose

Alcohol Use Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Brief intervention

About this trial

This is an interventional other trial for Alcohol Use Disorder focused on measuring brief intervention, fMRI

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

NYPInstitute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Brief Intervention

Delayed Intervention

Arm Description

Participants will receive a brief intervention at week 0

Participants will receive a brief intervention at 6 months

Outcomes

Primary Outcome Measures

Drinking

Heavy drinking days

Secondary Outcome Measures

Full Information

NCT ID

NCT03457077

First Posted

March 1, 2018

Last Updated

July 3, 2023

Sponsor

New York State Psychiatric Institute

Collaborators

Northwell Health

1. Study Identification

Unique Protocol Identification Number

NCT03457077

Brief Title

Neural and Mobile Assessment OF Behavior Change Among Problem Drinkers

Official Title

Neural and Mobile Assessment OF Behavior Change Among Problem Drinkers

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

February 27, 2018 (Actual)

Primary Completion Date

December 31, 2022 (Actual)

Study Completion Date

December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York State Psychiatric Institute

Collaborators

Northwell Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorder

Keywords

brief intervention, fMRI

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

164 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Brief Intervention

Arm Type

Experimental

Arm Description

Participants will receive a brief intervention at week 0

Arm Title

Delayed Intervention

Arm Type

Other

Arm Description

Participants will receive a brief intervention at 6 months

Intervention Type

Behavioral

Intervention Name(s)

Brief intervention

Intervention Description

A brief motivational intervention with feedback about drinking levels compared to norms

Primary Outcome Measure Information:

Title

Drinking

Description

Heavy drinking days

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nasir Naqvi, MD, PhD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

NYPInstitute

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Neural and Mobile Assessment OF Behavior Change Among Problem Drinkers

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