Neural and Mobile Assessment OF Behavior Change Among Problem Drinkers

NCT03457077 | Completed

• 1 other identifier: 7390
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Keywords

brief intervention; fMRI

Outcome Measures

Primary Outcomes (1)

• Drinking

  Heavy drinking days

  6 months

Study Arms (2)

Brief Intervention

EXPERIMENTAL

Participants will receive a brief intervention at week 0

Behavioral: Brief intervention

Delayed Intervention

OTHER

Participants will receive a brief intervention at 6 months

Behavioral: Brief intervention

Interventions

Brief intervention BEHAVIORAL

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

Brief Intervention; Delayed Intervention

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Northwell Health: collaborator

Study Sites (1)

NYPInstitute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Nasir Naqvi, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research psychiatrist

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 7, 2018
• Study Start: February 27, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 5, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)