Neural and Mobile Assessment OF Behavior Change Among Problem Drinkers

NCT ID: NCT03457077

Last Updated: 2023-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-27
• Study Completion Date: 2022-12-31

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.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Brief Intervention

Participants will receive a brief intervention at week 0

Group Type: EXPERIMENTAL

Brief intervention

Intervention Type: BEHAVIORAL

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

Delayed Intervention

Participants will receive a brief intervention at 6 months

Group Type: OTHER

Brief intervention

Intervention Type: BEHAVIORAL

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

Interventions

Brief intervention

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwell Health

OTHER

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Nasir Naqvi

research psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nasir Naqvi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

NYPInstitute

New York, New York, United States

Countries

United States

Other Identifiers

7390

Identifier Type: -

Identifier Source: org_study_id