Neural and Mobile Assessment OF Behavior Change Among Problem Drinkers

Not Applicable

Completed

• Conditions: Alcohol Use Disorder
• Interventions: Behavioral: Brief intervention

• Registration Number: NCT03457077
• Lead Sponsor: New York State Psychiatric Institute

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.

Study Timeline

• Study Start: 2018-02-27
• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-07
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed Intervention	Brief intervention	Participants will receive a brief intervention at 6 months
Brief Intervention	Brief intervention	Participants will receive a brief intervention at week 0

Primary Outcome Measures

Name	Time	Method
Drinking	6 months	Heavy drinking days

Trial Locations

Locations (1)

NYPInstitute; 🇺🇸 New York, New York, United States