Clinical trial NCT03457077: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: brief intervention
fMRI
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Northwell Health
First posted: 2018-03-07
Enrollment: 164
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Drinking
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYPInstitute
state: New York
Study officials:
affiliation: Columbia University
name: Nasir Naqvi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: