Status:
COMPLETED
Neural and Mobile Assessment OF Behavior Change Among Problem Drinkers
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
Northwell Health
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
21-55 years
Phase:
NA
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 und...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT03457077
Start Date
February 27 2018
End Date
December 31 2022
Last Update
July 5 2023
Active Locations (1)
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1
NYPInstitute
New York, New York, United States, 10032