Neural and Mobile Assessment OF Behavior Change Among Problem Drinkers

New York State Psychiatric Institute

Status: Completed

Conditions: Alcohol Use Disorder

Treatments: Behavioral: Brief intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03457077

7390

Details and patient eligibility

About

This study will examine the neural mechanisms underlying both spontaneous behavior change and behavior change in response to a brief intervention among problem drinkers.

Full 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.

Enrollment: 164 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

Brief Intervention

Experimental group

Description:

Participants will receive a brief intervention at week 0

Treatment:

Behavioral: Brief intervention

Delayed Intervention

Other group

Description:

Participants will receive a brief intervention at 6 months

Treatment:

Behavioral: Brief intervention