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Neural and Mobile Assessment OF Behavior Change Among Problem Drinkers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03457077
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
Northwell Health
Information provided by (Responsible Party):
Nasir Naqvi, 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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Behavioral: Brief intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Neural and Mobile Assessment OF Behavior Change Among Problem Drinkers
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : February 27, 2022
Estimated Study Completion Date : February 27, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brief Intervention
Participants will receive a brief intervention at week 0
Behavioral: Brief intervention
A brief motivational intervention with feedback about drinking levels compared to norms

Delayed Intervention
Participants will receive a brief intervention at 6 months
Behavioral: Brief intervention
A brief motivational intervention with feedback about drinking levels compared to norms




Primary Outcome Measures :
  1. Drinking [ Time Frame: 6 months ]
    Heavy drinking days



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (Problem Drinkers):

  • Age 21-55
  • English language fluency
  • Strongly right-handed
  • 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

Inclusion Criteria (Healthy Controls):

  • Age 21-55
  • English language fluency
  • Strongly right-handed
  • Have an average weekly consumption of less than 7 standard drinks for women and less than 14 standard drinks for men and no heavy drinking days (>4/5 standard drinks for a woman/man)
  • No lifetime diagnosis of AUD

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).
  • Recent use (past month, more than weekly) of recreational drugs.
  • Current or recent (past 5 years) Major Depressive Disorder, Psychotic Disorder, Bipolar
  • 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.
  • HIV infection
  • Pregnant, lactating (participation allowed 3 months after ceasing lactation), or currently intending to become pregnant
  • Medications that target CNS (e.g., neuroleptics, anticonvulsants, antidepressants, benzodiazepines) within the last month.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457077


Contacts
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Contact: Nasir Naqvi, MD, PhD (212) 923-3031 nhn2102@cumc.columbia.edu

Locations
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United States, New York
NYPInstitute Recruiting
New York, New York, United States, 10032
Contact: Nasir H. Naqvi, MD, PhD    212-923-3031    nhn2102@columbia.edu   
Principal Investigator: Nasir H. Naqvi, MD, PhD         
Sponsors and Collaborators
New York State Psychiatric Institute
Northwell Health

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Responsible Party: Nasir Naqvi, research psychiatrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03457077    
Other Study ID Numbers: 7390
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nasir Naqvi, New York State Psychiatric Institute:
brief intervention
fMRI
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders