Alcohol Use DisorderNCT03457077
Neural and Mobile Assessment OF Behavior Change Among Problem Drinkers
A study testing Brief intervention in people with Alcohol Use Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Brief intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- Age 21-55
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
This study will examine the neural mechanisms underlying both spontaneous behavior change and behavior change in response to a brief intervention among problem drinkers.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Brief intervention
- Keywords
- brief intervention, fMRI
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief interventionBehavioural
A brief motivational intervention with feedback about drinking levels compared to norms
| Study group | Role | What they receive |
|---|---|---|
| Brief Intervention | Experimental | Participants will receive a brief intervention at week 0 Receives: Behavioral: Brief intervention |
| Delayed Intervention | Other | Participants will receive a brief intervention at 6 months Receives: Behavioral: Brief intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinking
Heavy drinking days
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start27 Feb 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Northwell Health
- Responsible party
- Principal investigator, Nasir Naqvi, New York State Psychiatric Institute
- Investigators
- Nasir Naqvi, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457077
- Sponsor's protocol ID
- 7390
- Status last verified
- Jul 2023
- First submitted
- 1 Mar 2018
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural and Mobile Assessment OF Behavior Change Among Problem Drinkers
- ClinicalTrials.gov ID
- NCT03457077
- Acronym / sponsor ID
- 7390
- Conditions
- Alcohol Use Disorder
- Keywords
- brief intervention, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Northwell Health
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Brief Intervention | Experimental | Behavioral: Brief interventionParticipants will receive a brief intervention at week 0 |
| Delayed Intervention | Other | Behavioral: Brief interventionParticipants will receive a brief intervention at 6 months |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief interventionA brief motivational intervention with feedback about drinking levels compared to norms | Behavioural | Brief Intervention, Delayed Intervention |
Primary outcome
Drinking
Time frame: 6 months
Heavy drinking days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Alcohol Use Disorder
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasir Naqvi, MD, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief intervention in people with Alcohol Use Disorder, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drinking (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.