Heavy DrinkingPARSNCT04710095
Perceived Alcohol Rewards and Risks Study
A study testing Brief Alcohol Intervention in people with Heavy Drinking, run by University of California, Los Angeles.
Trial summary
The identification of mechanisms that underlie how people reduce or eliminate alcohol use is a critical public health issue. Understanding these mechanisms can inform how to effectively intervene with problem drinkers. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heavy Drinking
- What is being tested?
- Brief Alcohol Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 13 Nov 2015to 5 Apr 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- engaged in regular heavy drinking, as indicated by consuming 5 or more drinks per occasion for men or 4 or more drinks per occasion for women at least 4 times in the month prior to enrollment
- a score of ≥ 8 on the Alcohol Use Disorder Identification Test (AUDIT)
Who cannot join
- under the age of 21
- currently receiving treatment for alcohol problems, history of treatment in the 30 days before enrollment, or currently seeking treatment
- a positive urine toxicology screen for any drug other than cannabis
- a lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder
- serious alcohol withdrawal symptoms
- history of epilepsy, seizures, or severe head trauma
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- non-removable ferromagnetic objects in body
- claustrophobia
- pregnancy
About this study
Official title: Perceived Alcohol Reward Value and Risk: Neural Correlates and Treatment Effects
The identification of mechanisms that underlie how people reduce or eliminate alcohol use is a critical public health issue. Understanding these mechanisms can inform how to effectively intervene with problem drinkers. Thus far it has been a challenge for the alcohol research field to find consistent empirical evidence in support of candidate mechanisms of behavior change. Scientific advancement in this area may be aided by longitudinal transdisciplinary research on the interplay between behavioral intervention, cognition, and brain activity to understand underlying processes of behavior change among heavy drinkers. This study employed a randomized 2-arm repeated measures design with a sample of non-treatment seeking adult heavy drinkers to examine changes in perceived reward value and risks of alcohol use as a mechanism of alcohol behavior change after a brief behavioral intervention. Participants were randomized to either a 1-session behavioral intervention or to an attention-matched control condition and immediately after completed an fMRI scan. The focus of this project is to examine if group differences in perceived alcohol reward value after the intervention mediates an intervention effect on reducing alcohol use in the 1 month following the intervention.
- Conditions
- Heavy Drinking
- Being tested
- Brief Alcohol Intervention, Control Condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Alcohol InterventionBehavioural
Brief alcohol intervention uses a motivational interviewing approach and covers the following components: giving information about the possible health risks associated with alcohol use, placing the responsibility for change on the individual, discussing the reasons for drinking and downsides of drinking, and setting a goal and change plan if the participant is receptive.
Control ConditionBehavioural
The attention-matched control condition consisting of a 30-min video about astronomy.
| Study group | Role | What they receive |
|---|---|---|
| Brief Alcohol Intervention | Active comparator | A brief intervention consisting of a 30-45 minute individual face-to-face session based on the principles of motivational interviewing. Receives: Behavioral: Brief Alcohol Intervention |
| Attention-Matched Control Condition | Sham comparator | Brief attention-matched control condition. Receives: Behavioral: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Heavy Drinking Days
Percent heavy drinking days defined as 5+ drinks for men and 4+ for women according to self-reported Timeline Follow Back (TLFB) data
Measured: 4 weeks post intervention
Neural Alcohol Cue Reactivity
Neural alcohol cue reactivity as measured by whole brain activation to alcohol taste cue vs. water taste cue using functional magnetic resonance imaging (fMRI)
Measured: Single time point immediately post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start13 Nov 2015
- Primary completion5 Apr 2017
- Study completion5 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heavy DrinkingStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Lara Ray, PhD, University of California, Los Angeles
- Investigators
- Lara A Ray, PhD, Principal investigator, University of California, Los AngelesMitchell P Karno, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710095
- Sponsor's protocol ID
- IRB#15-000237
- Other IDs
- R21AA023669
- Acronym
- PARS
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grodin EN, Ray LA, MacKillop J, Lim AC, Karno MP. Elucidating the Effect of a Brief Drinking Intervention Using Neuroimaging: A Preliminary Study. Alcohol Clin Exp Res. 2019 Feb;43(2):367-377. doi: 10.1111/acer.13941. Epub 2019 Jan 20.
PubMed 30556913Grodin EN, Lim AC, MacKillop J, Karno MP, Ray LA. An Examination of Motivation to Change and Neural Alcohol Cue Reactivity Following a Brief Intervention. Front Psychiatry. 2019 Jun 11;10:408. doi: 10.3389/fpsyt.2019.00408. eCollection 2019.
PubMed 31244697Meredith LR, Grodin EN, Karno MP, Montoya AK, MacKillop J, Lim AC, Ray LA. Preliminary study of alcohol problem severity and response to brief intervention. Addict Sci Clin Pract. 2021 Aug 24;16(1):54. doi: 10.1186/s13722-021-00262-6.
PubMed 34429151
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceived Alcohol Reward Value and Risk: Neural Correlates and Treatment Effects
- ClinicalTrials.gov ID
- NCT04710095
- Acronym / sponsor ID
- PARS / IRB#15-000237
- Conditions
- Heavy Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 13 Nov 2015 (actual)
- Primary completion
- 5 Apr 2017 (actual)
- Study completion
- 5 Apr 2017 (actual)
- First posted
- 14 Jan 2021 (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.
The identification of mechanisms that underlie how people reduce or eliminate alcohol use is a critical public health issue. Understanding these mechanisms can inform how to effectively intervene with problem drinkers. Thus far it has been a challenge for the alcohol research field to find consistent empirical evidence in support of candidate mechanisms of behavior change. Scientific advancement in this area may be aided by longitudinal transdisciplinary research on the interplay between behavioral intervention, cognition, and brain activity to understand underlying processes of behavior change among heavy drinkers. This study employed a randomized 2-arm repeated measures design with a sample of non-treatment seeking adult heavy drinkers to examine changes in perceived reward value and risks of alcohol use as a mechanism of alcohol behavior change after a brief behavioral intervention. Participants were randomized to either a 1-session behavioral intervention or to an attention-matched control condition and immediately after completed an fMRI scan. The focus of this project is to examine if group differences in perceived alcohol reward value after the intervention mediates an intervention effect on reducing alcohol use in the 1 month following the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Alcohol Intervention | Active comparator | Behavioral: Brief Alcohol InterventionA brief intervention consisting of a 30-45 minute individual face-to-face session based on the principles of motivational interviewing. |
| Attention-Matched Control Condition | Sham comparator | Behavioral: Control ConditionBrief attention-matched control condition. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- engaged in regular heavy drinking, as indicated by consuming 5 or more drinks per occasion for men or 4 or more drinks per occasion for women at least 4 times in the month prior to enrollment
- a score of ≥ 8 on the Alcohol Use Disorder Identification Test (AUDIT)
Key exclusion criteria (9 listed)
- under the age of 21
- currently receiving treatment for alcohol problems, history of treatment in the 30 days before enrollment, or currently seeking treatment
- a positive urine toxicology screen for any drug other than cannabis
- a lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder
- serious alcohol withdrawal symptoms
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 Alcohol InterventionBrief alcohol intervention uses a motivational interviewing approach and covers the following components: giving information about the possible health risks associated with alcohol use, placing the responsibility for change on the individual, discussing the reasons for drinking and downsides of drinking, and setting a goal and change plan if the participant is receptive. | Behavioural | Brief Alcohol Intervention |
| Control ConditionThe attention-matched control condition consisting of a 30-min video about astronomy. | Behavioural | Attention-Matched Control Condition |
Primary outcome
Percent Heavy Drinking Days
Time frame: 4 weeks post intervention
Percent heavy drinking days defined as 5+ drinks for men and 4+ for women according to self-reported Timeline Follow Back (TLFB) data
Neural Alcohol Cue Reactivity
Time frame: Single time point immediately post intervention
Neural alcohol cue reactivity as measured by whole brain activation to alcohol taste cue vs. water taste cue using functional magnetic resonance imaging (fMRI)
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 25 Jan 2021.
- Results publication: PubMed 30556913Grodin EN, Ray LA, MacKillop J, Lim AC, Karno MP. Elucidating the Effect of a Brief Drinking Intervention Using Neuroimaging: A Preliminary Study. Alcohol Clin Exp Res. 2019 Feb;43(2):367-377. doi: 10.1111/acer.13941. Epub 2019 Jan 20.
- Results publication: PubMed 31244697Grodin EN, Lim AC, MacKillop J, Karno MP, Ray LA. An Examination of Motivation to Change and Neural Alcohol Cue Reactivity Following a Brief Intervention. Front Psychiatry. 2019 Jun 11;10:408. doi: 10.3389/fpsyt.2019.00408. eCollection 2019.
- Derived from this study: PubMed 34429151Meredith LR, Grodin EN, Karno MP, Montoya AK, MacKillop J, Lim AC, Ray LA. Preliminary study of alcohol problem severity and response to brief intervention. Addict Sci Clin Pract. 2021 Aug 24;16(1):54. doi: 10.1186/s13722-021-00262-6.
- Individual participant dataSharing planned: No
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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.
Lara A Ray, PhD principal investigator
University of California, Los Angeles
Mitchell P Karno, PhD principal investigator
University of California, Los Angeles
Questions about this trial
What is this clinical trial studying?
A study testing Brief Alcohol Intervention in people with Heavy Drinking, run by University of California, Los Angeles.
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 2 inclusion and 9 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 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Percent Heavy Drinking Days (time frame: 4 weeks post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04710095, which also lists 3 linked publications.
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 25 Jan 2021.