Behavioral Intervention for Impulsivity Related to Alcohol Consumption

Overseen By Shivani Doshi

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Younger than 21, Left-handed

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

280 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how stress and other factors affect alcohol use. Participants will engage in a task-based behavioral intervention to observe changes in behavior under different stress conditions. There are two groups: one exposed to stress and another not exposed. Ideal candidates are right-handed adults fluent in English who frequently drink impulsively or in stressful situations. As an unphased study, this trial allows participants to contribute to important research on stress and alcohol use without the constraints of a traditional clinical trial phase.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this behavioral intervention is safe?

Research has shown that task-based activities to change behavior are generally safe for people trying to drink less alcohol. Previous studies found that these activities help reduce drinking without causing major side effects. Participants reported no serious problems, indicating they handled the treatments well. This approach focuses on changing behavior through activities rather than medications, offering a low-risk option for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel way to manage impulsivity related to alcohol consumption. Traditional treatments often involve medications or talk therapy, but this trial uses a task-based behavioral intervention. This method focuses on changing behavior patterns directly through specific tasks, potentially offering a more immediate and practical approach to reducing impulsive drinking. By comparing stress exposure with no stress exposure, the trial aims to understand how stress influences impulsivity and alcohol use, which could lead to more personalized and effective treatment strategies.

What evidence suggests that this task-based behavioral intervention is effective for reducing impulsivity related to alcohol consumption?

Research shows that certain activities can help people reduce alcohol consumption. Studies have found that brief sessions with a doctor or nurse can decrease drinking in those who consume excessively. Combining various methods has also significantly reduced heavy drinking compared to standard care. The U.S. Preventive Services Task Force recommends these methods for individuals with unhealthy drinking habits. This trial will compare a task-based behavioral intervention under different conditions. One group will experience stress exposure, while another will not. This evidence suggests that these activities might help manage impulsive drinking triggered by stress. ^{1 6 7 8 9}

Who Is on the Research Team?

Uraina Clark, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for right-handed, English-speaking African Americans aged between 21 and 35 who are interested in understanding how stress affects impulsivity and alcohol use. It's not suitable for those under 21 or left-handed individuals.

Inclusion Criteria

I am between 21 and 35 years old.

Right-handed

Fluent in English

Exclusion Criteria

I am under 21 years old.

Left-handed

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline fMRI scans to measure resting-state functional connectivity and BOLD signal

1 week

1 visit (in-person)

Stress Exposure

Participants are exposed to stress threat or no threat stress to assess behavioral and neural responses

1 week

1 visit (in-person)

Follow-up

Participants are monitored for any changes in behavior or neural activity post-exposure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Task-based behavioral intervention

Trial Overview

The study tests a task-based behavioral intervention to see how it impacts impulsivity when facing stereotype threats, using fMRI to track brain activity and its relation to alcohol consumption.

How Is the Trial Designed?

Group I: stress exposure Active Control 1 Intervention

exposure to stress threat

Group II: no stress exposure Placebo Group 1 Intervention

no threat stress

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

Brief intervention is an effective and efficient counseling method for nondependent drinkers, aimed at reducing alcohol consumption and preventing future alcohol-related injuries and health issues.

This intervention is particularly beneficial for patients who have recently experienced alcohol-related injuries, as they are more open to receiving help and making changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief intervention after alcohol-related injuries. Dyehouse, JM., Sommers, MS.[2022]

Alcohol-dependent patients with borderline personality disorder (BPD) showed greater behavioral impulsivity, particularly in making omission errors, compared to those with antisocial personality disorder (AntPD), indicating different impulsivity patterns among these groups.

Overall, alcohol-dependent individuals with any Cluster-B personality disorder exhibited more impulsivity across various measures than those without personality disorders and healthy controls, suggesting that impulsivity may serve as a vulnerability marker for alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varieties of impulsivity in males with alcohol dependence: the role of Cluster-B personality disorder. Rubio, G., Jiménez, M., Rodríguez-Jiménez, R., et al.[2022]

A stepped care approach for addressing problem drinking, which starts with a brief intervention and intensifies if needed, was found to be as effective as a full-care approach while requiring significantly less intervention time.

Both the stepped care and full-care interventions showed small to medium improvements in drinking outcomes compared to an untreated control group, suggesting that even minimal interventions can be beneficial for at-risk drinkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a telephone-based stepped care intervention for alcohol-related disorders: a randomized controlled trial. Bischof, G., Grothues, JM., Reinhardt, S., et al.[2018]

Brief interventions for hazardous and harmful drinking are effective in encouraging individuals to change their alcohol use patterns, even when they do not meet the criteria for alcohol abuse or dependence.

Innovative delivery methods, like online platforms and interactive multimedia, can enhance the implementation of these interventions, making them more accessible and easier to disseminate to a wider audience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief interventions for alcohol problems: factors that facilitate implementation. Moyer, A., Finney, JW.[2021]

Cognito-behavioral therapy for alcohol dependence emphasizes improving social integration and conditioning, which are crucial for effective treatment.

The therapy can be tailored to individual needs or conducted in groups, adapting to the patient's level of neuropsychological impairment and motivation, enhancing its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Alcoholism: cognitive-behavioral therapy]. Uehlinger, C.[2019]

The Integrated Intervention Program for Alcoholism (IIPA) significantly reduced impulsivity and improved decision-making related to reward processing in 50 individuals with alcoholism over an 18-day period, compared to a treatment as usual (TAU) group that showed no significant changes.

These results suggest that IIPA may address core features of substance use disorders, potentially reducing the risk of relapse, and highlight the need for further research on its long-term effects on sobriety and relapse rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated intervention program for alcoholism improves impulsiveness and disadvantageous reward processing/risk-taking. Kumar, R., Kumar, KJ., Benegal, V., et al.[2022]

In a randomized trial involving 186 seriously injured individuals from alcohol-related crashes, brief counseling led to the lowest rate of binge drinking at 12 months, with an average of 1.97 binges per month compared to higher rates in other groups.

While the brief counseling intervention did not show a statistically significant difference compared to simple advice or control groups, it suggests that more intensive interventions may be beneficial in reducing binge drinking among this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Binge drinking, sensible drinking, and abstinence after alcohol-related vehicular crashes: the role of intervention versus screening. Sommers, MS., Dyehouse, JM., Howe, SR.[2016]

In a study involving 126 participants undergoing different therapies for alcohol use disorders, therapists who engaged in exploratory and connecting behaviors were more effective at encouraging clients to discuss positive changes in their drinking behavior.

Higher therapist skillfulness in exploring and connecting with clients significantly enhanced the effectiveness of these behaviors, leading to better client responses, while teaching behaviors were less effective in promoting discussions about change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapist and client discussions of drinking and coping: a sequential analysis of therapy dialogues in three evidence-based alcohol use disorder treatments. Magill, M., Walthers, J., Mastroleo, NR., et al.[2019]

A single motivational interviewing-based brief intervention (BI) counseling session given to first-time DUI arrestees did not significantly reduce self-reported drinking behavior over 90 days compared to a control group, with both groups showing similar decreases in problematic drinking as measured by AUDIT scores.

The study involved 200 participants and found no significant differences in binge drinking, abstinence, or seeking treatment between those who received the BI and those who did not, suggesting that this intervention may not be effective in changing drinking behaviors in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect on problematic drinking behavior of a brief motivational interview shortly after a first arrest for driving under the influence of alcohol: a randomized trial. Utter, GH., Young, JB., Theard, LA., et al.[2014]

Behavioral approaches are effective and cost-efficient in treating alcohol problems, and they can enhance the effectiveness of medication-based treatments.

Cognitive-behavioral strategies are particularly useful for improving treatment motivation and retention, suggesting that similar methods could be beneficial for treating other substance use issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral treatments for drug problems: lessons from the alcohol treatment outcome literature. Miller, WR.[2007]

In a 4-year follow-up study of 471 heavy drinkers, those with alcohol use disorders showed significantly higher levels of behavioral impulsivity compared to healthy controls, indicating a strong link between impulsivity and alcohol dependence.

The Stop-Signal Task (SST) was identified as a significant predictor of developing alcohol dependence, suggesting that difficulties in inhibitory control may contribute to the progression of alcohol use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of behavioral impulsivity in the development of alcohol dependence: a 4-year follow-up study. Rubio, G., Jiménez, M., Rodríguez-Jiménez, R., et al.[2022]

Impulsivity, particularly in the context of alcohol use, can be divided into two types: behavioral inhibition, which affects a person's ability to control their actions, and delay of reward, which influences how immediate rewards impact decision-making.

The review suggests that difficulties in delaying gratification may indicate early alcohol use or abuse, while impairments in behavioral inhibition could signal a progression towards alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laboratory paradigms of impulsivity and alcohol dependence: a review. Aragues, M., Jurado, R., Quinto, R., et al.[2019]

In a study of 20 participants, including 10 nondependent alcohol bingers, it was found that binge drinkers did not exhibit higher impulsivity but were more concerned about their drinking control and experienced greater tolerance to alcohol's sedative effects.

Alcohol consumption led to a priming effect, increasing the urge to drink among participants, particularly in bingers, indicating that the risk of binge drinking is more closely related to the subjective effects of alcohol rather than impulsive behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The subjective, rather than the disinhibiting, effects of alcohol are related to binge drinking. Rose, AK., Grunsell, L.[2022]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/15068985/

Behavioral counseling interventions in primary care to ...

Behavioral counseling interventions for risky/harmful alcohol use among adult primary care patients could provide an effective component of ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6491186/

Effectiveness of brief alcohol interventions in primary care ...

Brief interventions aim to reduce alcohol consumption and related harm in hazardous and harmful drinkers who are not actively seeking help for alcohol problems.

3.

jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2714537

Screening and Behavioral Counseling Interventions to ...

This 2018 Recommendation Statement from the US Preventive Services Task Force recommends screening for unhealthy alcohol use in primary care ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0376871624003296

Integrated behavioral interventions for adults with alcohol ...

Studies revealed that integrated intervention led to significant reductions in heavy drinking compared to usual care or other interventions. •.

5.

aafp.org

aafp.org/pubs/afp/issues/2019/0615/od1.html

Screening and Behavioral Counseling Interventions to ...

The USPSTF recommends screening for unhealthy alcohol use in primary care settings in adults 18 years or older, including pregnant women, ...

6.

uspreventiveservicestaskforce.org

uspreventiveservicestaskforce.org/uspstf/recommendation/unhealthy-alcohol-use-in-adolescents-and-adults-screening-and-behavioral-counseling-interventions

Unhealthy Alcohol Use in Adolescents and Adults ...

... drinking with brief behavioral counseling interventions to reduce unhealthy alcohol use. B. Adolescents aged 12 to 17 years, The USPSTF ...

7.

jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2714536

Screening and Behavioral Counseling Interventions to ...

Counseling interventions in those who screen positive are associated with reductions in unhealthy alcohol use. There was no evidence that these interventions ...

8.

uptodate.com

uptodate.com/contents/brief-interventions-for-unhealthy-alcohol-and-other-substance-use-in-adults/print

Brief interventions for unhealthy alcohol and other substance ...

The term “brief” was used to distinguish these preventive or “early” interventions by nonspecialists from intensive specialty alcohol treatment.

9.

withpower.com

withpower.com/trial/phase-impulsive-behavior-11-2022-eee12

Behavioral Intervention for Impulsivity Related to Alcohol ...

This N/A medical study run by Icahn School of Medicine at Mount Sinai is evaluating whether Task-based behavioral intervention will have tolerable side ...