Cognitive and Mindfulness Therapies for Alcohol Abuse

(A-ROC-T Trial)

Overseen By Hedy Kober, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Psychoactive medications

Disqualifiers: Severe AUD, Severe SUD, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 3 weeks

177 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two strategies—cognitive-behavioral therapy (focusing on the negative consequences of drinking) and mindfulness (using meditation to manage cravings)—can help reduce alcohol use. The aim is to determine if these approaches, including the Regulation of Craving training, change drinking habits. The trial seeks young adults who have experienced at least three heavy drinking days in the past month and wish to cut back or quit drinking. Participants should be comfortable using a smartphone and have internet access. As an unphased trial, this study provides a unique opportunity to contribute to understanding innovative strategies for reducing alcohol use.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that psychoactive medications (like mood stabilizers) must be at a stable dose unless approved by the study psychiatrist.

What prior data suggests that these therapies are safe for treating alcohol use disorder?

Research has shown that mindfulness-based treatments for substance use problems, such as alcohol abuse, are generally easy for people to handle. Studies have found that these treatments work as well as other proven methods in reducing alcohol use. Participants often report positive outcomes, particularly in managing stress and reducing substance use.

Evidence supports cognitive behavioral therapy (CBT) for its safety and effectiveness. It is commonly used to treat alcohol and drug issues. Studies indicate that CBT helps people reduce their drinking and is well-received by participants.

Both mindfulness and cognitive behavioral therapies have strong safety records. Participants typically manage these treatments well, with few reports of negative effects. These therapies are promising options for anyone considering joining a clinical trial for alcohol abuse therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for alcohol abuse because they offer new ways to manage cravings without medication. Mindfulness-Based Treatment uses mindfulness and meditation to help individuals become more aware of their cravings and respond to them more calmly. This approach is different because it focuses on present-moment awareness, which can help reduce impulsive drinking behaviors. On the other hand, Cognitive Behavioral Therapy encourages individuals to think about the negative consequences of alcohol use, helping them to resist cravings by changing their thought patterns. These methods provide alternative strategies to traditional medication-based treatments, potentially offering fewer side effects and empowering individuals to manage their cravings through mental techniques.

What evidence suggests that this trial's treatments could be effective for alcohol abuse?

Research shows that both mindfulness-based treatments (MBT) and cognitive-behavioral therapy (CBT) can help manage alcohol cravings. In this trial, participants will join different treatment arms to evaluate these approaches. The Mindfulness-Based Treatment arm employs mindfulness and meditative strategies to reduce cravings and the chance of relapse. For instance, individuals using mindfulness techniques were less likely to return to heavy drinking. Meanwhile, the Cognitive Behavioral Therapy arm helps participants consider the negative effects of drinking, which can lead to reduced alcohol consumption. Overall, both methods have successfully helped people control cravings and decrease alcohol use. ^{2 4 6 7 8}

Who Is on the Research Team?

Hedy Kober, Ph.D.

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-26 who drink heavily and are motivated to cut down. They must speak English, have at least a 6th-grade reading level, internet access, and a smartphone. Pregnant women or those with severe physical diseases, psychiatric illnesses, drug abuse (except tobacco), unstable medication doses, or color blindness cannot join.

Inclusion Criteria

Participants who can commit to the full length of the protocol

I am 18-26 years old and have had 3 or more heavy drinking days last month.

I am willing to be assigned to a treatment group by chance.

Exclusion Criteria

Participants with current clinically-severe alcohol use disorder or current severe alcohol withdrawal

Participants who will not complete at least 70% of past day EMA reports in the pre-intervention phase will not be randomized

Participants with current clinically-severe substance use disorder (except tobacco) or current severe drug withdrawal

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

1 visit (phone and online)

Treatment

Participants undergo 4 x 45-minute web-based sessions of CBT-ROC-T or MBT-ROC-T over three weeks

3 weeks

4 visits (web-based)

Post-intervention Assessment

Participants complete a post-intervention assessment visit

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

1-2 visits (phone/online)

What Are the Treatments Tested in This Trial?

Interventions

• Regulation of Craving

Trial Overview

The study tests if brief training in craving regulation can affect alcohol consumption among young adults. It compares two methods: cognitive-behavioral treatments (CBT) and mindfulness-based treatments (MBT). Participants will undergo assessments before and after the intervention plus follow-ups via phone/online.

How Is the Trial Designed?

Group I: Mindfulness-Based Treatment Experimental Treatment 1 Intervention

Using mindfulness and meditative strategies to control craving

Group II: Cognitive Behavioral Therapy Experimental Treatment 1 Intervention

Thinking of negative consequences to control craving

Group III: Control Active Control 1 Intervention

No regulatory strategy

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

In a study with 84 heavy drinkers, a distraction-based strategy was found to be more effective than mindfulness or no strategy in reducing cravings for alcohol during exposure to alcohol cues.

The study highlights that while mindfulness is often considered beneficial for managing cravings, immediate distraction techniques may provide better short-term relief from alcohol cravings in high-stress situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness as a strategy for coping with cue-elicited cravings for alcohol: an experimental examination. Murphy, CM., MacKillop, J.[2022]

In a study of 182 individuals seeking to reduce hazardous drinking, mindfulness-based relapse prevention (MBRP) was compared to traditional relapse prevention (RP) over 8 weeks, revealing that mindfulness may reduce drinking primarily by decreasing cravings rather than enhancing effortful control.

The results indicated that the mechanism of craving reduction was consistent across both MBRP and RP treatments, suggesting that both explicit and subtle mindfulness training can effectively help manage alcohol cravings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness mechanisms in alcohol use: Comparing top-down and bottom-up processes. Skrzynski, CJ., Bryan, AD., Hutchison, KE.[2023]

Mindfulness-based therapies have shown promising results in reducing substance use in individuals with addictive disorders, with five out of six studies indicating significant reductions in substance use, particularly when follow-up periods were longer.

These interventions not only decreased substance use but also helped participants manage withdrawal-like sensations and emotional responses, suggesting that mindfulness can enhance coping strategies and reduce the risk of relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mindfulness based interventions for addictive disorders: a review]. Skanavi, S., Laqueille, X., Aubin, HJ.[2018]

Mindfulness-based therapy (MBT) showed significantly greater reductions in smoking compared to a control group over 16 weeks, indicating its potential long-term effectiveness in managing nicotine dependence.

Both MBT and cognitive behavioral therapy (CBT) effectively reduced cue-induced craving, but only MBT maintained its effectiveness without increasing smoking rates during follow-up, suggesting it may be a more durable intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of mindfulness- and reappraisal-based regulation of craving training among daily cigarette smokers. Roos, CR., Harp, NR., Vafaie, N., et al.[2023]

In a study of 68 individuals with alcohol use disorder, mindfulness-based relapse prevention (MBRP) significantly reduced craving for alcohol cues, with greater reductions linked to more MBRP sessions attended.

The study also found that while active transcranial direct current stimulation (tDCS) did not directly affect craving ratings, it increased brain activity related to emotional responses, suggesting that MBRP may effectively target alcohol cue hypersensitivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreases in the Late Positive Potential to Alcohol Images Among Alcohol Treatment Seekers Following Mindfulness-Based Relapse Prevention. Brown, DR., Jackson, TCJ., Claus, ED., et al.[2020]

Mindfulness-Based Relapse Prevention (MBRP) is a leading program in addiction treatment that enhances awareness of triggers and automatic behaviors associated with drug abuse.

Research indicates that mindfulness practices can effectively reduce cravings and improve predictions of relapse, showing promising results in supporting individuals recovering from addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mindfulness in addiction therapy]. Nallet, A., Briefer, JF., Perret, I.[2015]

Participants in the mindfulness-based relapse prevention (MBRP) program significantly increased their home mindfulness practice, which was linked to reduced alcohol and other drug (AOD) use and cravings at 2- and 4-month follow-ups, based on a study of 93 individuals.

The study highlights the importance of integrating mindfulness practice into daily life for sustained recovery, suggesting that ongoing support for home practice could enhance the long-term benefits of MBRP in reducing AOD use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enactment of home practice following mindfulness-based relapse prevention and its association with substance-use outcomes. Grow, JC., Collins, SE., Harrop, EN., et al.[2022]

The mindfulness-based relapse prevention for alcohol dependence (MBRP-A) did not show significant improvements in drinking outcomes compared to usual care alone in a study of 123 alcohol-dependent adults over 26 weeks.

However, participants who attended more MBRP-A sessions and practiced mindfulness techniques at home tended to have better long-term drinking-related outcomes, suggesting that adherence to the intervention may be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based relapse prevention for alcohol dependence: Findings from a randomized controlled trial. Zgierska, AE., Burzinski, CA., Mundt, MP., et al.[2020]

Mindfulness-based cognitive therapy (MBCT) can enhance traditional cognitive-behavioral therapy (CBT) for treating substance use disorders, especially when co-occurring mood disorders are present, by addressing specific challenges related to affect regulation.

The article proposes a structured protocol that combines CBT with mindfulness techniques to help individuals in early recovery manage emotional dysregulation, which is crucial for reducing the risk of relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of mindfulness-based cognitive interventions in the treatment of co-occurring addictive and mood disorders. Hoppes, K.[2019]

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