Binge DrinkingA-ROC-TNCT05491551
Alcohol-ROC-Training
A study testing Mindfulness-Based Treatment-Regulation of Craving and Cognitive-Based Therapy-Regulation of Craving in people with Binge Drinking and Heavy Drinking, run by Yale University at 2 sites in United States.
Trial summary
The goal of the proposed study is to examine whether brief training in regulation of craving (ROC-T) affects alcohol drinking. The study will consist of a basic screening (phone and online), and in person visit to determine eligibility and conduct pre-intervention baseline assessments, 1-4 training (ROC-T) visits, a… Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Binge Drinking, Heavy Drinking, Young Adult
- What is being tested?
- Mindfulness-Based Treatment-Regulation of Craving and Cognitive-Based Therapy-Regulation of Craving
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Sep 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 26 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Young adults ages 18-26 years, who (2) report ≥ 3 heavy drinking days (i.e., heavy drinking defined by >3 drinks for women, >4 drinks for men) in the prior month; (3) are motivated to quit or reduce drinking; (4) are fluent in English and have a 6th grade or higher reading level; (5) have access to a computer with working internet; (6) use a working smartphone; (7) can commit to the full length of the protocol; and (8) are willing to be randomized to intervention condition.
Who cannot join
- Current (past 12 months) clinically-severe alcohol use disorder (AUD; e.g., history of seizures, delirium, or hallucinations during withdrawal) or current severe alcohol withdrawal; (2) Current (past 12 months) clinically-severe substance use disorder (except tobacco) or current severe drug withdrawal; (3) serious other psychiatric illness by history or examination; (4) severe or unstable physical disease within the past 6 months; (5) psychoactive medications (e.g., mood stabilizers) that have not been at a stable dose unless determined to be on a stable dose of medication by the study psychiatrist; (6) current use of any investigational medication; (7) color blindness; (8) biological females who are pregnant; and (9) notable dislike to any particular type of alcoholic beverage depicted in study stimuli; (10) Participants who will not complete at least 70% of past day EMA reports in the pre-intervention phase will not be randomized; (11) Participants who cannot understand or follow study-related instructions (e.g., unable to correctly use the intervention strategies, indicate lack of understanding of study instructions despite multiple attempts).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of California, Berkeley
Berkeley, California, 94720
Hedy Kober, PhD, 917-470-8331, hedy@berkeley.edu
- Recruiting
Yale University
New Haven, Connecticut, 06510
Hedy Kober, PhD, 917-470-8331, hedy.kober@yale.edu
Corey Roos, PhD, 2036235882, corey.roos@yale.edu
About this study
Official title: Brief Training for Heavy Drinking Young Adults: Regulation of Alcohol Craving
The goal of the proposed study is to examine whether brief training in regulation of craving (ROC-T) affects alcohol drinking. The study will consist of a basic screening (phone and online), and in person visit to determine eligibility and conduct pre-intervention baseline assessments, 1-4 training (ROC-T) visits, a post-intervention assessment visit, and 1-2 phone/online follow up assessments.The two active conditions of ROC-T are based on cognitive-behavioral treatments (CBT) and mindfulness-based treatments (MBT).
Read the detailed description
This is a Stage 1B Randomized-Controlled Trial (RCT). 177 heavy drinking young adult participants will be randomized to 4 x 45-minute web-based sessions of (1) CBT-ROC-T training, (2) MBT-ROC-T, or (3) CONTROL (no strategy) delivered over three weeks. Participants will be enrolled for 16 weeks (three weeks pre-, three weeks during, and ten weeks post-intervention).
- Conditions
- Binge Drinking, Heavy Drinking, Young Adult, Heavy Drinker
- Being tested
- Mindfulness-Based Treatment-Regulation of Craving, Cognitive-Based Therapy-Regulation of Craving
- Keywords
- Binge Drinking, Heavy Drinking, Young Adult, Heavy Drinker, Regulation of Craving, Cognitive Behavioral Therapy, Neurocognitive Training, Mindfulness-Based Therapy
- Medical subject headings
- Binge Drinking, Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Treatment-Regulation of CravingBehavioural
Also called MBT-ROC
Participants will be trained in using the MBT-based mindfulness strategy as described above ("notice craving and accept the feeling without judgment or reaction"). Participants will then be instructed to think of accepting and non-reactive responses when they see the instruction "ACCEPT" during ROC-T. On each trial, participants will receive an instruction and then be exposed to a novel alcohol image for 6 seconds. On 25% of the trials, they will see the LOOK instruction, and be allowed to experience craving (as baseline). On 75% of the trials, participants will see ACCEPT and then practice thinking about the negative consequences of drinking. After the picture disappears, they will rate their craving on every trial using a 1-5 Likert scale.
Cognitive-Based Therapy-Regulation of CravingBehavioural
Also called CBT-ROC
Participants will be trained in using the CBT strategy by first considering and reading about the negative consequences of drinking. Participants will then be instructed to think of those negative consequences ("Focus on the negative consequences associated with drinking)" when they see the instruction "REFRAME" during ROC-T.On each trial, participants will receive an instruction and then be exposed to a novel alcohol image for 6 seconds. On 25% of the trials, they will see the LOOK instruction, and be allowed to experience craving (as baseline). On 75% of the trials, participants will see REFRAME and then practice thinking about the negative consequences of drinking. After the picture disappears, they will rate their craving on every trial using a 1-5 Likert scale
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Treatment | Experimental | Using mindfulness and meditative strategies to control craving Receives: Behavioral: Mindfulness-Based Treatment-Regulation of Craving |
| Cognitive Behavioral Therapy | Experimental | Thinking of negative consequences to control craving Receives: Behavioral: Cognitive-Based Therapy-Regulation of Craving |
| Control | No intervention | No regulatory strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of heavy drinking days
Self-reports of daily alcohol use via smartphone-based ecological momentary assessment (EMA) is the primary source for this outcome variable, with Timeline Follow-Back (TLFB) data inserted to replace missing data from EMA. A heavy drinking day is defined as more than 3 or 4 standard drinks per day for women/men.
Measured: From baseline to 2-weeks post-intervention and to the 10-week follow-up
Change in average estimated blood alcohol concentration (eBAC) per drinking day
Daily self-reports of alcohol use via smartphone-based ecological momentary assessment (EMA) is the primary source for this outcome variable, with Timeline Follow-Back (TLFB) data inserted to replace missing data from EMA. Estimated blood alcohol concentration (eBAC) is based on number of standard drinks reported per day, duration of drinking, and total body water (based on sex, age, height, and weight).
Measured: From baseline to 2-weeks post-intervention and to the 10-week follow-up
Secondary outcomes (2)
Change in alcohol-related negative consequences
Daily self-reports of alcohol-related negative consequences (Brief Young Adult Alcohol Consequences Questionnaire) via smartphone-based ecological momentary assessment (EMA) is the primary source for this outcome variable. Total scores range from 0 to 24, with higher scores indicating greater alcohol-related negative consequences.
Measured: From baseline to 2-weeks post-intervention and the 10-week follow-up
Reduction in World Health Organization (WHO) drinking risk level
Drinking risk levels are based on grams of pure alcohol per day in a given period and include abstinent (0 grams males/females), low risk (1 to 40g males/1 to 20g females), medium risk (41 to 60g males/21 to 40g females), high risk (61 to 100g males/41 to 60g females), or very high risk (greater to or equal to 101g males/61g females).
Measured: From baseline to 2-weeks post-intervention and the 10-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start28 Sep 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge DrinkingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Model description
- Randomized Control Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Hedy Kober, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491551
- Sponsor's protocol ID
- 2000029394
- Other IDs
- 1R01AA029137-01
- Acronym
- A-ROC-T
- Status last verified
- Feb 2026
- First submitted
- 7 Jul 2022
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will adhere to the NIH Grants Policy on Sharing of Unique Research Resources. In compliance with HIPAA and Yale Human Investigation Committee standards, any data sets that will be shared will not include any personally identifiable information. Requests for data sharing will be considered within the context of ongoing and planned research being performed within the research group at Yale in order to avoid duplication of effort and overlap in data analysis that might compromise communication of findings. Data to be shared will be de-identified and transmission electronically and securely, as we have done previously with investigators at other institutions.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Training for Heavy Drinking Young Adults: Regulation of Alcohol Craving
- ClinicalTrials.gov ID
- NCT05491551
- Acronym / sponsor ID
- A-ROC-T / 2000029394
- Conditions
- Binge Drinking, Heavy Drinking, Young Adult, Heavy Drinker
- Keywords
- Binge Drinking, Heavy Drinking, Young Adult, Heavy Drinker, Regulation of Craving, Cognitive Behavioral Therapy, Neurocognitive Training, Mindfulness-Based Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Aug 2022 (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 goal of the proposed study is to examine whether brief training in regulation of craving (ROC-T) affects alcohol drinking. The study will consist of a basic screening (phone and online), and in person visit to determine eligibility and conduct pre-intervention baseline assessments, 1-4 training (ROC-T) visits, a post-intervention assessment visit, and 1-2 phone/online follow up assessments.The two active conditions of ROC-T are based on cognitive-behavioral treatments (CBT) and mindfulness-based treatments (MBT).
Detailed description
This is a Stage 1B Randomized-Controlled Trial (RCT). 177 heavy drinking young adult participants will be randomized to 4 x 45-minute web-based sessions of (1) CBT-ROC-T training, (2) MBT-ROC-T, or (3) CONTROL (no strategy) delivered over three weeks. Participants will be enrolled for 16 weeks (three weeks pre-, three weeks during, and ten weeks post-intervention).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Treatment | Experimental | Behavioral: Mindfulness-Based Treatment-Regulation of CravingUsing mindfulness and meditative strategies to control craving |
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive-Based Therapy-Regulation of CravingThinking of negative consequences to control craving |
| Control | No intervention | –No regulatory strategy |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Young adults ages 18-26 years, who (2) report ≥ 3 heavy drinking days (i.e., heavy drinking defined by >3 drinks for women, >4 drinks for men) in the prior month; (3) are motivated to quit or reduce drinking; (4) are fluent in English and have a 6th grade or higher reading level; (5) have access to a computer with working internet; (6) use a working smartphone; (7) can commit to the full length of the protocol; and (8) are willing to be randomized to intervention condition.
Key exclusion criteria (1 listed)
- Current (past 12 months) clinically-severe alcohol use disorder (AUD; e.g., history of seizures, delirium, or hallucinations during withdrawal) or current severe alcohol withdrawal; (2) Current (past 12 months) clinically-severe substance use disorder (except tobacco) or current severe drug withdrawal; (3) serious other psychiatric illness by history or examination; (4) severe or unstable physical disease within the past 6 months; (5) psychoactive medications (e.g., mood stabilizers) that have not been at a stable dose unless determined to be on a stable dose of medication by the study psychiatrist; (6) current use of any investigational medication; (7) color blindness; (8) biological females who are pregnant; and (9) notable dislike to any particular type of alcoholic beverage depicted in study stimuli; (10) Participants who will not complete at least 70% of past day EMA reports in the pre-intervention phase will not be randomized; (11) Participants who cannot understand or follow study-related instructions (e.g., unable to correctly use the intervention strategies, indicate lack of understanding of study instructions despite multiple attempts).
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 |
|---|---|---|
| Mindfulness-Based Treatment-Regulation of CravingAlso: MBT-ROCParticipants will be trained in using the MBT-based mindfulness strategy as described above ("notice craving and accept the feeling without judgment or reaction"). Participants will then be instructed to think of accepting and non-reactive responses when they see the instruction "ACCEPT" during ROC-T. On each trial, participants will receive an instruction and then be exposed to a novel alcohol image for 6 seconds. On 25% of the trials, they will see the LOOK instruction, and be allowed to experience craving (as baseline). On 75% of the trials, participants will see ACCEPT and then practice thinking about the negative consequences of drinking. After the picture disappears, they will rate their craving on every trial using a 1-5 Likert scale. | Behavioural | Mindfulness-Based Treatment |
| Cognitive-Based Therapy-Regulation of CravingAlso: CBT-ROCParticipants will be trained in using the CBT strategy by first considering and reading about the negative consequences of drinking. Participants will then be instructed to think of those negative consequences ("Focus on the negative consequences associated with drinking)" when they see the instruction "REFRAME" during ROC-T.On each trial, participants will receive an instruction and then be exposed to a novel alcohol image for 6 seconds. On 25% of the trials, they will see the LOOK instruction, and be allowed to experience craving (as baseline). On 75% of the trials, participants will see REFRAME and then practice thinking about the negative consequences of drinking. After the picture disappears, they will rate their craving on every trial using a 1-5 Likert scale | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
Change in frequency of heavy drinking days
Time frame: From baseline to 2-weeks post-intervention and to the 10-week follow-up
Self-reports of daily alcohol use via smartphone-based ecological momentary assessment (EMA) is the primary source for this outcome variable, with Timeline Follow-Back (TLFB) data inserted to replace missing data from EMA. A heavy drinking day is defined as more than 3 or 4 standard drinks per day for women/men.
Change in average estimated blood alcohol concentration (eBAC) per drinking day
Time frame: From baseline to 2-weeks post-intervention and to the 10-week follow-up
Daily self-reports of alcohol use via smartphone-based ecological momentary assessment (EMA) is the primary source for this outcome variable, with Timeline Follow-Back (TLFB) data inserted to replace missing data from EMA. Estimated blood alcohol concentration (eBAC) is based on number of standard drinks reported per day, duration of drinking, and total body water (based on sex, age, height, and weight).
2 secondary outcomes
Change in alcohol-related negative consequences
Time frame: From baseline to 2-weeks post-intervention and the 10-week follow-up
Reduction in World Health Organization (WHO) drinking risk level
Time frame: From baseline to 2-weeks post-intervention and the 10-week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: Yes. We will adhere to the NIH Grants Policy on Sharing of Unique Research Resources. In compliance with HIPAA and Yale Human Investigation Committee standards, any data sets that will be shared will not include any personally identifiable information. Requests for data sharing will be considered within the context of ongoing and planned research being performed within the research group at Yale in order to avoid duplication of effort and overlap in data analysis that might compromise communication of findings. Data to be shared will be de-identified and transmission electronically and securely, as we have done previously with investigators at other institutions.
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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.
Hedy Kober, Ph.D. principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Treatment-Regulation of Craving and Cognitive-Based Therapy-Regulation of Craving in people with Binge Drinking and Heavy Drinking, run by Yale University at 2 sites 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hedy Kober, PhD (917-470-8331, hedy.kober@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of heavy drinking days (time frame: From baseline to 2-weeks post-intervention and to the 10-week follow-up). 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?
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 19 Feb 2026.