Alcohol-ROC-Training
A-ROC-T
Brief Training for Heavy Drinking Young Adults: Regulation of Alcohol Craving
2 other identifiers
interventional
177
1 country
2
Brief 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 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2022
CompletedFirst Posted
Study publicly available on registry
August 8, 2022
CompletedStudy Start
First participant enrolled
September 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
February 19, 2026
February 1, 2026
5.2 years
July 7, 2022
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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).
From baseline to 2-weeks post-intervention and to the 10-week follow-up
Secondary Outcomes (2)
Change in alcohol-related negative consequences
From baseline to 2-weeks post-intervention and the 10-week follow-up
Reduction in World Health Organization (WHO) drinking risk level
From baseline to 2-weeks post-intervention and the 10-week follow-up
Other Outcomes (4)
Change in momentary alcohol craving in daily life
From baseline to 2-weeks post-intervention and the 10-week follow-up
Change in momentary acceptance of craving in daily life
From baseline to 2-weeks post-intervention and the 10-week follow-up
Change in momentary reframing of craving in daily life
From baseline to 2-weeks post-intervention and the 10-week follow-up
- +1 more other outcomes
Study Arms (3)
Mindfulness-Based Treatment
EXPERIMENTALUsing mindfulness and meditative strategies to control craving
Cognitive Behavioral Therapy
EXPERIMENTALThinking of negative consequences to control craving
Control
NO INTERVENTIONNo regulatory strategy
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- (1) 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.
You may not qualify if:
- (1) 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of California, Berkeley
Berkeley, California, 94720, United States
Yale University
New Haven, Connecticut, 06510, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hedy Kober, Ph.D.
Yale University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2022
First Posted
August 8, 2022
Study Start
September 28, 2022
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
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.