Recruiting

ROC-T

Sponsor:

Yale University

Code:

NCT05491551

Conditions

Binge Drinking

Heavy Drinking

Young Adult

Heavy Drinker

Eligibility Criteria

Sex: All

Age: 18 - 26

Healthy Volunteers: Not accepted

Interventions

Mindfulness-Based Treatment-Regulation of Craving

Cognitive-Based Therapy-Regulation of Craving

Study Details

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).

Conditions

Binge Drinking

Heavy Drinking

Young Adult

Heavy Drinker

Study ID

NCT05491551

Start date

Sep 28, 2022

Status verified date

Feb, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 26

Healthy Volunteers: Not accepted

Inclusion Criteria:

(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.

Exclusion Criteria:

(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).

Study Design

Enrollment

177 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mindfulness-Based Treatment

Using mindfulness and meditative strategies to control craving

experimental: Cognitive Behavioral Therapy

Thinking of negative consequences to control craving

no intervention: Control

No regulatory strategy

Interventions

Mindfulness-Based Treatment-Regulation of Craving

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 Craving

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

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 ]
  • 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 ]

Central Contacts and Locations

Locations

University of California, Berkeley

Recruiting

Berkeley, California, United States, 94720

Contacts

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

More Information

Sponsor

Yale University

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Keywords

  • Binge Drinking
  • Heavy Drinking
  • Young Adult
  • Heavy Drinker
  • Regulation of Craving
  • Cognitive Behavioral Therapy
  • Neurocognitive Training
  • Mindfulness-Based Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-02-19.