Alcohol-ROC-Training (A-ROC-T)

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).

Study Overview

• Status: Recruiting
• Conditions: Binge Drinking; Heavy Drinking; Young Adult; Heavy Drinker
• Intervention / Treatment: Behavioral: Mindfulness-Based Treatment-Regulation of Craving; Behavioral: Cognitive-Based Therapy-Regulation of Craving

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 Type: Interventional
• Enrollment (Estimated): 177
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hedy Kober, PhD; Phone Number: 917-470-8331; Email: hedy.kober@yale.edu
• Study Contact Backup: Name: Corey Roos; Phone Number: 203-623-5882; Email: corey.roos@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale University
      • Contact: Hedy Kober, PhD; Phone Number: 917-470-8331; Email: hedy.kober@yale.edu
      • Contact: Corey Roos, PhD; Phone Number: 2036235882; Email: corey.roos@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 26 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-Based Treatment; Using mindfulness and meditative strategies to control craving	Behavioral: 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.; Other Names: MBT-ROC
Experimental: Cognitive Behavioral Therapy; Thinking of negative consequences to control craving	Behavioral: 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; Other Names: CBT-ROC
No Intervention: Control; No regulatory strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	From baseline to 2-weeks post-intervention and the 10-week follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in momentary alcohol craving in daily life	Twice daily self-reports of momentary craving for alcohol via smartphone-based ecological momentary assessment (EMA). Alcohol craving scores range from 0 to 10, with higher scores indicating greater alcohol craving.	From baseline to 2-weeks post-intervention and the 10-week follow-up
Change in momentary acceptance of craving in daily life	Twice daily self-reports of momentary acceptance of alcohol craving via smartphone-based ecological momentary assessment (EMA). Acceptance of alcohol craving scores range from 0 to 10, with higher scores indicating greater acceptance of alcohol craving.	From baseline to 2-weeks post-intervention and the 10-week follow-up
Change in momentary reframing of craving in daily life	Twice daily self-reports of momentary reframing of alcohol craving via smartphone-based ecological momentary assessment (EMA). Reframing of alcohol craving scores range from 0 to 10, with higher scores indicating greater reframing of alcohol craving.	From baseline to 2-weeks post-intervention and the 10-week follow-up
Change in momentary craving during Regulation of Craving (ROC) task	The ROC task involves viewing a series of alcohol images and following various instructions on particular trial when an alcohol image is shown. Participants report self-reported craving after each trial. There are 3 types of trials: 1) LOOK = look at alcohol image, 2) ACCEPT = use acceptance strategy, and 3) REFRAME = use the reframing strategy.	From baseline ROC task to post-intervention ROC task (approximately 3 weeks)

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Hedy Kober, Ph.D., Yale University

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cognitive Behavioral Therapy; Heavy Drinking; Binge Drinking; Young Adult; Heavy Drinker; Regulation of Craving; Neurocognitive Training; Mindfulness-Based Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Binge Drinking; Alcoholic Intoxication
• Other Study ID Numbers: 2000029394; 1R01AA029137-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No