Alcohol-ROC-Training

Binge Drinking Clinical Trial

— A-ROC-T  

Official title:

Brief Training for Heavy Drinking Young Adults: Regulation of Alcohol Craving

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05491551
• Other study ID #: 2000029394
• Secondary ID: 1R01AA029137-01
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2022
• Est. completion date: December 2027

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: Hedy Kober, PhD
• Phone: 917-470-8331
• Email: hedy.kober[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 177
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

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).

Related Conditions & MeSH terms

• Alcoholic Intoxication
• Binge Drinking
• Heavy Drinker
• Heavy Drinking
• Young Adult

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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)
Primary	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
Primary	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	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
Secondary	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