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

Primary Purpose

Binge Drinking, Heavy Drinking, Young Adult

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mindfulness-Based Treatment-Regulation of Craving

Cognitive-Based Therapy-Regulation of Craving

About this trial

This is an interventional treatment trial for Binge Drinking focused on measuring Binge Drinking, Heavy Drinking, Young Adult, Heavy Drinker, Regulation of Craving, Cognitive Behavioral Therapy, Neurocognitive Training, Mindfulness-Based Therapy

Eligibility Criteria

18 Years - 26 Years (Adult)All SexesDoes not accept healthy volunteers

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; (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; (8) Participants who will not complete at least 70% of past day EMA reports in the pre-intervention phase will not be randomized.

Sites / Locations

Yale UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Mindfulness-Based Treatment

Cognitive Behavioral Therapy

Control

Arm Description

Using mindfulness and meditative strategies to control craving

Thinking of negative consequences to control craving

No regulatory strategy

Outcomes

Primary Outcome Measures

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.

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).

Secondary Outcome Measures

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.

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).

Full Information

NCT ID

NCT05491551

First Posted

July 7, 2022

Last Updated

October 16, 2023

Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT05491551

Brief Title

Alcohol-ROC-Training

Acronym

A-ROC-T

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 28, 2022 (Actual)

Primary Completion Date

December 2027 (Anticipated)

Study Completion Date

December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized Control Trial

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

177 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness-Based Treatment

Arm Type

Experimental

Arm Description

Using mindfulness and meditative strategies to control craving

Arm Title

Cognitive Behavioral Therapy

Arm Type

Experimental

Arm Description

Thinking of negative consequences to control craving

Arm Title

Control

Arm Type

No Intervention

Arm Description

No regulatory strategy

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness-Based Treatment-Regulation of Craving

Other Intervention Name(s)

MBT-ROC

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Cognitive-Based Therapy-Regulation of Craving

Other Intervention Name(s)

CBT-ROC

Intervention Description

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 Information:

Title

Change in frequency of heavy drinking days

Description

Time Frame

From baseline to 2-weeks post-intervention and to the 10-week follow-up

Title

Change in average estimated blood alcohol concentration (eBAC) per drinking day

Description

Time Frame

From baseline to 2-weeks post-intervention and to the 10-week follow-up

Secondary Outcome Measure Information:

Title

Change in alcohol-related negative consequences

Description

Time Frame

From baseline to 2-weeks post-intervention and the 10-week follow-up

Title

Reduction in World Health Organization (WHO) drinking risk level

Description

Time Frame

From baseline to 2-weeks post-intervention and the 10-week follow-up

Other Pre-specified Outcome Measures:

Title

Change in momentary alcohol craving in daily life

Description

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.

Time Frame

From baseline to 2-weeks post-intervention and the 10-week follow-up

Title

Change in momentary acceptance of craving in daily life

Description

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.

Time Frame

From baseline to 2-weeks post-intervention and the 10-week follow-up

Title

Change in momentary reframing of craving in daily life

Description

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.

Time Frame

From baseline to 2-weeks post-intervention and the 10-week follow-up

Title

Change in momentary craving during Regulation of Craving (ROC) task

Description

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.

Time Frame

From baseline ROC task to post-intervention ROC task (approximately 3 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

26 Years

Accepts Healthy Volunteers

Eligibility Criteria

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; (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; (8) Participants who will not complete at least 70% of past day EMA reports in the pre-intervention phase will not be randomized.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hedy Kober, PhD

Phone

917-470-8331

hedy.kober@yale.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Corey Roos

Phone

203-623-5882

corey.roos@yale.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hedy Kober, Ph.D.

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hedy Kober, PhD

Phone

917-470-8331

hedy.kober@yale.edu

First Name & Middle Initial & Last Name & Degree

Corey Roos, PhD

Phone

2036235882

corey.roos@yale.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

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Alcohol-ROC-Training

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