Clinical trial NCT05491551: Alcohol-ROC-Training
Official title: Brief Training for Heavy Drinking Young Adults: Regulation of Alcohol Craving
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-08-08
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

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).

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 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).

Primary outcomes:
measure: Change in frequency of heavy drinking days
timeFrame: From baseline to 2-weeks post-intervention and to the 10-week follow-up
measure: Change in average estimated blood alcohol concentration (eBAC) per drinking day
timeFrame: From baseline to 2-weeks post-intervention and to the 10-week follow-up
Secondary outcomes:
measure: Change in alcohol-related negative consequences
timeFrame: From baseline to 2-weeks post-intervention and the 10-week follow-up
measure: Reduction in World Health Organization (WHO) drinking risk level
timeFrame: From baseline to 2-weeks post-intervention and the 10-week follow-up
Other outcomes:
measure: Change in momentary alcohol craving in daily life
timeFrame: From baseline to 2-weeks post-intervention and the 10-week follow-up
measure: Change in momentary acceptance of craving in daily life
timeFrame: From baseline to 2-weeks post-intervention and the 10-week follow-up
measure: Change in momentary reframing of craving in daily life
timeFrame: From baseline to 2-weeks post-intervention and the 10-week follow-up
measure: Change in momentary craving during Regulation of Craving (ROC) task
timeFrame: From baseline ROC task to post-intervention ROC task (approximately 3 weeks)
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Hedy Kober, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: