Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Managing Physical Reactions to Overwhelming Emotions (IMPROVE), Health Education Training (HET).
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Brief Digitally-Enhanced Intervention for Managing Emotional Pain and Reducing Alcohol Use During Medication for OUD
Overview
The goal of this clinical trial is to reduce heavy drinking and enhance medication for opioid use disorder (MOUD) outcomes in individuals receiving MOUD. The main questions it aims to answer are: * Does the brief, digitally-enhanced, virtual psychotherapeutic intervention, called Managing Physical Reactions to Overwhelming Emotions (IMPROVE), impact daily alcohol use and MOUD adherence? * Does the intervention change self-report and physiological responses to intolerance to uncertainty and anxiety sensitivity? Researchers will compare IMPROVE to a control intervention (health education treatment) to see if IMPROVE impacts daily alcohol use and MOUD adherence. Participants will: * Complete a baseline electroencephalography (EEG) and self-report questionnaires. * Complete three one-hour intervention sessions (IMPROVE or control) each one week a part. * Complete a post-intervention EEG and self-report questionnaires. * Complete five ecological momentary assessment (EMA) surveys a day for 21 days. * Complete self-report questionnaires one-month after their last intervention session.
Interventions
- Behavioral Managing Physical Reactions to Overwhelming Emotions (IMPROVE)
Participants may be randomized to IMPROVE. IMPROVE is a three session virtual intervention delivered by research clinicians and augmented by a mobile application. The treatment is designed to target and reduce distress contributing to heavy alcohol use during medication for opioid use disorder treatment. - Behavioral Health Education Training (HET)
Participants may be randomized to HET. HET is an active control intervention that is equally intensive as IMPROVE It includes three virtual sessions and a mobile application. HET is designed to target healthy lifestyle behaviors such as diet and sleep.
Primary outcome measures
- Alcohol Use [Time frame: Change from baseline to post-treatment (week 4)]
- Startle eyeblink potentiation during unpredictable threat [Time frame: Change from baseline to post-treatment (week 4)]
- Self-reported Intolerance of Uncertainty [Time frame: Change from baseline to post-treatment (week 4)]
- Late positive potential when viewing anxiety sensitivity evoking images [Time frame: Change from baseline to post-treatment (week 4)]
- Self-reported Anxiety Sensitivity [Time frame: Change from baseline to post-treatment (week 4)]
Secondary outcome measures (3)
- Medication Adherence [Time frame: Change from baseline to post-treatment (week 4)]
- Distress-related alcohol use [Time frame: Assessed multiple times a day for 21 days]
- Daily alcohol craving [Time frame: Assessed multiple times a day for 21 days]
Eligibility criteria
Inclusion criteria
- Enrolled in outpatient medication for opioid use disorder (MOUD) program (within the past month)
- Heavy alcohol user defined using the National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria (i.e., consume 8+/15+ drinks per week \[women/men\] with at least two binge episodes \[4/5+ drinks for women/men in a 2 hour period\] in the past month)
- Elevated psychological distress defined as a total score of > 12 on the Kessler Psychological Distress Scale (K10; 0 to 40 range)
- 18 years of age or older
- Can read and comprehend English
Exclusion criteria
- Do not pass the informed decision-making capacity screener, suggesting cognitive impairment or an inability to provide informed consent
- Presence of a psychiatric or medical condition that would prevent them from providing informed consent or participating in the treatments (e.g., psychosis, mania, acute intoxication)
- Current comorbid moderate to severe substance use disorder other than alcohol and opioids
- Limited or no access to a smart phone that is compatible with the mobile application
- Participation in Phase One
- Possibility of being pregnant (by self-report)
- Current suicidal or homicidal intent indicating a need for immediate hospitalization or treatment as determined by clinical interviewer
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Ohio State University — Columbus
Identifiers
NCT: NCT06718491 · 2024H0358