Clinical trial NCT06718491: Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD
Official title: Brief Digitally-Enhanced Intervention for Managing Emotional Pain and Reducing Alcohol Use During Medication for OUD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Opioid Use Disorder
Keywords: Medications for Opioid Use Disorder
Heavy Alcohol Use
Ecological Momentary Assessments
Electroencephalography
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive one of two possible interventions.
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Alcohol Use
timeFrame: Change from baseline to post-treatment (week 4)
measure: Startle eyeblink potentiation during unpredictable threat
timeFrame: Change from baseline to post-treatment (week 4)
measure: Self-reported Intolerance of Uncertainty
timeFrame: Change from baseline to post-treatment (week 4)
measure: Late positive potential when viewing anxiety sensitivity evoking images
timeFrame: Change from baseline to post-treatment (week 4)
measure: Self-reported Anxiety Sensitivity
timeFrame: Change from baseline to post-treatment (week 4)
Secondary outcomes:
measure: Medication Adherence
timeFrame: Change from baseline to post-treatment (week 4)
measure: Distress-related alcohol use
timeFrame: Assessed multiple times a day for 21 days
measure: Daily alcohol craving
timeFrame: Assessed multiple times a day for 21 days
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
References: