Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD
ConditionOpioid Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Managing Physical Reactions to Overwhelming Emotions (IMPROVE)
BehavioralParticipants 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.
Health Education Training (HET)
BehavioralParticipants 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Managing Physical Reactions to Overwhelming Emotions (IMPROVE)Experimental treatment 1 intervention
Group B: Health Education Training (HET)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Alcohol Use
Changes in proportion of heavy drinking days and drinks per drinking day following the intervention.
Time frame
Change from baseline to post-treatment (week 4)2
Startle eyeblink potentiation during unpredictable threat
Startle eyeblink potentiation will be collected during the No-, Predictable-, Unpredictable -Threat (NPU) startle paradigm. Startle is a cross-species index of aversive reactivity. Startle during unpredictable threat is an objective indicator of response to uncertain stress.
Time frame
Change from baseline to post-treatment (week 4)3
Self-reported Intolerance of Uncertainty
The Intolerance of Uncertainty- Short Form is a gold-standard self-report assessment. Subscale scores on the measure range from 7-35 for 'prospective intolerance of uncertainty' and 5-25 for 'inhibitory intolerance of uncertainty', with higher scores indicating greater intolerance of uncertainty.
Time frame
Change from baseline to post-treatment (week 4)4
Late positive potential when viewing anxiety sensitivity evoking images
The late positive potential will be collected from the emotional picture paradigm. The late positive potential captures emotional reactivity. Emotional reactivity to a battery of anxiety sensitivity-evoking images is an objective indicator of response to bodily anxiety sensations.
Time frame
Change from baseline to post-treatment (week 4)Secondary outcomes
1
Medication Adherence
Changes in proportion of days compliant with medication for opioid use disorder.
Time frame
Change from baseline to post-treatment (week 4)2
Distress-related alcohol use
Participants will report their psychological distress and subsequent alcohol use behavior.
Time frame
Assessed multiple times a day for 21 days3
Daily alcohol craving
Participants will report their alcohol craving throughout each day.
Time frame
Assessed multiple times a day for 21 daysSponsors and contacts
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Source ClinicalTrials.gov