Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Researchers will compare IMPROVE to a control intervention (health education treatment) to see if IMPROVE impacts daily alcohol use and MOUD adherence.
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Managing Physical Reactions to Overwhelming Emotions (IMPROVE) | Experimental | In this arm, participants will receive the IMPROVE intervention, a clinician-delivered protocol targeting anxiety and uncertainty. |
|
| Health Education Training (HET) | Active Comparator | In this arm, participants will receive a clinician-delivered protocol with a digital component, called HET. HET focuses on healthy living more broadly and does not include information about anxiety or uncertainty. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Managing Physical Reactions to Overwhelming Emotions (IMPROVE) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Use | Changes in proportion of heavy drinking days and drinks per drinking day following the intervention. | Change from baseline to post-treatment (week 4) |
| 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. | Change from baseline to post-treatment (week 4) |
| 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. | Change from baseline to post-treatment (week 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. | Change from baseline to post-treatment (week 4) |
| Self-reported Anxiety Sensitivity | The Anxiety Sensitivity Index-3 scale is a gold standard self-report assessment. Scores range from 0 to 72 where higher scores indicate higher anxiety sensitivity. | Change from baseline to post-treatment (week 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence | Changes in proportion of days compliant with medication for opioid use disorder. | Change from baseline to post-treatment (week 4) |
| Distress-related alcohol use | Participants will report their psychological distress and subsequent alcohol use behavior. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Gorka, PhD | Contact | 614-366-1027 | stephanie.gorka@osumc.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
De-identified data, including electroencephalography (EEG), startle eyeblink, and behavior, from this project will be submitted to the National Institute of Mental Health Data Archive (NDA) at the subject level along with appropriate supporting documentation to enable efficient use of the data by the research community. We will follow instructions as discussed in the NDA Data Sharing Terms and Conditions.
Not provided
The data will be submitted at the conclusion of the study.
Not provided
Not provided
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Participants will be randomized to receive one of two possible interventions.
Not provided
Not provided
Participants will be blind to the condition.
|
| Health Education Training (HET) | Behavioral | 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. |
|
| Assessed multiple times a day for 21 days |
| Daily alcohol craving | Participants will report their alcohol craving throughout each day. | Assessed multiple times a day for 21 days |