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| ID | Type | Description | Link |
|---|---|---|---|
| P30GM122734 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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The goal of this small (n=75) proof-of-concept randomized clinical trial is to test the effects of transcranial alternating current stimulation (tACS) during motivational interviewing (MI) sessions with participants who drink at above the low-risk level. Participants will be randomized to receive either MI with active stimulation, MI with sham stimulation, or a delayed treatment group that receives MI with no stimulation. Measures will include brain imaging, alcohol use, cannabis use, risk-taking behavior, emotions, and others. Participants who are randomized to the delayed-treatment group will not receive brain imaging.
This proof-of-concept randomized clinical trial will recruit n=75 people with problematic levels of drinking who are considering treatment for their alcohol use. These participants will be randomized to one of three conditions: a condition that applies active tACS during an MI session (MI+tACS), a condition that applies sham stimulation during an MI session (MI+sham), or a waitlist control condition (MI-only). Only participants the MI+tACS and MI+sham conditions will be included in the brain imaging portion of the study. One month after their intervention session, all participants will report their use of alcohol in the prior 30 days via an online assessment battery. This will allow us to test the effects of tACS on within-session client speech and outcomes.
Participants will have magnetoencephalography (MEG) scans including rest and an alcohol cue task to measure the acute effects of brain stimulation. Participants will also have MRI scans including structure and rest. The Motivational Interviewing Skill Code (MISC 2.5) and the CASAA Application for Coding Treatment Interactions (CACTI) will be used to assess counselor and participant speech in the recorded MI sessions and to ensure that sessions comply with the principles of MI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MI with tACS | Experimental | Motivational interviewing with concurrent active stimulation |
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| MI with sham | Sham Comparator | Motivational interviewing with concurrent sham stimulation |
|
| MI-only | Active Comparator | Motivational interviewing only, delayed treatment control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-density transcranial alternating current stimulation | Device | High-density electrode configuration with transcranial alternating current stimulation in the beta (15-40Hz) frequency range |
| Measure | Description | Time Frame |
|---|---|---|
| Heavy drinking days | Number of heavy drinking days in the prior 30 days | One month |
| Measure | Description | Time Frame |
|---|---|---|
| Drinks per drinking day | Number of drinks per drink day in the prior 30 days | One month |
| Percent days abstinent | Percent days abstinent in the prior 30 days |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jon M Houck, PhD | Contact | (505) 925-2372 | brainstim@mrn.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Mind Research Network | Recruiting | Albuquerque | New Mexico | 87106 | United States |
Individual participant data that underlie results reported in a peer-reviewed publication, after deidentification (text, tables, figures, and appendices). Session audio recordings will not be shared.
Beginning 3 months and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal will have access to the data. A data use agreement will be required, signed by the requesting investigator and their Authorized Organization Representative (AOR)/Signing Official (SO)
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form: Informed Consent | Sep 20, 2020 |
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Double-blind proof-of-concept randomized clinical trial
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Double (Participant, Providers/Research Assistants)
| Sham stimulation | Device | High-density electrode configuration with sham stimulation |
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| Motivational interviewing | Behavioral | Motivational interviewing session focused on alcohol use, approximately 30 minutes in length |
|
| One month |
| Feb 22, 2021 |
| ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent - Phase I online-only | Sep 20, 2020 | Feb 22, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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