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| ID | Type | Description | Link |
|---|---|---|---|
| R00AA027830 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The goal of this clinical study is to test the effectiveness of a supplemental fMRI neurofeedback and/or TMS intervention in individuals seeking treatment for Alcohol Use Disorder.
After an initial visit, participants will come in once a week for four (4) weeks for an intervention session, which may or may not include TMS and MRI. Participants will be contacted for monthly follow-ups (remotely) for up to 12 months and will be asked to come in for two MRI follow-ups at 6 and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurofeedback-active + TMS-active | Experimental | 4 sessions of: TMS (protocol: 10 Hz pulses delivered at 110% of MT in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of own brain activity from multiple ROIs measured using fMRI) |
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| Neurofeedback-active + TMS-sham | Active Comparator | 4 sessions of: TMS (protocol: 10 Hz pulses delivered using the Sham TMS coil in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of own brain activity from multiple ROIs measured using fMRI) |
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| Neurofeedback-sham + TMS-active | Active Comparator | 4 sessions of: TMS (protocol: 10 Hz pulses delivered at 110% of MT in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of other's brain activity from multiple ROIs measured using fMRI) |
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| Neurofeedback-sham + TMS-sham | Sham Comparator | 4 sessions of: TMS (protocol: 10 Hz pulses delivered using the Sham TMS coil in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of other's brain activity from multiple ROIs measured using fMRI) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Realtime fMRI Neurofeedback - Active | Behavioral | fMRI aided reinforcement of craving regulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Alcohol Use over Time | Alcohol Timeline Followback (alc-TLFB) | Assessed at weeks: 1 (baseline), 2-5 (intervention sessions, pre and post), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups) |
| Change in Alcohol Craving over Time | Alcohol Craving Questionnaire (ACQ) | Assessed at weeks: 1 (baseline), 2-5 (intervention sessions, pre and post), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups) |
| Change in Community Functioning over Time | Drinker Inventory of Consequences (DrInC) | Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups) |
| Change in Employment Status over Time | self-reported employment status | Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups) |
| Change in Aggression and Victimization over Time | Revised Conflict Tactics Scales (CTS-R) | Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups) |
| Change in Antisocial Behavior over Time | number of self-reported contacts with the police, convictions, and other criminal behaviors | Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups) |
| Change in Brain Activity during Alcohol Cue Presentation over Time |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brain Gray Matter Structure over Time | Measured via MRI; gray matter volume | Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups) |
| Change in Brain White Matter Structure over Time |
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Inclusion Criteria:
Exclusion Criteria:
MRI Contraindications
TMS Contraindications
Family history of schizophrenia or presence of psychotic symptoms
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SCAMPI Lab | Contact | 334-521-2807 | scampi@auburn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Samantha J Fede, PhD | Auburn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auburn University | Recruiting | Auburn | Alabama | 36849 | United States |
Data will be shared within the NIAAA Data Archive according to the standard data sharing plan. Deidentified individual data regarding the outcome variables (clinical and MRI) will be included. Participants will have the option to opt out of sharing their individual data.
Given the highly sensitive and confidential nature of the information, and the magnitude of potential harms to participants associated with disclosure, clinical outcome data pertaining to criminal acts and illegal activities will not be available in the data repository.
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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The PI will prospectively assign treatment groups with blind codes and so will not be blind to treatment type. Other staff, who are the individuals primarily working with the patients and who will be conducting follow-up interviews, will be blind to treatment type. It is not possible to blind the 5th condition (treatment as usual with a brief check-in).
| Check-In Only | No Intervention | 4 sessions of: Completing typical pre-TMS/MRI procedures Being prompted to reflect on outside treatment (TAU) |
| TMS - Active | Device | rTMS to right dorsolateral prefrontal cortex to reduce craving |
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| Realtime fMRI Neurofeedback - Yoked Sham | Behavioral | Display of feedback from other participant's sessions to serve as a sham for fMRI aided reinforcement of craving regulation |
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| TMS - Sham | Device | rTMS using placebo coil (no brain stimulation, emulates other features of active TMS), placed over right dorsolateral prefrontal cortex |
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Measured via fMRI; standard alcohol cue reactivity |
| Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups) |
| Change in Brain Activity during Simultaneous Sociomoral & Alcohol Cue Presentation over Time | Measured via fMRI; alcohol-cued sociomoral processing | Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups) |
Measured via MRI; white matter diffusion
| Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups) |
| Change in Resting State Functional Connectivity over Time | Measured via fMRI | Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups) |