Alcohol Use Disorder
Conditions
Keywords
treatment seeking, alcohol, TMS, neurofeedback, supplemental intervention, heavy drinking, problems with drinking
Brief summary
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.
Interventions
BEHAVIORALRealtime fMRI Neurofeedback - Active
fMRI aided reinforcement of craving regulation
DEVICETMS - Active
rTMS to right dorsolateral prefrontal cortex to reduce craving
BEHAVIORALRealtime fMRI Neurofeedback - Yoked Sham
Display of feedback from other participant's sessions to serve as a sham for fMRI aided reinforcement of craving regulation
DEVICETMS - Sham
rTMS using placebo coil (no brain stimulation, emulates other features of active TMS), placed over right dorsolateral prefrontal cortex
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Auburn University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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).
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 19-65 2. Receiving treatment for Alcohol Use Disorder
Exclusion criteria
1. MRI Contraindications 1. Presence of metal in the body that would make having a 7T MRI unsafe (including facial tattoos) 2. Claustrophobia, such that individual would be unable to stay in the MRI for up to 1 hr 3. Hearing loss, including tinnitus, that might be made worse by MRI or TMS 2. TMS Contraindications 1. Has ever had a seizure, or has a family history of epilepsy 2. Taking medications or substances that lower the seizure threshold 3. Implanted devices that are in the head or rely on physiological signals 4. History of neurological disease, such as stroke or brain tumor 5. Head injury with loss of consciousness greater than 30 minutes 6. Actively withdrawing from alcohol 3. Family history of schizophrenia or presence of psychotic symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brain Activity during Simultaneous Sociomoral & Alcohol Cue Presentation over Time | Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups) | Measured via fMRI; alcohol-cued sociomoral processing |
| Change in Aggression and Victimization over Time | Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups) | Revised Conflict Tactics Scales (CTS-R) |
| Change in Antisocial Behavior over Time | Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups) | number of self-reported contacts with the police, convictions, and other criminal behaviors |
| Change in Brain Activity during Alcohol Cue Presentation over Time | Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups) | Measured via fMRI; standard alcohol cue reactivity |
| Change in Alcohol Use over Time | 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) | Alcohol Timeline Followback (alc-TLFB) |
| Change in Alcohol Craving over Time | 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) | Alcohol Craving Questionnaire (ACQ) |
| Change in Community Functioning over Time | Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups) | Drinker Inventory of Consequences (DrInC) |
| Change in Employment Status over Time | Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups) | self-reported employment status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brain White Matter Structure over Time | Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups) | Measured via MRI; white matter diffusion |
| Change in Resting State Functional Connectivity over Time | Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups) | Measured via fMRI |
| Change in Brain Gray Matter Structure over Time | Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups) | Measured via MRI; gray matter volume |
Countries
United States
Contacts
Primary ContactSCAMPI Lab
Outcome results
None listed