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New treatment option for Alcohol Use Disorder
Official title tAN for Substance Use Disorder
ClinicalTrials.gov ID: NCT07281261
What this study is testing
- What it's testing
- The study will involve a 5-day tAN treatment to attenuate alcohol withdrawal syndrome (AWS) and alter resting state functional connectivity (RSFC) between OFC and striatum in patients with alcohol use disorder (AUD). Enrolled participants will wear the tAN device on-site (at The Menninger Clinic) for the 5-day detox treatment period.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- Male or female (evenly recruited) aged 18-64 years old
- Meeting DSM-5 criteria of moderate or above AUD at screening using the structured clinical interview for DSM-5 (SCID-5)
- Demonstration of at least moderate risk of alcohol use at screening using the WHO-ASSIST
- Demonstration of high risk for moderate to severe alcohol withdrawal syndrome (Prediction of Alcohol Withdrawal Severity Scale [PAWSS] \> 4 at...
- Demonstration of severe withdrawal symptoms (Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised [CIWA-Ar] ≥ 8 at screening)
You likely can't join if
- In the opinion of the clinician and the research team at admission, be expected to fail to complete the study protocol due to probably relocation...
- Current use of tobacco
- Is pregnant or nursing
- Contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.)
- Do not meet the pre-screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI) at BCM
See the full eligibility criteria
- Male or female (evenly recruited) aged 18-64 years old
- Meeting DSM-5 criteria of moderate or above AUD at screening using the structured clinical interview for DSM-5 (SCID-5)
- Demonstration of at least moderate risk of alcohol use at screening using the WHO-ASSIST
- Demonstration of high risk for moderate to severe alcohol withdrawal syndrome (Prediction of Alcohol Withdrawal Severity Scale [PAWSS] \> 4 at admission)
- Demonstration of severe withdrawal symptoms (Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised [CIWA-Ar] ≥ 8 at screening)
- Positive urine test for alcohol at screening
- Be able to provide written informed consent
- Female people must be non-nursing and not pregnant
- Meet the MRI safety screening form provided by the Center for Advanced MR Imaging (CAMRI) at BCM.
- In the opinion of the clinician and the research team at admission, be expected to fail to complete the study protocol due to probably relocation from The Menninger Clinic area or not tolerable to receive tAN
- Current use of tobacco
- Is pregnant or nursing
- Contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.)
- Do not meet the pre-screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI) at BCM
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.