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New treatment option for Binge Drinking
Official title The Brain, the Bug, and the Binge: the Interplay Between Binge Drinking, Gut Microbiota, and Brain Functioning
ClinicalTrials.gov ID: NCT05946083
What this study is testing
- What it's testing
- Adolescence and youth are periods of significant maturational changes which seems to involve greater susceptibility to disruptive events in the brain such as binge drinking (BD). This prevalent pattern of consumption -characterized by repeated alcohol intoxications- is of special concern, as it has been associated with major neurocognitive impairments in the young brain.
- Phase 2: a mid-size study of how well it works
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 23. Healthy volunteers may be eligible.
You may be able to join if
- College students whose native language is Portuguese;
- Age 18-23 years;
- Binge Drinkers: report (i) drinking 4 (for women)/5 (for men) or more drinks on one occasion at least once a month, (ii) drinking at a speed of at...
- Non/Low-Drinkers: report (i) never drinking 4/5 or more drinks on one occasion and (ii) having an AUDIT score ≤ 4.
You likely can't join if
- Use of illicit drugs as determined by the Drug Use Disorders Identification Test (DUDIT);
- Alcohol abuse (i.e., AUDIT ≥ 20);
- Personal history of psychopathological disorders (according to DSM-V criteria);
- History of traumatic brain injury or neurological disorder;
- Family history (mother/father) of alcoholism diagnosis of substance abuse;
- Occurrence of one or more episodes of loss of consciousness for more than 30 minutes;
See the full eligibility criteria
- College students whose native language is Portuguese;
- Age 18-23 years;
- Binge Drinkers: report (i) drinking 4 (for women)/5 (for men) or more drinks on one occasion at least once a month, (ii) drinking at a speed of at least two drinks per hour during these episodes (which brings blood...
- Non/Low-Drinkers: report (i) never drinking 4/5 or more drinks on one occasion and (ii) having an AUDIT score ≤ 4.
- Use of illicit drugs as determined by the Drug Use Disorders Identification Test (DUDIT);
- Alcohol abuse (i.e., AUDIT ≥ 20);
- Personal history of psychopathological disorders (according to DSM-V criteria);
- History of traumatic brain injury or neurological disorder;
- Family history (mother/father) of alcoholism diagnosis of substance abuse;
- Occurrence of one or more episodes of loss of consciousness for more than 30 minutes;
- Non-corrected sensory deficits;
- Diagnosis of any gut disease/problems or other medical conditions: inflammatory bowel disease, irritable bowel syndrome, Crohn's Disease, celiac disease, lactose intolerance, autoimmune disease;
- Consumption of medical drugs with psychoactive effects (e.g., antidepressants, anxiolytics or benzodiazepines) during the 4 weeks prior to the experiment;
- Use of any of the following drugs in the last 4 weeks: laxatives, antibiotics, anticoagulants, non-steroidal anti-inflammatory drugs, analgesics, corticosteroids;
- No type of metal object implanted in the body, especially in the head (orthodontic appliances are not excluded).
The study team makes the final eligibility decision.
Where it's taking place
- Braga, Gualtar, Braga, Portugal
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 23 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Braga, Gualtar, Braga, Portugal. 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.