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New treatment option for Alcohol Use Disorder
Official title Neural Correlates During Alcohol Intoxication
ClinicalTrials.gov ID: NCT06118580
What this study is testing
What is Alcohol (Ethanol)?
Alcohol (Ethanol) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for alcohol use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Alcohol intoxication is responsible for a large proportion of violent crime/assault and personal injury in our society. While a number of variables have been associated with alcohol-related aggression, high trait aggression and impaired executive function have been identified as key factors.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 55. Healthy volunteers may be eligible.
You may be able to join if
- for All Participants: All candidates for this study must meet the following criteria:
- 21 to 55 years of age (and be righted handed) and not a current (past 3 months) alcohol abstainer.
- Consumes \> 10 drinks/week or reports binge drinking at least once a month, and is not in, or currently seeking, treatment for AUD.
- PCL-SV psychopathy score \< 18
- Able/willing to abstain from alcohol for 24 hours before MRI scanning.
You likely can't join if
- 1) \ 55 years of age. 2) Meets criteria for other (Non-AUD) current DSM-5 Substance Use Disorder (excluding tobacco use disorder provided the...
- 3) Life history of bipolar disorder, schizophrenia, organic mental syndrome or intellectual deficiency (i.e., IQ \< 70 by WRAT).
- 4) Drug screen positive for amphetamines, barbituates, benzodiazepines, cocaine, phencyclidine, or opiates.
- 5) Positive urine pregnancy test 6) Clinically significant medical condition (current and active medical condition requiring daily prescribed...
- 7) PCL-SV psychopathy score \> 18 (see above). 8) Score \> 8 on the Clinical Institute Withdrawal Assessment-Revised (CIWA-Ar).
- 9) Treatment with antipsychotic medications within two weeks of study entry. 10) Current suicidal ideation. 11) Metal in body, history of \> 5 min...
See the full eligibility criteria
- for All Participants: All candidates for this study must meet the following criteria:
- 21 to 55 years of age (and be righted handed) and not a current (past 3 months) alcohol abstainer.
- Consumes \> 10 drinks/week or reports binge drinking at least once a month, and is not in, or currently seeking, treatment for AUD.
- PCL-SV psychopathy score \< 18
- Able/willing to abstain from alcohol for 24 hours before MRI scanning.
- Physically healthy (confirmed by comprehensive medical history and physical exam) and does not have metal implants, plates, or screws in body or head (MRI safety issue).
- If a smoker, consumes no more than 15 cigarettes per day.
- Able to give informed consent.
- for AGG (Only) Participants: In addition to the above, all AGG candidates must meet the following criteria:
- Life History of Aggression (LHA) score \> 12
- In addition AGG participants must report:
- Current history of at least two (2) angry outbursts a week (on average) for the past three months and/or three significant angry aggressive outbursts in which other people are assaulted and/or property is damaged in the...
- Angry outbursts are out of proportion to provocation and not associated with a tangible goal (not premeditated).
- Angry outbursts are associated with distress and/or impairment;
- Angry outbursts do not occur exclusively during another disorder or condition.
- No lifetime history of AUD (from DSM-5 criteria).
- for AUD (Only) Participants: In addition to the above, all AUD candidates must meet the following criteria:
- Meets DSM-5 criteria for alcohol use disorder (AUD) without significant history of alcohol withdrawal, seizures, or delirium tremens.
- Consumes \> 10 drinks/week or reports binge drinking at least once a month, and is not in, or currently seeking, treatment for AUD.
- for AUD+ / AGG+ Participants: These participants meet criteria for both AUD and AGG as described above.
- for Non-AGG/Non-AUD (Healthy Control) Participants: All Non-AGG/Non-AUD candidates must meet the following criteria:
- Does not meet DSM-5 criteria for current or past alcohol use disorder (AUD).
- LHA score is less than 12.
- Does not meet DSM-5 Criteria for a current, or past, major psychiatric disorder. b. Study
- 1) \ 55 years of age. 2) Meets criteria for other (Non-AUD) current DSM-5 Substance Use Disorder (excluding tobacco use disorder provided the participant consumes no more than 15 cigarettes per day).
- 3) Life history of bipolar disorder, schizophrenia, organic mental syndrome or intellectual deficiency (i.e., IQ \< 70 by WRAT).
- 4) Drug screen positive for amphetamines, barbituates, benzodiazepines, cocaine, phencyclidine, or opiates.
- 5) Positive urine pregnancy test 6) Clinically significant medical condition (current and active medical condition requiring daily prescribed medication).
- 7) PCL-SV psychopathy score \> 18 (see above). 8) Score \> 8 on the Clinical Institute Withdrawal Assessment-Revised (CIWA-Ar).
- 9) Treatment with antipsychotic medications within two weeks of study entry. 10) Current suicidal ideation. 11) Metal in body, history of \> 5 min loss of consciousness, left-handedness or body weight \> 300lbs (fMRI...
- 12) Unable/unwilling to abstain from alcohol for 24 hours and recreational drugs for 48 hours prior to session arrival.
- 13) Unable to comply with study procedures. 14) Unable to sign informed consent document. 15) Taking of anticoagulants. 16) Drinks less than 2 drinks per week 17) Has not had a binge drinking episode (5+ for men, 4+ for...
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
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, 21 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, 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.