Alcohol Use Disorder study: Intravenous Alcohol
Official title Motivation for IV Alcohol Self-Administration in Humans
ClinicalTrials.gov ID: NCT06494891
What this study is testing
What is Intravenous Alcohol?
This is an investigational procedure where alcohol is given through a vein to study why people with alcohol use disorder are motivated to use it.
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
- This study aims to understand how desire for rewards, emotions, and thinking skills affect a person's motivation to use alcohol.
- Who it's for
- The study is looking for adults aged 21 to 65 who have alcohol use disorder.
- What's involved
- Participants will fill out questionnaires about their mood and habits, and receive alcohol through an IV by pressing a button to get more doses.
- Time commitment
- The source text does not specify the total duration or number of visits required.
- 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 21 to 65
You may be able to join if
- Be between the ages of 21 and 65
- Have self-reported alcohol use in the past 30 days
- Meet current (i.e., past 12 months) DSM-5 diagnostic criteria for alcohol use disorder mild-to-severe
You likely can't join if
- Currently be treatment seeking, in treatment for alcohol use, or have a history of treatment in the 30 days prior to consent
- Have current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine
- Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any other psychotic disorder
- Have current suicidal ideation or lifetime history of suicide attempt as reported on the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Have a positive urine screen for drugs other than cannabis
- Oral contraceptives
See the full eligibility criteria
- Be between the ages of 21 and 65
- Have self-reported alcohol use in the past 30 days
- Meet current (i.e., past 12 months) DSM-5 diagnostic criteria for alcohol use disorder mild-to-severe
- Currently be treatment seeking, in treatment for alcohol use, or have a history of treatment in the 30 days prior to consent
- Have current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine
- Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any other psychotic disorder
- Have current suicidal ideation or lifetime history of suicide attempt as reported on the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Have a positive urine screen for drugs other than cannabis
- Oral contraceptives
- Contraceptive sponge
- Patch
- Double barrier
- Intrauterine contraceptive device
- Etonogestrel implant
- Medroxyprogesterone acetate contraceptive injection
- Hormonal vaginal contraceptive ring
- Complete abstinence from sexual intercourse
- Have clinically significant abnormalities identified in the physical exam that may interfere with safe study participation (e.g. unstable cardiac, renal, or liver disease; diabetes; uncontrolled hypertension; or HIV)
- Exceed Grade 2 laboratory abnormalities, based on FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials"
- Currently use any medications known to interact with alcohol, including: antidepressants, anticonvulsants, opioids, benzodiazepines, medications for diabetes, and medications that affect alcohol metabolism
- Have an intense fear of needles or have had adverse reactions to needle puncture
- Have a BrAC \> 0.000 g/dl
- Have clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R)
- Exceed Grade 2 clinical vital sign abnormalities, based on FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials"
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, 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, but 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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.