NCT06494891 Motivation for IV Alcohol Self-Administration in Humans
| NCT ID | NCT06494891 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, Los Angeles |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2024-01-16 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 210 participants in total. It began in 2024-01-16 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this translational study is to understand different reasons why people between the ages of 21 and 65 with alcohol use disorder are motivated to self-administer alcohol. The main questions it aims to answer are: * How does a person's desire for a reward affect their motivation to self-administer alcohol? * How does a person's emotions affect their motivation to self-administer alcohol? * How does a person's cognitive functioning affect their motivation to self-administer alcohol? Participants will be asked to complete questionnaires about their mood, habits, and functioning and will complete an IV alcohol administration that will include pressing a button to receive additional doses of IV alcohol.
Eligibility Criteria
Inclusion Criteria: To be included in the study, participants must: 1. Be between the ages of 21 and 65 2. Have self-reported alcohol use in the past 30 days 3. Meet current (i.e., past 12 months) DSM-5 diagnostic criteria for alcohol use disorder mild-to-severe Exclusion Criteria: To be included in the study, participants must not: 1. Currently be treatment seeking, in treatment for alcohol use, or have a history of treatment in the 30 days prior to consent 2. Have current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine 3. Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any other psychotic disorder 4. Have current suicidal ideation or lifetime history of suicide attempt as reported on the Columbia-Suicide Severity Rating Scale (C-SSRS) 5. Have a positive urine screen for drugs other than cannabis 6. Be pregnant, nursing, or planning to become pregnant while taking part in the study; and must agree to one of the following methods of birth control (if female), unless she or partner are surgically sterile: * 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 7. 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) 8. 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" 9. Currently use any medications known to interact with alcohol, including: antidepressants, anticonvulsants, opioids, benzodiazepines, medications for diabetes, and medications that affect alcohol metabolism 10. Have an intense fear of needles or have had adverse reactions to needle puncture 11. Have any other circumstances that, in the opinion of the investigators, would not be a good fit for study participation Exclusion Criteria for Experimental Visit To participate in the IV alcohol administration, participants must not: 1. Have a BrAC \> 0.000 g/dl 2. Have clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R) 3. 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"
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06494891 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06494891 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06494891 currently recruiting?
Yes, NCT06494891 is actively recruiting participants. Contact the research team at jenkinsj@ucla.edu for enrollment information.
Where is the NCT06494891 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06494891 clinical trial?
NCT06494891 is sponsored by University of California, Los Angeles. The trial plans to enroll 210 participants.