💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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"
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