Motivation for IV Alcohol Self-Administration in Humans (NCT06494891) | Clinical Trial Compass
RecruitingPhase 2
Motivation for IV Alcohol Self-Administration in Humans
United States210 participantsStarted 2024-01-16
Plain-language 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.
Who can participate
Age range21 Years – 65 Years
SexALL
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Inclusion 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
Exclusion criteria
✕. 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
✕. 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:
What they're measuring
1
Incentive Salience, Craving, and Self-Administration
Timeframe: 10 hours
2
Negative Emotionality, Negative Mood, and Self-Administration
Timeframe: 10 hours
3
Executive Dysfunction, Loss of Control, and Self-Administration
✕. 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"