Alcohol Abuse Clinical Trial
Official title:
Human Alcohol Seeking Despite Aversion
Verified date | February 2024 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prolonged alcohol use results in drinking despite resultant problems and adverse consequences. The investigators propose to test a laboratory model of human seeking despite aversion to use as an early marker of disease onset, and as a tool for study of its neural functional substrates, and identification of effective treatments.
Status | Terminated |
Enrollment | 216 |
Est. completion date | May 4, 2022 |
Est. primary completion date | May 4, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 55 Years |
Eligibility | Inclusion Criteria: - Healthy men and women age 21-55 - Range of lifetime alcohol drinking history from 25 kg to 500 kg, with preference for extremes, plus recent drinking at least 7 drinks/week (women) and 20 drinks/week (men) - Able to understand and complete questionnaires and procedures in English - Willing and able to tolerate iv placement - Right-handed (for fMRI Arm only) Exclusion Criteria: - Pregnant or breast-feeding - Seeking or in treatment for substance use disorder or under court ordered abstinence - Medications, medical disorders or conditions that could affect study outcome or subject safety - Positive urine drug screen for amphetamines/methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, or phencyclidine - Positive breath alcohol (BrAC) reading on arrival at any study visit - Actively suicidal (within previous year) - Left-handed or ambidextrous (for fMRI Arm only) |
Country | Name | City | State |
---|---|---|---|
United States | University Hospital | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University | National Institute on Alcohol Abuse and Alcoholism (NIAAA), Purdue University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IV alcohol self-administration | Between session differences in self-administration will be evaluated using progressive work breakpoint | In two infusion sessions, to occur approximately 1-2 weeks apart |
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