Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
11 participants
INTERVENTIONAL
2021-03-24
2024-11-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Alcohol
Participants will receive experimental doses of active or placebo alcohol, p.o. Alcohol/placebo will be administered once per session.
Alcohol
Active alcohol or placebo, administered orally
Opioid Agonist
Participants will receive non-therapeutic, experimental doses of an active opioid agonist or placebo. Active opioid agonist/placebo will be administered once per session and will be administered orally
Opioid Agonist
Active opioid agonist or placebo, administered orally
Opioid Agonist/Alcohol Combination
Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.
Alcohol
Active alcohol or placebo, administered orally
Opioid Agonist
Active opioid agonist or placebo, administered orally
Interventions
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Alcohol
Active alcohol or placebo, administered orally
Opioid Agonist
Active opioid agonist or placebo, administered orally
Eligibility Criteria
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Inclusion Criteria
* Current non-medical use of opioids
* Previous alcohol use
Exclusion Criteria
* Seeking treatment for drug use
* Significant medical problems
21 Years
55 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Sharon Walsh
OTHER
Responsible Party
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Sharon Walsh
Director of the Center on Drug and Alcohol Research
Principal Investigators
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Sharon L Walsh, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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University of Kentucky
Lexington, Kentucky, United States
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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55176
Identifier Type: -
Identifier Source: org_study_id
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