Clinical Trials Directory

Trials / Terminated

TerminatedNCT03648840

Human Alcohol Seeking Despite Aversion

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
84 (actual)
Sponsor
Indiana University · Academic / Other
Sex
All
Age
21 Years – 55 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

The long-term goal for this project is to establish a model of alcohol seeking despite aversion (SDA) as a platform for the laboratory testing of novel pharmacologic and behavioral interventions that can be used among those with the highest risk, but who have yet to progress to treatment-resistant drinking. The objective of this application is to test SDA across multiple levels of analysis. The investigators consider SDA as an early marker of alcohol use disorder progression that is related to lifetime drinking history, alcohol use disorder risks, and brain physiology. The investigators have completed a pilot study demonstrating that SDA can be objectively quantified via an intravenous alcohol self-administration task, in which operant work for identical incremental alcohol rewards is paired with aversive stimuli. This preliminary data supports the central hypotheses that behavior in the SDA model is attributable to lifetime alcohol exposure, is related to alcohol use disorder risk factors and phenotypes, and reflects alterations in neural system function. In this project, SDA will be measured along with recent and lifetime drinking history, negative affect-based rash action (i.e. negative urgency, including action with respect to alcohol use), and self-rating of the effects of alcohol. The rationale for this work is that it would lead to the first objective, well-validated measure of SDA in humans.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAversive CueParticipants will be exposed to unpleasant pictures and tones during performance of a task to earn alcohol
BEHAVIORALNeutral CueParticipants will be exposed to neutral pictures and tones during performance of a task to earn alcohol

Timeline

Start date
2018-04-04
Primary completion
2022-05-04
Completion
2022-05-04
First posted
2018-08-27
Last updated
2025-02-25
Results posted
2025-02-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03648840. Inclusion in this directory is not an endorsement.