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OpenTrials
Completed

NCT Number: NCT04300751

The Behavioral Effects of Opioids and Alcohol

This study will examine the effects of doses of alcohol/placebo and doses of opioid/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.

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Key information

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Kentucky

Lexington, Kentucky, 40508, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults ages 21-55
  • Current non-medical use of opioids
  • Previous alcohol use

Exclusion criteria

  • Physical dependence on opioids, alcohol, or benzodiazepines/sedative/hypnotics
  • Seeking treatment for drug use
  • Significant medical problems

Treatment and study plan

Alcohol

Drug

Active alcohol or placebo, administered orally

Opioid Agonist

Drug

Active opioid agonist or placebo, administered orally

Primary outcomes

  1. Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking

    Time frame: These outcomes (visual analog scores, scale of 0-100) are recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)

    Participants rated their subjective drug liking on a standardized VAS scale (0 to 100; 0=Not at all, 100=Extremely). A higher score indicates greater drug liking. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM).

Secondary outcomes

  1. Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel?

    Time frame: These outcomes (visual analog scores, scale of 0-100) are recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)

    Participants rated their subjective response to the question "How drunk do you feel?" on a standardized VAS scale (0 to 100; 0=Not at all, 100=Extremely). A higher score indicates greater feeling of drunk. TThis outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM).

  2. Trough Oxygen Saturation

    Time frame: Oxygen Saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).

    Oxygen saturation (measured as a percentage through pulse ox) monitored throughout each session. Lower scores indicate greater impairment. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' trough value was pulled from the raw data and averaged to yield one mean (SEM).

  3. Peak Cold Pressor Test Threshold

    Time frame: Cold Pressor Test Threshold was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).

    Participants immerse their forearm in cold water (1.0 +/- .5 degree Celsius) and remove their arm from the cold water to indicated pain tolerance (max 5 mins). Cold Pressor Test Threshold (time elapsed since cold water immersion measured in seconds) monitored throughout each session. Higher scores indicate greater impairment. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM).

Sponsors and collaborators

Lead sponsor

Sharon Walsh

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Interactions of Alcohol and Opioids: Pharmacodynamic Effects

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 9, 2020
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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