Trial Outcomes & Findings for The Behavioral Effects of Opioids and Alcohol (NCT NCT04300751)

Last Updated: 2025-11-20

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

11 participants

Primary outcome timeframe

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)

Results posted on

2025-11-20

Participant Flow

This is a crossover study with 9 conditions tested in random order in each completing subject.

Participant milestones

Participant milestones
Measure	The Behavioral Effects of Opioids and Alcohol 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
Overall Study STARTED	11
Overall Study Placebo/Placebo	10
Overall Study Oxycodone 20mg/Placebo	10
Overall Study Oxycodone 40mg/Placebo	10
Overall Study Placebo/Alcohol 0.5g/kg	10
Overall Study Placebo/Alcohol 0.8g/kg	11
Overall Study Oxycodone 20mg/Alcohol 0.5g/kg	10
Overall Study Oxycodone 20mg/Alcohol 0.8g/kg	10
Overall Study Oxycodone 40mg/Alcohol 0.5g/kg	11
Overall Study Oxycodone 40mg/Alcohol 0.8g/kg	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	The Behavioral Effects of Opioids and Alcohol 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
Overall Study Withdrawal by Subject	1

Baseline Characteristics

The Behavioral Effects of Opioids and Alcohol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alcohol and Opioids n=10 Participants 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
Age, Continuous	38.30 years STANDARD_DEVIATION 6.45 • n=39 Participants
Sex: Female, Male Female	2 Participants n=39 Participants
Sex: Female, Male Male	8 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	2 Participants n=39 Participants
Race (NIH/OMB) White	8 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Region of Enrollment United States	10 Participants n=39 Participants

PRIMARY outcome

Timeframe: 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)

Population: Per Protocol population, defined as participants completing the 9 experimental dosing conditions.

Outcome measures

Outcome measures
Measure	Placebo/Placebo n=10 Participants 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	Oxycodone 20mg/Placebo n=10 Participants 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	Oxycodone 40mg/Placebo n=10 Participants 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	Placebo/Alcohol 0.5g/kg n=10 Participants 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	Placebo/Alcohol 0.8g/kg n=10 Participants 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	Oxycodone 20mg/Alcohol 0.5g/kg n=10 Participants 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	Oxycodone 20mg/Alcohol 0.8g/kg n=10 Participants 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	Oxycodone 40mg/Alcohol 0.5g/kg n=10 Participants 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	Oxycodone 40mg/Alcohol 0.8g/kg n=10 Participants 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
Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking	12.9 score on a scale Standard Error 8.6	47.1 score on a scale Standard Error 9.4	49.9 score on a scale Standard Error 7.9	54.8 score on a scale Standard Error 8.8	61.2 score on a scale Standard Error 8.2	54.6 score on a scale Standard Error 9.4	66.9 score on a scale Standard Error 9.4	57.2 score on a scale Standard Error 9.1	72.9 score on a scale Standard Error 7.2

SECONDARY outcome

Population: Per Protocol population, defined as participants completing the 9 experimental dosing conditions.

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).

Outcome measures

Outcome measures
Measure	Placebo/Placebo n=10 Participants 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	Oxycodone 20mg/Placebo n=10 Participants 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	Oxycodone 40mg/Placebo n=10 Participants 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	Placebo/Alcohol 0.5g/kg n=10 Participants 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	Placebo/Alcohol 0.8g/kg n=10 Participants 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	Oxycodone 20mg/Alcohol 0.5g/kg n=10 Participants 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	Oxycodone 20mg/Alcohol 0.8g/kg n=10 Participants 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	Oxycodone 40mg/Alcohol 0.5g/kg n=10 Participants 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	Oxycodone 40mg/Alcohol 0.8g/kg n=10 Participants 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
Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel?	6.1 score on a scale Standard Error 4.7	6.5 score on a scale Standard Error 5.7	8.6 score on a scale Standard Error 5.0	41.2 score on a scale Standard Error 7.6	54 score on a scale Standard Error 7.6	39.6 score on a scale Standard Error 8.3	49.5 score on a scale Standard Error 8.5	33.4 score on a scale Standard Error 8.2	56.1 score on a scale Standard Error 8.7

SECONDARY outcome

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

Population: Per Protocol population, defined as participants completing the 9 experimental drug conditions.

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).

Outcome measures

Outcome measures
Measure	Placebo/Placebo n=10 Participants 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	Oxycodone 20mg/Placebo n=10 Participants 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	Oxycodone 40mg/Placebo n=10 Participants 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	Placebo/Alcohol 0.5g/kg n=10 Participants 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	Placebo/Alcohol 0.8g/kg n=10 Participants 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	Oxycodone 20mg/Alcohol 0.5g/kg n=10 Participants 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	Oxycodone 20mg/Alcohol 0.8g/kg n=10 Participants 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	Oxycodone 40mg/Alcohol 0.5g/kg n=10 Participants 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	Oxycodone 40mg/Alcohol 0.8g/kg n=10 Participants 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
Trough Oxygen Saturation	97.4 Percentage of oxygen in blood Standard Error 0.35	96.8 Percentage of oxygen in blood Standard Error 0.29	96.6 Percentage of oxygen in blood Standard Error 0.36	96.6 Percentage of oxygen in blood Standard Error 0.43	96.2 Percentage of oxygen in blood Standard Error 0.30	96.1 Percentage of oxygen in blood Standard Error 0.34	95.7 Percentage of oxygen in blood Standard Error 0.30	95.6 Percentage of oxygen in blood Standard Error 0.49	95.2 Percentage of oxygen in blood Standard Error 0.47

SECONDARY outcome

Timeframe: 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).

Population: Per Protocol population, defined as participants completing the 9 experimental drug conditions.

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).

Outcome measures

Outcome measures
Measure	Placebo/Placebo n=10 Participants 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	Oxycodone 20mg/Placebo n=10 Participants 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	Oxycodone 40mg/Placebo n=10 Participants 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	Placebo/Alcohol 0.5g/kg n=10 Participants 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	Placebo/Alcohol 0.8g/kg n=10 Participants 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	Oxycodone 20mg/Alcohol 0.5g/kg n=10 Participants 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	Oxycodone 20mg/Alcohol 0.8g/kg n=10 Participants 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	Oxycodone 40mg/Alcohol 0.5g/kg n=10 Participants 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	Oxycodone 40mg/Alcohol 0.8g/kg n=10 Participants 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
Peak Cold Pressor Test Threshold	22.6 Seconds Standard Error 7.3	63.3 Seconds Standard Error 30.2	74.2 Seconds Standard Error 32.4	43.4 Seconds Standard Error 24.2	60.6 Seconds Standard Error 31.7	54.1 Seconds Standard Error 20.1	73.2 Seconds Standard Error 31.9	81.5 Seconds Standard Error 30.0	98.9 Seconds Standard Error 30.9

Deaths: 0 deaths

Oxycodone 40mg/Alcohol 0.8g/kg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo/Placebo n=10 participants at risk 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	Pre-Intervention / Days Off n=11 participants at risk Prior to any drug administration or on participant days off when AE is not related to drug conditions.	Qualification: Oxycodone 30mg / Placebo n=11 participants at risk Prior to the experimental conditions, participants will receive a non-therapeutic dose of oxycodone 30 mg, p.o. during a qualifying day session. This session serves as a responsive challenge which is intended to confirm that subjects are able to detect the active drug.	Oxycodone 20mg/Placebo n=11 participants at risk 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	Oxycodone 40mg/Placebo n=10 participants at risk 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	Placebo/Alcohol 0.5g/kg n=10 participants at risk 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	Placebo/Alcohol 0.8g/kg n=10 participants at risk 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	Oxycodone 20mg/Alcohol 0.5g/kg n=10 participants at risk 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	Oxycodone 20mg/Alcohol 0.8g/kg n=11 participants at risk 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	Oxycodone 40mg/Alcohol 0.5g/kg n=10 participants at risk 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	Oxycodone 40mg/Alcohol 0.8g/kg n=10 participants at risk 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
Gastrointestinal disorders Diarrrhea	10.0% 1/10 • Number of events 1 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.
Ear and labyrinth disorders Ear Pain	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Generalized Body Aches	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	9.1% 1/11 • Number of events 1 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.
Nervous system disorders Headache	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.
Gastrointestinal disorders Nausea / Vomitting	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	9.1% 1/11 • Number of events 1 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	18.2% 2/11 • Number of events 2 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Sinus Symptoms	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	9.1% 1/11 • Number of events 1 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Tooth Pain	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	9.1% 1/11 • Number of events 1 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/11 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.	0.00% 0/10 • Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit. AE definitions are the same as the clnicaltrials.gov definitions.

Additional Information

Director for the Center on Drug and Alcohol Research

University of Kentucky

Phone: 859-257-6485

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place