Alcohol Drinking, Opioid Use
Conditions
Keywords
opioid, opiate, alcohol
Brief summary
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.
Interventions
DRUGAlcohol
Active alcohol or placebo, administered orally
DRUGOpioid Agonist
Active opioid agonist or placebo, administered orally
Sponsors
National Institute on Drug Abuse (NIDA)
Sharon Walsh
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
This is a randomized, double-blind, double-dummy, placebo-controlled, within-subjects design
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking | 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
| Measure | Time frame | Description |
|---|---|---|
| Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel? | 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). |
| Trough Oxygen Saturation | 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). |
| Peak Cold Pressor Test Threshold | 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). |
Countries
United States
Participant flow
Pre-assignment details
This is a crossover study with 9 conditions tested in random order in each completing subject.
Participants by arm
| Arm | Count |
|---|---|
| Alcohol and Opioids 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 | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Alcohol and Opioids |
|---|---|
| Age, Continuous | 38.30 years STANDARD_DEVIATION 6.45 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 | 0 / 10 | 0 / 11 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 11 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 4 / 11 | 2 / 11 | 1 / 10 | 0 / 11 | 1 / 10 | 1 / 10 | 1 / 10 | 0 / 10 | 0 / 11 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 | 0 / 10 | 0 / 11 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 11 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking
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).
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)
Population: Per Protocol population, defined as participants completing the 9 experimental dosing conditions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/Placebo | Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking | 12.9 score on a scale | Standard Error 8.6 |
| Oxycodone 20mg/Placebo | Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking | 47.1 score on a scale | Standard Error 9.4 |
| Oxycodone 40mg/Placebo | Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking | 49.9 score on a scale | Standard Error 7.9 |
| Placebo/Alcohol 0.5g/kg | Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking | 54.8 score on a scale | Standard Error 8.8 |
| Placebo/Alcohol 0.8g/kg | Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking | 61.2 score on a scale | Standard Error 8.2 |
| Oxycodone 20mg/Alcohol 0.5g/kg | Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking | 54.6 score on a scale | Standard Error 9.4 |
| Oxycodone 20mg/Alcohol 0.8g/kg | Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking | 66.9 score on a scale | Standard Error 9.4 |
| Oxycodone 40mg/Alcohol 0.5g/kg | Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking | 57.2 score on a scale | Standard Error 9.1 |
| Oxycodone 40mg/Alcohol 0.8g/kg | Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking | 72.9 score on a scale | Standard Error 7.2 |
Secondary
Peak Cold Pressor Test Threshold
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).
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).
Population: Per Protocol population, defined as participants completing the 9 experimental drug conditions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/Placebo | Peak Cold Pressor Test Threshold | 22.6 Seconds | Standard Error 7.3 |
| Oxycodone 20mg/Placebo | Peak Cold Pressor Test Threshold | 63.3 Seconds | Standard Error 30.2 |
| Oxycodone 40mg/Placebo | Peak Cold Pressor Test Threshold | 74.2 Seconds | Standard Error 32.4 |
| Placebo/Alcohol 0.5g/kg | Peak Cold Pressor Test Threshold | 43.4 Seconds | Standard Error 24.2 |
| Placebo/Alcohol 0.8g/kg | Peak Cold Pressor Test Threshold | 60.6 Seconds | Standard Error 31.7 |
| Oxycodone 20mg/Alcohol 0.5g/kg | Peak Cold Pressor Test Threshold | 54.1 Seconds | Standard Error 20.1 |
| Oxycodone 20mg/Alcohol 0.8g/kg | Peak Cold Pressor Test Threshold | 73.2 Seconds | Standard Error 31.9 |
| Oxycodone 40mg/Alcohol 0.5g/kg | Peak Cold Pressor Test Threshold | 81.5 Seconds | Standard Error 30 |
| Oxycodone 40mg/Alcohol 0.8g/kg | Peak Cold Pressor Test Threshold | 98.9 Seconds | Standard Error 30.9 |
Secondary
Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel?
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).
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)
Population: Per Protocol population, defined as participants completing the 9 experimental dosing conditions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/Placebo | Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel? | 6.1 score on a scale | Standard Error 4.7 |
| Oxycodone 20mg/Placebo | Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel? | 6.5 score on a scale | Standard Error 5.7 |
| Oxycodone 40mg/Placebo | Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel? | 8.6 score on a scale | Standard Error 5 |
| Placebo/Alcohol 0.5g/kg | Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel? | 41.2 score on a scale | Standard Error 7.6 |
| Placebo/Alcohol 0.8g/kg | Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel? | 54 score on a scale | Standard Error 7.6 |
| Oxycodone 20mg/Alcohol 0.5g/kg | Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel? | 39.6 score on a scale | Standard Error 8.3 |
| Oxycodone 20mg/Alcohol 0.8g/kg | Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel? | 49.5 score on a scale | Standard Error 8.5 |
| Oxycodone 40mg/Alcohol 0.5g/kg | Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel? | 33.4 score on a scale | Standard Error 8.2 |
| Oxycodone 40mg/Alcohol 0.8g/kg | Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel? | 56.1 score on a scale | Standard Error 8.7 |
Secondary
Trough Oxygen Saturation
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).
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).
Population: Per Protocol population, defined as participants completing the 9 experimental drug conditions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/Placebo | Trough Oxygen Saturation | 97.4 Percentage of oxygen in blood | Standard Error 0.35 |
| Oxycodone 20mg/Placebo | Trough Oxygen Saturation | 96.8 Percentage of oxygen in blood | Standard Error 0.29 |
| Oxycodone 40mg/Placebo | Trough Oxygen Saturation | 96.6 Percentage of oxygen in blood | Standard Error 0.36 |
| Placebo/Alcohol 0.5g/kg | Trough Oxygen Saturation | 96.6 Percentage of oxygen in blood | Standard Error 0.43 |
| Placebo/Alcohol 0.8g/kg | Trough Oxygen Saturation | 96.2 Percentage of oxygen in blood | Standard Error 0.3 |
| Oxycodone 20mg/Alcohol 0.5g/kg | Trough Oxygen Saturation | 96.1 Percentage of oxygen in blood | Standard Error 0.34 |
| Oxycodone 20mg/Alcohol 0.8g/kg | Trough Oxygen Saturation | 95.7 Percentage of oxygen in blood | Standard Error 0.3 |
| Oxycodone 40mg/Alcohol 0.5g/kg | Trough Oxygen Saturation | 95.6 Percentage of oxygen in blood | Standard Error 0.49 |
| Oxycodone 40mg/Alcohol 0.8g/kg | Trough Oxygen Saturation | 95.2 Percentage of oxygen in blood | Standard Error 0.47 |