The present proposal will evaluate the ability of gabapentin maintenance to reduce the abuse liability of alcohol, oxycodone, and alcohol in combination with oxycodone in participants with both Opioid Use Disorder and Alcohol Use Disorder.
Currently, the abuse of prescription opioid medications is a pervasive problem in the U.S. In addition, co-abuse of opioids and alcohol represents a significant problem from the perspective of increased toxicity and decreased success in treatment. Surprisingly few studies have examined the effects of combined administration of opioids and alcohol in humans, and no clinical studies have examined the reinforcing effects of this combination. The current 8-9-week inpatient study will systematically evaluate gabapentin because it shows promise for treating both opioid and alcohol use disorders (OUD and AUD). The guiding principle is that a medication's effects on positive subjective responses and reinforcing effects are the best laboratory procedures to date in predicting its clinical efficacy. We will examine the ability of gabapentin (0 mg or 1800 mg) to alter opioid-, alcohol-,and combined opioid/alcohol-mediated responses. Participants will meet DSM-5 criteria for moderate-severe OUD and be physically dependent on opioids. In addition, participants will meet DSM-5 criteria for moderate-severe AUD, but they will not be physically dependent on alcohol. All of the participants will be maintained on oral morphine throughout the study and different doses of gabapentin will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
17
Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
New York State Psychiatric Institute in the Division on Substance Use Disorders
New York, New York, United States
Peak Positive Subjective Responses to Placebo.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Time frame: Assessed every 15 minutes following drug administration,for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Peak Positive Subjective Responses to Oxycodone (30mg) + Low Alcohol Dose.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Time frame: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Peak Positive Subjective Responses to Oxycodone (30mg) + High Alcohol Dose.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Time frame: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Peak Positive Subjective Responses to Oxycodone (15mg) + High Alcohol Dose.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Time frame: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Peak Positive Subjective Responses to Oxycodone (15mg) + Low Alcohol Dose.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Time frame: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Peak Positive Subjective Responses to Low Alcohol Dose.
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Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Time frame: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Peak Positive Subjective Responses to High Alcohol Dose.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Time frame: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Peak Positive Subjective Responses to Oxycodone (30mg)
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Time frame: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Peak Positive Subjective Responses to Oxycodone (15mg)
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Time frame: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.