NCT03205423

Medication Development for Opioid and Alcohol Abuse

Medication Development for Opioid and Alcohol Abuse: Laboratory Study in Humans.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 21 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Opioid-use Disorder
• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Gabapentin	Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.

Timeline

• Start date: 2017-08-01
• Primary completion: 2021-06-30
• Completion: 2021-12-30
• First posted: 2017-07-02
• Last updated: 2024-09-19
• Results posted: 2022-10-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study