Medication Development for Opioid and Alcohol Abuse

  • STATUS
    Recruiting
  • End date
    Dec 9, 2021
  • participants needed
    36
  • sponsor
    New York State Psychiatric Institute
Updated on 9 June 2021
opioid
anxiety
gabapentin
drug abuse
alcohol abuse

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.

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 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.

Details
Condition Alcohol abuse, Alcohol Use Disorder, Opioid Use Disorder, Alcohol Use Disorders, Alcohol Dependence
Treatment Gabapentin
Clinical Study IdentifierNCT03205423
SponsorNew York State Psychiatric Institute
Last Modified on9 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

DSM-5 criteria for moderate-severe opioid use disorder with physical dependence
DSM-5 criteria for moderate-severe alcohol use disorder without physical dependence
No current major mood, psychotic, or anxiety disorder
Physically healthy
Able to perform study procedures
21-59 years of age
Normal body weight/Within 20% of body weight (for appropriate frame) according to 1983 Metropolitan Weight tables
Current or history of illicit opioid use
Current use of opioids in amounts and/or frequencies that meet or exceed those used in the proposed study (e.g., 3-4 tablets of a Rx opioid medication per day or 1-2 bags of heroin per day). Not seeking treatment for opioid use disorder (neutral attitude or not wanting treatment only)
Participants will consume alcohol at least 3 times per week (15 drinks per week for men and 8 drinks per week for women). In addition, they will drink alcohol and use opioids simultaneously

Exclusion Criteria

DSM-5 criteria for substance use disorder (moderate to severe) on drugs other than opioids, alcohol, nicotine or caffeine (must be less than 500 mg caffeine daily)
Participants requesting treatment
Pregnancy or lactation
Current or recent history of significant violent or suicidal behavior and/or suicidal/homicidal risk
Cannot read or understand the self-report assessment forms unaided, or are so severely disabled that they cannot comply with the requirements of the study
Elevated liver function tests (i.e., AST and ALT > 3 times the upper limit of normal) or impaired renal function (creatinine must be within normal limits)
Physical disorders that might make participation hazardous such as AIDS, cancer, hypertension (blood pressure > 140/90), uncontrolled diabetes, pulmonary hypertension or heart disease (please note that participants will be asked about previous visits to a cardiologist, chest pain, or strong palpitations; if these exist, they will be referred to a cardiologist and excluded unless cleared for participation by a cardiologist)
Current major Axis I psychopathology, other than OUD and AUD (e.g., mood disorder with functional impairment, schizophrenia), that might interfere with ability to participate in the study
Sensitivity, allergy, or contraindication to opioids, alcohol, gabapentin or similar medications
Taken an investigational drug within the past 30 days
Current or history of chronic pain within the past 3 months
Taking prescription psychotropic medications that would potentially interfere with study procedures
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