Medication Development for Opioid and Alcohol Abuse
Condition: Opioid-use Disorder; Alcohol Use Disorder
MeSH terms: Alcoholism; Opioid-Related Disorders
Intervention: Gabapentin
Intervention description: Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
Intervention MeSH terms: Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be randomized to receive one of two treatment conditions: gabapentin 0 mg or gabapentin 1800 mg/day first. Participants crossover to the 2nd gabapentin condition following a washout period.
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 21 Years
Maximum age: 59 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. DSM-5 criteria for moderate-severe opioid use disorder with physical dependence.

          2. DSM-5 criteria for moderate-severe alcohol use disorder without physical dependence.

          3. No current major mood, psychotic, or anxiety disorder.

          4. Physically healthy.

          5. Able to perform study procedures.

          6. 21-59 years of age.

          7. Normal body weight/Within 20% of body weight (for appropriate frame) according to 1983
             Metropolitan Weight tables.

          8. Current or history of illicit opioid use.

          9. 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).

         10. 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:

          1. 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).

          2. Participants requesting treatment.

          3. Pregnancy or lactation.

          4. Current or recent history of significant violent or suicidal behavior and/or
             suicidal/homicidal risk.

          5. 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.

          6. 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).

          7. 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).

          8. 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.

          9. Sensitivity, allergy, or contraindication to opioids, alcohol, gabapentin or similar
             medications.

         10. Taken an investigational drug within the past 30 days.

         11. Current or history of chronic pain within the past 3 months.

         12. Taking prescription psychotropic medications that would potentially interfere with
             study procedures.