Medication Development for Opioid and Alcohol Abuse

NCT03205423 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 7476
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid-use Disorder; Alcohol Use Disorder

Outcome Measures

Primary Outcomes (9)

• 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

  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

  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

  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

  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

  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.

  Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely

  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

  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

  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

  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.

Study Arms (2)

Gabapentin 0 mg

PLACEBO COMPARATOR

once daily at 8am

Drug: Gabapentin

Gabapentin 1800 mg

ACTIVE COMPARATOR

once daily at 8am

Drug: Gabapentin

Interventions

Gabapentin DRUG

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

Gabapentin 0 mg; Gabapentin 1800 mg

Eligibility Criteria

• Age: 21 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute in the Division on Substance Use Disorders

New York, New York, 10032, United States

Location

Related Publications (1)

• Castillo F, Harris HM, Lerman D, Bisaga A, Nunes EV, Zhang Z, Wall M, Comer SD. Clinical Implications of the Relationship Between Naltrexone Plasma Levels and the Subjective Effects of Heroin in Humans. J Addict Med. 2024 Mar-Apr 01;18(2):110-114. doi: 10.1097/ADM.0000000000001247. Epub 2023 Dec 20.

  PMID: 38126709 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Alcoholism

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Jermaine Jones
• Organization: New York State Psychiatric Institute

jermaine.jones@NYSPI.Columbia.edu

7577533212

Study Officials

• Sandra D. Comer, PhD.

  New York State Psychiatric Institute / Columbia University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurobiology

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: July 2, 2017
• Study Start: August 1, 2017
• Primary Completion: June 30, 2021
• Study Completion: December 30, 2021
• Last Updated: September 19, 2024
• Results First Posted: October 6, 2022

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)