Reducing the Abuse Liability of Prescription Opioids

NCT04587115 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: HSC20170141H
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Opioid (commonly called narcotic) pain medicines are, after marijuana, the most commonly abused substances in the United States. Patients who take opioids for legitimate reasons may become addicted; for example, as many as 1 in 4 patients meet the criteria for current opioid dependence. It is very important that a way is found to provide pain relief while minimizing the addiction potential of these widely used pain medications. The study aim to find out if the use of another type of medication given in addition to an opioid will reduce the addiction potential of the opioid. The study is trying to find out if the ability of the opioid to relieve pain is changed when given with the other medication, and to see if the euphoric sensation or "liking" of the opioid pain medication is reduced when taken with the other medication.

Conditions

Addiction

Keywords

opioid

Outcome Measures

Primary Outcomes (1)

• Evaluation of analgesic efficacy- Cold pressor

  Perform quantitative evaluations of the analgesic efficacy of a novel fixed dose combination (FDC) of an opioid (oxycodone) in combination with one of two atypical antipsychotic drugs (either risperidone or ziprasidone) compared to the opioid alone. Analgesic efficacy will be measured with the cold pressor task which measures thermal pain. The cold pressor task measures the time the participant can tolerate their hand being submerged in the cold water up to a maximum of 5 minutes.

  two weeks

Secondary Outcomes (4)

• Evaluation of analgesic efficacy- Thumb pressor

  two weeks

• Drug liking

  two weeks

• Addiction Research Center Inventory test questionnaire

  two weeks

• Profile of Mood States test questionnaire

  two weeks

Study Arms (3)

Oxycodone

PLACEBO COMPARATOR

This arm will be considered the control arm, containing oxycodone as the placebo.

Drug: Oxycodone

Oxycodone and Risperidone

EXPERIMENTAL

Administration of oxycodone plus risperidone in a single capsule

Drug: Risperidone; Drug: Oxycodone

Oxycodone and Ziprasidone

EXPERIMENTAL

Administration of oxycodone and risperidone in a single capsule

Drug: Ziprasidone; Drug: Oxycodone

Interventions

Risperidone DRUG

Risperidone 1mg to be used in combination with other drugs

Also known as: Risperdal

Oxycodone and Risperidone

Ziprasidone DRUG

Ziprasidone 80mg to be used in combination with other study drugs

Also known as: Geodon

Oxycodone and Ziprasidone

Oxycodone DRUG

Oxycodone alone in a capsule will be considered the control. Oxycodone 15 mg will also be used in combination with other study drugs

Also known as: Oxycontin

Oxycodone; Oxycodone and Risperidone; Oxycodone and Ziprasidone

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Requirement of prior exposure to opioids

You may not qualify if:

• Presence of psychiatric comorbidity
• Presence of chronic pain disorder
• Presence or history of substance use disorder
• Current analgesic or neuroleptic medication usage (any medication for pain, including over-the-counter analgesics like ibuprofen/acetaminophen)
• Pregnancy
• Positive drug urine test
• Continuous opioid misuse measure score of \< 9
• Presence or history of diabetes
• Presence or history of cardiac disease or arrhythmia

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Westgate Pain Clinic

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Behavior, Addictive

Interventions

Risperidone; ziprasidone; Oxycodone

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Max Eckmann, MD

  University of Texas Health at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subjects will be administered one of two fixed dose drug combinations. The control will be oxycodone plus placebo, whereas the treatment groups will receive oxycodone plus one of the two atypical antipsychotics (Risperidone, Ziprasidone) under study. Study drug will be compounded by outside research pharmacy.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: October 14, 2020
• Study Start: June 16, 2017
• Primary Completion: June 1, 2019
• Study Completion: January 1, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At study completion.

Locations

US (1)