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Completed

NCT Number: NCT04587115

Reducing the Abuse Liability of Prescription Opioids

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.

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Key information

Conditions

Addiction Behavior Behavior, Addictive Compulsive Behavior Impulsive Behavior

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Westgate Pain Clinic

San Antonio, Texas, 78229, United States

About this study

This study involves the use of an investigational combination of drugs. "Oxycodone with Risperidone" and "Oxycodone with Ziprasidone" are called "Investigational" because the U.S. Food & Drug Administration (FDA) has not approved these drug combinations for the purpose of this study. Individually, each of these drugs is approved by the FDA for other reasons (i.e. oxycodone as a painkiller, while risperidone and ziprasidone are approved as anti-psychotic medications), but the administration of these drugs together has not been studied before or been approved by the FDA for this purpose.

This is the first study involving humans to examine the safety of this combination of drugs and how they work together. The goal of the study is to find out what effects, good and/or bad, it has on people who take them. Because the combination has not been studied in humans before, information about the safety and effectiveness is incomplete and all of the side effects are not yet known.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Requirement of prior exposure to opioids

Exclusion criteria

  • 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

Treatment and study plan

Risperidone

Drug

Risperidone 1mg to be used in combination with other drugs

Other names: Risperdal

Ziprasidone

Drug

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

Other names: Geodon

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

Other names: Oxycontin

Primary outcomes

  1. Evaluation of analgesic efficacy- Cold pressor

    Time frame: two weeks

    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.

Secondary outcomes

  1. Evaluation of analgesic efficacy- Thumb pressor

    Time frame: two weeks

    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 thumb pressor task which measures mechanical pain. The thumb pressor task measures the amount of weight they can tolerate on the nail of their thumb up to a maximum of 10 kg.

  2. Drug liking

    Time frame: two weeks

    Examine subjective ratings of drug liking of the FDC compared to that of the opioid alone using the Bipolar Visual analog scale on a scale of 0-Dislike to 100-Extremely like.

  3. Addiction Research Center Inventory test questionnaire

    Time frame: two weeks

    Perform the Addiction Research Center Inventory Short Form (ARCI-SF) questionnaire to assess the drug-induced transient alterations in distinct mood states of the FDC compared to those of the opioid alone. The ARCI is a self-administered, standardized questionnaire for assessing subjective effects of psychoactive drugs that was developed in the early 1960s at the National Institute of Mental Health Addiction Research Center. For this study, the study team will be using the 49-item short form. Outcome will be assessed using categorical and continuous data analysis comparing across groups. The ARCI-SF measures the subjective effects of a variety of drugs such as alcohol, morphine, LSD, and pentobarbital by a score for each subset. The higher a participant scores on a subset, the more similar the effects of the drug are to the known drug such as alcohol.

  4. Profile of Mood States test questionnaire

    Time frame: two weeks

    Perform a subset of the Profile of Mood States questionnaire to assess drug-induced transient alterations in distinct mood states following administration of the FDC compared to those of the opioid alone. POMS is a self-administered, standard validated psychological test formulated by McNair et al. (1971). It is a used to assess transient, distinct mood states. The questionnaire contains 65 words/statements that describe feelings people have. Outcome will be assessed using categorical and continuous data analysis comparing across groups. The POMS is a non-diagnostic test that assesses transient and distinct mood states such as tension, depression, anger, fatigue, confusion, vigor, and total mood disturbance. The higher a participant scores in each group, the more they experience that mood state.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Oct 14, 2020
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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