Reducing the Abuse Liability of Prescription Opioids

Early Phase 1

Completed

• Conditions: Addiction
• Interventions: Drug: Risperidone; Drug: Ziprasidone; Drug: Oxycodone

• Registration Number: NCT04587115
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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 mi...

Detailed Description

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...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-06-16
• Primary Completion: 2019-06-01
• Study Completion: 2020-01-01
• Study First Submitted: 2020-08-19
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-13
• Last Update Submitted: 2020-10-13
• Study First Posted: 2020-10-14
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Requirement of prior exposure to opioids

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oxycodone and Risperidone	Oxycodone	Administration of oxycodone plus risperidone in a single capsule
Oxycodone and Risperidone	Risperidone	Administration of oxycodone plus risperidone in a single capsule
Oxycodone	Oxycodone	This arm will be considered the control arm, containing oxycodone as the placebo.
Oxycodone and Ziprasidone	Ziprasidone	Administration of oxycodone and risperidone in a single capsule
Oxycodone and Ziprasidone	Oxycodone	Administration of oxycodone and risperidone in a single capsule

Primary Outcome Measures

Name	Time	Method
Evaluation of analgesic efficacy- Cold pressor	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 t...

Secondary Outcome Measures

Name	Time	Method
Evaluation of analgesic efficacy- Thumb pressor	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 pres...
Drug liking	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.
Addiction Research Center Inventory test questionnaire	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 a...
Profile of Mood States test questionnaire	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 stat...

Trial Locations

Locations (1)

Westgate Pain Clinic; 🇺🇸 San Antonio, Texas, United States