Reducing the Abuse Liability of Prescription Opioids

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-16

Study Completion Date

2020-01-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Oxycodone

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

Group Type PLACEBO_COMPARATOR

Oxycodone

Intervention Type DRUG

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

Oxycodone and Risperidone

Administration of oxycodone plus risperidone in a single capsule

Group Type EXPERIMENTAL

Risperidone

Intervention Type DRUG

Risperidone 1mg to be used in combination with other drugs

Oxycodone

Intervention Type DRUG

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

Oxycodone and Ziprasidone

Administration of oxycodone and risperidone in a single capsule

Group Type EXPERIMENTAL

Ziprasidone

Intervention Type DRUG

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

Oxycodone

Intervention Type DRUG

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

Interventions

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Risperidone

Risperidone 1mg to be used in combination with other drugs

Intervention Type DRUG

Ziprasidone

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

Intervention Type DRUG

Oxycodone

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

Intervention Type DRUG

Other Intervention Names

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Risperdal Geodon Oxycontin

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes