Clinical trial NCT04587115: Reducing the Abuse Liability of Prescription Opioids
Official title: Reducing the Abuse Liability of Prescription Opioids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Addiction
Keywords: opioid
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 (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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of analgesic efficacy- Cold pressor
timeFrame: two weeks
Secondary outcomes:
measure: Evaluation of analgesic efficacy- Thumb pressor
timeFrame: two weeks
measure: Drug liking
timeFrame: two weeks
measure: Addiction Research Center Inventory test questionnaire
timeFrame: two weeks
measure: Profile of Mood States test questionnaire
timeFrame: two weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Westgate Pain Clinic
state: Texas
Study officials:
affiliation: University of Texas Health at San Antonio
name: Max Eckmann, MD
role: PRINCIPAL_INVESTIGATOR
References: