Purpose

The consequences of prescription opioid abuse are serious and the number of deaths from unintended overdose have quadrupled over the last 15+ years. Opioid analgesics remain among the most commonly abused class of substances in the United States. Moreover, patients who take pain medications for legitimate reasons may develop an opioid use disorder (OUD), with as many as 1 in 4 patients becoming dependent on their pain medications. Because of changing access to prescription opioid analgesics due to an increasingly negative prescribing climate and changes in guidelines, patients often turn to heroin, with an estimated 1 in 15 pain patients trying heroin within 10 years. Pain is a symptom that can be severely debilitating and needs to be treated adequately to improve the quality of life. Clinicians, then, are in a proverbial "catch-22" situation whereby treating a patient's chronic pain also exposes them to medications with substantial abuse liability and overdose risk. In this proposal, a method aimed at reducing the abuse potential of prescription opioid medications, without altering their analgesic efficacy, is described. The study team hypothesize that this can be accomplished by administering a fixed-dose-combination of an opioid with an atypical antipsychotic drug, in the same pill or capsule.

Conditions

Eligibility

Eligible Ages
Between 21 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult patients between 21 to 65 years of age, capable of understanding and providing consent in English, and capable of complying with the outcome instruments used.
  • Recreational opioid use (i.e. defined as prescription opioid use for nontherapeutic purposes on at least 10 occasions within the previous year and at least once in the 12 weeks prior to screening)
  • Reported tolerated doses of ≥ 30 morphine milligram equivalents (MME) (i.e. 20mg oxycodone)

Exclusion Criteria

  • Currently receiving pharmacotherapy for psychiatric disorder, current suicide risk, or past history of major psychiatric disorder such as bipolar disorder/psychosis
  • Patients who are actively prescribed chronic opioid therapy for the management of pain
  • Presence of dementia
  • Current neuroleptic medication in past 30 days
  • Pregnancy
  • Positive drug urine test for Barbiturates, Benzodiazepines, Methadone, and Buprenorphine.
  • Subjects with a prolonged QT interval greater than 430ms (i.e. QTc >430ms)
  • Subjects with a heart rate of less than 60 or greater than 100bpm will be assessed by a physician for symptomatic bradycardia/tachycardia and eligibility determined on a case-by-case basis
  • Subjects with serum potassium and/or magnesium outside of normal range of our institutional laboratory within the past three months from time of screening.
  • Subjects who appears intoxicated on the day of study visit by an on-site physician.

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Double-blinded, crossover study
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Oxycodone/Placebo
Each study participant will receive all three study interventions in random order.In this arm, the participant receives oxycodone or placebo
  • Drug: Oxycodone/Placebo
    Oxycodone 20 mg plus placebo
    Other names:
    • Oxycontin/Placebo
Active Comparator
Oxycodone/Risperidone
Each study participant will receive all three study interventions in random order. In this arm the participant receives a combination of oxycodone or risperidone
  • Drug: Oxycodone/Risperidone
    Oxycodone (20mg) plus Risperidone (2 mg)
    Other names:
    • Oxycontin/Risperdal
Active Comparator
Oxycodone/Ziprasidone
Each study participant will receive all three study interventions in random order. In this arm the participant receives a combination of oxycodone or ziprasidone
  • Drug: Oxycodone/Ziprasidone
    Oxycodone (20mg) plus Ziprasidone (80 mg)
    Other names:
    • Oxycontin/Geodon

Recruiting Locations

Westgate Pain Clinic
San Antonio, Texas 78229
Contact:
Grace Ihsiu Todd
210-567-5643
toddg@uthscsa.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Ameet Nagpal, MD
2104509848
nagpala@uthscsa.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.