Reducing the Abuse of Opioids in Drug Users

Overview

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.

Full Title of Study: “Reducing the Abuse Liability of Prescription Opioids in Recreational Drug Users: A Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2021

Interventions

  • Drug: Oxycodone/Placebo
    • Oxycodone 20 mg plus placebo
  • Drug: Oxycodone/Risperidone
    • Oxycodone (20mg) plus Risperidone (2 mg)
  • Drug: Oxycodone/Ziprasidone
    • Oxycodone (20mg) plus Ziprasidone (80 mg)

Arms, Groups and Cohorts

  • 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
  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Change in Bipolar Visual Analog Scale (VAS) of Drug Likability
    • Time Frame: Study visit 2 to study visit 6, an average of 10 days
    • The bipolar VAS is used to measure the Change in magnitude of “drug liking”. The Drug Effects Questionnaire AKA the bipolar VAS of Drug Likability is a 5 item self-administered assessment where participants place a mark on a line from 0 to 100, “strongly dislike” at 0 (on the left hand side), “no effect” at 50 (in the center) and “strongly like” at 100 (on the far right). Change from visit 2 to visit 6 will be measured.

Secondary Measures

  • Change in Profile of Mood States (POMS)
    • Time Frame: Study visit 2 to study visit 6, an average of 10 days
    • 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. Change from visit 2 to visit 6 will be measured.
  • Change in Addiction Research Center Inventory Short Form (ARCI-SF)
    • Time Frame: Study visit 2 to study visit 6, an average of 10 days
    • 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, we will be using the 49-item short form. Outcome will be assessed using categorical and continuous data analysis comparing across groups. Change from visit 2 to visit 6 will be measured.

Participating in This Clinical Trial

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 to opioid medications Exclusion Criteria:

  • Currently receiving pharmacotherapy for psychiatric disorder, current suicide risk, or past history of major psychiatric disorder such as bipolar disorder/psychosis – 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.

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center at San Antonio
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ameet Nagpal, MD, Principal Investigator, UT Health San Antonio
  • Overall Contact(s)
    • Ameet Nagpal, MD, 2104509848, nagpala@uthscsa.edu

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