NCT03837860

Reducing the Abuse of Opioids in Drug Users

Reducing the Abuse Liability of Prescription Opioids in Recreational Drug Users: A Pilot Study

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

• Opioid Abuse, Unspecified
• Opioid Dependence

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2019-04-01
• Primary completion: 2021-03-23
• Completion: 2022-01-21
• First posted: 2019-02-12
• Last updated: 2022-02-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study