Reducing the Abuse of Opioids in Drug Users

NCT ID: NCT03837860

Last Updated: 2022-02-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2022-01-21

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Oxycodone/Placebo

Each study participant will receive all three study interventions in random order.In this arm, the participant receives oxycodone or placebo

Group Type: ACTIVE_COMPARATOR

Oxycodone/Placebo

Intervention Type: DRUG

Oxycodone 20 mg plus placebo

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

Group Type: ACTIVE_COMPARATOR

Oxycodone/Risperidone

Intervention Type: DRUG

Oxycodone (20mg) plus Risperidone (2 mg)

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

Group Type: ACTIVE_COMPARATOR

Oxycodone/Ziprasidone

Intervention Type: DRUG

Oxycodone (20mg) plus Ziprasidone (80 mg)

Interventions

Oxycodone/Placebo

Oxycodone 20 mg plus placebo

Intervention Type: DRUG

Oxycodone/Risperidone

Oxycodone (20mg) plus Risperidone (2 mg)

Intervention Type: DRUG

Oxycodone/Ziprasidone

Oxycodone (20mg) plus Ziprasidone (80 mg)

Intervention Type: DRUG

Other Intervention Names

Oxycontin/Placebo; Oxycontin/Risperdal; Oxycontin/Geodon

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ameet Nagpal, MD

Role: PRINCIPAL_INVESTIGATOR

UT Health San Antonio

Locations

Westgate Pain Clinic

San Antonio, Texas, United States

Countries

United States

Other Identifiers

HSC20180167

Identifier Type: -

Identifier Source: org_study_id