Reducing the Abuse of Opioids in Drug Users

NCT03837860 | Terminated Early Phase 1 DMC FDA Drug

• 1 other identifier: HSC20180167
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Bipolar Visual Analog Scale (VAS) of Drug Likability

  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.

  Study visit 2 to study visit 6, an average of 10 days

Secondary Outcomes (2)

• Change in Profile of Mood States (POMS)

  Study visit 2 to study visit 6, an average of 10 days

• Change in Addiction Research Center Inventory Short Form (ARCI-SF)

  Study visit 2 to study visit 6, an average of 10 days

Study Arms (3)

Oxycodone/Placebo

ACTIVE COMPARATOR

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/Risperidone

ACTIVE COMPARATOR

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/Ziprasidone

ACTIVE COMPARATOR

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

Interventions

Oxycodone/Placebo DRUG

Oxycodone 20 mg plus placebo

Also known as: Oxycontin/Placebo

Oxycodone/Placebo

Oxycodone/Risperidone DRUG

Oxycodone (20mg) plus Risperidone (2 mg)

Also known as: Oxycontin/Risperdal

Oxycodone/Risperidone

Oxycodone/Ziprasidone DRUG

Oxycodone (20mg) plus Ziprasidone (80 mg)

Also known as: Oxycontin/Geodon

Oxycodone/Ziprasidone

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Westgate Pain Clinic

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Oxycodone; Risperidone; ziprasidone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Ameet Nagpal, MD

  UT Health San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded, crossover study

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 12, 2019
• Study Start: April 1, 2019
• Primary Completion: March 23, 2021
• Study Completion: January 21, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)