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Reducing the Abuse of Opioids in Drug Users

Primary Purpose

Opioid Abuse, Unspecified, Opioid Dependence

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxycodone/Placebo
Oxycodone/Risperidone
Oxycodone/Ziprasidone
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opioid Abuse, Unspecified

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Westgate Pain Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Oxycodone/Placebo

Oxycodone/Risperidone

Oxycodone/Ziprasidone

Arm Description

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

Each study participant will receive all three study interventions in random order. In this arm the participant receives a combination of oxycodone or risperidone

Each study participant will receive all three study interventions in random order. In this arm the participant receives a combination of oxycodone or ziprasidone

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Profile of Mood States (POMS)
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)
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.

Full Information

First Posted
February 5, 2019
Last Updated
January 31, 2022
Sponsor
The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT03837860
Brief Title
Reducing the Abuse of Opioids in Drug Users
Official Title
Reducing the Abuse Liability of Prescription Opioids in Recreational Drug Users: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
PI leaving institution
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
March 23, 2021 (Actual)
Study Completion Date
January 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Abuse, Unspecified, Opioid Dependence

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Model Description
Double-blinded, crossover study
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxycodone/Placebo
Arm Type
Active Comparator
Arm Description
Each study participant will receive all three study interventions in random order.In this arm, the participant receives oxycodone or placebo
Arm Title
Oxycodone/Risperidone
Arm Type
Active Comparator
Arm Description
Each study participant will receive all three study interventions in random order. In this arm the participant receives a combination of oxycodone or risperidone
Arm Title
Oxycodone/Ziprasidone
Arm Type
Active Comparator
Arm Description
Each study participant will receive all three study interventions in random order. In this arm the participant receives a combination of oxycodone or ziprasidone
Intervention Type
Drug
Intervention Name(s)
Oxycodone/Placebo
Other Intervention Name(s)
Oxycontin/Placebo
Intervention Description
Oxycodone 20 mg plus placebo
Intervention Type
Drug
Intervention Name(s)
Oxycodone/Risperidone
Other Intervention Name(s)
Oxycontin/Risperdal
Intervention Description
Oxycodone (20mg) plus Risperidone (2 mg)
Intervention Type
Drug
Intervention Name(s)
Oxycodone/Ziprasidone
Other Intervention Name(s)
Oxycontin/Geodon
Intervention Description
Oxycodone (20mg) plus Ziprasidone (80 mg)
Primary Outcome Measure Information:
Title
Change in Bipolar Visual Analog Scale (VAS) of Drug Likability
Description
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.
Time Frame
Study visit 2 to study visit 6, an average of 10 days
Secondary Outcome Measure Information:
Title
Change in Profile of Mood States (POMS)
Description
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.
Time Frame
Study visit 2 to study visit 6, an average of 10 days
Title
Change in Addiction Research Center Inventory Short Form (ARCI-SF)
Description
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.
Time Frame
Study visit 2 to study visit 6, an average of 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ameet Nagpal, MD
Organizational Affiliation
UT Health San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westgate Pain Clinic
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Reducing the Abuse of Opioids in Drug Users

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