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Reducing the Abuse of Opioids in Drug Users

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ClinicalTrials.gov Identifier: NCT03837860
Recruitment Status : Not yet recruiting
First Posted : February 12, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Ameet Nagpal, The University of Texas Health Science Center at San Antonio

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.


Condition or disease Intervention/treatment Phase
Opioid Abuse, Unspecified Opioid Dependence Drug: Oxycodone/Placebo Drug: Oxycodone/Risperidone Drug: Oxycodone/Ziprasidone Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double-blinded, crossover study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing the Abuse Liability of Prescription Opioids in Recreational Drug Users: A Pilot Study
Estimated Study Start Date : March 31, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020


Arm Intervention/treatment
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
Drug: Oxycodone/Placebo
Oxycodone 20 mg plus placebo
Other Name: Oxycontin/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
Drug: Oxycodone/Risperidone
Oxycodone (20mg) plus Risperidone (2 mg)
Other Name: Oxycontin/Risperdal

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
Drug: Oxycodone/Ziprasidone
Oxycodone (20mg) plus Ziprasidone (80 mg)
Other Name: Oxycontin/Geodon




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 of ≥ 30 morphine milligram equivalents (MME) (i.e. 20mg oxycodone)

Exclusion Criteria:

  • Presence of psychiatric comorbidity
  • Presence of heroin use
  • Current enrollment in opioid addiction program (i.e. buprenorphine or methadone clinic)"
  • Presence of chronic pain disorder
  • Current neuroleptic medication in past 30 days
  • Pregnancy
  • Positive drug urine test for Heroin, Cocaine, Amphetamine, Meth-amphetamine, Barbiturates, Benzodiazepines, Ecstasy, Methadone, Phencyclidine, and Buprenorphine.
  • Subjects with a prolonged QT interval greater than 430ms
  • Subjects with a heart rate of less than 60 or greater than 100bpm
  • Subjects with serum potassium and/or magnesium outside of normal range of our institutional laboratory within the past three months from time of screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837860


Contacts
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Contact: Ameet Nagpal, MD 2104509848 nagpala@uthscsa.edu
Contact: Grace Ihsiu Todd, MSN 2105510715 toddg@uthscsa.edu

Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Ameet Nagpal, MD UT Health San Antonio

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Responsible Party: Ameet Nagpal, Associate Professor, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT03837860     History of Changes
Other Study ID Numbers: HSC20180167
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Oxycodone
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Risperidone
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents