Opioid Abuse, UnspecifiedEarly Phase 1NCT03837860
Reducing the Abuse of Opioids in Drug Users
A Early Phase 1 study testing Oxycodone/Risperidone and Oxycodone/Ziprasidone in people with Opioid Abuse, Unspecified and Opioid Dependence, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Opioid Abuse, Unspecified, Opioid Dependence
- What is being tested?
- Oxycodone/Risperidone and Oxycodone/Ziprasidone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 21 Jan 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing the Abuse Liability of Prescription Opioids in Recreational Drug Users: A Pilot Study
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
- Being tested
- Oxycodone/Placebo, Oxycodone/Risperidone, Oxycodone/Ziprasidone
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone/PlaceboDrug
Also called Oxycontin/Placebo
Oxycodone 20 mg plus placebo
Oxycodone/RisperidoneDrug
Also called Oxycontin/Risperdal
Oxycodone (20mg) plus Risperidone (2 mg)
Oxycodone/ZiprasidoneDrug
Also called Oxycontin/Geodon
Oxycodone (20mg) plus Ziprasidone (80 mg)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: Oxycodone/Ziprasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study visit 2 to study visit 6, an average of 10 days
Secondary outcomes (2)
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.
Measured: Study visit 2 to study visit 6, an average of 10 days
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.
Measured: Study visit 2 to study visit 6, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start1 Apr 2019
- Primary completion23 Mar 2021
- Study completion21 Jan 2022
Why it stopped: PI leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Abuse, UnspecifiedStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blinded, crossover study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ameet Nagpal, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837860
- Sponsor's protocol ID
- HSC20180167
- Status last verified
- Jan 2022
- First submitted
- 5 Feb 2019
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing the Abuse Liability of Prescription Opioids in Recreational Drug Users: A Pilot Study
- ClinicalTrials.gov ID
- NCT03837860
- Acronym / sponsor ID
- HSC20180167
- Conditions
- Opioid Abuse, Unspecified, Opioid Dependence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI leaving institution
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blinded, crossover study
| Arm | Type | Receives |
|---|---|---|
| Oxycodone/Placebo | Active comparator | Drug: Oxycodone/PlaceboEach study participant will receive all three study interventions in random order.In this arm, the participant receives oxycodone or placebo |
| Oxycodone/Risperidone | Active comparator | Drug: Oxycodone/RisperidoneEach study participant will receive all three study interventions in random order. In this arm the participant receives a combination of oxycodone or risperidone |
| Oxycodone/Ziprasidone | Active comparator | Drug: Oxycodone/ZiprasidoneEach study participant will receive all three study interventions in random order. In this arm the participant receives a combination of oxycodone or ziprasidone |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycodone/PlaceboAlso: Oxycontin/PlaceboOxycodone 20 mg plus placebo | Drug | Oxycodone/Placebo |
| Oxycodone/RisperidoneAlso: Oxycontin/RisperdalOxycodone (20mg) plus Risperidone (2 mg) | Drug | Oxycodone/Risperidone |
| Oxycodone/ZiprasidoneAlso: Oxycontin/GeodonOxycodone (20mg) plus Ziprasidone (80 mg) | Drug | Oxycodone/Ziprasidone |
Primary outcome
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.
2 secondary outcomes
Change in Profile of Mood States (POMS)
Time frame: Study visit 2 to study visit 6, an average of 10 days
Change in Addiction Research Center Inventory Short Form (ARCI-SF)
Time frame: Study visit 2 to study visit 6, an average of 10 days
Results and safety
The study was stopped early (reason given: PI leaving institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ameet Nagpal, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oxycodone/Risperidone and Oxycodone/Ziprasidone in people with Opioid Abuse, Unspecified and Opioid Dependence, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI leaving institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bipolar Visual Analog Scale (VAS) of Drug Likability (time frame: Study visit 2 to study visit 6, an average of 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.