AddictionEarly Phase 1NCT04587115
Reducing the Abuse Liability of Prescription Opioids
A Early Phase 1 study testing Risperidone, Ziprasidone and Oxycodone in people with Addiction, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Opioid (commonly called narcotic) pain medicines are, after marijuana, the most commonly abused substances in the United States. Patients who take opioids for legitimate reasons may become addicted; for example, as many as 1 in 4 patients meet the criteria for current opioid dependence. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Addiction
- What is being tested?
- Risperidone, Ziprasidone and Oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2017to 1 Jan 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Requirement of prior exposure to opioids
Who cannot join
- Presence of psychiatric comorbidity
- Presence of chronic pain disorder
- Presence or history of substance use disorder
- Current analgesic or neuroleptic medication usage (any medication for pain, including over-the-counter analgesics like ibuprofen/acetaminophen)
- Pregnancy
- Positive drug urine test
Show all 9Show fewer
- Continuous opioid misuse measure score of < 9
- Presence or history of diabetes
- Presence or history of cardiac disease or arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
Opioid (commonly called narcotic) pain medicines are, after marijuana, the most commonly abused substances in the United States. Patients who take opioids for legitimate reasons may become addicted; for example, as many as 1 in 4 patients meet the criteria for current opioid dependence. It is very important that a way is found to provide pain relief while minimizing the addiction potential of these widely used pain medications.
The study aim to find out if the use of another type of medication given in addition to an opioid will reduce the addiction potential of the opioid.
The study is trying to find out if the ability of the opioid to relieve pain is changed when given with the other medication, and to see if the euphoric sensation or "liking" of the opioid pain medication is reduced when taken with the other medication.
Read the detailed description
This study involves the use of an investigational combination of drugs. "Oxycodone with Risperidone" and "Oxycodone with Ziprasidone" are called "Investigational" because the U.S. Food \& Drug Administration (FDA) has not approved these drug combinations for the purpose of this study. Individually, each of these drugs is approved by the FDA for other reasons (i.e. oxycodone as a painkiller, while risperidone and ziprasidone are approved as anti-psychotic medications), but the administration of these drugs together has not been studied before or been approved by the FDA for this purpose.
This is the first study involving humans to examine the safety of this combination of drugs and how they work together. The goal of the study is to find out what effects, good and/or bad, it has on people who take them. Because the combination has not been studied in humans before, information about the safety and effectiveness is incomplete and all of the side effects are not yet known.
- Conditions
- Addiction
- Being tested
- Risperidone, Ziprasidone, Oxycodone
- Keywords
- opioid
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
Also called Risperdal
Risperidone 1mg to be used in combination with other drugs
ZiprasidoneDrug
Also called Geodon
Ziprasidone 80mg to be used in combination with other study drugs
OxycodoneDrug
Also called Oxycontin
Oxycodone alone in a capsule will be considered the control. Oxycodone 15 mg will also be used in combination with other study drugs
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone | Placebo comparator | This arm will be considered the control arm, containing oxycodone as the placebo. Receives: Drug: Oxycodone |
| Oxycodone and Risperidone | Experimental | Administration of oxycodone plus risperidone in a single capsule Receives: Drug: Risperidone; Drug: Oxycodone |
| Oxycodone and Ziprasidone | Experimental | Administration of oxycodone and risperidone in a single capsule Receives: Drug: Ziprasidone; Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of analgesic efficacy- Cold pressor
Perform quantitative evaluations of the analgesic efficacy of a novel fixed dose combination (FDC) of an opioid (oxycodone) in combination with one of two atypical antipsychotic drugs (either risperidone or ziprasidone) compared to the opioid alone. Analgesic efficacy will be measured with the cold pressor task which measures thermal pain. The cold pressor task measures the time the participant can tolerate their hand being submerged in the cold water up to a maximum of 5 minutes.
Measured: two weeks
Secondary outcomes (4)
Evaluation of analgesic efficacy- Thumb pressor
Perform quantitative evaluations of the analgesic efficacy of a novel fixed dose combination (FDC) of an opioid (oxycodone) in combination with one of two atypical antipsychotic drugs (either risperidone or ziprasidone) compared to the opioid alone. Analgesic efficacy will be measured with the thumb pressor task which measures mechanical pain. The thumb pressor task measures the amount of weight they can tolerate on the nail of their thumb up to a maximum of 10 kg.
Measured: two weeks
Drug liking
Examine subjective ratings of drug liking of the FDC compared to that of the opioid alone using the Bipolar Visual analog scale on a scale of 0-Dislike to 100-Extremely like.
Measured: two weeks
Addiction Research Center Inventory test questionnaire
Perform the Addiction Research Center Inventory Short Form (ARCI-SF) questionnaire to assess the drug-induced transient alterations in distinct mood states of the FDC compared to those of the opioid alone. 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, the study team will be using the 49-item short form. Outcome will be assessed using categorical and continuous data analysis comparing across groups. The ARCI-SF measures the subjective effects of a variety of drugs such as alcohol, morphine, LSD, and pentobarbital by a score for each subset. The higher a participant scores on a subset, the more similar the effects of the drug are to the known drug such as alcohol.
Measured: two weeks
Profile of Mood States test questionnaire
Perform a subset of the Profile of Mood States questionnaire to assess drug-induced transient alterations in distinct mood states following administration of the FDC compared to those of the opioid alone. 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. The POMS is a non-diagnostic test that assesses transient and distinct mood states such as tension, depression, anger, fatigue, confusion, vigor, and total mood disturbance. The higher a participant scores in each group, the more they experience that mood state.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start16 Jun 2017
- Primary completion1 Jun 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AddictionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Eckmann, The University of Texas Health Science Center at San Antonio
- Investigators
- Max Eckmann, MD, Principal investigator, University of Texas Health at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587115
- Sponsor's protocol ID
- HSC20170141H
- Status last verified
- Oct 2020
- First submitted
- 19 Aug 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared with other collaborating investigators, and unidentified data will be shared at study completion as a publication.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing the Abuse Liability of Prescription Opioids
- ClinicalTrials.gov ID
- NCT04587115
- Acronym / sponsor ID
- HSC20170141H
- Conditions
- Addiction
- Keywords
- opioid
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 14 Oct 2020 (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.
Opioid (commonly called narcotic) pain medicines are, after marijuana, the most commonly abused substances in the United States. Patients who take opioids for legitimate reasons may become addicted; for example, as many as 1 in 4 patients meet the criteria for current opioid dependence. It is very important that a way is found to provide pain relief while minimizing the addiction potential of these widely used pain medications.
The study aim to find out if the use of another type of medication given in addition to an opioid will reduce the addiction potential of the opioid.
The study is trying to find out if the ability of the opioid to relieve pain is changed when given with the other medication, and to see if the euphoric sensation or "liking" of the opioid pain medication is reduced when taken with the other medication.
Detailed description
This study involves the use of an investigational combination of drugs. "Oxycodone with Risperidone" and "Oxycodone with Ziprasidone" are called "Investigational" because the U.S. Food \& Drug Administration (FDA) has not approved these drug combinations for the purpose of this study. Individually, each of these drugs is approved by the FDA for other reasons (i.e. oxycodone as a painkiller, while risperidone and ziprasidone are approved as anti-psychotic medications), but the administration of these drugs together has not been studied before or been approved by the FDA for this purpose.
This is the first study involving humans to examine the safety of this combination of drugs and how they work together. The goal of the study is to find out what effects, good and/or bad, it has on people who take them. Because the combination has not been studied in humans before, information about the safety and effectiveness is incomplete and all of the side effects are not yet known.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxycodone | Placebo comparator | Drug: OxycodoneThis arm will be considered the control arm, containing oxycodone as the placebo. |
| Oxycodone and Risperidone | Experimental | Drug: Risperidone, Drug: OxycodoneAdministration of oxycodone plus risperidone in a single capsule |
| Oxycodone and Ziprasidone | Experimental | Drug: Ziprasidone, Drug: OxycodoneAdministration of oxycodone and risperidone in a single capsule |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Requirement of prior exposure to opioids
Key exclusion criteria (9 listed)
- Presence of psychiatric comorbidity
- Presence of chronic pain disorder
- Presence or history of substance use disorder
- Current analgesic or neuroleptic medication usage (any medication for pain, including over-the-counter analgesics like ibuprofen/acetaminophen)
- Pregnancy
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 |
|---|---|---|
| RisperidoneAlso: RisperdalRisperidone 1mg to be used in combination with other drugs | Drug | Oxycodone and Risperidone |
| ZiprasidoneAlso: GeodonZiprasidone 80mg to be used in combination with other study drugs | Drug | Oxycodone and Ziprasidone |
| OxycodoneAlso: OxycontinOxycodone alone in a capsule will be considered the control. Oxycodone 15 mg will also be used in combination with other study drugs | Drug | Oxycodone, Oxycodone and Risperidone, Oxycodone and Ziprasidone |
Primary outcome
Evaluation of analgesic efficacy- Cold pressor
Time frame: two weeks
Perform quantitative evaluations of the analgesic efficacy of a novel fixed dose combination (FDC) of an opioid (oxycodone) in combination with one of two atypical antipsychotic drugs (either risperidone or ziprasidone) compared to the opioid alone. Analgesic efficacy will be measured with the cold pressor task which measures thermal pain. The cold pressor task measures the time the participant can tolerate their hand being submerged in the cold water up to a maximum of 5 minutes.
4 secondary outcomes
Evaluation of analgesic efficacy- Thumb pressor
Time frame: two weeks
Drug liking
Time frame: two weeks
Addiction Research Center Inventory test questionnaire
Time frame: two weeks
Profile of Mood States test questionnaire
Time frame: two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared with other collaborating investigators, and unidentified data will be shared at study completion as a publication.
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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.
Max Eckmann, MD principal investigator
University of Texas Health 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 Risperidone, Ziprasidone and Oxycodone in people with Addiction, 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 1 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: finished, as of the sponsor's last update on 14 Oct 2020. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of analgesic efficacy- Cold pressor (time frame: two weeks). 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 14 Oct 2020.