Prescription Drug Abuse (Not Dependent)Early Phase 1NCT03612713
Influence of Medication on Functional Connectivity
A Early Phase 1 study testing Oxycodone Medication First in people with Prescription Drug Abuse (Not Dependent), run by Yale University at 1 site in United States.
Trial summary
This study will assess the effects of acute low-dose opioid administration on functional neuroimaging measures in healthy individuals Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Prescription Drug Abuse (Not Dependent)
- What is being tested?
- Oxycodone Medication First
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2018to 2 Jun 2022
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- males or females, ages 18-30
- for women of a child-bearing age, acceptable birth control methods or a negative pregnancy test prior to MRI scanning
- ability to provide written, informed consent
- eligibility and willingness to participate in fMRI scanning and to receive oxycodone
- normal weight, as indicated by a body mass index (BMI) between 18.5 to 25
Who cannot join
- current DSM-5 Axis I disorder
- any psychotropic medication or medication known to interfere with metabolism of opioids
- medical contraindication to participate in study activities (acute low-dose opioid admin) as determined by study physician
- known family history (first-degree relative) of opioid-use disorder or alcohol-use disorder
- not eligible for MRI scanning
- positive drug screen
Show all 9Show fewer
- recent (past 6 months) medical or non-medical opioid-use
- current or previous chronic pain disorder
- significant lifetime use of prescription opioids (>7 days of consecutive medical use or nonmedical use on more than 5 occasions)
Trial locations and contacts
1 site in 1 country.
United States1 site
Magnetic Resonance Research Center at The Anlyan Center Yale School of Medicine
New Haven, Connecticut, 06511
About this study
This study will assess the effects of acute low-dose opioid administration on functional neuroimaging measures in healthy individuals
Read the detailed description
This study will assess the effects of acute low-dose opioid administration on functional neuroimaging measures in healthy individuals (N=40, 20 male, 20 female). The objective of this research is to develop an understanding of factors that may influence individual variability on resting state functional connectivity in response to low-dose opioid administration with the longer term aim of understanding addictions vulnerability. Specifically, the proposed pilot research will explore the effects of single dose of oxycodone (15mg) on resting state functional connectivity and other common neuroimaging measures (e.g., diffusion MRI, structural MRI).
- Conditions
- Prescription Drug Abuse (Not Dependent)
- Being tested
- Oxycodone Medication First, Placebo First
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone Medication FirstDrug
Also called Oxycodone
Participants will be given 15mg oxycodone one hour before fMRI scan. After at least 1 week wash out participants will be given placebo one hour before fMRI scan.
Placebo FirstDrug
Also called placebo
Participants will be given placebo one hour before fMRI scan. After at least 1 week wash out participants will be given 15mg oxycodone one hour before fMRI scan.
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone Medication First | Active comparator | one hour before fMRI scan participants will be given a single dose 15mg immediate release oxycodone Receives: Drug: Oxycodone Medication First |
| Placebo First | Placebo comparator | one hour before fMRI scan participants will be given a single dose placebo. Receives: Drug: Placebo First |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Connectivity Following Oxycodone Administration
Functional connectivity is measured by functional magnetic resonance imagery (fMRI). Change in functional connectivity (a statistical relationship between two regions in the brain) between placebo and oxycodone fMRI scans will be assessed. Result is a transformed z-score. A score of 0 indicates no change. Higher scores indicate increased connectivity.
Measured: Change in functional connectivity from initial fMRI scan to follow-up MRI scan, up to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start30 Oct 2018
- Primary completion2 Jun 2022
- Study completion2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prescription Drug Abuse (Not Dependent)Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Sarah Yip, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612713
- Sponsor's protocol ID
- 2000020857
- Other IDs
- 1R21DA045969-01, 1K01DA039299-01A1
- Status last verified
- Mar 2024
- First submitted
- 2 Jul 2018
- Last updated
- 8 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Medication on Functional Connectivity
- ClinicalTrials.gov ID
- NCT03612713
- Acronym / sponsor ID
- 2000020857
- Conditions
- Prescription Drug Abuse (Not Dependent)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Posted 8 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the effects of acute low-dose opioid administration on functional neuroimaging measures in healthy individuals
Detailed description
This study will assess the effects of acute low-dose opioid administration on functional neuroimaging measures in healthy individuals (N=40, 20 male, 20 female). The objective of this research is to develop an understanding of factors that may influence individual variability on resting state functional connectivity in response to low-dose opioid administration with the longer term aim of understanding addictions vulnerability. Specifically, the proposed pilot research will explore the effects of single dose of oxycodone (15mg) on resting state functional connectivity and other common neuroimaging measures (e.g., diffusion MRI, structural MRI).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxycodone Medication First | Active comparator | Drug: Oxycodone Medication Firstone hour before fMRI scan participants will be given a single dose 15mg immediate release oxycodone |
| Placebo First | Placebo comparator | Drug: Placebo Firstone hour before fMRI scan participants will be given a single dose placebo. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- males or females, ages 18-30
- for women of a child-bearing age, acceptable birth control methods or a negative pregnancy test prior to MRI scanning
- ability to provide written, informed consent
- eligibility and willingness to participate in fMRI scanning and to receive oxycodone
- normal weight, as indicated by a body mass index (BMI) between 18.5 to 25
Key exclusion criteria (9 listed)
- current DSM-5 Axis I disorder
- any psychotropic medication or medication known to interfere with metabolism of opioids
- medical contraindication to participate in study activities (acute low-dose opioid admin) as determined by study physician
- known family history (first-degree relative) of opioid-use disorder or alcohol-use disorder
- not eligible for MRI scanning
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 Medication FirstAlso: OxycodoneParticipants will be given 15mg oxycodone one hour before fMRI scan. After at least 1 week wash out participants will be given placebo one hour before fMRI scan. | Drug | Oxycodone Medication First |
| Placebo FirstAlso: placeboParticipants will be given placebo one hour before fMRI scan. After at least 1 week wash out participants will be given 15mg oxycodone one hour before fMRI scan. | Drug | Placebo First |
Primary outcome
Change in Functional Connectivity Following Oxycodone Administration
Time frame: Change in functional connectivity from initial fMRI scan to follow-up MRI scan, up to 4 weeks.
Functional connectivity is measured by functional magnetic resonance imagery (fMRI). Change in functional connectivity (a statistical relationship between two regions in the brain) between placebo and oxycodone fMRI scans will be assessed. Result is a transformed z-score. A score of 0 indicates no change. Higher scores indicate increased connectivity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Sarah Yip, PhD principal investigator
Yale University
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 Medication First in people with Prescription Drug Abuse (Not Dependent), run by Yale University 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 5 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 8 Mar 2024. 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?
Yes. Results are posted in the registry (first posted 8 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Functional Connectivity Following Oxycodone Administration (time frame: Change in functional connectivity from initial fMRI scan to follow-up MRI scan, up to 4 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 8 Mar 2024.