Narcotic AbuseNCT00999544
Aprepitant Effects on Oxycodone Response
A study testing Aprepitant 0mg, Aprepitant 40mg and Aprepitant 200mg in people with Narcotic Abuse, run by Sharon Walsh at 1 site in United States.
Trial summary
Addressing the issue of opioid dependence and tolerance has public health implications for the treatment of opioid abuse (both heroin as well as pharmaceutical opioids) and for the treatment of pain. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Narcotic Abuse
- What is being tested?
- Aprepitant 0mg, Aprepitant 40mg and Aprepitant 200mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Apr 2011
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recreational user of opioids
- Healthy
- Ages 18-55 years old
- Able to provide informed consent
Who cannot join
- Ongoing medical or psychiatric condition that would be contraindicated for participation
- Past 30 day use of and P4503A4 inhibitor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Neural Drug Targets: An Evaluation of the Effects of Aprepitant on the Response to Oxycodone
Addressing the issue of opioid dependence and tolerance has public health implications for the treatment of opioid abuse (both heroin as well as pharmaceutical opioids) and for the treatment of pain. Recent preclinical data suggest a role for Substance P (NK-1) receptors in modulating both the acute and chronic response to opioids. The objective of this study is to determine whether pretreatment with aprepitant, a selective neurokinin-1 (NK-1) antagonist can reduce the direct response to an opioid agonist (oxycodone) on measures related to abuse liability and reinforcing effects.
Read the detailed description
Healthy adult volunteers with histories of illicit opioid use by the intranasal and oral routes will be admitted to this 6-week inpatient, crossover study. They will participate in 15 experimental test sessions, each lasting approximately 6.5 hours, during which they will receive a range of acute doses of aprepitant, including placebo, followed by challenge with oxycodone or placebo (given intranasally or orally). Multi-dimensional outcomes, including physiological (blood pressure, oxygen saturation, pupil diameter), subjective (questionnaires related to mood, abuse liability) and observer ratings will be collected repeatedly throughout each session. Data will be analyzed using parametric approaches to within-subject designs.
- Conditions
- Narcotic Abuse
- Being tested
- Aprepitant 0mg, Aprepitant 40mg, Aprepitant 200mg, Oxycodone 0mg, p.o., Oxycodone 20mg, p.o.
- Keywords
- opioid, oxycodone, NK1 antagonist, aprepitant, intranasal, abuse
- Medical subject headings
- Narcotic-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aprepitant 0mgDrug
Aprepitant 0mg, p.o. pretreatment
Aprepitant 40mgDrug
Aprepitant 40mg, p.o. pretreatment
Aprepitant 200mgDrug
Aprepitant 200mg, p.o. pretreatment
Oxycodone 0mg, p.o.Drug
Oxycodone 0mg, p.o.
Oxycodone 20mg, p.o.Drug
Oxycodone 20mg, p.o.
Oxycodone 40mg, p.o.Drug
Oxycodone 40mg, p.o.
Oxycodone 0mg, INDrug
Oxycodone 0mg, IN
Oxycodone 15mg, INDrug
Oxycodone 15mg, IN
Oxycodone 30mg, INDrug
Oxycodone 30mg, IN
| Study group | Role | What they receive |
|---|---|---|
| Placebo aprepitant/0 mg oxycodone IN PO | Experimental | Placebo aprepitant/Placebo oxycodone IN/PO Receives: Drug: Aprepitant 0mg; Drug: Oxycodone 0mg, p.o.; Drug: Oxycodone 0mg, IN |
| Placebo aprepitant/ oxycodone 15 IN 0 PO | Experimental | Placebo aprepitant/ oxycodone 15 IN 0 PO Receives: Drug: Aprepitant 0mg; Drug: Oxycodone 0mg, p.o.; Drug: Oxycodone 15mg, IN |
| Placebo aprepitant/ oxycodone 30 IN 0 PO | Experimental | Placebo aprepitant/ oxycodone 30 IN 0 PO Receives: Drug: Aprepitant 0mg; Drug: Oxycodone 0mg, p.o.; Drug: Oxycodone 30mg, IN |
| Placebo aprepitant/ oxycodone 0 IN 20 PO | Experimental | Placebo aprepitant/ oxycodone 0 IN 20 PO Receives: Drug: Aprepitant 0mg; Drug: Oxycodone 20mg, p.o.; Drug: Oxycodone 0mg, IN |
| Placebo aprepitant/ oxycodone 0 IN 40 PO | Experimental | Placebo aprepitant/ oxycodone 0 IN 40 PO Receives: Drug: Aprepitant 0mg; Drug: Oxycodone 40mg, p.o.; Drug: Oxycodone 0mg, IN |
| Aprepitant 40 mg/ oxycodone 0 IN 0 PO | Experimental | Aprepitant 40 mg/ oxycodone 0 IN 0 PO Receives: Drug: Aprepitant 40mg; Drug: Oxycodone 0mg, p.o.; Drug: Oxycodone 0mg, IN |
| Aprepitant 40 mg/ oxycodone 0 IN 20 PO | Experimental | Aprepitant 40 mg/ oxycodone 0 IN 20 PO Receives: Drug: Aprepitant 40mg; Drug: Oxycodone 20mg, p.o.; Drug: Oxycodone 0mg, IN |
| Aprepitant 40 mg/ oxycodone 0 IN 40 PO | Experimental | Aprepitant 40 mg/ oxycodone 0 IN 40 PO Receives: Drug: Aprepitant 40mg; Drug: Oxycodone 40mg, p.o.; Drug: Oxycodone 0mg, IN |
| Aprepitant 40 mg/ oxycodone 15 IN 0 PO | Experimental | Aprepitant 40 mg/ oxycodone 15 IN 0 PO Receives: Drug: Aprepitant 40mg; Drug: Oxycodone 0mg, p.o.; Drug: Oxycodone 15mg, IN |
| Aprepitant 40 mg/ oxycodone 30 IN 0 PO | Experimental | Aprepitant 40 mg/ oxycodone 30 IN 0 PO Receives: Drug: Aprepitant 40mg; Drug: Oxycodone 0mg, p.o.; Drug: Oxycodone 30mg, IN |
| Aprepitant 200 mg/ oxycodone 0 IN 0 PO | Experimental | Aprepitant 200 mg/ oxycodone 0 IN 0 PO Receives: Drug: Aprepitant 200mg; Drug: Oxycodone 0mg, p.o.; Drug: Oxycodone 0mg, IN |
| Aprepitant 200 mg/ oxycodone 0 IN 20 PO | Experimental | Aprepitant 200 mg/ oxycodone 0 IN 20 PO Receives: Drug: Aprepitant 200mg; Drug: Oxycodone 20mg, p.o.; Drug: Oxycodone 0mg, IN |
| Aprepitant 200 mg/ oxycodone 0 IN 40 PO | Experimental | Aprepitant 200 mg/ oxycodone 0 IN 40 PO Receives: Drug: Aprepitant 200mg; Drug: Oxycodone 40mg, p.o.; Drug: Oxycodone 0mg, IN |
| Aprepitant 200 mg/ oxycodone 15 IN 0 PO | Experimental | Aprepitant 200 mg/ oxycodone 15 IN 0 PO Receives: Drug: Aprepitant 200mg; Drug: Oxycodone 0mg, p.o.; Drug: Oxycodone 15mg, IN |
| Aprepitant 200 mg/ oxycodone 30 IN 0 PO | Experimental | Aprepitant 200 mg/ oxycodone 30 IN 0 PO Receives: Drug: Aprepitant 200mg; Drug: Oxycodone 0mg, p.o.; Drug: Oxycodone 30mg, IN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abuse Liability Proxy
Visual analog scale ratings (from 0-100) on the subject-rated measure of "How much do you like the drug?" with higher scores indicating greater abuse liability (and 100 anchored with "extremely" and zero indicating none anchored with "none at all." Data were collected across multiple time points but the peak maximum score was used for the primary outcome measure.
Measured: 42 days
Secondary outcomes (1)
Respiration Depression
Respiration rate measured over 60 seconds. Data were collected across multiple time points, but the peak minimum score was used for this outcome measure.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionApr 2011
- Study completionApr 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Narcotic AbuseStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Within subject crossover designed that examined 15 experimental conditions within a single group of participants
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharon Walsh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Sharon Walsh, University of Kentucky
- Investigators
- Sharon L Walsh, Ph.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999544
- Sponsor's protocol ID
- 09-0446
- Other IDs
- R01DA027031
- Status last verified
- Aug 2017
- First submitted
- 20 Oct 2009
- Last updated
- 1 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Walsh SL, Heilig M, Nuzzo PA, Henderson P, Lofwall MR. Effects of the NK1 antagonist, aprepitant, on response to oral and intranasal oxycodone in prescription opioid abusers. Addict Biol. 2013 Mar;18(2):332-43. doi: 10.1111/j.1369-1600.2011.00419.x. Epub 2012 Jan 19.
PubMed 22260216
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Neural Drug Targets: An Evaluation of the Effects of Aprepitant on the Response to Oxycodone
- ClinicalTrials.gov ID
- NCT00999544
- Acronym / sponsor ID
- 09-0446
- Conditions
- Narcotic Abuse
- Keywords
- opioid, oxycodone, NK1 antagonist, aprepitant, intranasal, abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Sharon WalshUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Merck Sharp & Dohme LLC
- Study start
- Oct 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 21 Oct 2009 (estimated)
- Results
- Posted 23 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Addressing the issue of opioid dependence and tolerance has public health implications for the treatment of opioid abuse (both heroin as well as pharmaceutical opioids) and for the treatment of pain. Recent preclinical data suggest a role for Substance P (NK-1) receptors in modulating both the acute and chronic response to opioids. The objective of this study is to determine whether pretreatment with aprepitant, a selective neurokinin-1 (NK-1) antagonist can reduce the direct response to an opioid agonist (oxycodone) on measures related to abuse liability and reinforcing effects.
Detailed description
Healthy adult volunteers with histories of illicit opioid use by the intranasal and oral routes will be admitted to this 6-week inpatient, crossover study. They will participate in 15 experimental test sessions, each lasting approximately 6.5 hours, during which they will receive a range of acute doses of aprepitant, including placebo, followed by challenge with oxycodone or placebo (given intranasally or orally). Multi-dimensional outcomes, including physiological (blood pressure, oxygen saturation, pupil diameter), subjective (questionnaires related to mood, abuse liability) and observer ratings will be collected repeatedly throughout each session. Data will be analyzed using parametric approaches to within-subject designs.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 15
- Model description
- Within subject crossover designed that examined 15 experimental conditions within a single group of participants
| Arm | Type | Receives |
|---|---|---|
| Placebo aprepitant/0 mg oxycodone IN PO | Experimental | Drug: Aprepitant 0mg, Drug: Oxycodone 0mg, p.o., Drug: Oxycodone 0mg, INPlacebo aprepitant/Placebo oxycodone IN/PO |
| Placebo aprepitant/ oxycodone 15 IN 0 PO | Experimental | Drug: Aprepitant 0mg, Drug: Oxycodone 0mg, p.o., Drug: Oxycodone 15mg, INPlacebo aprepitant/ oxycodone 15 IN 0 PO |
| Placebo aprepitant/ oxycodone 30 IN 0 PO | Experimental | Drug: Aprepitant 0mg, Drug: Oxycodone 0mg, p.o., Drug: Oxycodone 30mg, INPlacebo aprepitant/ oxycodone 30 IN 0 PO |
| Placebo aprepitant/ oxycodone 0 IN 20 PO | Experimental | Drug: Aprepitant 0mg, Drug: Oxycodone 20mg, p.o., Drug: Oxycodone 0mg, INPlacebo aprepitant/ oxycodone 0 IN 20 PO |
| Placebo aprepitant/ oxycodone 0 IN 40 PO | Experimental | Drug: Aprepitant 0mg, Drug: Oxycodone 40mg, p.o., Drug: Oxycodone 0mg, INPlacebo aprepitant/ oxycodone 0 IN 40 PO |
| Aprepitant 40 mg/ oxycodone 0 IN 0 PO | Experimental | Drug: Aprepitant 40mg, Drug: Oxycodone 0mg, p.o., Drug: Oxycodone 0mg, INAprepitant 40 mg/ oxycodone 0 IN 0 PO |
| Aprepitant 40 mg/ oxycodone 0 IN 20 PO | Experimental | Drug: Aprepitant 40mg, Drug: Oxycodone 20mg, p.o., Drug: Oxycodone 0mg, INAprepitant 40 mg/ oxycodone 0 IN 20 PO |
| Aprepitant 40 mg/ oxycodone 0 IN 40 PO | Experimental | Drug: Aprepitant 40mg, Drug: Oxycodone 40mg, p.o., Drug: Oxycodone 0mg, INAprepitant 40 mg/ oxycodone 0 IN 40 PO |
| Aprepitant 40 mg/ oxycodone 15 IN 0 PO | Experimental | Drug: Aprepitant 40mg, Drug: Oxycodone 0mg, p.o., Drug: Oxycodone 15mg, INAprepitant 40 mg/ oxycodone 15 IN 0 PO |
| Aprepitant 40 mg/ oxycodone 30 IN 0 PO | Experimental | Drug: Aprepitant 40mg, Drug: Oxycodone 0mg, p.o., Drug: Oxycodone 30mg, INAprepitant 40 mg/ oxycodone 30 IN 0 PO |
| Aprepitant 200 mg/ oxycodone 0 IN 0 PO | Experimental | Drug: Aprepitant 200mg, Drug: Oxycodone 0mg, p.o., Drug: Oxycodone 0mg, INAprepitant 200 mg/ oxycodone 0 IN 0 PO |
| Aprepitant 200 mg/ oxycodone 0 IN 20 PO | Experimental | Drug: Aprepitant 200mg, Drug: Oxycodone 20mg, p.o., Drug: Oxycodone 0mg, INAprepitant 200 mg/ oxycodone 0 IN 20 PO |
| Aprepitant 200 mg/ oxycodone 0 IN 40 PO | Experimental | Drug: Aprepitant 200mg, Drug: Oxycodone 40mg, p.o., Drug: Oxycodone 0mg, INAprepitant 200 mg/ oxycodone 0 IN 40 PO |
| Aprepitant 200 mg/ oxycodone 15 IN 0 PO | Experimental | Drug: Aprepitant 200mg, Drug: Oxycodone 0mg, p.o., Drug: Oxycodone 15mg, INAprepitant 200 mg/ oxycodone 15 IN 0 PO |
| Aprepitant 200 mg/ oxycodone 30 IN 0 PO | Experimental | Drug: Aprepitant 200mg, Drug: Oxycodone 0mg, p.o., Drug: Oxycodone 30mg, INAprepitant 200 mg/ oxycodone 30 IN 0 PO |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Recreational user of opioids
- Healthy
- Ages 18-55 years old
- Able to provide informed consent
Key exclusion criteria (2 listed)
- Ongoing medical or psychiatric condition that would be contraindicated for participation
- Past 30 day use of and P4503A4 inhibitor
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 |
|---|---|---|
| Aprepitant 0mgAprepitant 0mg, p.o. pretreatment | Drug | Placebo aprepitant/ oxycodone 0 IN 20 PO, Placebo aprepitant/ oxycodone 0 IN 40 PO, Placebo aprepitant/ oxycodone 15 IN 0 PO, Placebo aprepitant/ oxycodone 30 IN 0 PO, Placebo aprepitant/0 mg oxycodone IN PO |
| Aprepitant 40mgAprepitant 40mg, p.o. pretreatment | Drug | Aprepitant 40 mg/ oxycodone 0 IN 0 PO, Aprepitant 40 mg/ oxycodone 0 IN 20 PO, Aprepitant 40 mg/ oxycodone 0 IN 40 PO, Aprepitant 40 mg/ oxycodone 15 IN 0 PO, Aprepitant 40 mg/ oxycodone 30 IN 0 PO |
| Aprepitant 200mgAprepitant 200mg, p.o. pretreatment | Drug | Aprepitant 200 mg/ oxycodone 0 IN 0 PO, Aprepitant 200 mg/ oxycodone 0 IN 20 PO, Aprepitant 200 mg/ oxycodone 0 IN 40 PO, Aprepitant 200 mg/ oxycodone 15 IN 0 PO, Aprepitant 200 mg/ oxycodone 30 IN 0 PO |
| Oxycodone 0mg, p.o.Oxycodone 0mg, p.o. | Drug | Aprepitant 200 mg/ oxycodone 0 IN 0 PO, Aprepitant 200 mg/ oxycodone 15 IN 0 PO, Aprepitant 200 mg/ oxycodone 30 IN 0 PO, Aprepitant 40 mg/ oxycodone 0 IN 0 PO, Aprepitant 40 mg/ oxycodone 15 IN 0 PO, Aprepitant 40 mg/ oxycodone 30 IN 0 PO, Placebo aprepitant/ oxycodone 15 IN 0 PO, Placebo aprepitant/ oxycodone 30 IN 0 PO, Placebo aprepitant/0 mg oxycodone IN PO |
| Oxycodone 20mg, p.o.Oxycodone 20mg, p.o. | Drug | Aprepitant 200 mg/ oxycodone 0 IN 20 PO, Aprepitant 40 mg/ oxycodone 0 IN 20 PO, Placebo aprepitant/ oxycodone 0 IN 20 PO |
| Oxycodone 40mg, p.o.Oxycodone 40mg, p.o. | Drug | Aprepitant 200 mg/ oxycodone 0 IN 40 PO, Aprepitant 40 mg/ oxycodone 0 IN 40 PO, Placebo aprepitant/ oxycodone 0 IN 40 PO |
| Oxycodone 0mg, INOxycodone 0mg, IN | Drug | Aprepitant 200 mg/ oxycodone 0 IN 0 PO, Aprepitant 200 mg/ oxycodone 0 IN 20 PO, Aprepitant 200 mg/ oxycodone 0 IN 40 PO, Aprepitant 40 mg/ oxycodone 0 IN 0 PO, Aprepitant 40 mg/ oxycodone 0 IN 20 PO, Aprepitant 40 mg/ oxycodone 0 IN 40 PO, Placebo aprepitant/ oxycodone 0 IN 20 PO, Placebo aprepitant/ oxycodone 0 IN 40 PO, Placebo aprepitant/0 mg oxycodone IN PO |
| Oxycodone 15mg, INOxycodone 15mg, IN | Drug | Aprepitant 200 mg/ oxycodone 15 IN 0 PO, Aprepitant 40 mg/ oxycodone 15 IN 0 PO, Placebo aprepitant/ oxycodone 15 IN 0 PO |
| Oxycodone 30mg, INOxycodone 30mg, IN | Drug | Aprepitant 200 mg/ oxycodone 30 IN 0 PO, Aprepitant 40 mg/ oxycodone 30 IN 0 PO, Placebo aprepitant/ oxycodone 30 IN 0 PO |
Primary outcome
Abuse Liability Proxy
Time frame: 42 days
Visual analog scale ratings (from 0-100) on the subject-rated measure of "How much do you like the drug?" with higher scores indicating greater abuse liability (and 100 anchored with "extremely" and zero indicating none anchored with "none at all." Data were collected across multiple time points but the peak maximum score was used for the primary outcome measure.
1 secondary outcome
Respiration Depression
Time frame: 42 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22260216Walsh SL, Heilig M, Nuzzo PA, Henderson P, Lofwall MR. Effects of the NK1 antagonist, aprepitant, on response to oral and intranasal oxycodone in prescription opioid abusers. Addict Biol. 2013 Mar;18(2):332-43. doi: 10.1111/j.1369-1600.2011.00419.x. Epub 2012 Jan 19.
Related trials for Narcotic Abuse
Active, not recruiting
The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
Opioid Dependence, Substance Abuse Disorders
Recruiting
Improving Jail Response to the Overdose Crisis: A Hybrid Trial of Jail ECHO to Improve MOUD Implementation and Public Health Outcomes
Opioid Abuse (Disorder)
Not yet recruitingPhase 1
Cannabis Effects on Opioid Self-Administration
Opioid Use Disorder, Cannabis Use
Not yet recruitingPhase 1
Cannabis and Opioid Use Disorder, Study 2
Opioid Use Disorders, Cannabis Use
Enrolling by invitationPhase 4
Reducing Opioid Use After Upper Extremity Surgery: Testing Lower Prescriptions and Pill Quantity
Opioid Abuse (Disorder), Opioid Analgesia
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.
Sharon L Walsh, Ph.D. principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aprepitant 0mg, Aprepitant 40mg and Aprepitant 200mg in people with Narcotic Abuse, run by Sharon Walsh 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 4 inclusion and 2 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 1 Sep 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2013). 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?
Abuse Liability Proxy (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00999544, which also lists 1 linked publication.
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 1 Sep 2017.