Cocaine Use DisorderEarly Phase 1NCT03348384
[11C]NOP-1A and Cocaine Use Disorders
A Early Phase 1 study testing [C-11] and NOP-1A in people with Cocaine Use Disorder, run by University of Pittsburgh at 1 site in United States.
Trial summary
The goal of this study is to compared [C-11]NOP-1A binding in recently abstinent cocaine use disorders and controls. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- [C-11] and NOP-1A
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2014to 20 Feb 2019
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or Females 18-50
- Fulfill DSM-5 Diagnosis for Cocaine use disorder
- Medically Healthy
- Major exclusion criteria:
- Pregnancy or lactation
- Comorbid medical, psychiatric, drug use disorders (other than cocaine, tobacco use, and recreational marijuana/alcohol use)
Show all 21Show fewer
- Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
- Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year
- Currently on any psychotropic medications that can influence nociceptin transmission in the brain (e.g., morphine, suboxone, SSRIs, etc.)
- [B] Healthy controls
- Males or Females 18-50
- Absence of present or past psychiatric conditions (including alcohol or drug use disorders)
- A negative urine drug screen
- Medically Healthy
- Major exclusion criteria
- Pregnancy or lactation
- Medical, psychiatric or drug \& alcohol use disorders
- Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
- Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year
- Currently on any psychotropic medications that can influence nociceptin transmission in the brain
- Family history of a psychotic disorder, manic episode, drug use disorders in first-degree relatives.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Linking Nociceptive Opioid Peptide (NOP) Receptors With Relapse in Cocaine Use Disorders
The goal of this study is to compared [C-11]NOP-1A binding in recently abstinent cocaine use disorders and controls.
Read the detailed description
This will allow for understanding brain stress and anti-stress mechanisms that underlie abuse of cocaine in humans.
- Conditions
- Cocaine Use Disorder
- Being tested
- [C-11], NOP-1A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[C-11]Radiation
Radiolabel
NOP-1ADrug
Tracer
| Study group | Role | What they receive |
|---|---|---|
| Cocaine use disorders | Experimental | PET scan Receives: Radiation: [C-11]; Drug: NOP-1A |
| Controls | Experimental | PET scan Receives: Radiation: [C-11]; Drug: NOP-1A |
What is being measured
The primary outcome is the main question the study is designed to answer.
[C-11]NOP-1A VT
VT-volume of distribution expressed relative to total plasma
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start30 Oct 2014
- Primary completion20 Feb 2019
- Study completion20 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- \[C-11\]NOP-1A
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Rajesh Narendran, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348384
- Sponsor's protocol ID
- PRO14080588
- Other IDs
- R01DA026472
- Status last verified
- Aug 2019
- First submitted
- 16 Nov 2017
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Nociceptive Opioid Peptide (NOP) Receptors With Relapse in Cocaine Use Disorders
- ClinicalTrials.gov ID
- NCT03348384
- Acronym / sponsor ID
- PRO14080588
- Conditions
- Cocaine Use Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 30 Oct 2014 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 20 Nov 2017 (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 goal of this study is to compared [C-11]NOP-1A binding in recently abstinent cocaine use disorders and controls.
Detailed description
This will allow for understanding brain stress and anti-stress mechanisms that underlie abuse of cocaine in humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- [C-11]NOP-1A
| Arm | Type | Receives |
|---|---|---|
| Cocaine use disorders | Experimental | Radiation: [C-11], Drug: NOP-1APET scan |
| Controls | Experimental | Radiation: [C-11], Drug: NOP-1APET scan |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Males or Females 18-50
- Fulfill DSM-5 Diagnosis for Cocaine use disorder
- Medically Healthy
- Pregnancy or lactation
- Comorbid medical, psychiatric, drug use disorders (other than cocaine, tobacco use, and recreational marijuana/alcohol use)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| [C-11]Radiolabel | Radiation | Cocaine use disorders, Controls |
| NOP-1ATracer | Drug | Cocaine use disorders, Controls |
Primary outcome
[C-11]NOP-1A VT
Time frame: Baseline
VT-volume of distribution expressed relative to total plasma
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 5 Aug 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 [C-11] and NOP-1A in people with Cocaine Use Disorder, run by University of Pittsburgh 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 21 inclusion and 0 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 5 Aug 2019. 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 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?
[C-11]NOP-1A VT (time frame: Baseline). 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 5 Aug 2019.