Alcohol Use DisorderEarly Phase 1NCT03448016
[C-11]NOP-1A and Alcohol Use Disorder
A Early Phase 1 study testing [C-11] and NOP-1A in people with Alcohol Use Disorder, run by Rajesh Narendran at 1 site in United States.
Trial summary
The goal of this study is to compare [C-11]NOP-1A binding in recently abstinent alcohol use disorders and controls Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol 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
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2016to 30 Mar 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or Females
- Fulfill DSM5 diagnosis for alcohol use disorder
- Medically Healthy
- Males or females
- Absence of present or past psychiatric conditions (including alcohol or drug use disorders)
- Medically Healthy
Who cannot join
- Pregnancy or lactation
- Comorbid severe/major medical, psychiatric (such as bipolar and psychotic disorders, etc.,) and current comorbid drug use disorders (other than tobacco use and recreational marijuana use)
- Metal implants or paramagnetic objects contained within the body which may interfere with MRI scans
- Currently employed as a radiation worker, or participation in radiation drug research procedures within the previous year
- Currently on any psychotropic medications that can influence nociceptin transmission in the brain
- [B]Healthy controls
Show all 12Show fewer
- Pregnancy of lactation
- Medical, psychiatric or comorbid drug/alcohol use disorders
- Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
- Currently employed as a 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 psychotic disorder, manic episode, drug and alcohol use disorder in first-degree relatives
Trial locations and contacts
1 site in 1 country.
United States1 site
University of PIttsburgh PET Facility
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Linking Nociceptive Opioid Peptide (NOP) Receptors With Relapse in Alcoholism
The goal of this study is to compare [C-11]NOP-1A binding in recently abstinent alcohol use disorders and controls
Read the detailed description
This will allow for understanding brain stress and antistress mechanisms that underlie abuse of alcohol in humans
- Conditions
- Alcohol Use Disorder
- Being tested
- [C-11], NOP-1A
- Medical subject headings
- Alcoholism
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 |
|---|---|---|
| Alcohol use disorders | Experimental | [C-11]NOP-1A PET Scan Receives: Radiation: [C-11]; Drug: NOP-1A |
| Controls | Experimental | [C-11]NOP-1A 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 posted27 Feb 2018
- Study start27 May 2016
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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
- 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rajesh Narendran
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Rajesh Narendran, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448016
- Sponsor's protocol ID
- PRO16030103 & PRO13080387
- Other IDs
- R01AA025247
- Status last verified
- Jul 2022
- First submitted
- 21 Feb 2018
- Last updated
- 11 Jul 2022
- 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 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Nociceptive Opioid Peptide (NOP) Receptors With Relapse in Alcoholism
- ClinicalTrials.gov ID
- NCT03448016
- Acronym / sponsor ID
- PRO16030103 & PRO13080387
- Conditions
- Alcohol Use Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Rajesh NarendranUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 27 May 2016 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 27 Feb 2018 (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 compare [C-11]NOP-1A binding in recently abstinent alcohol use disorders and controls
Detailed description
This will allow for understanding brain stress and antistress mechanisms that underlie abuse of alcohol 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 |
|---|---|---|
| Alcohol use disorders | Experimental | Radiation: [C-11], Drug: NOP-1A[C-11]NOP-1A PET Scan |
| Controls | Experimental | Radiation: [C-11], Drug: NOP-1A[C-11]NOP-1A PET Scan |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males or Females
- Fulfill DSM5 diagnosis for alcohol use disorder
- Medically Healthy
- Males or females
- Absence of present or past psychiatric conditions (including alcohol or drug use disorders)
Key exclusion criteria (12 listed)
- Pregnancy or lactation
- Comorbid severe/major medical, psychiatric (such as bipolar and psychotic disorders, etc.,) and current comorbid drug use disorders (other than tobacco use and recreational marijuana use)
- Metal implants or paramagnetic objects contained within the body which may interfere with MRI scans
- Currently employed as a radiation worker, or participation in radiation drug research procedures within the previous year
- Currently on any psychotropic medications that can influence nociceptin transmission in the brain
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 | Alcohol use disorders, Controls |
| NOP-1ATracer | Drug | Alcohol 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 11 Jul 2022.
- 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 Alcohol Use Disorder, run by Rajesh Narendran 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 6 inclusion and 12 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 11 Jul 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 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 11 Jul 2022.