AlcoholismPhase 1NCT02262026
The Tolerability and Effects of AZD0530 in Individuals With or Without a Family History of Alcoholism
A Phase 1 study testing 125 mg AZD0530 and 50 mg AZD0530 in people with Alcoholism, run by Yale University at 1 site in United States.
Trial summary
Functional neuroimaging of alcoholism vulnerability: glutamate, reward, impulsivity, and Pavlovian-to-instrumental transfer (PIT), part II Saracatinib Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholism
- What is being tested?
- 125 mg AZD0530 and 50 mg AZD0530
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2014to 26 Apr 2019
- Phase
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clear History of a father having a history of alcoholism, OR a mother AND another 1st or 2nd degree relative having a history of alcoholism, OR no 1st or 2nd degree relatives with alcoholism or substance abuse
Who cannot join
- Current diagnosis of DSM-IV-TR Axis I disorder, or past diagnosis of any substance use disorder or moderate alcohol use disorder
- Report of psychotic disorder in a 1º relative
- Auditory or visual impairment that interferes with test taking
- History of prenatal exposure to alcohol plus currently meeting criteria for features of fetal alcohol syndrome
- Not speaking English fluently or being a non-native English speaker, or being educated in a primary language other than English >grade 1
- Mental retardation (Full Scale IQ<70) using 2 WASI subtests for IQ estimate
Show all 18Show fewer
- Traumatic brain injury with loss of consciousness > 30 minutes, or concussion in last 30 days
- Presence or history of any medical/neurologic illness that may affect brain physiology (e.g., epilepsy, Multiple Sclerosis), including focal brain lesion seen on structural MRI (all structural scans are read by a licensed radiologist)
- Current pregnancy (all females will be tested with urine screens on the day of MRI and prior to each phase of drug treatment)
- Positive urine screen for the presence of marijuana, cocaine, opiates or breath screen to detect the presence of alcohol, administered at each lab visit.
- Inability to comprehend the consent form appropriately
- Ferromagnetic metal devices, clips or fragments in body (orbital x-ray performed if needed).
- Current use (within 30 days of screening) of specific psychoactive medications (e.g., typical neuroleptics, narcotic analgesics, antiparkinsonian medications, systemic corticosteroids, or medications with significant central anticholinergic activity, etc.). Current use of warfarin.
- Current use of the following medications (CYP3A4 substrates whose metabolism may be slowed by AZD0530): carbamazepine, colchicine, cyclosporine, disopyramide, fluticasone, quinidine, vinblastine, vincristine, nifedipine. Patients taking sildenafil, tadalafil, and vardenafil will be advised to stop taking these medications for the duration of the trial. Patients cannot take the following drugs which inhibit the CYP3A4 isoenzyme: cimetidine, cyclosporine, danazol, fluconazole, grapefruit juice, HIV protease inhibitors, itraconazole, ketoconazole, macrolides, miconazole, nefazodone, omeprazole, ritonavir, and verapamil, aromatase inhibitors, docetaxel
- Neutropenia defined as absolute neutrophils count of <1,500/microliter.
- Thrombocytopenia defined as platelet count <100x103/microliter.
- AST, ALT, total bilirubin >1.5 times upper normal; serum creatinine, >2 time upper normal limit, total bilirubin>1.5 times ULN; Serum creatinine >2.0 times ULN.
- History of interstitial lung disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase One Study Investigating the Tolerability and Effects of AZD0530 on Functional Neuroimaging Responses in Individuals With or Without a Family History of Alcoholism
Functional neuroimaging of alcoholism vulnerability: glutamate, reward, impulsivity, and Pavlovian-to-instrumental transfer (PIT), part II Saracatinib
Read the detailed description
To assess the effect of oral AZ D0530 at various doses on neuroimaging parameters associated with various forms of impulsivity mediated through glutamate-dopamine interactions, as ascertained through functional magnetic resonance imaging. -- --NOTE-- AZD0530 dosage of 50mg was discontinued by manufacturer. Adjustments were made to account for the removal of the 50mg dosage in all arms of the study.
- Conditions
- Alcoholism
- Being tested
- 125 mg AZD0530, 50 mg AZD0530, Placebo
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
125 mg AZD0530Drug
Also called saracatinib, AZD0530
Randomized to receive 125 mg of AZD0530
50 mg AZD0530Drug
Also called saracatinib, AZD0530
Randomized to receive 50 mg of AZD0530
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| FHP; 125mg AZD0530, then 50mg AZD0530, then placebo | Experimental | Family History positive for alcoholism will take place in blinded testing of 125 mg, then 50 mg, then placebo separated by 1 week for each test Receives: Drug: 125 mg AZD0530; Drug: 50 mg AZD0530; Drug: Placebo |
| FHP; 125mg AZD0530, then placebo, then 50mg AZD0530 | Experimental | Family History positive for alcoholism will take place in blinded testing of 125 mg, then placebo, then 50mg separated by 1 week for each test Receives: Drug: 125 mg AZD0530; Drug: 50 mg AZD0530; Drug: Placebo |
| FHP; 50mg AZD0530, then 125mg AZD0530, then placebo | Experimental | Family History positive for alcoholism will take place in blinded testing of 50mg, then 125mg, then placebo separated by 1 week for each test Receives: Drug: 125 mg AZD0530; Drug: 50 mg AZD0530; Drug: Placebo |
| FHP; 50mg AZD0530, then placebo, then 125mg AZD0530 | Experimental | Family History positive for alcoholism will take place in blinded testing of 50mg, then placebo, then 125mg separated by 1 week for each test Receives: Drug: 125 mg AZD0530; Drug: 50 mg AZD0530; Drug: Placebo |
| FHP; placebo, then 50mg AZD0530, then 125mg AZD0530 | Experimental | Family History positive for alcoholism will take place in blinded testing of placebo, then 50 mg, then 125 mg separated by 1 week for each test Receives: Drug: 125 mg AZD0530; Drug: 50 mg AZD0530; Drug: Placebo |
| FHP; placebo, then 125mg AZD0530,then 50mg AZD0530 | Experimental | Family History positive for alcoholism will take place in blinded testing of placebo, then 125 mg, then 50 mg separated by 1 week for each test Receives: Drug: 125 mg AZD0530; Drug: 50 mg AZD0530; Drug: Placebo |
| FHN; 125mg AZD0530, then 50mg AZD0530, then placebo | Active comparator | Family History negative for alcoholism will take place in blinded testing of 125 mg, then 50 mg, then placebo separated by 1 week for each test Receives: Drug: 125 mg AZD0530; Drug: 50 mg AZD0530; Drug: Placebo |
| FHN; 125mg AZD0530, then placebo, then 50mg AZD0530 | Active comparator | Family History negative for alcoholism will take place in blinded testing of 125 mg, then placebo, then 50mg separated by 1 week for each test Receives: Drug: 125 mg AZD0530; Drug: 50 mg AZD0530; Drug: Placebo |
| FHN; 50mg AZD0530, then 125mg AZD0530, then placebo | Active comparator | Family History negative for alcoholism will take place in blinded testing of 50mg, then 125mg, then placebo separated by 1 week for each test Receives: Drug: 125 mg AZD0530; Drug: 50 mg AZD0530; Drug: Placebo |
| FHN; 50mg AZD0530, then placebo, then 125mg AZD0530 | Active comparator | Family History negative for alcoholism will take place in blinded testing of 50mg, then placebo, then 125mg separated by 1 week for each test Receives: Drug: 125 mg AZD0530; Drug: 50 mg AZD0530; Drug: Placebo |
| FHN; placebo, then 50mg AZD0530, then 125mg AZD0530 | Active comparator | Family History negative for alcoholism will take place in blinded testing of placebo, then 50 mg, then 125 mg separated by 1 week for each test Receives: Drug: 125 mg AZD0530; Drug: 50 mg AZD0530; Drug: Placebo |
| FHN; placebo, then 125mg AZD0530, then 50mg AZD0530 | Active comparator | Family History negative for alcoholism will take place in blinded testing of placebo, then 125 mg, then 50 mg separated by 1 week for each test Receives: Drug: 125 mg AZD0530; Drug: 50 mg AZD0530; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD activation during A1 phase
BOLD activation during the A1 phase of the MRI Monetary Incentive Delay task
Measured: 4 Hours post medication administration
Secondary outcomes (1)
BOLD signal activation in the anterior cingulate cortex(ACC)
BOLD signal activation in the anterior cingulate cortex (ACC) observed during False Alarms of the GoNoGo Task
Measured: 4 Hours post medication administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study start1 Nov 2014
- Primary completion26 Apr 2019
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Godfrey D Pearlson, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262026
- Sponsor's protocol ID
- 1503015528
- Status last verified
- Feb 2023
- First submitted
- 1 Oct 2014
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase One Study Investigating the Tolerability and Effects of AZD0530 on Functional Neuroimaging Responses in Individuals With or Without a Family History of Alcoholism
- ClinicalTrials.gov ID
- NCT02262026
- Acronym / sponsor ID
- 1503015528
- Conditions
- Alcoholism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 10 Oct 2014 (estimated)
- 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.
Functional neuroimaging of alcoholism vulnerability: glutamate, reward, impulsivity, and Pavlovian-to-instrumental transfer (PIT), part II Saracatinib
Detailed description
To assess the effect of oral AZ D0530 at various doses on neuroimaging parameters associated with various forms of impulsivity mediated through glutamate-dopamine interactions, as ascertained through functional magnetic resonance imaging. -- --NOTE-- AZD0530 dosage of 50mg was discontinued by manufacturer. Adjustments were made to account for the removal of the 50mg dosage in all arms of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| FHP; 125mg AZD0530, then 50mg AZD0530, then placebo | Experimental | Drug: 125 mg AZD0530, Drug: 50 mg AZD0530, Drug: PlaceboFamily History positive for alcoholism will take place in blinded testing of 125 mg, then 50 mg, then placebo separated by 1 week for each test |
| FHP; 125mg AZD0530, then placebo, then 50mg AZD0530 | Experimental | Drug: 125 mg AZD0530, Drug: 50 mg AZD0530, Drug: PlaceboFamily History positive for alcoholism will take place in blinded testing of 125 mg, then placebo, then 50mg separated by 1 week for each test |
| FHP; 50mg AZD0530, then 125mg AZD0530, then placebo | Experimental | Drug: 125 mg AZD0530, Drug: 50 mg AZD0530, Drug: PlaceboFamily History positive for alcoholism will take place in blinded testing of 50mg, then 125mg, then placebo separated by 1 week for each test |
| FHP; 50mg AZD0530, then placebo, then 125mg AZD0530 | Experimental | Drug: 125 mg AZD0530, Drug: 50 mg AZD0530, Drug: PlaceboFamily History positive for alcoholism will take place in blinded testing of 50mg, then placebo, then 125mg separated by 1 week for each test |
| FHP; placebo, then 50mg AZD0530, then 125mg AZD0530 | Experimental | Drug: 125 mg AZD0530, Drug: 50 mg AZD0530, Drug: PlaceboFamily History positive for alcoholism will take place in blinded testing of placebo, then 50 mg, then 125 mg separated by 1 week for each test |
| FHP; placebo, then 125mg AZD0530,then 50mg AZD0530 | Experimental | Drug: 125 mg AZD0530, Drug: 50 mg AZD0530, Drug: PlaceboFamily History positive for alcoholism will take place in blinded testing of placebo, then 125 mg, then 50 mg separated by 1 week for each test |
| FHN; 125mg AZD0530, then 50mg AZD0530, then placebo | Active comparator | Drug: 125 mg AZD0530, Drug: 50 mg AZD0530, Drug: PlaceboFamily History negative for alcoholism will take place in blinded testing of 125 mg, then 50 mg, then placebo separated by 1 week for each test |
| FHN; 125mg AZD0530, then placebo, then 50mg AZD0530 | Active comparator | Drug: 125 mg AZD0530, Drug: 50 mg AZD0530, Drug: PlaceboFamily History negative for alcoholism will take place in blinded testing of 125 mg, then placebo, then 50mg separated by 1 week for each test |
| FHN; 50mg AZD0530, then 125mg AZD0530, then placebo | Active comparator | Drug: 125 mg AZD0530, Drug: 50 mg AZD0530, Drug: PlaceboFamily History negative for alcoholism will take place in blinded testing of 50mg, then 125mg, then placebo separated by 1 week for each test |
| FHN; 50mg AZD0530, then placebo, then 125mg AZD0530 | Active comparator | Drug: 125 mg AZD0530, Drug: 50 mg AZD0530, Drug: PlaceboFamily History negative for alcoholism will take place in blinded testing of 50mg, then placebo, then 125mg separated by 1 week for each test |
| FHN; placebo, then 50mg AZD0530, then 125mg AZD0530 | Active comparator | Drug: 125 mg AZD0530, Drug: 50 mg AZD0530, Drug: PlaceboFamily History negative for alcoholism will take place in blinded testing of placebo, then 50 mg, then 125 mg separated by 1 week for each test |
| FHN; placebo, then 125mg AZD0530, then 50mg AZD0530 | Active comparator | Drug: 125 mg AZD0530, Drug: 50 mg AZD0530, Drug: PlaceboFamily History negative for alcoholism will take place in blinded testing of placebo, then 125 mg, then 50 mg separated by 1 week for each test |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clear History of a father having a history of alcoholism, OR a mother AND another 1st or 2nd degree relative having a history of alcoholism, OR no 1st or 2nd degree relatives with alcoholism or substance abuse
Key exclusion criteria (18 listed)
- Current diagnosis of DSM-IV-TR Axis I disorder, or past diagnosis of any substance use disorder or moderate alcohol use disorder
- Report of psychotic disorder in a 1º relative
- Auditory or visual impairment that interferes with test taking
- History of prenatal exposure to alcohol plus currently meeting criteria for features of fetal alcohol syndrome
- Not speaking English fluently or being a non-native English speaker, or being educated in a primary language other than English >grade 1
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 |
|---|---|---|
| 125 mg AZD0530Also: saracatinib, AZD0530Randomized to receive 125 mg of AZD0530 | Drug | FHN; 125mg AZD0530, then 50mg AZD0530, then placebo, FHN; 125mg AZD0530, then placebo, then 50mg AZD0530, FHN; 50mg AZD0530, then 125mg AZD0530, then placebo, FHN; 50mg AZD0530, then placebo, then 125mg AZD0530, FHN; placebo, then 125mg AZD0530, then 50mg AZD0530, FHN; placebo, then 50mg AZD0530, then 125mg AZD0530, FHP; 125mg AZD0530, then 50mg AZD0530, then placebo, FHP; 125mg AZD0530, then placebo, then 50mg AZD0530, FHP; 50mg AZD0530, then 125mg AZD0530, then placebo, FHP; 50mg AZD0530, then placebo, then 125mg AZD0530, FHP; placebo, then 125mg AZD0530,then 50mg AZD0530, FHP; placebo, then 50mg AZD0530, then 125mg AZD0530 |
| 50 mg AZD0530Also: saracatinib, AZD0530Randomized to receive 50 mg of AZD0530 | Drug | FHN; 125mg AZD0530, then 50mg AZD0530, then placebo, FHN; 125mg AZD0530, then placebo, then 50mg AZD0530, FHN; 50mg AZD0530, then 125mg AZD0530, then placebo, FHN; 50mg AZD0530, then placebo, then 125mg AZD0530, FHN; placebo, then 125mg AZD0530, then 50mg AZD0530, FHN; placebo, then 50mg AZD0530, then 125mg AZD0530, FHP; 125mg AZD0530, then 50mg AZD0530, then placebo, FHP; 125mg AZD0530, then placebo, then 50mg AZD0530, FHP; 50mg AZD0530, then 125mg AZD0530, then placebo, FHP; 50mg AZD0530, then placebo, then 125mg AZD0530, FHP; placebo, then 125mg AZD0530,then 50mg AZD0530, FHP; placebo, then 50mg AZD0530, then 125mg AZD0530 |
| PlaceboPlacebo | Drug | FHN; 125mg AZD0530, then 50mg AZD0530, then placebo, FHN; 125mg AZD0530, then placebo, then 50mg AZD0530, FHN; 50mg AZD0530, then 125mg AZD0530, then placebo, FHN; 50mg AZD0530, then placebo, then 125mg AZD0530, FHN; placebo, then 125mg AZD0530, then 50mg AZD0530, FHN; placebo, then 50mg AZD0530, then 125mg AZD0530, FHP; 125mg AZD0530, then 50mg AZD0530, then placebo, FHP; 125mg AZD0530, then placebo, then 50mg AZD0530, FHP; 50mg AZD0530, then 125mg AZD0530, then placebo, FHP; 50mg AZD0530, then placebo, then 125mg AZD0530, FHP; placebo, then 125mg AZD0530,then 50mg AZD0530, FHP; placebo, then 50mg AZD0530, then 125mg AZD0530 |
Primary outcome
BOLD activation during A1 phase
Time frame: 4 Hours post medication administration
BOLD activation during the A1 phase of the MRI Monetary Incentive Delay task
1 secondary outcome
BOLD signal activation in the anterior cingulate cortex(ACC)
Time frame: 4 Hours post medication administration
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 24 Feb 2023.
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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.
Godfrey D Pearlson, MD 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 Phase 1 study testing 125 mg AZD0530 and 50 mg AZD0530 in people with Alcoholism, 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 1 inclusion and 18 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 24 Feb 2023. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
BOLD activation during A1 phase (time frame: 4 Hours post medication administration). 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 24 Feb 2023.