The Tolerability and Effects of AZD0530 in Individuals With or Without a Family History of Alcoholism

February 22, 2023 updated by: Yale University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. Current diagnosis of DSM-IV-TR Axis I disorder, or past diagnosis of any substance use disorder or moderate alcohol use disorder
  2. Report of psychotic disorder in a 1º relative
  3. Auditory or visual impairment that interferes with test taking
  4. History of prenatal exposure to alcohol plus currently meeting criteria for features of fetal alcohol syndrome
  5. Not speaking English fluently or being a non-native English speaker, or being educated in a primary language other than English >grade 1
  6. Mental retardation (Full Scale IQ<70) using 2 WASI subtests for IQ estimate
  7. Traumatic brain injury with loss of consciousness > 30 minutes, or concussion in last 30 days
  8. 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)
  9. Current pregnancy (all females will be tested with urine screens on the day of MRI and prior to each phase of drug treatment)
  10. Positive urine screen for the presence of marijuana, cocaine, opiates or breath screen to detect the presence of alcohol, administered at each lab visit.
  11. Inability to comprehend the consent form appropriately
  12. Ferromagnetic metal devices, clips or fragments in body (orbital x-ray performed if needed).
  13. 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.
  14. 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
  15. Neutropenia defined as absolute neutrophils count of <1,500/microliter.
  16. Thrombocytopenia defined as platelet count <100x103/microliter.
  17. 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.
  18. History of interstitial lung disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FHP; 125mg AZD0530, then 50mg AZD0530, then placebo
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
Drug: Placebo
Placebo
Drug: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Experimental: FHP; 125mg AZD0530, then placebo, then 50mg AZD0530
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
Drug: Placebo
Placebo
Drug: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Experimental: FHP; 50mg AZD0530, then 125mg AZD0530, then placebo
Family History positive for alcoholism will take place in blinded testing of 50mg, then 125mg, then placebo separated by 1 week for each test
Drug: Placebo
Placebo
Drug: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Experimental: FHP; 50mg AZD0530, then placebo, then 125mg AZD0530
Family History positive for alcoholism will take place in blinded testing of 50mg, then placebo, then 125mg separated by 1 week for each test
Drug: Placebo
Placebo
Drug: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Experimental: FHP; placebo, then 50mg AZD0530, then 125mg AZD0530
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
Drug: Placebo
Placebo
Drug: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Experimental: FHP; placebo, then 125mg AZD0530,then 50mg AZD0530
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
Drug: Placebo
Placebo
Drug: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Active Comparator: FHN; 125mg AZD0530, then 50mg AZD0530, then placebo
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
Drug: Placebo
Placebo
Drug: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Active Comparator: FHN; 125mg AZD0530, then placebo, then 50mg AZD0530
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
Drug: Placebo
Placebo
Drug: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Active Comparator: FHN; 50mg AZD0530, then 125mg AZD0530, then placebo
Family History negative for alcoholism will take place in blinded testing of 50mg, then 125mg, then placebo separated by 1 week for each test
Drug: Placebo
Placebo
Drug: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Active Comparator: FHN; 50mg AZD0530, then placebo, then 125mg AZD0530
Family History negative for alcoholism will take place in blinded testing of 50mg, then placebo, then 125mg separated by 1 week for each test
Drug: Placebo
Placebo
Drug: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Active Comparator: FHN; placebo, then 50mg AZD0530, then 125mg AZD0530
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
Drug: Placebo
Placebo
Drug: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Active Comparator: FHN; placebo, then 125mg AZD0530, then 50mg AZD0530
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
Drug: Placebo
Placebo
Drug: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib
Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • AZD0530
  • saracatinib

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
4 Hours post medication administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
BOLD signal activation in the anterior cingulate cortex(ACC)
Time Frame: 4 Hours post medication administration
BOLD signal activation in the anterior cingulate cortex (ACC) observed during False Alarms of the GoNoGo Task
4 Hours post medication administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 26, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 26, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1503015528

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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