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

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ClinicalTrials.gov Identifier: NCT02262026
Recruitment Status : Recruiting
First Posted : October 10, 2014
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
Functional neuroimaging of alcoholism vulnerability: glutamate, reward, impulsivity, and Pavlovian-to-instrumental transfer (PIT), part II Saracatinib

Condition or disease Intervention/treatment Phase
Alcoholism Drug: 125 mg AZD0530 Drug: 50 mg AZD0530 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : November 2014
Estimated Primary Completion Date : April 28, 2019
Estimated Study Completion Date : April 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: Placebo
Placebo

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: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: Placebo
Placebo

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: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: Placebo
Placebo

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: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: Placebo
Placebo

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: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: Placebo
Placebo

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: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: Placebo
Placebo

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: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: Placebo
Placebo

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: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: Placebo
Placebo

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: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: Placebo
Placebo

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: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: Placebo
Placebo

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: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: Placebo
Placebo

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: 125 mg AZD0530
Randomized to receive 125 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: 50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Other Names:
  • saracatinib
  • AZD0530

Drug: Placebo
Placebo




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clear History of at least 1 parent having a history of alcoholism or no first or second degree relatives with alcoholism or substance abuse

Exclusion Criteria:

  1. Exclusion criteria include: Current diagnosis of DSM-IV-TR Axis I 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02262026


Contacts
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Contact: Godfrey D Pearlson, MD 203-737-3416 Godfrey.Pearlson@hhchealth.org

Locations
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United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Godfrey Pearlson, MD    203-737-3416    godfrey.pearlson@hhchealth.org   
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Godfrey D Pearlson, MD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02262026     History of Changes
Other Study ID Numbers: 1503015528
First Posted: October 10, 2014    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Saracatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action