The Tolerability and Effects of AZD0530 in Individuals With or Without a Family History of Alcoholism
NCT ID: NCT02262026
Last Updated: 2023-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
49 participants
INTERVENTIONAL
2014-11-01
2019-04-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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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
125 mg AZD0530
Randomized to receive 125 mg of AZD0530
50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Placebo
Placebo
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
125 mg AZD0530
Randomized to receive 125 mg of AZD0530
50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Placebo
Placebo
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
125 mg AZD0530
Randomized to receive 125 mg of AZD0530
50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Placebo
Placebo
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
125 mg AZD0530
Randomized to receive 125 mg of AZD0530
50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Placebo
Placebo
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
125 mg AZD0530
Randomized to receive 125 mg of AZD0530
50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Placebo
Placebo
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
125 mg AZD0530
Randomized to receive 125 mg of AZD0530
50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Placebo
Placebo
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
125 mg AZD0530
Randomized to receive 125 mg of AZD0530
50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Placebo
Placebo
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
125 mg AZD0530
Randomized to receive 125 mg of AZD0530
50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Placebo
Placebo
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
125 mg AZD0530
Randomized to receive 125 mg of AZD0530
50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Placebo
Placebo
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
125 mg AZD0530
Randomized to receive 125 mg of AZD0530
50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Placebo
Placebo
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
125 mg AZD0530
Randomized to receive 125 mg of AZD0530
50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Placebo
Placebo
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
125 mg AZD0530
Randomized to receive 125 mg of AZD0530
50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Placebo
Placebo
Interventions
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125 mg AZD0530
Randomized to receive 125 mg of AZD0530
50 mg AZD0530
Randomized to receive 50 mg of AZD0530
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Report of psychotic disorder in a 1ยบ 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.
18 Years
40 Years
ALL
Yes
Sponsors
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Yale University
OTHER
Responsible Party
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Principal Investigators
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Godfrey D Pearlson, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Hartford Hospital
Hartford, Connecticut, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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1503015528
Identifier Type: -
Identifier Source: org_study_id
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