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Protein Kinase Inhibitor

50 mg AZD0530 for Alcoholism

Phase 1
Waitlist Available
Led By Godfrey D Pearlson, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours post medication administration
Awards & highlights

Study Summary

This trial looks at how well a certain drug works in treating alcoholism by looking at how it affects the brain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 hours post medication administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 hours post medication administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
BOLD activation during A1 phase
Secondary outcome measures
BOLD signal activation in the anterior cingulate cortex(ACC)

Side effects data

From 2018 Phase 2 trial • 159 Patients • NCT02167256
48%
Gastrointestinal disorders
35%
Infections and infestations
34%
Psychiatric disorders
30%
Investigations
23%
Nervous system disorders
23%
Skin and subcutaneous tissue disorders
19%
General disorders and administration site conditions
18%
Musculoskeletal and connective tissue disorders
16%
Respiratory, thoracic and mediastinal disorders
16%
Injury, poisoning and procedural complications
14%
Metabolism and nutrition disorders
8%
Renal and urinary disorders
6%
Eye disorders
5%
Blood and lymphatic system disorders
4%
Ear and labyrinth disorders
4%
Reproductive system and breast disorders
4%
Vascular disorders
4%
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
4%
Cardiac disorders
3%
Immune system disorders
1%
Endocrine disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
AZD0530 100mg/125mg Daily
AZD0530 Placebo

Trial Design

12Treatment groups
Experimental Treatment
Active Control
Group I: FHP; placebo, then 50mg AZD0530, then 125mg AZD0530Experimental Treatment3 Interventions
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
Group II: FHP; placebo, then 125mg AZD0530,then 50mg AZD0530Experimental Treatment3 Interventions
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
Group III: FHP; 50mg AZD0530, then placebo, then 125mg AZD0530Experimental Treatment3 Interventions
Family History positive for alcoholism will take place in blinded testing of 50mg, then placebo, then 125mg separated by 1 week for each test
Group IV: FHP; 50mg AZD0530, then 125mg AZD0530, then placeboExperimental Treatment3 Interventions
Family History positive for alcoholism will take place in blinded testing of 50mg, then 125mg, then placebo separated by 1 week for each test
Group V: FHP; 125mg AZD0530, then placebo, then 50mg AZD0530Experimental Treatment3 Interventions
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
Group VI: FHP; 125mg AZD0530, then 50mg AZD0530, then placeboExperimental Treatment3 Interventions
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
Group VII: FHN; 125mg AZD0530, then 50mg AZD0530, then placeboActive Control3 Interventions
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
Group VIII: FHN; 125mg AZD0530, then placebo, then 50mg AZD0530Active Control3 Interventions
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
Group IX: FHN; 50mg AZD0530, then 125mg AZD0530, then placeboActive Control3 Interventions
Family History negative for alcoholism will take place in blinded testing of 50mg, then 125mg, then placebo separated by 1 week for each test
Group X: FHN; 50mg AZD0530, then placebo, then 125mg AZD0530Active Control3 Interventions
Family History negative for alcoholism will take place in blinded testing of 50mg, then placebo, then 125mg separated by 1 week for each test
Group XI: FHN; placebo, then 50mg AZD0530, then 125mg AZD0530Active Control3 Interventions
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
Group XII: FHN; placebo, then 125mg AZD0530, then 50mg AZD0530Active Control3 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
125 mg AZD0530
2014
Completed Phase 1
~50
50 mg AZD0530
2014
Completed Phase 1
~50
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,846 Previous Clinical Trials
2,736,430 Total Patients Enrolled
83 Trials studying Alcoholism
10,180 Patients Enrolled for Alcoholism
Godfrey D Pearlson, MDPrincipal InvestigatorYale University
2 Previous Clinical Trials
151 Total Patients Enrolled
2 Trials studying Alcoholism
151 Patients Enrolled for Alcoholism

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric individuals being included in this trial's cohort?

"This trial is exclusively open to individuals aged 18-40. By contrast, there are 20 clinical trials catered for minors and 201 studies that accommodate seniors over 65."

Answered by AI

Do I meet the prerequisites to be part of this experiment?

"The necessary prerequisites to take part in this clinical trial are a diagnosis of alcoholism and an age between 18-40 years old. The research team is seeking 49 participants for their study."

Answered by AI

Is there a need for more participants in this clinical trial?

"According to clinicaltrials.gov, registration for this medical trial is not taking place presently. Initially posted on November 1st 2014 and last updated on January 24th 2022, the study has yet to reopen participation; however, there are 271 other studies actively recruiting patients at present."

Answered by AI

What is the maximum capacity for participants in this research trial?

"Unfortunately, this clinical trial is not seeking participants at the present moment. Originally posted on November 1st 2014, and most recently edited on January 24th 2022, it does not appear to be recruiting any subjects. Alternatively, there are 269 trials for alcoholics that welcome new enrollees as well as two studies with AZD0530 dosed at 50 mg actively welcoming volunteers."

Answered by AI

Has the Federal Drug Administration (FDA) validated 50 mg of AZD0530?

"Our team has scored 50 mg AZD0530 a 1 on a scale of 1 to 3 in terms of safety due to the trial being at Phase 1, meaning that there is only limited evidence supporting its efficacy and precautionary data."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Tolerability and Effects of AZD0530 in Individuals With or Without a Family History of Alcoholism
2014. "The Tolerability and Effects of AZD0530 in Individuals With or Without a Family History of Alcoholism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02262026.
~5 spots leftby Apr 2025
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