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RNAi Therapeutics
DCR-AUD for Alcoholism
Phase 1
Waitlist Available
Led By Lev G. Gertsik, MD
Research Sponsored by Dicerna Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Summary
This trial is testing DCR-AUD, a new treatment for adults with alcohol use disorder. It aims to potentially reduce alcohol cravings or effects. The study will check its safety and how well people tolerate it.
Eligible Conditions
- Alcoholism
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence and severity of AEs, SAEs, and DLTs as assessed by CTCAE v5.0.
Number of participants with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings.
Secondary study objectives
Facial skin temperature.
Heart rate.
Plasma acetaldehyde levels.
+6 moreTrial Design
8Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 4 (OPTIONAL) DCR-AUDExperimental Treatment1 Intervention
Single dose, subcutaneous administration of 960 mg of DCR-AUD (HV)
Group II: Cohort 3 DCR-AUDExperimental Treatment1 Intervention
Single dose, subcutaneous administration of 480 mg of DCR-AUD (HV)
Group III: Cohort 2 DCR-AUDExperimental Treatment1 Intervention
Single dose, subcutaneous administration of 240 mg of DCR-AUD (HV)
Group IV: Cohort 1 DCR-AUDExperimental Treatment1 Intervention
Single dose, subcutaneous administration of 80 mg of DCR-AUD (HV)
Group V: Cohort 1 DCR-AUD PlaceboPlacebo Group1 Intervention
Single dose, subcutaneous administration of Placebo for DCR-AUD (HV), volume to match active single dose
Group VI: Cohort 2 DCR-AUD PlaceboPlacebo Group1 Intervention
Single dose, subcutaneous administration of Placebo for DCR-AUD (HV), volume to match active single dose
Group VII: Cohort 3 DCR-AUD PlaceboPlacebo Group1 Intervention
Single dose, subcutaneous administration of Placebo for DCR-AUD (HV), volume to match active single dose
Group VIII: Cohort 4 (OPTIONAL) DCR-AUD PlaceboPlacebo Group1 Intervention
Single dose, subcutaneous administration of Placebo for DCR-AUD (HV), volume to match active single dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DCR-AUD
2023
Completed Phase 1
~60
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Dicerna Pharmaceuticals, Inc.Lead Sponsor
14 Previous Clinical Trials
462 Total Patients Enrolled
Dicerna Pharmaceuticals, Inc., a Novo Nordisk companyLead Sponsor
18 Previous Clinical Trials
542 Total Patients Enrolled
1 Trials studying Alcoholism
16 Patients Enrolled for Alcoholism
ParexelIndustry Sponsor
311 Previous Clinical Trials
101,515 Total Patients Enrolled
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