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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., a Novo Nordisk company

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

Awards & highlights

Study Summary

This trial tests if a drug is safe and effective in healthy adults who drink socially. Participants receive drug/placebo, monitored in visits & 10 ethanol tests. Researchers compare groups to see if drug is safe/effective.

Eligible Conditions

Alcoholism

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of participants with changes from baseline in vital signs, 12-lead ECG, clinical laboratory tests, and physical examination findings

Secondary outcome measures

Facial skin temperature.

Heart rate.

Number of participants with changes in the occurrence and/or severity of 6 symptoms related to plasma acetaldehyde accumulation observed during in-clinic EIAs over the course of the study.

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DCR-AUDExperimental Treatment1 Intervention

Multiple doses of DCR-AUD. Subcutaneous administration of of DCR-AUD.

Group II: DCR-AUD PlaceboPlacebo Group1 Intervention

Multiple doses of placebo comparator. Subcutaneous administration of Placebo for DCR-AUD, 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

Do I qualify?Apply below to find out

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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., a Novo Nordisk companyLead Sponsor

17 Previous Clinical Trials

549 Total Patients Enrolled

1 Trials studying Alcoholism

36 Patients Enrolled for Alcoholism

John Hanrahan, MD, MPHStudy DirectorDicerna Pharmaceuticals, Inc., a Novo Nordisk company

1 Previous Clinical Trials

36 Total Patients Enrolled

1 Trials studying Alcoholism

36 Patients Enrolled for Alcoholism

Lev G. Gertsik, MDPrincipal InvestigatorParexel

1 Previous Clinical Trials

36 Total Patients Enrolled

1 Trials studying Alcoholism

36 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 there any eligibility criteria I must meet to join this experiment?

"To qualify for this research project, alcoholics aged between 21 and 65 must apply. Currently the study is seeking to enrol 16 individuals."

Answered by AI

Has the DCR-AUD received regulatory sanction from the FDA?

"Limited data on DCR-AUD's efficacy and safety results in an estimated score of 1."

Answered by AI

Does this research accommodate participants aged over fifty-five?

"This study is specifically looking for participants between 21 and 65 years of age. Separately, there are 19 trials recruiting minors while 197 clinical trials have been established to evaluate the efficacy of various treatments in seniors."

Answered by AI

Is this experiment recruiting participants at the present time?

"According to the information provided by clinicaltrials.gov, this trial is not presently recruiting patients; it was first posted on January 29th 2023 and last updated April 26th 2023. However, there are currently 272 other medical trials actively in need of volunteers."

Answered by AI

What is the chief aim of this medical study?

"The primary goal of this 24-week clinical investigation is to observe alterations from baseline in vital signs, 12-lead ECG results, lab tests and physical exam findings. Secondary objectives encompass assessing the plasma AUC (area under curve), Cmax (maximum observed concentration) and Tmax (time to maximum concentration) of multi doses of DCR-AUD with regards to social drinkers amongst adult human volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 1b Study of DCR-AUD in Healthy Volunteers

2023. "Phase 1b Study of DCR-AUD in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05845398.