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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
Systolic BP in the range of 90 to 140 mmHg and diastolic BP in the range of 50 to 95 mmHg.
Negative screen for drugs of abuse (to include at minimum: amphetamines, barbiturates, cocaine, opioids, and benzodiazepines) at Screening and Day 1. Cannabis will not be recorded as a drug of abuse for this study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study Summary

This trial will test a new drug for safety and how well it works in healthy volunteers.

Eligible Conditions
  • Alcoholism

Eligibility Criteria

Inclusion Criteria

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

Timeline

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 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 outcome measures
Facial skin temperature.
Heart rate.
Plasma acetaldehyde levels.
+6 more

Trial 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
2021
Completed Phase 1
~40

Find a Location

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
481 Total Patients Enrolled
Dicerna Pharmaceuticals, Inc., a Novo Nordisk companyLead Sponsor
17 Previous Clinical Trials
529 Total Patients Enrolled
1 Trials studying Alcoholism
16 Patients Enrolled for Alcoholism
ParexelIndustry Sponsor
302 Previous Clinical Trials
100,658 Total Patients Enrolled

Frequently Asked Questions

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

Who would be an ideal candidate for participation in this investigation?

"This research initiative is searching for 36 individuals suffering from alcoholism, aged between 21 and 65. These patients are eligible to participate in the trial."

Answered by AI

Is this research project enrolling participants over the age of 45?

"Those who hope to qualify for this clinical trial must fall into the age range of 21-65; however, there are separate studies available for those younger than 18 and older than 65. In total, 20 spots have been allocated to minors while 200 opportunities exist for seniors."

Answered by AI

Are there available vacancies for this clinical research?

"Clinicaltrials.gov reports that the recruitment phase of this trial has ceased; it was initially posted on September 21st 2021 and last updated on September 15th 2022. However, there are currently 269 other medical trials which remain open for enrollment."

Answered by AI

Has the FDA sanctioned DCR-AUD?

"Due to the limited data backing up its efficacy and safety, DCR-AUD was given a score of 1 on our scale from 1 to 3."

Answered by AI

What are the desired end results of this medical research?

"This 24-week clinical trial is primarily assessing abnormalities in vital signs, ECG readings and laboratory findings. Secondary objectives include the evaluation of plasma ethanol levels, acetaldehyde levels and Cmax concentrations to understand the pharmacokinetics of DCR-AUD among adult human volunteers."

Answered by AI
~10 spots leftby Mar 2025