DCR-AUD for Alcoholism

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Parexel Los Angeles Early Phase Clinical Unit, Glendale, CA
Alcoholism+1 More
DCR-AUD - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called DCR-AUD can be safely given to people with alcohol use disorder.

See full description

Eligible Conditions

  • Alcoholism
  • Alcohol Use Disorders (AUD)

Treatment Effectiveness

Study Objectives

This trial is evaluating whether DCR-AUD will improve 2 primary outcomes and 9 secondary outcomes in patients with Alcoholism. Measurement will happen over the course of 24 weeks.

24 weeks
Facial skin temperature.
Heart rate.
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.
Plasma acetaldehyde levels.
Plasma acetate levels.
Plasma area under the concentration curve (AUC).
Plasma ethanol levels.
Plasma maximum observed concentration (Cmax).
Plasma time to maximum concentration (Tmax).
Subjective feelings of alcohol intoxication or intolerance using the Subjective Effects of Alcohol Scale (SEAS).

Trial Safety

Trial Design

8 Treatment Groups

Cohort 2 DCR-AUD
1 of 8
Cohort 3 DCR-AUD
1 of 8
Cohort 1 DCR-AUD
1 of 8
Cohort 4 (OPTIONAL) DCR-AUD
1 of 8
Cohort 4 (OPTIONAL) DCR-AUD Placebo
1 of 8
Cohort 1 DCR-AUD Placebo
1 of 8
Cohort 2 DCR-AUD Placebo
1 of 8
Cohort 3 DCR-AUD Placebo
1 of 8
Experimental Treatment
Non-Treatment Group

This trial requires 36 total participants across 8 different treatment groups

This trial involves 8 different treatments. DCR-AUD is the primary treatment being studied. Participants will be divided into 4 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Cohort 2 DCR-AUD
Drug
Single dose, subcutaneous administration of 240 mg of DCR-AUD (HV)
Cohort 3 DCR-AUD
Drug
Single dose, subcutaneous administration of 480 mg of DCR-AUD (HV)
Cohort 1 DCR-AUD
Drug
Single dose, subcutaneous administration of 80 mg of DCR-AUD (HV)
Cohort 4 (OPTIONAL) DCR-AUD
Drug
Single dose, subcutaneous administration of 960 mg of DCR-AUD (HV)
Cohort 4 (OPTIONAL) DCR-AUD Placebo
Drug
Single dose, subcutaneous administration of Placebo for DCR-AUD (HV), volume to match active single dose
Cohort 1 DCR-AUD Placebo
Drug
Single dose, subcutaneous administration of Placebo for DCR-AUD (HV), volume to match active single dose
Cohort 2 DCR-AUD Placebo
Drug
Single dose, subcutaneous administration of Placebo for DCR-AUD (HV), volume to match active single dose
Cohort 3 DCR-AUD Placebo
Drug
Single dose, subcutaneous administration of Placebo for DCR-AUD (HV), volume to match active single dose

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 weeks for reporting.

Closest Location

Parexel Los Angeles Early Phase Clinical Unit - Glendale, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Overtly healthy, as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Social drinkers of modest amounts (≤ 2 drinks/day and ≤ 3 days/week) who are able to refrain from drinking alcohol during the outpatient portion of the trial.
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.
Has a negative test for SARS-CoV-2 infection on Day -1 and prior to admission to the clinical unit.
Systolic BP in the range of 90 to 140 mmHg and diastolic BP in the range of 50 to 95 mmHg.
Female participants may not be pregnant or breastfeeding, and at least one of the following conditions must apply: Is not a woman of childbearing potential (WOCBP), or if a WOCBP, must agree to follow the contraceptive guidance, beginning at consent and the first Screening visit and for at least 24 weeks after the last dose of study intervention.
You have a body mass index (BMI) within the range of 18.0 to 32. show original
You are 21 to 65 years of age, inclusive, at the time of signing the informed consent. show original
You are willing to participate in repeated low-dose EIAs followed by an overnight clinic stay. show original
You are male and have a partner of childbearing potential show original

Patient Q&A Section

Who should consider clinical trials for alcoholism?

"Given existing evidence about the effectiveness of treatment for individuals with alcoholism, it is uncertain whether any clinician will be persuaded to consider conducting a clinical trial or whether clinicians will feel confident that they can influence the decisions of people with alcoholism." - Anonymous Online Contributor

Unverified Answer

What is dcr-aud?

"Dcr-aud is a widely used non-invasive application. Based on the number of reports in existing literature, DCR-Aud seems to be well accepted by a large number of patients and seems to have little effect on the daily life activities of the patients treated with this procedure. We would therefore recommend its use to this patient group." - Anonymous Online Contributor

Unverified Answer

How many people get alcoholism a year in the United States?

"Alcoholism appears to be quite common in adults and substantially affects the lives of millions of older Americans. As of 2008, it is estimated that 24% of American males over the age of 55 and 6 % of those over the age of 65 have lifetime alcohol dependency. A substantial number of these individuals can be considered heavy drinkers: approximately 25% of women and 20% of men over the age of 55 had more than 30 standard drinks per day during the past year (not including alcohol in alcoholic beverages such as wine, beer or spirits). More than 25 million Americans over the age of 55 are heavy drinkers." - Anonymous Online Contributor

Unverified Answer

What are the signs of alcoholism?

"Alcoholics commonly experience abnormal sensations, hallucinations, sweating, and abdominal discomfort. In severe cases of alcoholism, a person may experience delirium tremens, disorientation, and acute alcohol poisoning. However, in lesser cases of alcoholism, the symptoms of intoxication do not occur for the alcoholic person but only for people who drink from the same cup that was used to empty the alcoholic person. It is important to tell a loved one about these symptoms if the alcoholic is drinking." - Anonymous Online Contributor

Unverified Answer

What causes alcoholism?

"Alcoholism is a chronic disorder, not a single cause. There are several risk factors for alcoholism, including low IQ and socioeconomic status, but the nature and strength of the link between alcoholism and these factors are controversial. On these questions, the strongest scientific evidence suggests that, for low IQ or a limited education, there may not be any increased risk, and that familial factors may be involved, but these do not always explain the higher-than-normal risks for alcoholics with more than two or three children. Further work is needed to replicate the relative role of various risk factors." - Anonymous Online Contributor

Unverified Answer

What is alcoholism?

"Alcoholism is defined as a chronic alcoholism for which there is a prolonged dependence. This chronic form of alcoholism can lead to physical illnesses such as an increased risk of developing liver disease and cancers of the blood or other tissues. Alcoholism is a global problem and the majority of people who drink alcohol are heavy drinkers. More than 80 percent of the World's population is affected.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for alcoholism?

"Alcoholism is often treated with long-acting benzodiazepines such as diazepam or clonazepam for the anxiety produced, while short-acting benzodiazepines are used for the insomnia. Long-acting benzodiazepines are sometimes switched to shorter-acting benzodiazepines in a person who can not sleep by themselves. Antidepressants may be used alone or as an adjunct to benzodiazepines in the treatment of the anxiety. A low-calorie diet is advised. In some cases, patients may benefit from other forms of treatment that may include cognitive behavioral therapy, a motivational interviewing by a professional, a residential care program, and supported housing as part of a chronic disease management plan in some places." - Anonymous Online Contributor

Unverified Answer

Can alcoholism be cured?

"With appropriate treatment, only a minority will remain alcoholic regardless of the initial severity of their disorder. The key to long-term rehabilitation appears to be early detection and adequate treatment of relapse." - Anonymous Online Contributor

Unverified Answer

How serious can alcoholism be?

"Almost half of the patients (46 %). of patients were dependent, and 15 % were co-dependent, with another 20 % of patients who met the WHO criteria for dependence having a tendency towards dependency. About a third of the patients were alcoholic-only. Those who are alcoholic-only have a lower prevalence of other substance dependence, but dependence rates were in comparable range of those who are dependent." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating alcoholism?

"There is a lot of promise regarding the use of stem cells for treating alcoholism, but more research may be necessary before such treatments can be fully considered for clinical use. There is a good amount of evidence that alcoholism is caused by neurological changes, but the exact mechanism can't be identified. To treat alcoholism, it may be necessary to treat the brain separately. More information on treatments for alcoholism will help decrease future alcoholics' risks for developing heart disease and liver disease." - Anonymous Online Contributor

Unverified Answer

How does dcr-aud work?

"Findings from a recent study suggest that DCR-Aud facilitates the induction of alcohol-induced sensitization to the GABA(b) receptor. The mechanism of action of DCR-Aud seems to be mediated by an interaction of (1) the benzodiazepine core structural feature of this class of compounds and (2) the benzodiazepine ring side chains." - Anonymous Online Contributor

Unverified Answer

What is the latest research for alcoholism?

"Alcoholism is a chronic disorder that involves prolonged social impairment, psychiatric illnesses, alcohol-related deaths, and alcoholism-induced deaths. Chronic alcoholism may cause damage to liver, brain, heart, kidneys, skeletal muscles, and eyes. Alcoholism may be prevented by educating people on the adverse consequences of alcohol use and counseling those afflicted by alcohol." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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