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5-alpha-reductase inhibitor
Dutasteride for Alcoholism
Phase 2 & 3
Waitlist Available
Led By Jonathan Covault, MD, PhD
Research Sponsored by UConn Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and women age 35 to 70 yo inclusive
Average weekly ethanol consumption of >24 SD for men and >18 for women and at least 2 HDD/wk over the 8 weeks prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks (from initiation to end of treatment phase 1)
Awards & highlights
Study Summary
This trial will test whether the medication dutasteride is safe and effective for reducing drinking in people with alcohol use disorder.
Who is the study for?
This trial is for men and women aged 35-70 with alcohol use disorder who drink heavily. Women must not be pregnant, should practice birth control, and can't join if they have severe alcohol dependence or significant physical/mental health issues. Participants shouldn't be on certain medications like finasteride or treatments for AUD.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of dutasteride capsules in reducing heavy drinking among adults with alcoholism compared to placebo capsules. The hypothesis is that taking dutasteride daily will lead to fewer drinks per week and less frequent heavy drinking days.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with dutasteride may include sexual side effects (like reduced libido), minor swelling or tenderness in the chest area, dizziness, and rarely more serious reactions like allergic symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 35 and 70 years old.
Select...
I drink more than the recommended amount of alcohol weekly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks (from initiation to end of treatment phase 1)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks (from initiation to end of treatment phase 1)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Drinks Per Week by Medication Group
Change in Heavy Drinking Days Per Week by Medication Group
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: dutasterideActive Control1 Intervention
two 0.5 mg capsules of dutasteride daily
Group II: placebo capsulePlacebo Group1 Intervention
inactive placebo matched in appearance with dutasteride capsules
Find a Location
Who is running the clinical trial?
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
799 Previous Clinical Trials
1,362,331 Total Patients Enrolled
422 Trials studying Alcoholism
985,028 Patients Enrolled for Alcoholism
UConn HealthLead Sponsor
211 Previous Clinical Trials
60,441 Total Patients Enrolled
19 Trials studying Alcoholism
3,372 Patients Enrolled for Alcoholism
Jonathan Covault, MD, PhDPrincipal Investigator - UConn Health
John Dempsey Hospital-UConn Health Center
University Of Iowa College Of Medicine (Medical School)
University Of Ct School Of Medicine (Residency)
2 Previous Clinical Trials
141 Total Patients Enrolled
2 Trials studying Alcoholism
141 Patients Enrolled for Alcoholism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking medication for hair loss, alcohol use disorder, or chronic pain.I am between 35 and 70 years old.You don't have any major problems with your memory or thinking abilities.I have been deemed unsuitable for experimental drug trials.I drink more than the recommended amount of alcohol weekly.I am a woman who can have children, using birth control, not breastfeeding, and have a negative pregnancy test.My health is generally good without major uncontrolled diseases, except for common conditions like hypertension or diabetes which are under control.You have experienced severe symptoms when trying to stop drinking alcohol, such as seeing or hearing things that aren't there, having seizures, confusion, or feeling like you're not in touch with reality.You currently have an alcohol use disorder according to the DSM-5 guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: placebo capsule
- Group 2: dutasteride
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How can I become a patient in this clinical trial?
"The primary requirement for admission into this clinical trial is that the patient must have a history of alcoholism. Additionally, all candidates must be between 35 and 70 years old. Up to 190 people will be accepted."
Answered by AI
Would this trial be interested in enrolling middle-aged individuals?
"Patients who want to enroll in this particular trial must be between 35 and 70 years old. If a patient does not meet this age requirement, there are 20 other trials they could enroll in."
Answered by AI
Are there any positions open in this trial for new patients?
"The information available on clinicaltrials.gov affirms that this study is still looking for participants. This trial was first posted on October 15th, 2019 and was updated on June 14th, 2020. Presently, the research team requires 190 more individuals from 1 more site."
Answered by AI
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