AlcoholismPhase 4NCT01262287
Dutasteride for the Reduction of Alcohol Use in Male Drinkers
A Phase 4 study testing Dutasteride in people with Alcoholism and Alcohol Abuse, run by UConn Health at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether dutasteride is safe and effective for reducing alcohol use in male drinkers who want to stop or reduce their drinking. The investigators hypothesize that at a dosage of 1mg/day, dutasteride will be well tolerated and that, compared to placebo treatment, dutasteride will… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Alcoholism, Alcohol Abuse, Alcohol Dependence
- What is being tested?
- Dutasteride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Dec 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male outpatients age 18 to 65 years
- Have an average weekly ethanol consumption of >24 standard drinks
- Be able to read English at the 8th grade or higher level and show no evidence of significant cognitive impairment
- Be willing to nominate an individual who will know the patient's whereabouts in order to facilitate follow up during the study
- Be willing to provide signed, informed consent to participate in the study (including a willingness to reduce drinking to non-hazardous levels)
Who cannot join
- Have a current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation
- Have a serious psychiatric illness (e.g., schizophrenia, bipolar disorder, severe or psychotic major depression, organic mood or mental disorders, current eating disorder symptoms, or substantial suicide or violence risk) on the basis of history or psychiatric examination
- Have a current diagnosis of drug dependence (other than nicotine or alcohol dependence)
- Have a current diagnosis of alcohol dependence who on clinical examination by a physician, are deemed to be too severely alcohol dependent to permit them to participate in a placebo-controlled pilot study
- Have a history of hypersensitivity to dutasteride
- Current or past 4 month use of finasteride (Propecia), dutasteride (Avodart) or testosterone
- Are currently taking psychotropics other than a single antidepressant with stable dose for at least 4 weeks or a non-benzodiazepine sleep medication
- Are considered by the investigators to be an unsuitable candidate for receipt of an investigational drug
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
Official title: Placebo Controlled Pilot Study of Dutasteride for the Reduction of Alcohol Use in Male Drinkers
The purpose of this study is to evaluate whether dutasteride is safe and effective for reducing alcohol use in male drinkers who want to stop or reduce their drinking. The investigators hypothesize that at a dosage of 1mg/day, dutasteride will be well tolerated and that, compared to placebo treatment, dutasteride will result in a greater reduction in the amount of alcohol consumed per week. The study sample size is of a pilot scale and is designed to provide additional support for the study hypothesis and provide an estimate of likely effect sizes in order to design a more definitive study.
- Conditions
- Alcoholism, Alcohol Abuse, Alcohol Dependence
- Being tested
- Dutasteride, Placebo
- Keywords
- Randomized Trial, Medication for Heavy Drinking, Dutasteride Treatment
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DutasterideDrug
Also called Avodart
dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period
PlaceboDrug
Also called Lactose
placebo capsules in same number as active drug, daily for 8-week treatment period
| Study group | Role | What they receive |
|---|---|---|
| dutasteride | Experimental | dutasteride (1 mg oral daily dose) for 8-week treatment period Receives: Drug: Dutasteride |
| Placebo | Placebo comparator | placebo daily for 8-week treatment period Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Number of Standard Drinks Per Week.
Change in Average Standard Drinks (14 gr ethanol) per week: last 2 weeks of treatment (wk 7-8) minus baseline average drinking average from baseline 90 day drinking history
Measured: Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)
Secondary outcomes (1)
Change in Standard Drinks Per Week - Moderation by Genetic Variation
Moderation of primary outcome measure [change in standard drinks per week from baseline to end point (average weeks 7 and 8 of treatment)] by genetic variation rs12529 in neuroactive steroid biosynthetic enzyme gene AKR1C (AKR1C3*2 C-allele associated with alcohol use disorder)
Measured: Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Jonathan Covault, UConn Health
- Investigators
- Jonathan Covault, MD, PhD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262287
- Sponsor's protocol ID
- 11-036-2
- Other IDs
- P60AA003510
- Status last verified
- Feb 2017
- First submitted
- 15 Dec 2010
- Last updated
- 20 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Controlled Pilot Study of Dutasteride for the Reduction of Alcohol Use in Male Drinkers
- ClinicalTrials.gov ID
- NCT01262287
- Acronym / sponsor ID
- 11-036-2
- Conditions
- Alcoholism, Alcohol Abuse, Alcohol Dependence
- Keywords
- Randomized Trial, Medication for Heavy Drinking, Dutasteride Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Posted 10 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether dutasteride is safe and effective for reducing alcohol use in male drinkers who want to stop or reduce their drinking. The investigators hypothesize that at a dosage of 1mg/day, dutasteride will be well tolerated and that, compared to placebo treatment, dutasteride will result in a greater reduction in the amount of alcohol consumed per week. The study sample size is of a pilot scale and is designed to provide additional support for the study hypothesis and provide an estimate of likely effect sizes in order to design a more definitive study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dutasteride | Experimental | Drug: Dutasteridedutasteride (1 mg oral daily dose) for 8-week treatment period |
| Placebo | Placebo comparator | Drug: Placeboplacebo daily for 8-week treatment period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male outpatients age 18 to 65 years
- Have an average weekly ethanol consumption of >24 standard drinks
- Be able to read English at the 8th grade or higher level and show no evidence of significant cognitive impairment
- Be willing to nominate an individual who will know the patient's whereabouts in order to facilitate follow up during the study
- Be willing to provide signed, informed consent to participate in the study (including a willingness to reduce drinking to non-hazardous levels)
Key exclusion criteria (8 listed)
- Have a current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation
- Have a serious psychiatric illness (e.g., schizophrenia, bipolar disorder, severe or psychotic major depression, organic mood or mental disorders, current eating disorder symptoms, or substantial suicide or violence risk) on the basis of history or psychiatric examination
- Have a current diagnosis of drug dependence (other than nicotine or alcohol dependence)
- Have a current diagnosis of alcohol dependence who on clinical examination by a physician, are deemed to be too severely alcohol dependent to permit them to participate in a placebo-controlled pilot study
- Have a history of hypersensitivity to dutasteride
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DutasterideAlso: Avodartdutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period | Drug | dutasteride |
| PlaceboAlso: Lactoseplacebo capsules in same number as active drug, daily for 8-week treatment period | Drug | Placebo |
Primary outcome
Change Number of Standard Drinks Per Week.
Time frame: Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)
Change in Average Standard Drinks (14 gr ethanol) per week: last 2 weeks of treatment (wk 7-8) minus baseline average drinking average from baseline 90 day drinking history
1 secondary outcome
Change in Standard Drinks Per Week - Moderation by Genetic Variation
Time frame: Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Covault, MD, PhD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dutasteride in people with Alcoholism and Alcohol Abuse, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Number of Standard Drinks Per Week. (time frame: Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.