AlcoholismPhase 4NCT01758523
Dutasteride Treatment for the Reduction of Heavy Drinking in Men
A Phase 4 study testing Dutasteride and sugar pill in people with Alcoholism and Alcohol Abuse, run by UConn Health at 1 site in United States.
Trial summary
This study will examine the safety and potential benefit of the medication dutasteride to help men reduce or stop drinking alcohol. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Alcoholism, Alcohol Abuse, Alcohol Dependence
- What is being tested?
- Dutasteride and sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 28 Feb 2018
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- an average weekly ethanol consumption of at least 24 standard drinks;
- be able to read English at the 8th grade or higher level;
- no evidence of significant cognitive impairment;
- be willing to provide signed, informed consent to participate in the study (including a willingness to stop or reduce drinking to non-hazardous levels);
- be willing to nominate an individual who will know the patient's whereabouts to facilitate follow up during the study
Who cannot join
- history of significant alcohol withdrawal symptoms (e.g. substantial tremor, autonomic changes, perceptual distortions, seizures, delirium, or hallucinations);
- current Diagnostic and Statistical Manual Version IV (DSM-IV) 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 study (e.g. evidence of serious adverse medical or psychiatric effects that are exacerbated by heavy drinking and would, for safety reasons, lead the physician to urge the patient to be totally abstinent and engage in an empirically supported treatment).
- current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation,(we will not exclude patients with hypertension, diabetes mellitus, asthma or other common medical conditions, if these are adequately controlled and the patient has an ongoing relationship with a primary care provider)
- serious psychiatric illness on the basis of history or psychiatric examination (i.e., schizophrenia, bipolar disorder, severe or psychotic major depression, organic mental disorder, current clinically significant eating disorder, or substantial suicide or violence risk);
- current DSM-IV diagnosis of drug dependence (other than nicotine dependence);
- currently taking psychotropics other than medication for depression/anxiety disorder (with stable dose for at least 4 weeks),medications for treatment of Attention Deficit/Hyperactivity Disorder (with stable dose for at least 4 weeks), a non-benzodiazepine sleep medication or a low dose of benzodiazepine equivalent to 2 mg clonazepam or lorazepam per day;
- 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: Dutasteride Treatment for the Reduction of Heavy Drinking
This study will examine the safety and potential benefit of the medication dutasteride to help men reduce or stop drinking alcohol.
Read the detailed description
Extensive preclinical studies indicate that neuroactive steroids medicate important effects of alcohol and support the examination of neuroactive steroid modulators as treatment options for alcohol use problems. Dutasteride, a widely prescribed medication for benign prostatic hypertrophy, blocks a key step in the production of neuroactive steroids and represents a promising candidate for treatment of alcohol use disorders. This study will use a 12-week randomized placebo controlled design to examine the safety and efficacy of dutasteride to reduce drinking among a sample of 160 men with hazardous levels of alcohol use. It will additionally examine the potential moderation of dutasteride treatment effects by a common missense polymorphism in a neuroactive steroid biosynthetic enzyme that we have previously reported to be associated with alcohol dependence. Identification of genetic predictors of medication response offers the potential for matching alcohol treatment medications with those most likely to respond.
- Conditions
- Alcoholism, Alcohol Abuse, Alcohol Dependence
- Being tested
- Dutasteride, sugar pill
- Keywords
- neuroactive steroids
- 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
sugar pillDrug
Also called placebo
| Study group | Role | What they receive |
|---|---|---|
| dutasteride | Experimental | 4 mg oral loading dose of dutasteride followed by 1 mg/day dutasteride for 12 weeks. Receives: Drug: Dutasteride |
| Sugar Pill | Placebo comparator | Placebo pills prepared to appear the same as active medication and taken in the same number as active medication for 12 weeks. Receives: Drug: sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heavy Drinking Days Per Week
Number of days / study week with 5 or more drinks consumed
Measured: 12-week treatment period
Drinks Per Week
Total number of drinks aggregated by week
Measured: 12-week treatment period
Number of Participants With no Heavy Drinking Days
Number of participants with no heavy drinking days (days with 5 or more drinks) during the last 4 weeks of treatment.
Measured: Last 4 weeks of treatment
Number of Participants With no Hazardous Drinking
Number of participants with no hazardous drinking (not more than 4 drinks on one day and not more than 14 drinks per week) during the last 4 weeks of treatment.
Measured: Last 4 weeks of treatment
Secondary outcomes (2)
HDD/ Week by Treatment Group and AKR1C3*2 Genotype
Change in Number of days / week with 5 or more drinks consumed contrasting AKR1C3*2 CC vs. G-carrier genotype and treatment group
Measured: 12-week treatment period
Carbohydrate-deficient Transferrin
Carbohydrate-deficient transferrin (CDT) at end of treatment as percentage of baseline. Serum CDT is a biochemical measure of heavy alcohol use.
Measured: end of 12-week treatment vs. baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startJan 2013
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 189 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, M.D., PhD., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758523
- Sponsor's protocol ID
- 13-056-2
- Other IDs
- 2P60AA003510
- Status last verified
- Apr 2019
- First submitted
- 24 Dec 2012
- Last updated
- 26 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Covault J, Tennen H, Feinn R. Randomized Placebo-Controlled Clinical Trial of Dutasteride for Reducing Heavy Drinking in Men. J Clin Psychopharmacol. 2024 May-Jun 01;44(3):223-231. doi: 10.1097/JCP.0000000000001849.
PubMed 38684046
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dutasteride Treatment for the Reduction of Heavy Drinking
- ClinicalTrials.gov ID
- NCT01758523
- Acronym / sponsor ID
- 13-056-2
- Conditions
- Alcoholism, Alcohol Abuse, Alcohol Dependence
- Keywords
- neuroactive steroids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jan 2013
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 1 Jan 2013 (estimated)
- Results
- Posted 26 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the safety and potential benefit of the medication dutasteride to help men reduce or stop drinking alcohol.
Detailed description
Extensive preclinical studies indicate that neuroactive steroids medicate important effects of alcohol and support the examination of neuroactive steroid modulators as treatment options for alcohol use problems. Dutasteride, a widely prescribed medication for benign prostatic hypertrophy, blocks a key step in the production of neuroactive steroids and represents a promising candidate for treatment of alcohol use disorders. This study will use a 12-week randomized placebo controlled design to examine the safety and efficacy of dutasteride to reduce drinking among a sample of 160 men with hazardous levels of alcohol use. It will additionally examine the potential moderation of dutasteride treatment effects by a common missense polymorphism in a neuroactive steroid biosynthetic enzyme that we have previously reported to be associated with alcohol dependence. Identification of genetic predictors of medication response offers the potential for matching alcohol treatment medications with those most likely to respond.
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: Dutasteride4 mg oral loading dose of dutasteride followed by 1 mg/day dutasteride for 12 weeks. |
| Sugar Pill | Placebo comparator | Drug: sugar pillPlacebo pills prepared to appear the same as active medication and taken in the same number as active medication for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- an average weekly ethanol consumption of at least 24 standard drinks;
- be able to read English at the 8th grade or higher level;
- no evidence of significant cognitive impairment;
- be willing to provide signed, informed consent to participate in the study (including a willingness to stop or reduce drinking to non-hazardous levels);
- be willing to nominate an individual who will know the patient's whereabouts to facilitate follow up during the study
Key exclusion criteria (7 listed)
- history of significant alcohol withdrawal symptoms (e.g. substantial tremor, autonomic changes, perceptual distortions, seizures, delirium, or hallucinations);
- current Diagnostic and Statistical Manual Version IV (DSM-IV) 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 study (e.g. evidence of serious adverse medical or psychiatric effects that are exacerbated by heavy drinking and would, for safety reasons, lead the physician to urge the patient to be totally abstinent and engage in an empirically supported treatment).
- current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation,(we will not exclude patients with hypertension, diabetes mellitus, asthma or other common medical conditions, if these are adequately controlled and the patient has an ongoing relationship with a primary care provider)
- serious psychiatric illness on the basis of history or psychiatric examination (i.e., schizophrenia, bipolar disorder, severe or psychotic major depression, organic mental disorder, current clinically significant eating disorder, or substantial suicide or violence risk);
- current DSM-IV diagnosis of drug dependence (other than nicotine dependence);
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: Avodart | Drug | dutasteride |
| sugar pillAlso: placebo | Drug | Sugar Pill |
Primary outcome
Heavy Drinking Days Per Week
Time frame: 12-week treatment period
Number of days / study week with 5 or more drinks consumed
Drinks Per Week
Time frame: 12-week treatment period
Total number of drinks aggregated by week
Number of Participants With no Heavy Drinking Days
Time frame: Last 4 weeks of treatment
Number of participants with no heavy drinking days (days with 5 or more drinks) during the last 4 weeks of treatment.
Number of Participants With no Hazardous Drinking
Time frame: Last 4 weeks of treatment
Number of participants with no hazardous drinking (not more than 4 drinks on one day and not more than 14 drinks per week) during the last 4 weeks of treatment.
2 secondary outcomes
HDD/ Week by Treatment Group and AKR1C3*2 Genotype
Time frame: 12-week treatment period
Carbohydrate-deficient Transferrin
Time frame: end of 12-week treatment vs. baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38684046Covault J, Tennen H, Feinn R. Randomized Placebo-Controlled Clinical Trial of Dutasteride for Reducing Heavy Drinking in Men. J Clin Psychopharmacol. 2024 May-Jun 01;44(3):223-231. doi: 10.1097/JCP.0000000000001849.
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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, M.D., 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 and sugar pill 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 7 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 26 Apr 2019. 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 26 Apr 2019). 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?
Heavy Drinking Days Per Week (time frame: 12-week treatment period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01758523, which also lists 1 linked publication.
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 26 Apr 2019.