Alcohol DependencePhase 2NCT00874003
The Effects of Mirtazapine Versus Placebo on Alcohol Consumption in Male Alcohol High Consumers
A Phase 2 study testing mirtazapine in people with Alcohol Dependence, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to study the effects of 8 weeks of treatment with mirtazapine on alcohol consumption in alcohol high consuming men. This study is a randomized, double-blind placebo controlled clinical trial with parallel group design(N=59). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- mirtazapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2004to Feb 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- 18-65 years of age
- male sex
- alcohol high consumption
- signed informed consent
Who cannot join
- psychiatric disorders (except nicotine and alcohol dependence)
- severe somatic disorders
- inadequate knowledge of the Swedish language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Mirtazapine vs Placebo on Alcohol Consumption in Male Alcohol High Consumers; a Randomized Controlled Trial
The purpose of this study is to study the effects of 8 weeks of treatment with mirtazapine on alcohol consumption in alcohol high consuming men. This study is a randomized, double-blind placebo controlled clinical trial with parallel group design(N=59).
- Conditions
- Alcohol Dependence
- Being tested
- mirtazapine, placebo
- Keywords
- alcohol dependence, anti-depressant, 5-HT, NE
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirtazapineDrug
oral tablet, 30 mg daily
placeboDrug
oral tablet, 1 daily
| Study group | Role | What they receive |
|---|---|---|
| mirtazapine, tablet, 30 mg | Experimental | n=29 Receives: Drug: mirtazapine |
| sugar pill | Placebo comparator | n=30 Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol consumption measured by alcohol diary (units/week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startApr 2004
- Primary completionJul 2006
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Andrea deBejczy, MD, Study director, Addiction Biology UnitBo Söderpalm, MD, PhD, Principal investigator, Addiction Biology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874003
- Sponsor's protocol ID
- GOTABU-BO1
- Status last verified
- Mar 2009
- First submitted
- 1 Apr 2009
- Last updated
- 2 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mirtazapine vs Placebo on Alcohol Consumption in Male Alcohol High Consumers; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00874003
- Acronym / sponsor ID
- GOTABU-BO1
- Conditions
- Alcohol Dependence
- Keywords
- alcohol dependence, anti-depressant, 5-HT, NE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 2 Apr 2009 (estimated)
- Results
- Not posted in the source record
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 study the effects of 8 weeks of treatment with mirtazapine on alcohol consumption in alcohol high consuming men. This study is a randomized, double-blind placebo controlled clinical trial with parallel group design(N=59).
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 |
|---|---|---|
| mirtazapine, tablet, 30 mg | Experimental | Drug: mirtazapinen=29 |
| sugar pill | Placebo comparator | Drug: placebon=30 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years of age
- male sex
- alcohol high consumption
- signed informed consent
Key exclusion criteria (3 listed)
- psychiatric disorders (except nicotine and alcohol dependence)
- severe somatic disorders
- inadequate knowledge of the Swedish language
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 |
|---|---|---|
| mirtazapineoral tablet, 30 mg daily | Drug | mirtazapine, tablet, 30 mg |
| placebooral tablet, 1 daily | Drug | sugar pill |
Primary outcome
Alcohol consumption measured by alcohol diary (units/week).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2009.
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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.
Andrea deBejczy, MD study director
Addiction Biology Unit
Bo Söderpalm, MD, PhD principal investigator
Addiction Biology Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mirtazapine in people with Alcohol Dependence, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 4 inclusion and 3 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 2 Apr 2009. 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 Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Alcohol consumption measured by alcohol diary (units/week).. 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 2 Apr 2009.