Alcohol DependencePhase 2/3ATNCT00884884
Aripiprazole and Topiramate on Free-Choice Alcohol Use
A Phase 2/3 study of Alcohol Dependence, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
The current study investigates the effects of two potential alcohol treatment medications on drinking in a laboratory setting. Aripiprazole (APZ), effects dopamine and serotonin receptors with fewer limiting side effects seen with other atypical antipsychotics. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Dependence
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Oct 2015
- Phase
- Phase 2/3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must be non-treatment seeking for alcohol dependence
- a current DSM-IV-TR diagnosis of alcohol dependence supported by the Structured Clinical Interview for DSM-IV-TR Axis I Disorders Patient Edition (SCID-I/P a minimum of ≥ 35drinks a week for men or ≥ 28 or more drinks a week for women
- must be suitable for outpatient treatment
- able to read English at an eighth grade level, understand their rights as provided by the informed consent, and be willing to sign an informed consent to participate in the study
- be between 21 and 65 years on age (inclusive)
- provide evidence of stable residence in the two months prior to enrollment and no plans to move for the next four months
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- provide a verifiable contact person prior to randomization
- be in generally good health as determined by the physical exam, medical history, ECG and laboratory tests
- have a Body Mass Index >18kg/m2 and < 33 kg/m2
- if female, must be postmenopausal practicing an effective method of birth control, have negative pregnancy tests at randomization and before the ASAE;
- be willing to be adherent to medication dosing.
Who cannot join
- clinically significant medical abnormalities (i.e. ECG, hematological assessment, bilirubin > 150% of the upper limit of normal or ALT or AST elevations >300% the upper limit of normal, biochemistry including urinalysis, electrolytes,). (Persons with medical conditions that are adequately controlled by their primary care physician will not be excluded.)
- have significant alcohol withdrawal symptoms (clinical institute withdrawal assessment for alcohol revised (CIWA-Ar) >10
- a history of suicide; history of renal impairment or nephrolithiasis; creatinine clearance of <60 dl/minute
- pregnant or lactating or not using an adequate form of birth control
- taking other medications that may have an effect on alcohol consumption or are carbonic anhydrase inhibitors
- clinically significant diseases of the gastrointestinal system or active liver disease; subjects compelled to receive treatment to avoid imprisonment or loss of employment
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- previously with a history of adverse reaction or hypersensitivity to either Topiramate or aripiprazole
- have a diagnosis of with schizophrenia or bipolar disorder and/or taking antipsychotics and other drugs that inhibit CYP3A4 or CYP2D6 isoenzymes
- history of seizures (e.g. epilepsy)
- patients currently diagnosed with a substance dependence diagnosis other than alcohol or tobacco
- patients who have participated in any clinical trial with an investigational agent within the past 30 days
- individuals with a reasonable expectation of being institutionalized during the course of the trial or pending legal charges
- pregnant or nursing women.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University Center for Addiction Studies
Providence, Rhode Island, 02903
About this study
The current study investigates the effects of two potential alcohol treatment medications on drinking in a laboratory setting. Aripiprazole (APZ), effects dopamine and serotonin receptors with fewer limiting side effects seen with other atypical antipsychotics. Topiramate (TPMT), an antiepileptic, affects glutamate and GABA-A receptors and shows promise in reducing heavy drinking. Few studies have used two medications with such a diverse combination of actions to examine a potential synergistic effect on reducing alcohol consumption.
The primary aims are to:
- determine if APZ and TPMT are each more effective than placebo, and the combination of APZ and TPMT is more effective than either drug alone or placebo, in reducing alcohol use in non-treatment seeking alcohol dependent subjects in a laboratory based alcohol self-administration experiment (ASAE)
- examine a hypothesized dose-response for three doses of APZ (0, 7.5 mg/d and 15 mg/d) along with three doses of TPMT (0, 100mg/d and 200mg/d)
- examine the putative mechanisms of action of APZ, TPMT alone and together on craving, subjective stimulation, candidate gene influences and other behavioral effects associated with alcohol consumption
- establish the safety of giving APZ and TPMT together. Non-treatment seeking, alcohol dependent Participants (N=216) will be recruited from the community and randomly assigned to one of the 9 cells. Subjects drinking and safety is monitored over a 5-week titration to their target dose, leading to an in-laboratory alcohol self administration session, during which clinical and behavioral effects are assessed during access to alcohol. A 1 month follow-up assesses adverse events and drinking.
Read the detailed description
Due to the modest effect of current pharmacotherapies, more effective treatments must be developed to optimally treat alcohol dependent patients. Treatments combining pharmacotherapies with different mechanisms of action may better address the diverse neurobiology of alcohol and the heterogeneity of alcoholics. However, little is known about how medication may affect behavior to reduce drinking. Aripiprazole (APZ), a partial dopamine agonist, affects dopamine and serotonin receptors without the limiting side effects seen with other atypical antipsychotics. Dopamine mediates reward based drinking and craving. Topiramate (TPMT), an antiepileptic, affects glutamate and GABA-A receptors and shows promise in reducing heavy drinking. Glutamate and GABA may mediate relief-based drinking and protracted withdrawal. Despite strong evidence that multiple neurotransmitters contribute to alcoholism, few studies have used two medications with such a diverse combination of actions to examine a potential synergistic effect on reducing alcohol consumption.
The present study will recruit 216 healthy, alcohol-dependent volunteers who are not currently seeking treatment for their alcohol dependence to learn more about how these medications may work.
The primary aims are to: (1) determine if APZ and TPMT are each more effective than placebo, and the combination of APZ and TPMT is more effective than either drug alone or placebo, in reducing alcohol use in non-treatment seeking alcohol dependent subjects in an alcohol self administration experiment (ASAE); (2) examine a hypothesized dose-response for three doses of APZ (0, 7.5mg/d and 15 mg/d) and three doses of TPMT (0, 100mg/d, 200mg/d); (3) examine the putative mechanisms of action of APZ, TPMT alone and together on craving, subjective stimulation, candidate gene influences and other behavioral effects associated with alcohol consumption; and (4) establish the safety of giving APZ and TPMT together. We will use of a 3 X 3 drug (7.5mg, 15mg APZ vs. placebo) by drug (100mg, 200mg TPMT vs. placebo) between-subjects factorial design. Participants are randomly assigned to one of 9 cells. Subjects drinking and safety is monitored over a 5-week titration to their target dose, leading to an in-laboratory alcohol self administration session, during which clinical and behavioral effects are assessed during access to alcohol. A 1 month follow-up assesses adverse events and drinking. The long term objectives of this research are to improve medications available for alcoholism treatment and inform research and theory on the mechanisms of action of such medications.
- Conditions
- Alcohol Dependence
- Being tested
- Double Placebo, Aripiprazole 15, placebo, Aripiprazole 7.5, Placebo, Topiramate 100, Placebo, Topiramate 200, Placebo
- Keywords
- Alcohol dependence, alcohol abuse, topiramate, aripiprazole
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double PlaceboDrug
1 capsule daily
Aripiprazole 15, placeboDrug
Also called Abilify, Topamax
15 mg Aripiprazole daily plus placebo daily
Aripiprazole 7.5, PlaceboDrug
Aripiprazole 7.5 mg daily plus Placebo daily
Topiramate 100, PlaceboDrug
Topiramate 100 mg daily plus Placebo daily
Topiramate 200, PlaceboDrug
Topiramate 200 mg daily plus Placebo daily
Topiramate 100, Aripiprazole 15Drug
Also called Abilify, Topamax
Topiramate 100 mg daily plus Aripiprazole 15mg daily
Topiramate 100, Aripiprazole 7.5Drug
Topiramate 100 mg daily plus Aripiprazole 7.5mg daily
Topiramate 100, Aripiprazole 15mgDrug
Also called Abilify, Topamax
Topiramate 100 mg daily plus Aripiprazole 15mg daily
Topiramate 200, Aripiprazole 7.5mgDrug
Also called Abilify, Topamax
Topiramate 200 mg daily plus Aripiprazole 7.5mg daily
Topiramate 200, Aripiprazole 15Drug
Also called Abilify, Topamax
Topiramate 200mg daily plus Aripiprazole 15mg daily
| Study group | Role | What they receive |
|---|---|---|
| Double Placebo | Placebo comparator | Placebo, Placebo Receives: Drug: Double Placebo |
| Aripiprazole 15, Placebo | Experimental | 15 mg Aripiprazole, Placebo Receives: Drug: Aripiprazole 15, placebo |
| Aripiprazole 7.5, Placebo | Experimental | Aripiprazole 7.5 mg daily plus Placebo daily Receives: Drug: Aripiprazole 7.5, Placebo |
| Topiramate 100mg, Placebo | Experimental | Topiramate 100 mg daily plus Placebo daily Receives: Drug: Topiramate 100, Placebo |
| Topiramate 200, Placebo | Experimental | Topiramate 200 mg daily plus Placebo daily Receives: Drug: Topiramate 200, Placebo |
| Topiramate 100, Aripiprazole 5 | Experimental | Topiramate 100 daily plus, Aripiprazole 5mg daily Receives: Drug: Topiramate 100, Aripiprazole 15; Drug: Topiramate 100, Aripiprazole 15mg |
| Topiramate 200, Aripiprazole 15 | Experimental | Topiramate 200 mg daily plus Aripiprazole 15mg daily Receives: Drug: Topiramate 200, Aripiprazole 15 |
| Topiramate 100, Aripiprazole 7.5 | Experimental | Topiramate 100 mg daily, Aripiprazole 7.5 mg daily Receives: Drug: Topiramate 100, Aripiprazole 7.5 |
| Topiramate 200, Aripiprazole 7.5mg | Experimental | Topiramate 200 mg daily plus Aripiprazole 7.5mg daily Receives: Drug: Topiramate 200, Aripiprazole 7.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of alcoholic drinks consumed in a laboratory setting
Measured: 90 minutes
Safety and tolerability of the medications singly and in combination, compared to placebo
Measured: 4 years
Secondary outcomes (1)
Drinks consumed during the medication titration period
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startSep 2007
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Brown University
- Responsible party
- Principal investigator, Robert Swift, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- Robert M Swift, MD, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884884
- Sponsor's protocol ID
- NIAAA-Swift-AA015753
- Other IDs
- NIH Grant 5RO1AA015753-02
- Acronym
- AT
- Status last verified
- Oct 2015
- First submitted
- 20 Apr 2009
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Haass-Koffler CL, Goodyear K, Zywiak WH, Leggio L, Kenna GA, Swift RM. Comparing and Combining Topiramate and Aripiprazole on Alcohol-Related Outcomes in a Human Laboratory Study. Alcohol Alcohol. 2018 May 1;53(3):268-276. doi: 10.1093/alcalc/agx108.
PubMed 29281033
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aripiprazole and Topiramate on Free-Choice Alcohol Use
- ClinicalTrials.gov ID
- NCT00884884
- Acronym / sponsor ID
- AT / NIAAA-Swift-AA015753
- Conditions
- Alcohol Dependence
- Keywords
- Alcohol dependence, alcohol abuse, topiramate, aripiprazole
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Collaborators
- Brown University
- Study start
- Sep 2007
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 21 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 current study investigates the effects of two potential alcohol treatment medications on drinking in a laboratory setting. Aripiprazole (APZ), effects dopamine and serotonin receptors with fewer limiting side effects seen with other atypical antipsychotics. Topiramate (TPMT), an antiepileptic, affects glutamate and GABA-A receptors and shows promise in reducing heavy drinking. Few studies have used two medications with such a diverse combination of actions to examine a potential synergistic effect on reducing alcohol consumption.
The primary aims are to:
- determine if APZ and TPMT are each more effective than placebo, and the combination of APZ and TPMT is more effective than either drug alone or placebo, in reducing alcohol use in non-treatment seeking alcohol dependent subjects in a laboratory based alcohol self-administration experiment (ASAE)
- examine a hypothesized dose-response for three doses of APZ (0, 7.5 mg/d and 15 mg/d) along with three doses of TPMT (0, 100mg/d and 200mg/d)
- examine the putative mechanisms of action of APZ, TPMT alone and together on craving, subjective stimulation, candidate gene influences and other behavioral effects associated with alcohol consumption
- establish the safety of giving APZ and TPMT together. Non-treatment seeking, alcohol dependent Participants (N=216) will be recruited from the community and randomly assigned to one of the 9 cells. Subjects drinking and safety is monitored over a 5-week titration to their target dose, leading to an in-laboratory alcohol self administration session, during which clinical and behavioral effects are assessed during access to alcohol. A 1 month follow-up assesses adverse events and drinking.
Detailed description
Due to the modest effect of current pharmacotherapies, more effective treatments must be developed to optimally treat alcohol dependent patients. Treatments combining pharmacotherapies with different mechanisms of action may better address the diverse neurobiology of alcohol and the heterogeneity of alcoholics. However, little is known about how medication may affect behavior to reduce drinking. Aripiprazole (APZ), a partial dopamine agonist, affects dopamine and serotonin receptors without the limiting side effects seen with other atypical antipsychotics. Dopamine mediates reward based drinking and craving. Topiramate (TPMT), an antiepileptic, affects glutamate and GABA-A receptors and shows promise in reducing heavy drinking. Glutamate and GABA may mediate relief-based drinking and protracted withdrawal. Despite strong evidence that multiple neurotransmitters contribute to alcoholism, few studies have used two medications with such a diverse combination of actions to examine a potential synergistic effect on reducing alcohol consumption.
The present study will recruit 216 healthy, alcohol-dependent volunteers who are not currently seeking treatment for their alcohol dependence to learn more about how these medications may work.
The primary aims are to: (1) determine if APZ and TPMT are each more effective than placebo, and the combination of APZ and TPMT is more effective than either drug alone or placebo, in reducing alcohol use in non-treatment seeking alcohol dependent subjects in an alcohol self administration experiment (ASAE); (2) examine a hypothesized dose-response for three doses of APZ (0, 7.5mg/d and 15 mg/d) and three doses of TPMT (0, 100mg/d, 200mg/d); (3) examine the putative mechanisms of action of APZ, TPMT alone and together on craving, subjective stimulation, candidate gene influences and other behavioral effects associated with alcohol consumption; and (4) establish the safety of giving APZ and TPMT together. We will use of a 3 X 3 drug (7.5mg, 15mg APZ vs. placebo) by drug (100mg, 200mg TPMT vs. placebo) between-subjects factorial design. Participants are randomly assigned to one of 9 cells. Subjects drinking and safety is monitored over a 5-week titration to their target dose, leading to an in-laboratory alcohol self administration session, during which clinical and behavioral effects are assessed during access to alcohol. A 1 month follow-up assesses adverse events and drinking. The long term objectives of this research are to improve medications available for alcoholism treatment and inform research and theory on the mechanisms of action of such medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Double Placebo | Placebo comparator | Drug: Double PlaceboPlacebo, Placebo |
| Aripiprazole 15, Placebo | Experimental | Drug: Aripiprazole 15, placebo15 mg Aripiprazole, Placebo |
| Aripiprazole 7.5, Placebo | Experimental | Drug: Aripiprazole 7.5, PlaceboAripiprazole 7.5 mg daily plus Placebo daily |
| Topiramate 100mg, Placebo | Experimental | Drug: Topiramate 100, PlaceboTopiramate 100 mg daily plus Placebo daily |
| Topiramate 200, Placebo | Experimental | Drug: Topiramate 200, PlaceboTopiramate 200 mg daily plus Placebo daily |
| Topiramate 100, Aripiprazole 5 | Experimental | Drug: Topiramate 100, Aripiprazole 15, Drug: Topiramate 100, Aripiprazole 15mgTopiramate 100 daily plus, Aripiprazole 5mg daily |
| Topiramate 200, Aripiprazole 15 | Experimental | Drug: Topiramate 200, Aripiprazole 15Topiramate 200 mg daily plus Aripiprazole 15mg daily |
| Topiramate 100, Aripiprazole 7.5 | Experimental | Drug: Topiramate 100, Aripiprazole 7.5Topiramate 100 mg daily, Aripiprazole 7.5 mg daily |
| Topiramate 200, Aripiprazole 7.5mg | Experimental | Drug: Topiramate 200, Aripiprazole 7.5mgTopiramate 200 mg daily plus Aripiprazole 7.5mg daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- must be non-treatment seeking for alcohol dependence
- a current DSM-IV-TR diagnosis of alcohol dependence supported by the Structured Clinical Interview for DSM-IV-TR Axis I Disorders Patient Edition (SCID-I/P a minimum of ≥ 35drinks a week for men or ≥ 28 or more drinks a week for women
- must be suitable for outpatient treatment
- able to read English at an eighth grade level, understand their rights as provided by the informed consent, and be willing to sign an informed consent to participate in the study
- be between 21 and 65 years on age (inclusive)
Key exclusion criteria (13 listed)
- clinically significant medical abnormalities (i.e. ECG, hematological assessment, bilirubin > 150% of the upper limit of normal or ALT or AST elevations >300% the upper limit of normal, biochemistry including urinalysis, electrolytes,). (Persons with medical conditions that are adequately controlled by their primary care physician will not be excluded.)
- have significant alcohol withdrawal symptoms (clinical institute withdrawal assessment for alcohol revised (CIWA-Ar) >10
- a history of suicide; history of renal impairment or nephrolithiasis; creatinine clearance of <60 dl/minute
- pregnant or lactating or not using an adequate form of birth control
- taking other medications that may have an effect on alcohol consumption or are carbonic anhydrase inhibitors
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 |
|---|---|---|
| Double Placebo1 capsule daily | Drug | Double Placebo |
| Aripiprazole 15, placeboAlso: Abilify, Topamax15 mg Aripiprazole daily plus placebo daily | Drug | Aripiprazole 15, Placebo |
| Aripiprazole 7.5, PlaceboAripiprazole 7.5 mg daily plus Placebo daily | Drug | Aripiprazole 7.5, Placebo |
| Topiramate 100, PlaceboTopiramate 100 mg daily plus Placebo daily | Drug | Topiramate 100mg, Placebo |
| Topiramate 200, PlaceboTopiramate 200 mg daily plus Placebo daily | Drug | Topiramate 200, Placebo |
| Topiramate 100, Aripiprazole 15Also: Abilify, TopamaxTopiramate 100 mg daily plus Aripiprazole 15mg daily | Drug | Topiramate 100, Aripiprazole 5 |
| Topiramate 100, Aripiprazole 7.5Topiramate 100 mg daily plus Aripiprazole 7.5mg daily | Drug | Topiramate 100, Aripiprazole 7.5 |
| Topiramate 100, Aripiprazole 15mgAlso: Abilify, TopamaxTopiramate 100 mg daily plus Aripiprazole 15mg daily | Drug | Topiramate 100, Aripiprazole 5 |
| Topiramate 200, Aripiprazole 7.5mgAlso: Abilify, TopamaxTopiramate 200 mg daily plus Aripiprazole 7.5mg daily | Drug | Topiramate 200, Aripiprazole 7.5mg |
| Topiramate 200, Aripiprazole 15Also: Abilify, TopamaxTopiramate 200mg daily plus Aripiprazole 15mg daily | Drug | Topiramate 200, Aripiprazole 15 |
Primary outcome
Number of alcoholic drinks consumed in a laboratory setting
Time frame: 90 minutes
Safety and tolerability of the medications singly and in combination, compared to placebo
Time frame: 4 years
1 secondary outcome
Drinks consumed during the medication titration period
Time frame: 4 weeks
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 7 Oct 2015.
- Derived from this study: PubMed 29281033Haass-Koffler CL, Goodyear K, Zywiak WH, Leggio L, Kenna GA, Swift RM. Comparing and Combining Topiramate and Aripiprazole on Alcohol-Related Outcomes in a Human Laboratory Study. Alcohol Alcohol. 2018 May 1;53(3):268-276. doi: 10.1093/alcalc/agx108.
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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.
Robert M Swift, MD, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study of Alcohol Dependence, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) 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 11 inclusion and 13 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 7 Oct 2015. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Number of alcoholic drinks consumed in a laboratory setting (time frame: 90 minutes). The study lists 2 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 NCT00884884, 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 7 Oct 2015.