Alcohol Use DisorderPhase 2NCT04066192
Brexpiprazole in Alcohol Use Disorder
A Phase 2 study testing Brexpiprazole in people with Alcohol Use Disorder, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Few medications are currently Food \& Drug Administration (FDA)-approved for the treatment of Alcohol Use Disorder (AUD), and those that are have, on average, modest effects on drinking. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Brexpiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2020to 31 Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 21-65.
- Meet DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) diagnostic criteria for AUD, as assessed by the Structured Clinical Interview for DSM-5 (SCID-5).
- Currently not engaged in, and does not want treatment for, AUD.
- Currently not taking any medication for AUD.
- Able to read and understand questionnaires and informed consent.
- Lives within 50 miles of the study site.
Show all 9Show fewer
- Physically healthy with no history of significant medical illness.
- Negative urine drug screen (UDS) for all substances of abuse prior to taking the first dose of medication.
- Please contact clinical site for additional inclusion criteria.
Who cannot join
- Refusal of valid written consent.
- Insufficient English skills for consenting or interviews.
- Severe claustrophobia or morbid obesity that preclude placement in the MRI scanner.
- Contraindications to MRI scanning, ferrous metal in the body including intracranial, intraorbital, or intraspinal metal, pacemakers, cochlear implants or other non-MRI-compatible devices.
- History of head injury with loss of consciousness for more than 2 minutes, neurological illness, or history of neurosurgical procedures.
- Current DSM-5 diagnosis of any other substance use disorder except Nicotine Use Disorder.
Show all 19Show fewer
- Current DSM-5 psychotic, mood, anxiety, obsessive-compulsive, trauma-related, or eating disorder, as assessed by SCID-5.
- Current suicidal ideation or homicidal ideation.
- Current use of any psychoactive medication, as evidenced by self-report and UDS.
- History of severe alcohol withdrawal (e.g., seizure, delirium tremens), as evidenced by self-report and assessment with Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar).
- Clinically significant medical problems such as cardiovascular, renal, gastrointestinal, or endocrine problems, as evidenced by medical history and physical exam.
- Past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, or peptic ulcer.
- Current or past hepatocellular disease, as indicated by verbal report or elevations of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of the normal range at screening.
- Females of childbearing potential who are pregnant (by plasma or urine HCG), nursing, or who are not using a reliable form of contraception.
- Current charges pending for a violent crime (not including DUI-related offenses).
- Currently incarcerated.
- Lack of a stable living situation.
- History of head injury with loss of consciousness for more than 2 minutes, neurological illness, or history of neurosurgical procedures.
- Decisionally challenged.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Joseph P Schacht, PhD, 303-724-3773, joseph.schacht@cuanschutz.edu
Kristen M Raymond, BA, 303-724-3196, kristen.raymond@ucdenver.edu
About this study
Official title: A Pharmacogenetic Human Laboratory Investigation of Brexpiprazole in Alcohol Use Disorder
Few medications are currently Food \& Drug Administration (FDA)-approved for the treatment of Alcohol Use Disorder (AUD), and those that are have, on average, modest effects on drinking. "Precision medicine" research has explored whether patient-level variables, such as genetic variation, may identify subgroups of individuals with larger medication effects, but few findings have been replicated. A promising novel medication for AUD is brexpiprazole (BREX), a serotonin/dopamine activity modulator (SDAM). The investigators conducted a prior study in which the effects of another SDAM, aripiprazole, were influenced by genetic variation in the gene encoding the dopamine transporter (DAT1). This study will evaluate the effects of two doses of BREX, relative to placebo, among non-treatment-seeking individuals with AUD, and will test whether DAT1 genotype influences these effects. Primary outcomes are drinking under natural conditions and in a laboratory paradigm. Functional magnetic resonance imaging (fMRI) will be used to explore whether BREX effects on brain activation associated with cognitive control or elicited by alcohol cues accounts for its effects on drinking. The investigators hypothesize that BREX, relative to placebo, will reduce drinking under natural conditions and in the lab, and will do so to a greater extent among individuals who carry the DAT1 9-repeat allele, relative to those homozygous for the 10-repeat allele. If these hypotheses are supported, BREX may represent a novel pharmacogenetic treatment for AUD.
Read the detailed description
The overarching hypothesis of this study is that brexpiprazole (BREX) (2 or 4 mg/day), relative to placebo, will reduce alcohol consumption and modulate the neural substrates of moderate-severe Alcohol Use Disorder (AUD), and that genotype at a variable number tandem repeat polymorphism (VNTR) in the DAT1/SLC6A3 gene will predict BREX effects. Participants will be non-treatment-seeking AUD individuals, and will be prospectively randomized to medication on the basis of their DAT1 VNTR genotype. Since BREX affects both cortical and striatal neurophysiology, the investigators will use functional magnetic resonance imaging (fMRI) to test its effects on cortical (right inferior frontal gyrus; rIFG) activation associated with response inhibition and on striatal activation elicited by alcohol cues, and will explore whether either of these measures mediates BREX effects on drinking in the natural environment vs. a bar-lab setting, which may reflect different aspects of lost control over drinking.
Aim 1: Test BREX effects on inhibition-related cortical activation and alcohol cue-elicited striatal activation, and evaluate whether DAT1 VNTR genotype predicts these effects.
Hypothesis 1: There will be a linear effect of BREX dose, relative to placebo, in increasing inhibition-related rIFG activation and reducing cue-elicited ventral striatum (VS) activation, and these effects will be greater among DAT1 9R carriers than 10R homozygotes.
Aim 2: Test BREX effects on drinking in the natural environment and alcohol self-administration in the bar lab, and evaluate whether DAT1 VNTR genotype predicts these effects.
Hypothesis 2: There will be a linear effect of BREX dose, relative to placebo, in reducing natural drinking and alcohol self-administration, and these effects will be greater among DAT1 9R carriers.
Aim 3: Test inhibition-related cortical activation and cue-elicited VS activation as mechanisms of action for BREX's effects on natural and bar-lab drinking.
Hypothesis 3: Cue-elicited VS activation will mediate BREX effects on natural drinking, while inhibition-related rIFG activation will mediate its effects on bar-lab drinking.
This study will recruit up to 250 study participants with Alcohol Use Disorder (AUD) who are not seeking treatment for AUD. Individuals will complete an initial phone screen to assess inclusion/exclusion criteria that can be determined over the phone, and eligible participants will subsequently be scheduled for an in-person screening session. After giving informed consent, participants will complete a medical screening and psychiatric assessment, and biological samples (blood and urine) will be collected. Participants who remain eligible after this screening session will be randomly assigned to take one of two doses of brexpiprazole (2 milligram (mg) or 4 mg per day) or matched placebo for 14 days. Both investigators and participants will be blind to medication group assignments. After the in-person screening session, there are five study visits. 1) Day 1 of study medication: participants will complete a one-hour-long functional magnetic resonance imaging (fMRI) brain scan and take the first dose of study medication. 2) Day 7: participants will return to the lab for a brief check-in at which medication side effects will be assessed. 3) Day 13: blood and urine samples will be collected again; participants will take that day's dose of medication in the lab and then complete another one-hour-long fMRI brain scan. 4) Day 14: participants will take the last dose of medication in the lab and then complete a day-long procedure in which alcohol will be administered. 5) Day 15: participants will be debriefed and compensated $600 for study participation.
- Conditions
- Alcohol Use Disorder
- Being tested
- Brexpiprazole, Placebo
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrexpiprazoleDrug
Brexpiprazole will be used in .5mg, 1mg, 2mg, and 4mg doses as described in the study arms.
PlaceboDrug
A medically inert placebo medication will be used as described in the study arms.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants in this Arm will take a medically inert placebo. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the capsule orally each morning. Receives: Drug: Placebo |
| BREX 2mg | Active comparator | The BREX 2mg group will start at the same dose at the BREX 4mg group and titrate up at the same rate, so the BREX 2mg Arm will take .5 mg of brexpiprazole on day 1-2, 1 mg on day 3-4, and 2mg on day 5, to reach its final 2mg dose for day 5-14. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the medication orally each morning. Receives: Drug: Brexpiprazole |
| BREX 4mg | Active comparator | The BREX 4mg group will start at the same dose as the BREX 2mg group and titrate up at the same rate, so the BREX 4mg Arm will take .5 mg of brexpiprazole on day 1-2, 1 mg on day 3-4, 2mg on day 5-6, and 4mg on day 7 to reach its final 4mg dose for days 7-14. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the medication orally each morning. Receives: Drug: Brexpiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of drinks consumed in natural environment
The number of standard alcoholic drinks participants consume during the first 13 days of the medication period, as reported on the Timeline Follow-Back Interview.
Measured: First 13 days of medication period
Number of drinks consumed in bar lab
The number of drinks (out of 8 possible) that participants choose to consume in the bar lab.
Measured: Day 14 of medication period
Change in alcohol cue-elicited brain activation (fMRI)
Magnitude of change between baseline and day 14 fMRI scan in the blood oxygenation level dependent (BOLD) signal to alcohol cues, relative to neutral beverage cues on the Alcohol Cue Reactivity Task.
Measured: 14 days - change between baseline and day 14 scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start30 Oct 2020
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
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 Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Factorial
- Model description
- Double-blind placebo controlled clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Joseph P Schacht, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066192
- Sponsor's protocol ID
- 19-1658
- Other IDs
- 1R01AA027765-01
- Status last verified
- Apr 2026
- First submitted
- 21 Aug 2019
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified, individual-level phenotypic data will be submitted to the NIAAA Data Archive (NDA) portal once it is available, and genotypic data (e.g., DAT1 genotypes and any other genomic data generated from study participants' whole blood samples) will be submitted to the NIH dbGAP repository. Informed consent that allows for broad sharing of each subject's de-identified data will be obtained and personally identifiable information that allows the creation of an NDA Global Unique Identifier will be collected. Study staff will work with NDA staff to specify and/or define measures to be collected (including the manner in which raw and pre-processed neuroimaging data will be shared), and data will be submitted in accordance with NDA submission due dates.
Publications
Schacht JP, Voronin KE, Randall PK, Anton RF. Dopaminergic Genetic Variation Influences Aripiprazole Effects on Alcohol Self-Administration and the Neural Response to Alcohol Cues in a Randomized Trial. Neuropsychopharmacology. 2018 May;43(6):1247-1256. doi: 10.1038/npp.2017.298. Epub 2017 Dec 6.
PubMed 29362512
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacogenetic Human Laboratory Investigation of Brexpiprazole in Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT04066192
- Acronym / sponsor ID
- 19-1658
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 26 Aug 2019 (actual)
- 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.
Few medications are currently Food \& Drug Administration (FDA)-approved for the treatment of Alcohol Use Disorder (AUD), and those that are have, on average, modest effects on drinking. "Precision medicine" research has explored whether patient-level variables, such as genetic variation, may identify subgroups of individuals with larger medication effects, but few findings have been replicated. A promising novel medication for AUD is brexpiprazole (BREX), a serotonin/dopamine activity modulator (SDAM). The investigators conducted a prior study in which the effects of another SDAM, aripiprazole, were influenced by genetic variation in the gene encoding the dopamine transporter (DAT1). This study will evaluate the effects of two doses of BREX, relative to placebo, among non-treatment-seeking individuals with AUD, and will test whether DAT1 genotype influences these effects. Primary outcomes are drinking under natural conditions and in a laboratory paradigm. Functional magnetic resonance imaging (fMRI) will be used to explore whether BREX effects on brain activation associated with cognitive control or elicited by alcohol cues accounts for its effects on drinking. The investigators hypothesize that BREX, relative to placebo, will reduce drinking under natural conditions and in the lab, and will do so to a greater extent among individuals who carry the DAT1 9-repeat allele, relative to those homozygous for the 10-repeat allele. If these hypotheses are supported, BREX may represent a novel pharmacogenetic treatment for AUD.
Detailed description
The overarching hypothesis of this study is that brexpiprazole (BREX) (2 or 4 mg/day), relative to placebo, will reduce alcohol consumption and modulate the neural substrates of moderate-severe Alcohol Use Disorder (AUD), and that genotype at a variable number tandem repeat polymorphism (VNTR) in the DAT1/SLC6A3 gene will predict BREX effects. Participants will be non-treatment-seeking AUD individuals, and will be prospectively randomized to medication on the basis of their DAT1 VNTR genotype. Since BREX affects both cortical and striatal neurophysiology, the investigators will use functional magnetic resonance imaging (fMRI) to test its effects on cortical (right inferior frontal gyrus; rIFG) activation associated with response inhibition and on striatal activation elicited by alcohol cues, and will explore whether either of these measures mediates BREX effects on drinking in the natural environment vs. a bar-lab setting, which may reflect different aspects of lost control over drinking.
Aim 1: Test BREX effects on inhibition-related cortical activation and alcohol cue-elicited striatal activation, and evaluate whether DAT1 VNTR genotype predicts these effects.
Hypothesis 1: There will be a linear effect of BREX dose, relative to placebo, in increasing inhibition-related rIFG activation and reducing cue-elicited ventral striatum (VS) activation, and these effects will be greater among DAT1 9R carriers than 10R homozygotes.
Aim 2: Test BREX effects on drinking in the natural environment and alcohol self-administration in the bar lab, and evaluate whether DAT1 VNTR genotype predicts these effects.
Hypothesis 2: There will be a linear effect of BREX dose, relative to placebo, in reducing natural drinking and alcohol self-administration, and these effects will be greater among DAT1 9R carriers.
Aim 3: Test inhibition-related cortical activation and cue-elicited VS activation as mechanisms of action for BREX's effects on natural and bar-lab drinking.
Hypothesis 3: Cue-elicited VS activation will mediate BREX effects on natural drinking, while inhibition-related rIFG activation will mediate its effects on bar-lab drinking.
This study will recruit up to 250 study participants with Alcohol Use Disorder (AUD) who are not seeking treatment for AUD. Individuals will complete an initial phone screen to assess inclusion/exclusion criteria that can be determined over the phone, and eligible participants will subsequently be scheduled for an in-person screening session. After giving informed consent, participants will complete a medical screening and psychiatric assessment, and biological samples (blood and urine) will be collected. Participants who remain eligible after this screening session will be randomly assigned to take one of two doses of brexpiprazole (2 milligram (mg) or 4 mg per day) or matched placebo for 14 days. Both investigators and participants will be blind to medication group assignments. After the in-person screening session, there are five study visits. 1) Day 1 of study medication: participants will complete a one-hour-long functional magnetic resonance imaging (fMRI) brain scan and take the first dose of study medication. 2) Day 7: participants will return to the lab for a brief check-in at which medication side effects will be assessed. 3) Day 13: blood and urine samples will be collected again; participants will take that day's dose of medication in the lab and then complete another one-hour-long fMRI brain scan. 4) Day 14: participants will take the last dose of medication in the lab and then complete a day-long procedure in which alcohol will be administered. 5) Day 15: participants will be debriefed and compensated $600 for study participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind placebo controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants in this Arm will take a medically inert placebo. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the capsule orally each morning. |
| BREX 2mg | Active comparator | Drug: BrexpiprazoleThe BREX 2mg group will start at the same dose at the BREX 4mg group and titrate up at the same rate, so the BREX 2mg Arm will take .5 mg of brexpiprazole on day 1-2, 1 mg on day 3-4, and 2mg on day 5, to reach its final 2mg dose for day 5-14. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the medication orally each morning. |
| BREX 4mg | Active comparator | Drug: BrexpiprazoleThe BREX 4mg group will start at the same dose as the BREX 2mg group and titrate up at the same rate, so the BREX 4mg Arm will take .5 mg of brexpiprazole on day 1-2, 1 mg on day 3-4, 2mg on day 5-6, and 4mg on day 7 to reach its final 4mg dose for days 7-14. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the medication orally each morning. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ages 21-65.
- Meet DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) diagnostic criteria for AUD, as assessed by the Structured Clinical Interview for DSM-5 (SCID-5).
- Currently not engaged in, and does not want treatment for, AUD.
- Currently not taking any medication for AUD.
- Able to read and understand questionnaires and informed consent.
Key exclusion criteria (19 listed)
- Refusal of valid written consent.
- Insufficient English skills for consenting or interviews.
- Severe claustrophobia or morbid obesity that preclude placement in the MRI scanner.
- Contraindications to MRI scanning, ferrous metal in the body including intracranial, intraorbital, or intraspinal metal, pacemakers, cochlear implants or other non-MRI-compatible devices.
- History of head injury with loss of consciousness for more than 2 minutes, neurological illness, or history of neurosurgical procedures.
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 |
|---|---|---|
| BrexpiprazoleBrexpiprazole will be used in .5mg, 1mg, 2mg, and 4mg doses as described in the study arms. | Drug | BREX 2mg, BREX 4mg |
| PlaceboA medically inert placebo medication will be used as described in the study arms. | Drug | Placebo |
Primary outcome
Number of drinks consumed in natural environment
Time frame: First 13 days of medication period
The number of standard alcoholic drinks participants consume during the first 13 days of the medication period, as reported on the Timeline Follow-Back Interview.
Number of drinks consumed in bar lab
Time frame: Day 14 of medication period
The number of drinks (out of 8 possible) that participants choose to consume in the bar lab.
Change in alcohol cue-elicited brain activation (fMRI)
Time frame: 14 days - change between baseline and day 14 scan.
Magnitude of change between baseline and day 14 fMRI scan in the blood oxygenation level dependent (BOLD) signal to alcohol cues, relative to neutral beverage cues on the Alcohol Cue Reactivity Task.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 29362512Schacht JP, Voronin KE, Randall PK, Anton RF. Dopaminergic Genetic Variation Influences Aripiprazole Effects on Alcohol Self-Administration and the Neural Response to Alcohol Cues in a Randomized Trial. Neuropsychopharmacology. 2018 May;43(6):1247-1256. doi: 10.1038/npp.2017.298. Epub 2017 Dec 6.
- Individual participant dataSharing planned: Yes. De-identified, individual-level phenotypic data will be submitted to the NIAAA Data Archive (NDA) portal once it is available, and genotypic data (e.g., DAT1 genotypes and any other genomic data generated from study participants' whole blood samples) will be submitted to the NIH dbGAP repository. Informed consent that allows for broad sharing of each subject's de-identified data will be obtained and personally identifiable information that allows the creation of an NDA Global Unique Identifier will be collected. Study staff will work with NDA staff to specify and/or define measures to be collected (including the manner in which raw and pre-processed neuroimaging data will be shared), and data will be submitted in accordance with NDA submission due dates.
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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.
Joseph P Schacht, PhD principal investigator
University of Colorado, Denver
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 Brexpiprazole in people with Alcohol Use Disorder, run by University of Colorado, Denver 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 9 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 1 May 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph P Schacht, PhD (303-724-3773, joseph.schacht@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of drinks consumed in natural environment (time frame: First 13 days of medication period). The study lists 3 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 NCT04066192, 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 1 May 2026.