Alcohol DrinkingNCT03353701
30-to-90 Day Challenge: Effects of Alcohol Cessation on Health Outcomes
A study testing Contingency Management (CM) in people with Alcohol Drinking and Chronic Inflammation, run by University of Florida at 1 site in United States.
Trial summary
The objective for this project is to determine whether how certain behavioral and health functions change in persons with heavy drinking when they stop (or reduce) drinking for 30 days, and whether changes continue for up to 90 days. The study will also identify barriers and facilitators related to drinking reduction. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Chronic Inflammation, Neurocognitive Dysfunction
- What is being tested?
- Contingency Management (CM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2017to 1 Jan 2024
- Phase
- Interventional
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women;
- Age: 50-75 yrs.;
- 140 participants will have confirmed HIV (confirmed via baseline bloodwork) and 40 participants will be HIV negative
- English speaking (will have protocol ready in Spanish in 2017);
- Physically mobile;
- Willing to participate in CM to reduce alcohol consumption, and to wear the alcohol biosensor for at least 30 days. All participants will be current, heavy drinkers (>=14 drinks/week women, >=21 drinks/week men), confirmed by baseline timeline follow-back, and by having evidence of at least 3 drinking episodes on the alcohol biosensor prior to baseline). Must blow a "zero" on breathalyzer at time of informed consent
Who cannot join
- Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury).
- Evidence of dementia (MOCA < 17).
- Past opportunistic brain infection
- Major psychiatric illness (schizophrenia, intractable affective disorder, current substance dependence diagnosis).
- Current major psychiatric disturbance, including severe major depression.
- Unstable medical conditions (e.g., cancer).
Show all 10Show fewer
- MRI contraindications (e.g., pregnancy, severe claustrophobia, metal implants).
- Physical impairment precluding motor response or lying still.
- Significant history of alcohol withdrawal as indicated by an Alcohol Withdrawal Symptom Checklist score ≥ 23 (within past year).
- Unable to correctly answer a set of questions that demonstrate understanding of key aspects of the study, including the voluntary nature of the study, the purpose of the study, what participants are being asked to do as part of the study, and what are the risks related to participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Experimentally-induced Reductions in Alcohol Consumption on Brain Cognitive and Clinical Outcomes, and Motivation for Changing Drinking in Older Persons With HIV Infection
The objective for this project is to determine whether how certain behavioral and health functions change in persons with heavy drinking when they stop (or reduce) drinking for 30 days, and whether changes continue for up to 90 days. The study will also identify barriers and facilitators related to drinking reduction. The project will focus on clinical comorbidities including HIV disease control, cognitive and brain function, liver abnormalities, and chronic inflammation. The study teams propose to enroll 140 HIV+ and 40 HIV- adults with heavy drinking, and then use Contingency Management (CM) with financial incentives to encourage participants to maximally reduce alcohol consumption for 30 days. Participants will be required to wear an ankle biosensor (SCRAM monitor) at all times, which is used to monitor participants' drinking behavior. At 30 days, participants will complete a full day of follow-up, including cognitive testing, neuroimaging, blood testing, liver Fibroscan, and questionnaires. Many participants will also provide a stool sample for gut microbiome assessment at each time point. At 30 days, participants will participate in a motivational interview to discuss perceived benefits and obstacles to drinking reduction, and most participants will continue CM to 90 days (but can opt out at this point). Participants will complete another full-day assessment at 90 days, at which point persons may choose to drink or not on their own (no more CM). A final assessment will be conducted at 12 months. This A-B-A design will enable us to clearly identify whether alcohol effects on cognition and brain function are reversible in the context of HIV, and analyze specific cerebral and systemic pathophysiological factors contributing to these effects. The inclusion of HIV- adults will enable subgroup comparisons of alcohol reduction effects in the context of HIV vs. no-HIV. These HIV-negative participants will be recruited from the same settings as our HIV+ participants, and will include a similar proportion by age, race, and gender as the HIV+ participants. The study team will use information from the MI data and our other assessments to elucidate factors that predict both short term (during CM) and long-term (1-year) alcohol reductions, and study how changes in alcohol consumption affect important HIV clinical outcomes that will be monitored over time.
Read the detailed description
This proposed study continues a line of research by Doctors Cohen, Cook, Kahler, and colleagues on heavy alcohol use, HIV-associated brain dysfunction, and long-term HIV outcomes. The study will build on our past findings to determine the extent to which marked reductions in alcohol consumption at 30 days and again at 90 days via contingency management (CM) improves cognitive-behavioral performance, underlying brain functions and pathophysiology, and HIV-associated health outcomes. This feature in itself is a novel contribution and has rarely been done, but more importantly, it reflects the mission of the collaboration to develop actionable data on clinical trajectories in HIV infected heavy drinkers over age 50 that will instill high confidence in guiding next therapeutic steps. The study team will obtain a better understanding of how persons with HIV stop drinking, and what factors influence long-term drinking changes. These important clinical and scientific questions need resolution for successful treatment and management of HIV+ adults. This study is motivated by evidence that HIV-associated neurocognitive dysfunction continues despite effective combined anti-retroviral therapies (cART). Even mild cognitive impairments have detrimental functional effects and health outcomes that worsen as HIV+ people age. Heavy alcohol consumption is common among HIV+ adults, and contributes to functional brain disturbances directly or indirectly via systemic metabolic or inflammatory disturbances. However, our past findings indicate that current alcohol use is more strongly associated with cognitive and brain dysfunction among HIV+ adults than lifetime consumption; and that adverse brain effects occur primarily with heavy drinking. Our overarching hypothesis is that the impact of ongoing heavy alcohol use on the brain and cognition may be reversible, providing a strong impetus for the proposed study. The study team will conduct our research in Florida, which has the highest number of new HIV infections in the US, as well as an increasingly diverse population with HIV+, 50% of whom are now aged 50 years or over in the state.
Our research will seek to modify alcohol consumption by using contingency management (CM) and measure for changes in brain pathophysiology and function, as well as changes in systemic inflammation, and gut and liver pathologies which are hypothesized pathways by which alcohol may increase brain dysfunction. The study team will also measure neurocognitive functioning related to learning, attention-executive functions, working memory, and processing speed, domains in which HIV+ persons experience persistent impairment. the study team will use Motivational Interviewing (MI) to learn more about how persons with and without HIV reduce drinking, what factors are associated with long-term drinking changes, and how these drinking changes influence HIV clinical health behavior and outcomes. If the impact of alcohol on systemic and cerebral inflammation is temporary, then reducing or eliminating alcohol consumption could dramatically improve cognitive function and indices of brain health, even among people who have consumed alcohol for many years in the past. Our research will directly test hypotheses that ongoing heavy alcohol consumption is associated with brain pathophysiology and inflammation that impairs both functioning and cognitive processing, and that the inflammation and its sequelae are reversible in most HIV+ persons with alcohol cessation. The proposed sample will be 140 adults with HIV infection and 40 adults without HIV infection (at least 25% female; age >50 years). Participants will be recruited from heavy drinkers (>=14 drinks/week women, >=21 drinks/week men) with HIV infection identified from our ongoing Florida Cohort. HIV- participants will be recruited from community medical clinics where flyers will be posted.
- Conditions
- Alcohol Drinking, Chronic Inflammation, Neurocognitive Dysfunction, Liver Diseases, HIV Infections
- Being tested
- Contingency Management (CM)
- Medical subject headings
- Alcohol Drinking, Cognition Disorders, Liver Diseases, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency Management (CM)Behavioural
A reinforcement delivery method that involves financial incentive to participants for sustained alcohol abstinence. CM will start after the participants complete the baseline measures and last for at least 30 days and up to 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Adults with or without HIV infection | Other | Participants will be asked to stop drinking for at least 30 and up to 90 days. The study will use Contingency Management (CM) with financial incentives to encourage participants to maximally reduce alcohol consumption. Receives: Behavioral: Contingency Management (CM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neurocognitive Functions
Change in cognitive performance from baseline to 30-day follow-up. NIH Toolbox Cognition Battery is administered by a research assistant and consists of seven tests assessing memory, attention, cognitive flexibility, processing speed, and executive functioning. Summary scores will be calculated.
Measured: Baseline, 30 Days
Secondary outcomes (6)
Change in Neuroinflammation
Change in brain inflammation from baseline to 30-day follow-ups. Neuroinflammation is measured by cerebral metabolic neuroinflammatory markers, which include Magnetic Resonance Spectroscopy (MRS) metabolite concentrations (Cho and Myo-Inositol) and extracellular free water from Diffusor Tension Imaging sequences (DTI-FW).
Measured: Baseline, 30 Days
Change in Brain Function
Change in Brain Function from baseline to 30-day follow-up. Brain function is measured by mean signal intensity for specific task-dependent brain regions from functional magnetic resonance imaging (fMRI).
Measured: Baseline, 30 Days
Change in markers of systemic Inflammation
Blood testing for biomarkers of systemic inflammation such as cytokines, ceramides, FIB-4, and marker of abnormal liver function.
Measured: 30 Days
Change in liver Status
Evidence of liver fibrosis, fatty liver, and liver inflammation as measured by fibroscan
Measured: 30 Days
Change in Drinks/week in the Past 30 Days
Change in number of standard drinks per week in the past 30 days from baseline to 1 year follow-up, calculated from Timeline Follow Back (TLFB) interview.
Measured: Baseline, 1 Year
Change in gut microbiome
Change in the ratio of Firmicutes: Bacteriodetes ratio, and change in the relative abundance of Proteobacteria
Measured: Baseline, 30-days, 90-days, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start11 Dec 2017
- Primary completion1 Aug 2022
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will serve as their own controls with pre- and post-measures.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, Florida International University, Brown University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Robert Cook, Principal investigator, University of FloridaRonald Cohen, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353701
- Sponsor's protocol ID
- CED000000011-N
- Other IDs
- U01AA020797-06, U01AA026225
- Status last verified
- Aug 2024
- First submitted
- 3 Nov 2017
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Limited and de-identified datasets will be available to researchers after signing a data-use agreement with the University of Florida.
Publications
Cook RL, Richards VL, Gullett JM, Lerner BDG, Zhou Z, Porges EC, Wang Y, Kahler CW, Barnett NP, Li Z, Pallikkuth S, Thomas E, Rodriguez A, Bryant KJ, Ghare S, Barve S, Govind V, Devieux JG, Cohen RA; 30-Day Challenge Research Team. Experimentally Induced Reductions in Alcohol Consumption and Brain, Cognitive, and Clinical Outcomes in Older Persons With and Those Without HIV Infection (30-Day Challenge Study): Protocol for a Nonrandomized Clinical Trial. JMIR Res Protoc. 2024 Apr 2;13:e53684. doi: 10.2196/53684.
PubMed 38564243Richards VL, Wang Y, Porges EC, Gullett JM, Leeman RF, Zhou Z, Barnett NP, Cook RL. Using alcohol biosensors and biomarkers to measure changes in drinking: Associations between transdermal alcohol concentration, phosphatidylethanol, and self-report in a contingency management study of persons with and without HIV. Exp Clin Psychopharmacol. 2023 Dec;31(6):991-997. doi: 10.1037/pha0000637. Epub 2023 Jan 16.
PubMed 36649152
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Experimentally-induced Reductions in Alcohol Consumption on Brain Cognitive and Clinical Outcomes, and Motivation for Changing Drinking in Older Persons With HIV Infection
- ClinicalTrials.gov ID
- NCT03353701
- Acronym / sponsor ID
- CED000000011-N
- Conditions
- Alcohol Drinking, Chronic Inflammation, Neurocognitive Dysfunction, Liver Diseases, HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- University of Miami, Florida International University, Brown University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 27 Nov 2017 (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.
The objective for this project is to determine whether how certain behavioral and health functions change in persons with heavy drinking when they stop (or reduce) drinking for 30 days, and whether changes continue for up to 90 days. The study will also identify barriers and facilitators related to drinking reduction. The project will focus on clinical comorbidities including HIV disease control, cognitive and brain function, liver abnormalities, and chronic inflammation. The study teams propose to enroll 140 HIV+ and 40 HIV- adults with heavy drinking, and then use Contingency Management (CM) with financial incentives to encourage participants to maximally reduce alcohol consumption for 30 days. Participants will be required to wear an ankle biosensor (SCRAM monitor) at all times, which is used to monitor participants' drinking behavior. At 30 days, participants will complete a full day of follow-up, including cognitive testing, neuroimaging, blood testing, liver Fibroscan, and questionnaires. Many participants will also provide a stool sample for gut microbiome assessment at each time point. At 30 days, participants will participate in a motivational interview to discuss perceived benefits and obstacles to drinking reduction, and most participants will continue CM to 90 days (but can opt out at this point). Participants will complete another full-day assessment at 90 days, at which point persons may choose to drink or not on their own (no more CM). A final assessment will be conducted at 12 months. This A-B-A design will enable us to clearly identify whether alcohol effects on cognition and brain function are reversible in the context of HIV, and analyze specific cerebral and systemic pathophysiological factors contributing to these effects. The inclusion of HIV- adults will enable subgroup comparisons of alcohol reduction effects in the context of HIV vs. no-HIV. These HIV-negative participants will be recruited from the same settings as our HIV+ participants, and will include a similar proportion by age, race, and gender as the HIV+ participants. The study team will use information from the MI data and our other assessments to elucidate factors that predict both short term (during CM) and long-term (1-year) alcohol reductions, and study how changes in alcohol consumption affect important HIV clinical outcomes that will be monitored over time.
Detailed description
This proposed study continues a line of research by Doctors Cohen, Cook, Kahler, and colleagues on heavy alcohol use, HIV-associated brain dysfunction, and long-term HIV outcomes. The study will build on our past findings to determine the extent to which marked reductions in alcohol consumption at 30 days and again at 90 days via contingency management (CM) improves cognitive-behavioral performance, underlying brain functions and pathophysiology, and HIV-associated health outcomes. This feature in itself is a novel contribution and has rarely been done, but more importantly, it reflects the mission of the collaboration to develop actionable data on clinical trajectories in HIV infected heavy drinkers over age 50 that will instill high confidence in guiding next therapeutic steps. The study team will obtain a better understanding of how persons with HIV stop drinking, and what factors influence long-term drinking changes. These important clinical and scientific questions need resolution for successful treatment and management of HIV+ adults. This study is motivated by evidence that HIV-associated neurocognitive dysfunction continues despite effective combined anti-retroviral therapies (cART). Even mild cognitive impairments have detrimental functional effects and health outcomes that worsen as HIV+ people age. Heavy alcohol consumption is common among HIV+ adults, and contributes to functional brain disturbances directly or indirectly via systemic metabolic or inflammatory disturbances. However, our past findings indicate that current alcohol use is more strongly associated with cognitive and brain dysfunction among HIV+ adults than lifetime consumption; and that adverse brain effects occur primarily with heavy drinking. Our overarching hypothesis is that the impact of ongoing heavy alcohol use on the brain and cognition may be reversible, providing a strong impetus for the proposed study. The study team will conduct our research in Florida, which has the highest number of new HIV infections in the US, as well as an increasingly diverse population with HIV+, 50% of whom are now aged 50 years or over in the state.
Our research will seek to modify alcohol consumption by using contingency management (CM) and measure for changes in brain pathophysiology and function, as well as changes in systemic inflammation, and gut and liver pathologies which are hypothesized pathways by which alcohol may increase brain dysfunction. The study team will also measure neurocognitive functioning related to learning, attention-executive functions, working memory, and processing speed, domains in which HIV+ persons experience persistent impairment. the study team will use Motivational Interviewing (MI) to learn more about how persons with and without HIV reduce drinking, what factors are associated with long-term drinking changes, and how these drinking changes influence HIV clinical health behavior and outcomes. If the impact of alcohol on systemic and cerebral inflammation is temporary, then reducing or eliminating alcohol consumption could dramatically improve cognitive function and indices of brain health, even among people who have consumed alcohol for many years in the past. Our research will directly test hypotheses that ongoing heavy alcohol consumption is associated with brain pathophysiology and inflammation that impairs both functioning and cognitive processing, and that the inflammation and its sequelae are reversible in most HIV+ persons with alcohol cessation. The proposed sample will be 140 adults with HIV infection and 40 adults without HIV infection (at least 25% female; age >50 years). Participants will be recruited from heavy drinkers (>=14 drinks/week women, >=21 drinks/week men) with HIV infection identified from our ongoing Florida Cohort. HIV- participants will be recruited from community medical clinics where flyers will be posted.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will serve as their own controls with pre- and post-measures.
| Arm | Type | Receives |
|---|---|---|
| Adults with or without HIV infection | Other | Behavioral: Contingency Management (CM)Participants will be asked to stop drinking for at least 30 and up to 90 days. The study will use Contingency Management (CM) with financial incentives to encourage participants to maximally reduce alcohol consumption. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women;
- Age: 50-75 yrs.;
- 140 participants will have confirmed HIV (confirmed via baseline bloodwork) and 40 participants will be HIV negative
- English speaking (will have protocol ready in Spanish in 2017);
- Physically mobile;
Key exclusion criteria (10 listed)
- Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury).
- Evidence of dementia (MOCA < 17).
- Past opportunistic brain infection
- Major psychiatric illness (schizophrenia, intractable affective disorder, current substance dependence diagnosis).
- Current major psychiatric disturbance, including severe major depression.
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 |
|---|---|---|
| Contingency Management (CM)A reinforcement delivery method that involves financial incentive to participants for sustained alcohol abstinence. CM will start after the participants complete the baseline measures and last for at least 30 days and up to 90 days. | Behavioural | Adults with or without HIV infection |
Primary outcome
Change in Neurocognitive Functions
Time frame: Baseline, 30 Days
Change in cognitive performance from baseline to 30-day follow-up. NIH Toolbox Cognition Battery is administered by a research assistant and consists of seven tests assessing memory, attention, cognitive flexibility, processing speed, and executive functioning. Summary scores will be calculated.
6 secondary outcomes
Change in Neuroinflammation
Time frame: Baseline, 30 Days
Change in Brain Function
Time frame: Baseline, 30 Days
Change in markers of systemic Inflammation
Time frame: 30 Days
Change in liver Status
Time frame: 30 Days
Change in Drinks/week in the Past 30 Days
Time frame: Baseline, 1 Year
Change in gut microbiome
Time frame: Baseline, 30-days, 90-days, 1 year
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 3 Sep 2024.
- Derived from this study: PubMed 38564243Cook RL, Richards VL, Gullett JM, Lerner BDG, Zhou Z, Porges EC, Wang Y, Kahler CW, Barnett NP, Li Z, Pallikkuth S, Thomas E, Rodriguez A, Bryant KJ, Ghare S, Barve S, Govind V, Devieux JG, Cohen RA; 30-Day Challenge Research Team. Experimentally Induced Reductions in Alcohol Consumption and Brain, Cognitive, and Clinical Outcomes in Older Persons With and Those Without HIV Infection (30-Day Challenge Study): Protocol for a Nonrandomized Clinical Trial. JMIR Res Protoc. 2024 Apr 2;13:e53684. doi: 10.2196/53684.
- Derived from this study: PubMed 36649152Richards VL, Wang Y, Porges EC, Gullett JM, Leeman RF, Zhou Z, Barnett NP, Cook RL. Using alcohol biosensors and biomarkers to measure changes in drinking: Associations between transdermal alcohol concentration, phosphatidylethanol, and self-report in a contingency management study of persons with and without HIV. Exp Clin Psychopharmacol. 2023 Dec;31(6):991-997. doi: 10.1037/pha0000637. Epub 2023 Jan 16.
- Individual participant dataSharing planned: Yes. Limited and de-identified datasets will be available to researchers after signing a data-use agreement with the University of Florida.
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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 Cook principal investigator
University of Florida
Ronald Cohen principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management (CM) in people with Alcohol Drinking and Chronic Inflammation, run by University of Florida 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 6 inclusion and 10 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 3 Sep 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in Neurocognitive Functions (time frame: Baseline, 30 Days). 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 NCT03353701, which also lists 2 linked publications.
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 3 Sep 2024.