Smoking CessationHCSNCT03169101
Cognition and Smoking Relapse (HCS)
An observational study of Smoking Cessation, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study tests whether withdrawal-related cognitive deficits increase smoking relapse among HIV-infected (HIV+) vs. HIV-uninfected smokers (HIV-). Adult smokers (N=300; 150 HIV+, 150 HIV-) will complete 2 sessions to assess cognition (24h abstinence vs. smoking-as-usual; order counterbalanced; weeks 0-2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nicotine patch and Behavioral counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 274 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 25 Apr 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Three hundred (150 HIV+ and 150 HIV-) adult male and female smokers 18 years of age or older who smoke at least 5 cigarettes per day and are interested in quitting smoking will complete the study. HIV-infected smokers have been diagnosed with HIV/AIDS and HIV-uninfected smokers will have no diagnosis of HIV, either via blood test or self-report.
Who may be able to join
- Males and females 18 years of age or older who self-report smoking at least 5 cigarettes (menthol and non-menthol) per day, on average.
- HIV status
- HIV-infected smokers: diagnosed with HIV infection and exhibiting viral load of less than or equal to 1000 copies/mL and CD4+ counts of greater than or equal to 200 cells/mm3 within 12 months prior to enrollment.
- HIV-uninfected smokers: negative HIV status will be confirmed by an on-site rapid HIV blood test.
- Able to use transdermal nicotine (TN) safely, based on a medical evaluation.
- Residing in the geographic area for at least 4 months.
Show all 9Show fewer
- Women of childbearing potential (based on medical history) must consent to use a medically accepted method of birth control (e.g., condoms and spermicide, oral contraceptive, Depo-Provera injection, contraceptive patch, tubal ligation) or abstain from sexual intercourse during the time they are in the study and using transdermal nicotine.
- Able to communicate fluently in English.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent/HIPAA form.
Who cannot join
- Smoking Behavior
- Current enrollment or plans to enroll in another smoking cessation program in the next 4 months.
- Regular (daily) use of electronic cigarettes, chewing tobacco, snuff, snus, cigars, cigarillos, or pipes.
- Current use or plans to use nicotine substitutes (gum, patch, lozenge, e-cigarette) or smoking cessation treatments in the next 4 months.
- Alcohol/Drug Exclusion Criteria
- Current untreated and unstable diagnosis of substance dependence (eligible if past use and if receiving treatment and stable for at least 30 days). Current untreated and unstable diagnosis of substance abuse requires Study Physician approval.
Show all 36Show fewer
- A positive urine drug screen for cocaine, amphetamines, methamphetamines, Phencyclidine (PCP), barbiturates, ecstasy (MDMA) at Intake (see Measures and Table 1 for details). At Lab 1 and Lab 2, positive urine drug screens will be reviewed on a case-by-case basis. The PI will determine if the participant will be excluded or allowed to reschedule the visit, at which time they must provide a negative drug screen to continue with the study.
- Medication Exclusion Criteria
- Current use or recent discontinuation (within last 14 days) of the following medications:
- Other smoking cessation medications (e.g. Zyban, Wellbutrin, Wellbutrin sustained release (SR), Chantix)
- Note: Once participants are found eligible for the study, they are instructed to only use the NRT provided to them by the study staff. If a subject reports using a non-study smoking cessation medication (including other forms of NRT), the study physician and PI will evaluate the situation and determine if it is safe for the subject to continue participation.
- Anti-psychotic medications (if used to treat psychotic symptoms. Other uses may be eligible pending physician approval).
- Daily use of opiate-containing medications for chronic pain (Duragesic/fentanyl patches, Percocet, Oxycontin). Smokers who report taking opiate-containing medications on an "as-needed" basis will be instructed to refrain from use until their study participation is over and that they will be tested to ensure they have complied with this requirement.
- Asthma medications/corticosteroids (requires physician approval)
- Anti-depressants (require physician approval)
- Medical Exclusion Criteria
- Females who self-report current pregnancy, planning a pregnancy during the study, or currently breastfeeding/lactating.
- Current diagnosis of unstable and untreated major depression, as determined by self-report \& Mini International Neuropsychiatric Interview (MINI) (eligible if stable for at least 30 days).
- Current or past diagnosis of bipolar disorder or psychotic disorder, as determined by self-report or MINI.
- History of heart disease, stroke or MI, unstable angina, or tachycardia (if stable, requires Study Physician approval).
- Uncontrolled hypertension (systolic blood pressure (SBP) greater than 160 or diastolic blood pressure (DBP) greater than 100) present at Intake.
- Note: If a participant presents with blood pressure greater than 160/100 at sessions occurring on Week 3 (Pre-Quit) or at any other point during the treatment period, they will not be provided with/able to continue on TN unless the study physician grants approval.
- Previous allergic reaction to TN.
- History of diabetes (requires Study Physician approval)
- History of seizures (requires Study Physician approval)
- History of stomach ulcers (requires Study Physician approval)
- Suicide History Exclusion Criteria
- 1. Suicide risk as indicated by at least one of the following on the Columbia Suicide Severity Rating Scale (the PI \&/or study psychologist will be consulted to assess safety and determine eligibility in cases close to the eligibility cutoffs):
- Current suicidal ideation (within 30 days of enrollment)
- Two or more lifetime suicide attempts
- Any suicide attempt within 2 years of enrollment
- General Exclusion Criteria
- Any medical condition or concomitant medication that could compromise subject safety or treatment, as determined by the Principal Investigator and/or Study Physician.
- Color blindness.
- Any impairment (physical and/or neurological) including visual or other impairment preventing cognitive task performance.
- Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Understanding the Role of Cognitive Dysfunction in the Treatment of Nicotine Dependence Among HIV-infected Smokers
This study tests whether withdrawal-related cognitive deficits increase smoking relapse among HIV-infected (HIV+) vs. HIV-uninfected smokers (HIV-). Adult smokers (N=300; 150 HIV+, 150 HIV-) will complete 2 sessions to assess cognition (24h abstinence vs. smoking-as-usual; order counterbalanced; weeks 0-2). Subjects will then receive smoking cessation counseling and open label transdermal nicotine (weeks 3-12). Outcomes are: 1) cognition; and 2) abstinence rates at the end-of-treatment.
Read the detailed description
Medical advances in the treatment of HIV/AIDS have improved the life expectancy of HIV-infected individuals. Unfortunately, HIV-infected individuals are three times more likely to use tobacco than those in the general population, but little is known about the mechanisms that underlie these high smoking rates. This will be the first study to test whether the neurocognitive impairments associated with HIV-1 infection may be exacerbated during nicotine withdrawal and increase the probability of smoking relapse among HIV-infected smokers (HIV+), compared to HIV-uninfected smokers (HIV-). To this end, adult treatment-seeking smokers (N=300; 150 HIV+ and 150 HIV-) will complete this 12-week study, which is divided into two phases: a pre-quit laboratory phase (weeks 0-2) and a treatment phase (weeks 3-12). Subjects will complete two laboratory sessions during the pre-quit phase: once following 24 hours of mandatory smoking abstinence and once while smoking-as-usual (order counterbalanced). A comprehensive cognitive task battery assessing memory, attention, and executive function will be administered during each laboratory session. During the treatment phase, all subjects will receive standard smoking cessation treatment, including counseling (weeks 3-8) and open-label transdermal nicotine (TN) patches (weeks 4-12). The primary outcomes are: 1) cognitive performance following 24-hours smoking abstinence (vs. smoking-as-usual) during the pre-quit phase; and 2) 7-day point-prevalence, biochemically-confirmed abstinence rates at the end-of-treatment (EOT) for the treatment phase.
- Conditions
- Smoking Cessation
- Being tested
- Nicotine patch, Behavioral counseling
- Keywords
- Smoking Cessation, HIV, Cognition
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine patchDrug
Also called Nicoderm CQ
All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use "the patch" in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
Behavioral counselingBehavioural
Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).
| Study group | Role | What they receive |
|---|---|---|
| HIV+ Smoking lab session first | HIV-infected smokers: diagnosed with HIV infection and exhibiting viral load of less than or equal to 1000 copies/mL and CD4+ counts of greater than or equal to 200 cells/mm3 within 6 months prior to enrollment Randomized to complete smoking-as-usual lab session first and 24-h abstinent lab session second Receives: Drug: Nicotine patch; Behavioral: Behavioral counseling | |
| HIV- Smoking lab session first | HIV-uninfected smokers: negative HIV status will be confirmed by an on-site rapid HIV blood test Randomized to complete smoking-as-usual lab session first and 24-h abstinent lab session second Receives: Drug: Nicotine patch; Behavioral: Behavioral counseling | |
| HIV+ Abstinent lab session first | HIV-infected smokers: diagnosed with HIV infection and exhibiting viral load of less than or equal to 1000 copies/mL and CD4+ counts of greater than or equal to 200 cells/mm3 within 6 months prior to enrollment Randomized to complete 24-h abstinent lab session first and smoking-as-usual lab session second Receives: Drug: Nicotine patch; Behavioral: Behavioral counseling | |
| HIV- Abstinent lab session first | HIV-uninfected smokers: negative HIV status will be confirmed by an on-site rapid HIV blood test Randomized to complete 24-h abstinent lab session first and smoking-as-usual lab session second Receives: Drug: Nicotine patch; Behavioral: Behavioral counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function
Cognitive function will be assessed at the Lab session 1 and lab session 2 visits as well as End of Treatment. Participants will complete measures of executive function, verbal learning and memory and response inhibition. The primary outcome is the change in cognitive function lab session 1, lab session 2, and End of Treatment measured by a composite score (calculated by averaging individual z-scores). Z-scores were calculated using the Stroop interference score (executive function; measured in milliseconds), the delayed recall score from the Hopkins Verbal Learning Test (verbal learning and memory), and the Stop signal reaction time from the Stop Signal Task (response inhibition, measured in milliseconds). A composite score will be created by computed standardized z-scores for each measure (where the mean is 0 and the standard deviation is 1) and then averaging the z-scores. Measures of response time were reverse coded such that higher z-scores indicate better cognitive performance.
Measured: Lab session 1 (week 1), lab session 2 (week 2), End of treatment (week 12)
Secondary outcomes (1)
7-day Point Prevalence Abstinence
Smoking abstinence (primary outcome) will be assessed and biochemically verified at the End of Treatment Visit (week 12). The primary smoking outcome variable will be 7-day point prevalence abstinence (no smoking, not even a puff, for at least 7 days prior to the assessment) biochemically verified by carbon monoxide < 5 ppm.
Measured: End of Treatment (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 Jul 2016
- Primary completion21 Apr 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Rebecca L Ashare, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169101
- Sponsor's protocol ID
- 824860
- Other IDs
- R01DA042682
- Acronym
- HCS
- Status last verified
- Apr 2024
- First submitted
- 2 May 2017
- Last updated
- 10 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Greene B, Schnoll RA, Gross R, Ashare RL. The role of alternative reinforcers in smoking outcomes among people with and without HIV. Psychol Addict Behav. 2025 Nov;39(7):632-643. doi: 10.1037/adb0001071. Epub 2025 Jun 5.
PubMed 40471817
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Role of Cognitive Dysfunction in the Treatment of Nicotine Dependence Among HIV-infected Smokers
- ClinicalTrials.gov ID
- NCT03169101
- Acronym / sponsor ID
- HCS / 824860
- Conditions
- Smoking Cessation
- Keywords
- Smoking Cessation, HIV, Cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 21 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Posted 10 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests whether withdrawal-related cognitive deficits increase smoking relapse among HIV-infected (HIV+) vs. HIV-uninfected smokers (HIV-). Adult smokers (N=300; 150 HIV+, 150 HIV-) will complete 2 sessions to assess cognition (24h abstinence vs. smoking-as-usual; order counterbalanced; weeks 0-2). Subjects will then receive smoking cessation counseling and open label transdermal nicotine (weeks 3-12). Outcomes are: 1) cognition; and 2) abstinence rates at the end-of-treatment.
Detailed description
Medical advances in the treatment of HIV/AIDS have improved the life expectancy of HIV-infected individuals. Unfortunately, HIV-infected individuals are three times more likely to use tobacco than those in the general population, but little is known about the mechanisms that underlie these high smoking rates. This will be the first study to test whether the neurocognitive impairments associated with HIV-1 infection may be exacerbated during nicotine withdrawal and increase the probability of smoking relapse among HIV-infected smokers (HIV+), compared to HIV-uninfected smokers (HIV-). To this end, adult treatment-seeking smokers (N=300; 150 HIV+ and 150 HIV-) will complete this 12-week study, which is divided into two phases: a pre-quit laboratory phase (weeks 0-2) and a treatment phase (weeks 3-12). Subjects will complete two laboratory sessions during the pre-quit phase: once following 24 hours of mandatory smoking abstinence and once while smoking-as-usual (order counterbalanced). A comprehensive cognitive task battery assessing memory, attention, and executive function will be administered during each laboratory session. During the treatment phase, all subjects will receive standard smoking cessation treatment, including counseling (weeks 3-8) and open-label transdermal nicotine (TN) patches (weeks 4-12). The primary outcomes are: 1) cognitive performance following 24-hours smoking abstinence (vs. smoking-as-usual) during the pre-quit phase; and 2) 7-day point-prevalence, biochemically-confirmed abstinence rates at the end-of-treatment (EOT) for the treatment phase.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIV+ Smoking lab session first | – | Drug: Nicotine patch, Behavioral: Behavioral counselingHIV-infected smokers: diagnosed with HIV infection and exhibiting viral load of less than or equal to 1000 copies/mL and CD4+ counts of greater than or equal to 200 cells/mm3 within 6 months prior to enrollment Randomized to complete smoking-as-usual lab session first and 24-h abstinent lab session second |
| HIV- Smoking lab session first | – | Drug: Nicotine patch, Behavioral: Behavioral counselingHIV-uninfected smokers: negative HIV status will be confirmed by an on-site rapid HIV blood test Randomized to complete smoking-as-usual lab session first and 24-h abstinent lab session second |
| HIV+ Abstinent lab session first | – | Drug: Nicotine patch, Behavioral: Behavioral counselingHIV-infected smokers: diagnosed with HIV infection and exhibiting viral load of less than or equal to 1000 copies/mL and CD4+ counts of greater than or equal to 200 cells/mm3 within 6 months prior to enrollment Randomized to complete 24-h abstinent lab session first and smoking-as-usual lab session second |
| HIV- Abstinent lab session first | – | Drug: Nicotine patch, Behavioral: Behavioral counselingHIV-uninfected smokers: negative HIV status will be confirmed by an on-site rapid HIV blood test Randomized to complete 24-h abstinent lab session first and smoking-as-usual lab session second |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Three hundred (150 HIV+ and 150 HIV-) adult male and female smokers 18 years of age or older who smoke at least 5 cigarettes per day and are interested in quitting smoking will complete the study. HIV-infected smokers have been diagnosed with HIV/AIDS and HIV-uninfected smokers will have no diagnosis of HIV, either via blood test or self-report.
Key inclusion criteria (9 listed)
- Males and females 18 years of age or older who self-report smoking at least 5 cigarettes (menthol and non-menthol) per day, on average.
- HIV status
- Able to use transdermal nicotine (TN) safely, based on a medical evaluation.
- Residing in the geographic area for at least 4 months.
- Women of childbearing potential (based on medical history) must consent to use a medically accepted method of birth control (e.g., condoms and spermicide, oral contraceptive, Depo-Provera injection, contraceptive patch, tubal ligation) or abstain from sexual intercourse during the time they are in the study and using transdermal nicotine.
Key exclusion criteria (36 listed)
- Smoking Behavior
- Current enrollment or plans to enroll in another smoking cessation program in the next 4 months.
- Regular (daily) use of electronic cigarettes, chewing tobacco, snuff, snus, cigars, cigarillos, or pipes.
- Current use or plans to use nicotine substitutes (gum, patch, lozenge, e-cigarette) or smoking cessation treatments in the next 4 months.
- Alcohol/Drug Exclusion Criteria
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 |
|---|---|---|
| Nicotine patchAlso: Nicoderm CQAll participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use "the patch" in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks. | Drug | HIV+ Abstinent lab session first, HIV+ Smoking lab session first, HIV- Abstinent lab session first, HIV- Smoking lab session first |
| Behavioral counselingParticipants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC). | Behavioural | HIV+ Abstinent lab session first, HIV+ Smoking lab session first, HIV- Abstinent lab session first, HIV- Smoking lab session first |
Primary outcome
Cognitive Function
Time frame: Lab session 1 (week 1), lab session 2 (week 2), End of treatment (week 12)
Cognitive function will be assessed at the Lab session 1 and lab session 2 visits as well as End of Treatment. Participants will complete measures of executive function, verbal learning and memory and response inhibition. The primary outcome is the change in cognitive function lab session 1, lab session 2, and End of Treatment measured by a composite score (calculated by averaging individual z-scores). Z-scores were calculated using the Stroop interference score (executive function; measured in milliseconds), the delayed recall score from the Hopkins Verbal Learning Test (verbal learning and memory), and the Stop signal reaction time from the Stop Signal Task (response inhibition, measured in milliseconds). A composite score will be created by computed standardized z-scores for each measure (where the mean is 0 and the standard deviation is 1) and then averaging the z-scores. Measures of response time were reverse coded such that higher z-scores indicate better cognitive performance.
1 secondary outcome
7-day Point Prevalence Abstinence
Time frame: End of Treatment (week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40471817Greene B, Schnoll RA, Gross R, Ashare RL. The role of alternative reinforcers in smoking outcomes among people with and without HIV. Psychol Addict Behav. 2025 Nov;39(7):632-643. doi: 10.1037/adb0001071. Epub 2025 Jun 5.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
Recruiting
Smoking Cessation in Patients With Cancer
Cancer, Tobacco Use
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Effectiveness Of Project EX: A Classroom-Based Smoking Prevention And Cessation Intervention Program
Focus of the Study is Smoking Cessation and Prevention, Smoking Prevention
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
Recruiting
Therapeutic Contact Intensity in a Psychological Smoking Cessation Intervention With an App
Smoking Behaviors
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.
Rebecca L Ashare, Ph.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation, run by University of Pennsylvania 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 36 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 10 May 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?
Yes. Results are posted in the registry (first posted 10 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function (time frame: Lab session 1 (week 1), lab session 2 (week 2), End of treatment (week 12)). 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 NCT03169101, 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 10 May 2024.