Tobacco UseJUSTNCT03799315
Jail-Based Use of Smoking Cessation Treatment Study
A study testing Nicotine Replacement Therapy and Counseling in people with Tobacco Use, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial summary
Smoking rates remain above 60% for individuals involved in the criminal justice system and contribute to elevated mortality rates in this population. Addressing smoking disparities among justice-involved individuals is a critical public health issue in Minnesota, one of a few states with rising incarceration rates. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- Nicotine Replacement Therapy and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2019to 29 Aug 2020
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Use of ≥ 1 cigarette per day prior to incarceration
- Expected release from the Hennepin Adult Detention Center to the community within 90 days
- Age 18-64
- English fluency
- Lives within 20 minutes of Hennepin County Medical Center and has no plans to move away from area for 4 months
- Willing to attempt quitting or reducing smoking at discharge
- Has a telephone
- Cleared for nicotine lozenge safety by jail health care provider and willing to use at discharge
Who cannot join
- Active tuberculosis
- Current mental health crisis (i.e., currently experiencing significant mania, psychosis, or suicidality)
- Unable to ambulate independently
- Acute medical condition that would impair participant's ability to follow-up for assessments
- Expected discharge to a control institutional setting (e.g., locked state mental health facility or prison)
- Active pregnancy
- Heart attack within the last two weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55415
About this study
Official title: Reducing Tobacco-Related Health Disparities Among Incarcerated Individuals in Hennepin County
Smoking rates remain above 60% for individuals involved in the criminal justice system and contribute to elevated mortality rates in this population. Addressing smoking disparities among justice-involved individuals is a critical public health issue in Minnesota, one of a few states with rising incarceration rates. People who are incarcerated represent the intersection of multiple high-priority populations (disproportionately African-American, Native American, low-income, homeless, on Medicaid, and suffering from mental illness and substance use disorders). This study examines the impact of a smoking cessation intervention for individuals discharged from jail to the community on smoking abstinence. Participants will be randomized to either 1) guideline-based, in-person smoking cessation counseling during incarceration, telephone counseling after incarceration, and nicotine replacement, or 2) enhanced treatment as usual. This study's findings will be used to develop a larger, multi-site study that is fully powered to measure longer-term health and smoking cessation outcomes.
Read the detailed description
Outcome assessments will be conducted for both arms at 1 week, 3 weeks, and 12 weeks post discharge from jail. During these assessments, seven-day point prevalence abstinence will be bio-verified with exhaled carbon monoxide, and self-reported general health, physical health, mental health, and substance use measures will also be obtained. The analysis is fully powered (i.e., power > .8) to detect significant between group effects on the primary outcome (i.e., the longitudinal, between group effect on bio-verified seven-day point prevalence abstinence over the 3 weeks post discharge). All analyses will be conducted on the intent to treat sample and will utilize pre-specified logistic and linear regression models.
- Conditions
- Tobacco Use
- Being tested
- Nicotine Replacement Therapy, Counseling
- Keywords
- Incarceration, Smoking, Counseling, Nicotine Replacement, Disparities
- Medical subject headings
- Tobacco Use, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Replacement TherapyDrug
All participants randomized to the JUST group will receive training on proper use of nicotine lozenges to aid in smoking cessation. Upon release from jail, participants will receive 2mg nicotine lozenges.
CounselingBehavioural
All participants randomized to the JUST group will receive one hour of in-person, individual, guideline-based smoking cessation counseling during their jail stay. Upon release from jail, they will receive four 30-minute counseling phone calls over 3 weeks. These phone calls will take place at 24 hours, day 7, day 14, and day 20.
| Study group | Role | What they receive |
|---|---|---|
| Jail-Based Use of Smoking Cessation Treatment (JUST) | Experimental | Participants will receive guidline-based smoking cessation counseling while in jail and phone-based smoking cessation counseling sessions and nicotine lozenges after release from jail. Receives: Drug: Nicotine Replacement Therapy; Behavioral: Counseling |
| Enhanced Treatment As Usual (TAU) | No intervention | Participants will receive the usual, limited smoking cessation treatment while in jail, plus an additional health and wellness education session in jail. Nicotine lozenges will be offered at the end of the study to those who did not quit smoking. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioverified 7-day point prevalence abstinence from smoking
Bioverified 7-day point prevalence abstinence from smoking
Measured: Over 3 weeks
Secondary outcomes (8)
Time to Lapse
Days to first lapse (i.e., any cigarette use, even a puff)
Measured: 1 week, 3 weeks, 12 weeks
Time to Relapse
Days to first relapse
Measured: 3 weeks, 12 weeks
Bio-verified 7-day point prevalence abstinence from smoking
Bioverified 7-day point prevalence abstinence from smoking
Measured: Over 12 weeks
Health-related quality of life
Self-Reported health using the SF-12 total score and physical and mental health composite scores. Lower scores indicate worse health.
Measured: 1 week, 3 weeks, 12 weeks
Depressive symptoms
The 10 item Center for Epidemiologic Studies Depression Scale (CESD-10) ranges from 0-30 with higher scores indicating higher depression symptoms.
Measured: 1 week, 3 weeks, 12 weeks
Self-Reported Affect
10-item Positive and Negative Affect Scales (PANAS). The 5-item positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect. The 5-item negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect.
Measured: 1 week, 3 weeks, 12 weeks
Health care utilization
Self-reported hospitalizations and use of the emergency department
Measured: 1 week, 3 weeks, 12 weeks
Substance abuse
Self-reported substance abuse using the Drug Abuse Screening Test-10. Higher scores indicate more severe drug abuse.
Measured: 1 week, 3 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start14 Jan 2019
- Primary completion16 Mar 2020
- Study completion29 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Tobacco UseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hennepin County Adult Detention Center, Brown University
- Responsible party
- Principal investigator, Tyler Winkelman, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799315
- Sponsor's protocol ID
- RC-2018-0013
- Acronym
- JUST
- Status last verified
- Sep 2020
- First submitted
- 4 Jan 2019
- Last updated
- 14 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jamal A, King BA, Neff LJ, Whitmill J, Babb SD, Graffunder CM. Current Cigarette Smoking Among Adults - United States, 2005-2015. MMWR Morb Mortal Wkly Rep. 2016 Nov 11;65(44):1205-1211. doi: 10.15585/mmwr.mm6544a2.
PubMed 27832052Winkelman TNA, Vickery KD, Busch AM. Tobacco use among non-elderly adults with and without criminal justice involvement in the past year: United States, 2008-2016. Addict Sci Clin Pract. 2019 Jan 11;14(1):2. doi: 10.1186/s13722-019-0131-y.
PubMed 30635028Puljevic C, Kinner SA, de Andrade D. Extending smoking abstinence after release from smoke-free prisons: protocol for a randomised controlled trial. Health Justice. 2017 Dec;5(1):1. doi: 10.1186/s40352-016-0046-6. Epub 2017 Jan 23.
PubMed 28116579Binswanger IA, Carson EA, Krueger PM, Mueller SR, Steiner JF, Sabol WJ. Prison tobacco control policies and deaths from smoking in United States prisons: population based retrospective analysis. BMJ. 2014 Aug 5;349:g4542. doi: 10.1136/bmj.g4542.
PubMed 25097186Travis J, Western B, Redburn S, eds. The Growth of Incarceration in the United States: Exploring Causes and Consequences. Washington, D.C.: The National Academies Press; 2014. doi:10.17226/18613.
Winkelman TN, Kieffer EC, Goold SD, Morenoff JD, Cross K, Ayanian JZ. Health Insurance Trends and Access to Behavioral Healthcare Among Justice-Involved Individuals-United States, 2008-2014. J Gen Intern Med. 2016 Dec;31(12):1523-1529. doi: 10.1007/s11606-016-3845-5.
PubMed 27638837Winkelman TN, Choi H, Davis MM. The Affordable Care Act, Insurance Coverage, and Health Care Utilization of Previously Incarcerated Young Men: 2008-2015. Am J Public Health. 2017 May;107(5):807-811. doi: 10.2105/AJPH.2017.303703. Epub 2017 Mar 21.
PubMed 28323472Vickery KD, Bodurtha P, Winkelman TNA, Hougham C, Owen R, Legler MS, Erickson E, Davis MM. Cross-Sector Service Use Among High Health Care Utilizers In Minnesota After Medicaid Expansion. Health Aff (Millwood). 2018 Jan;37(1):62-69. doi: 10.1377/hlthaff.2017.0991.
PubMed 29309230Frank JW, Linder JA, Becker WC, Fiellin DA, Wang EA. Increased hospital and emergency department utilization by individuals with recent criminal justice involvement: results of a national survey. J Gen Intern Med. 2014 Sep;29(9):1226-33. doi: 10.1007/s11606-014-2877-y. Epub 2014 May 10.
PubMed 24817280Clarke JG, Martin RA, Stein L, Lopes CE, Mello J, Friedmann P, Bock B. Working Inside for Smoking Elimination (Project W.I.S.E.) study design and rationale to prevent return to smoking after release from a smoke free prison. BMC Public Health. 2011 Oct 5;11:767. doi: 10.1186/1471-2458-11-767.
PubMed 21974746Clarke JG, Stein LA, Martin RA, Martin SA, Parker D, Lopes CE, McGovern AR, Simon R, Roberts M, Friedman P, Bock B. Forced smoking abstinence: not enough for smoking cessation. JAMA Intern Med. 2013 May 13;173(9):789-94. doi: 10.1001/jamainternmed.2013.197.
PubMed 23567902Mulder I, Tijhuis M, Smit HA, Kromhout D. Smoking cessation and quality of life: the effect of amount of smoking and time since quitting. Prev Med. 2001 Dec;33(6):653-60. doi: 10.1006/pmed.2001.0941.
PubMed 11716663Piper ME, Kenford S, Fiore MC, Baker TB. Smoking cessation and quality of life: changes in life satisfaction over 3 years following a quit attempt. Ann Behav Med. 2012 Apr;43(2):262-70. doi: 10.1007/s12160-011-9329-2.
PubMed 22160762Lemon SC, Friedmann PD, Stein MD. The impact of smoking cessation on drug abuse treatment outcome. Addict Behav. 2003 Sep;28(7):1323-31. doi: 10.1016/s0306-4603(02)00259-9.
PubMed 12915172Thurgood SL, McNeill A, Clark-Carter D, Brose LS. A Systematic Review of Smoking Cessation Interventions for Adults in Substance Abuse Treatment or Recovery. Nicotine Tob Res. 2016 May;18(5):993-1001. doi: 10.1093/ntr/ntv127. Epub 2015 Jun 11.
PubMed 26069036
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Tobacco-Related Health Disparities Among Incarcerated Individuals in Hennepin County
- ClinicalTrials.gov ID
- NCT03799315
- Acronym / sponsor ID
- JUST / RC-2018-0013
- Conditions
- Tobacco Use
- Keywords
- Incarceration, Smoking, Counseling, Nicotine Replacement, Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Collaborators
- Hennepin County Adult Detention Center, Brown University
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 29 Aug 2020 (actual)
- First posted
- 10 Jan 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.
Smoking rates remain above 60% for individuals involved in the criminal justice system and contribute to elevated mortality rates in this population. Addressing smoking disparities among justice-involved individuals is a critical public health issue in Minnesota, one of a few states with rising incarceration rates. People who are incarcerated represent the intersection of multiple high-priority populations (disproportionately African-American, Native American, low-income, homeless, on Medicaid, and suffering from mental illness and substance use disorders). This study examines the impact of a smoking cessation intervention for individuals discharged from jail to the community on smoking abstinence. Participants will be randomized to either 1) guideline-based, in-person smoking cessation counseling during incarceration, telephone counseling after incarceration, and nicotine replacement, or 2) enhanced treatment as usual. This study's findings will be used to develop a larger, multi-site study that is fully powered to measure longer-term health and smoking cessation outcomes.
Detailed description
Outcome assessments will be conducted for both arms at 1 week, 3 weeks, and 12 weeks post discharge from jail. During these assessments, seven-day point prevalence abstinence will be bio-verified with exhaled carbon monoxide, and self-reported general health, physical health, mental health, and substance use measures will also be obtained. The analysis is fully powered (i.e., power > .8) to detect significant between group effects on the primary outcome (i.e., the longitudinal, between group effect on bio-verified seven-day point prevalence abstinence over the 3 weeks post discharge). All analyses will be conducted on the intent to treat sample and will utilize pre-specified logistic and linear regression models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jail-Based Use of Smoking Cessation Treatment (JUST) | Experimental | Drug: Nicotine Replacement Therapy, Behavioral: CounselingParticipants will receive guidline-based smoking cessation counseling while in jail and phone-based smoking cessation counseling sessions and nicotine lozenges after release from jail. |
| Enhanced Treatment As Usual (TAU) | No intervention | –Participants will receive the usual, limited smoking cessation treatment while in jail, plus an additional health and wellness education session in jail. Nicotine lozenges will be offered at the end of the study to those who did not quit smoking. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Use of ≥ 1 cigarette per day prior to incarceration
- Expected release from the Hennepin Adult Detention Center to the community within 90 days
- Age 18-64
- English fluency
- Lives within 20 minutes of Hennepin County Medical Center and has no plans to move away from area for 4 months
Key exclusion criteria (7 listed)
- Active tuberculosis
- Current mental health crisis (i.e., currently experiencing significant mania, psychosis, or suicidality)
- Unable to ambulate independently
- Acute medical condition that would impair participant's ability to follow-up for assessments
- Expected discharge to a control institutional setting (e.g., locked state mental health facility or prison)
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 Replacement TherapyAll participants randomized to the JUST group will receive training on proper use of nicotine lozenges to aid in smoking cessation. Upon release from jail, participants will receive 2mg nicotine lozenges. | Drug | Jail-Based Use of Smoking Cessation Treatment (JUST) |
| CounselingAll participants randomized to the JUST group will receive one hour of in-person, individual, guideline-based smoking cessation counseling during their jail stay. Upon release from jail, they will receive four 30-minute counseling phone calls over 3 weeks. These phone calls will take place at 24 hours, day 7, day 14, and day 20. | Behavioural | Jail-Based Use of Smoking Cessation Treatment (JUST) |
Primary outcome
Bioverified 7-day point prevalence abstinence from smoking
Time frame: Over 3 weeks
Bioverified 7-day point prevalence abstinence from smoking
8 secondary outcomes
Time to Lapse
Time frame: 1 week, 3 weeks, 12 weeks
Time to Relapse
Time frame: 3 weeks, 12 weeks
Bio-verified 7-day point prevalence abstinence from smoking
Time frame: Over 12 weeks
Health-related quality of life
Time frame: 1 week, 3 weeks, 12 weeks
Depressive symptoms
Time frame: 1 week, 3 weeks, 12 weeks
Self-Reported Affect
Time frame: 1 week, 3 weeks, 12 weeks
Health care utilization
Time frame: 1 week, 3 weeks, 12 weeks
Substance abuse
Time frame: 1 week, 3 weeks, 12 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 14 Sep 2020.
- Background: PubMed 27832052Jamal A, King BA, Neff LJ, Whitmill J, Babb SD, Graffunder CM. Current Cigarette Smoking Among Adults - United States, 2005-2015. MMWR Morb Mortal Wkly Rep. 2016 Nov 11;65(44):1205-1211. doi: 10.15585/mmwr.mm6544a2.
- Background: PubMed 30635028Winkelman TNA, Vickery KD, Busch AM. Tobacco use among non-elderly adults with and without criminal justice involvement in the past year: United States, 2008-2016. Addict Sci Clin Pract. 2019 Jan 11;14(1):2. doi: 10.1186/s13722-019-0131-y.
- Background: PubMed 28116579Puljevic C, Kinner SA, de Andrade D. Extending smoking abstinence after release from smoke-free prisons: protocol for a randomised controlled trial. Health Justice. 2017 Dec;5(1):1. doi: 10.1186/s40352-016-0046-6. Epub 2017 Jan 23.
- Background: PubMed 25097186Binswanger IA, Carson EA, Krueger PM, Mueller SR, Steiner JF, Sabol WJ. Prison tobacco control policies and deaths from smoking in United States prisons: population based retrospective analysis. BMJ. 2014 Aug 5;349:g4542. doi: 10.1136/bmj.g4542.
- BackgroundTravis J, Western B, Redburn S, eds. The Growth of Incarceration in the United States: Exploring Causes and Consequences. Washington, D.C.: The National Academies Press; 2014. doi:10.17226/18613.
- Background: PubMed 27638837Winkelman TN, Kieffer EC, Goold SD, Morenoff JD, Cross K, Ayanian JZ. Health Insurance Trends and Access to Behavioral Healthcare Among Justice-Involved Individuals-United States, 2008-2014. J Gen Intern Med. 2016 Dec;31(12):1523-1529. doi: 10.1007/s11606-016-3845-5.
- Background: PubMed 28323472Winkelman TN, Choi H, Davis MM. The Affordable Care Act, Insurance Coverage, and Health Care Utilization of Previously Incarcerated Young Men: 2008-2015. Am J Public Health. 2017 May;107(5):807-811. doi: 10.2105/AJPH.2017.303703. Epub 2017 Mar 21.
- Background: PubMed 29309230Vickery KD, Bodurtha P, Winkelman TNA, Hougham C, Owen R, Legler MS, Erickson E, Davis MM. Cross-Sector Service Use Among High Health Care Utilizers In Minnesota After Medicaid Expansion. Health Aff (Millwood). 2018 Jan;37(1):62-69. doi: 10.1377/hlthaff.2017.0991.
- Background: PubMed 24817280Frank JW, Linder JA, Becker WC, Fiellin DA, Wang EA. Increased hospital and emergency department utilization by individuals with recent criminal justice involvement: results of a national survey. J Gen Intern Med. 2014 Sep;29(9):1226-33. doi: 10.1007/s11606-014-2877-y. Epub 2014 May 10.
- Background: PubMed 21974746Clarke JG, Martin RA, Stein L, Lopes CE, Mello J, Friedmann P, Bock B. Working Inside for Smoking Elimination (Project W.I.S.E.) study design and rationale to prevent return to smoking after release from a smoke free prison. BMC Public Health. 2011 Oct 5;11:767. doi: 10.1186/1471-2458-11-767.
- Background: PubMed 23567902Clarke JG, Stein LA, Martin RA, Martin SA, Parker D, Lopes CE, McGovern AR, Simon R, Roberts M, Friedman P, Bock B. Forced smoking abstinence: not enough for smoking cessation. JAMA Intern Med. 2013 May 13;173(9):789-94. doi: 10.1001/jamainternmed.2013.197.
- Background: PubMed 11716663Mulder I, Tijhuis M, Smit HA, Kromhout D. Smoking cessation and quality of life: the effect of amount of smoking and time since quitting. Prev Med. 2001 Dec;33(6):653-60. doi: 10.1006/pmed.2001.0941.
- Individual participant dataSharing planned: Undecided
Related trials for Tobacco Use
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Replacement Therapy and Counseling in people with Tobacco Use, run by Hennepin Healthcare Research Institute 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 8 inclusion and 7 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 14 Sep 2020. 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?
Bioverified 7-day point prevalence abstinence from smoking (time frame: Over 3 weeks). 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 NCT03799315, which also lists 24 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 14 Sep 2020.