Smoking, CigarettePhase 2NCT06296849
Dyadic Financial Incentive Treatments for Dual Smoker Couples
A Phase 2 study testing Financial Incentive Treatment (FIT) in people with Smoking, Cigarette, run by University of Oklahoma at 2 sites in United States.
Trial summary
Smokers partnered with other smokers (i.e., dual-smoker couples) represent ~2/3 of all smokers. Dual-smoker couples (DSCs) are less likely to try to quit smoking and more likely to relapse during a quit attempt, reducing overall smoking cessation rates and representing a high-risk clinical population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Cigarette
- What is being tested?
- Financial Incentive Treatment (FIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jan 2024to May 2028
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) age of 18+; 2) smoking of 5+ cigarettes/day; 3) relationship status of married to or living with a daily smoker of 5+ cigarettes who is also above the age of 18; and 4) romantic relationship duration of at least six months.
Who cannot join
- 1) less than 8th grade capacity to read and write in English; 2) recent hospitalization (past 6 months) 3) psychosis risk; 4) regular (4+ days weekly) use of e-cigarettes; 5) Contra-indication for NRT (e.g., pregnancy, heart disease); 6) Marijuana use.
- Inclusion and exclusion criteria apply to both members of each couple; both members of each couple must be eligible for the target to enroll.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Completed
University of Georgia
Athens, Georgia, 30602
- Recruiting
University of Oklahoma Health Campus
Tulsa, Oklahoma, 74135
Michelle vanDellen, PhD, mablab@ou.edu
Kirsten Blum, MS, kirsten-blum@ou.edu
About this study
Official title: Randomized Controlled Trial of Dyadic Financial Incentive Treatments for Dual Smoker Couples: Evaluation of Efficacy, Mechanisms, and Cost Effectiveness (1R01CA276594-01A1)
Smokers partnered with other smokers (i.e., dual-smoker couples) represent ~2/3 of all smokers. Dual-smoker couples (DSCs) are less likely to try to quit smoking and more likely to relapse during a quit attempt, reducing overall smoking cessation rates and representing a high-risk clinical population. Despite their high prevalence and risk for persistent smoking, however, there are limited data on smoking cessation interventions among DSCs. Building on previous research that suggests a) financial incentive treatments (FITs) are effective at increasing quit rates and b) dyadic adaptations of FITs are feasible for implementation in DSCs, the proposed study will systematically two versions of FITs to enhance smoking cessation among DSCs. In addition to determining the efficacy of these dyadic FITs for smoking abstinence in DSCs, the investigators will consider the cost and cost effectiveness of each adaptation as well as mechanisms of change to inform future implementation research. The investigators will additionally consider secondary outcomes including abstinence during treatment and long-term abstinence maintenance after end of treatment.
The investigators will address these questions in a three-group randomized controlled trial (RCT). In all conditions, individuals who have smoking partners (i.e., targets) will receive usual care (combination fast and slow acting Nicotine Replacement Therapy + quitting resources). In two conditions, participants will receive incentives for abstinence at three time points (1, 3, and 6 months post-baseline). In the SFIT condition, only the target in a couple will be offered incentives; in the DFIT condition, both target and partner will be offered incentives. Primary efficacy outcome is % point-prevalence abstinence at 6 months post-baseline among targets. Secondary outcomes are point-prevalence abstinence at 1 and 3 months during the treatment and 6 months post-treatment (12-months post-baseline), as well as partner outcomes. The investigators will evaluate possible mechanisms of change including partner support and individual and partner motivation to quit as well as evaluate the cost and relative cost of each abstainer within and across condition. These data on the efficacy, mechanisms, and costs of FITs for DSCs will inform population level implementation and promote successful quitting in this treatment refractory population.
Read the detailed description
The proposed study investigates the efficacy of implementing Financial Incentivized Treatments (FITs) in dyads on smoking abstinence in DSCs. The core design is a three-group longitudinal design in which participants are randomized into one of three conditions (no-FIT control, SFIT (one couple member offered incentives) and DFIT (both couple members offered incentives and tracked across 12 months. During this time, participants will complete a baseline session, be offered quitting resources (e.g. psychoeducation, NRT), and complete four follow-ups (1, 3, 6 [primary efficacy timepoint], and 12 months scheduled post-baseline). In all conditions, all participants (both targets and partners) will receive combination fast- and slow-acting NRT (calibrated to their smoking heaviness and/or time to first cigarette) and access to quitting resources.
In all conditions, the target will be determined as the first person to make contact with the research team in response to study advertising. The investigators estimate 70% of targets will be female. The investigators will stratify to create approximately equal proportions of target sex by cell. Same sex couples will be independently stratified across conditions to attempt to balance proportionate representation (estimated prevalence of same sex couples = 8%). Because heaviness of smoking (<20 vs 20+ cigarettes/day) requires a different NRT regimen and heaviness of smoking is associated with different quit rates, the investigators will also stratify random assignment based on number of cigarettes per day. Collectively, these strategies will enhance the likelihood of equivalent composition by condition.
Targets will be randomly assigned to one of three conditions. Consistent with the R21 design, participants in the no-FIT control condition will not receive incentives. Targets in the SFIT condition will be offered financial incentives for biochemically verified abstinence ($200 at each of three follow-ups [1, 3, and 6 Month]). In the DFIT condition, both targets and partners will be offered financial incentives for abstinence. Thus, in this condition, the total financial incentives offered to the dyad are twice the amount as offered to participants in the SFIT condition. However, because partners are involved in learning about the incentives, partner involvement is relatively high in both conditions. Partner involvement and understanding of the situation will be assessed as a potential mechanism of FIT efficacy. This design extends our pilot study to examine the efficacy of FITs for long-term abstinence and then then examines whether offering incentives to both members adds additional benefit beyond offering incentives to one member of the couple.
A total of 450 DSC targets (900 total smokers) will be recruited from across the United States. In all conditions, the target will be determined as the first person to contact the research team in response to study advertising. Couples will be defined as two people involved in a romantic relationship for at least 6 months who are married or cohabiting. Inclusion criteria are: 1) age of 18+; 2) smoking of 5+ cigarettes/day; 3) relationship status of married to or living with a daily smoker of 5+ cigarettes who is also above the age of 18; and 4) romantic Exclusion criteria are: 1) less than 8th grade capacity to read and write in English; 2) recent hospitalization (past 6 months) 3) psychosis risk; 4) regular (4+ days weekly) use of e-cigarettes; 5) Contra-indication for NRT (e.g., pregnancy, heart disease); 6) Marijuana use. Inclusion and exclusion criteria apply to both members of each couple; both members of each couple must be eligible for the target to enroll. Inclusion and exclusion criteria apply to both members of each couple. Study participation will last 1 year, including an initial Baseline session, three incentivized follow-ups (1 Mth, 3 Mth, 6 Mth follow-ups) and an unincentivized follow-up (12 Mth). Both members of each couple will be assessed at each time point, regardless of condition. Assessments will be completed by targets and partners via remote video conference at Baseline, 1 Mth, 3 Mth, 6 Mth, and 1 year. The investigators will measure smoking history, point-prevalence abstinence, heaviness of smoking, nicotine dependence, and possible motivational and dyadic mechanisms and moderators of anticipated effects.
- Conditions
- Smoking, Cigarette
- Being tested
- Financial Incentive Treatment (FIT)
- Keywords
- smoking cessation, dual-smoker couples, behavioral economics, financial incentives
- Medical subject headings
- Cigarette Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial Incentive Treatment (FIT)Behavioural
In the present study, the investigators will provide financial incentives of $200 for biochemically verified abstinence at each of three time points (1 month, 3 month, and 6 month) following baseline. Additionally, the investigators will provide a bonus of $200 for participants who demonstrate abstinence at each of the time points. This incentive value is consistent with recent research using macro-level financial incentives and incorporates both short-term and long-term incentives to shape behavior.
| Study group | Role | What they receive |
|---|---|---|
| No-FIT Treatment-as-Usual (TAU) Condition | No intervention | Participants in the no-FIT control condition will not receive incentives. |
| Single-Target FIT (SFIT) | Experimental | One couple member offered incentives. Targets in the SFIT condition will be offered financial incentives for biochemically verified abstinence ($200 at each of three follow-ups [1, 3, and 6 Month]). Receives: Behavioral: Financial Incentive Treatment (FIT) |
| Dyadic-FIT condition (DFIT) | Experimental | Both couple members offered incentives and tracked across 12 months. Both targets and partners will be offered financial incentives for abstinence. Thus, in this condition, the total financial incentives offered to the dyad are twice the amount as offered to participants in the SFIT condition. Receives: Behavioral: Financial Incentive Treatment (FIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point-Prevalence Abstinence at End of Treatment
% of targets (intent to treat sample) who are abstinent (self-report no smoking past 7 days + expired carbon monoxide (CO) <= 5 ppm
Measured: 6 Month
Secondary outcomes (5)
Point-Prevalence Abstinence After Treatment
% of targets (intent to treat sample) who are abstinent (self-report no smoking past 7 days + expired CO <= 5 ppm
Measured: 1 year
Point-Prevalence Abstinence at First Follow-up
% of targets (intent to treat sample) who are abstinent (self-report no smoking past 7 days + expired CO <= 5 ppm
Measured: 1 month
Point-Prevalence Abstinence at Second Follow-up
% of targets (intent to treat sample) who are abstinent (self-report no smoking past 7 days + expired CO <= 5 ppm
Measured: 3 month
Partner Point-Prevalence Abstinence
% of partners (intent to treat sample) who are abstinent (self-report no smoking past 7 days + expired CO <= 5 ppm at each follow-up
Measured: 1 Month, 3 Month, 6 Month, 1 Year
Smoking Heaviness
All participants will report their average daily cigarette consumption at each time point.
Measured: 1 Month, 3 Month, 6 Month, 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start18 Jan 2024
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (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 Smoking, CigaretteStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, University of Kentucky, University of Georgia
- Responsible party
- Sponsor
- Investigators
- Michelle R vanDellen, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296849
- Sponsor's protocol ID
- 17460
- Status last verified
- Apr 2026
- First submitted
- 29 Feb 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared including key study variables (predictors and outcomes) through Open Science Framework (OSF).
Publications
vanDellen MR, Wright JWC, Zhao B, Cullinan C, Beach SRH, Shen Y, Haskins LB, Schiavone WM, MacKillop JM. Partner-Involved Financial Incentives for Smoking Cessation in Dual-Smoker Couples: A Randomized Pilot Trial. Nicotine Tob Res. 2024 Jan 22;26(2):229-236. doi: 10.1093/ntr/ntad183.
PubMed 37742229
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Dyadic Financial Incentive Treatments for Dual Smoker Couples: Evaluation of Efficacy, Mechanisms, and Cost Effectiveness (1R01CA276594-01A1)
- ClinicalTrials.gov ID
- NCT06296849
- Acronym / sponsor ID
- 17460
- Conditions
- Smoking, Cigarette
- Keywords
- smoking cessation, dual-smoker couples, behavioral economics, financial incentives
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- McMaster University, University of Kentucky, University of Georgia
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 6 Mar 2024 (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.
Smokers partnered with other smokers (i.e., dual-smoker couples) represent ~2/3 of all smokers. Dual-smoker couples (DSCs) are less likely to try to quit smoking and more likely to relapse during a quit attempt, reducing overall smoking cessation rates and representing a high-risk clinical population. Despite their high prevalence and risk for persistent smoking, however, there are limited data on smoking cessation interventions among DSCs. Building on previous research that suggests a) financial incentive treatments (FITs) are effective at increasing quit rates and b) dyadic adaptations of FITs are feasible for implementation in DSCs, the proposed study will systematically two versions of FITs to enhance smoking cessation among DSCs. In addition to determining the efficacy of these dyadic FITs for smoking abstinence in DSCs, the investigators will consider the cost and cost effectiveness of each adaptation as well as mechanisms of change to inform future implementation research. The investigators will additionally consider secondary outcomes including abstinence during treatment and long-term abstinence maintenance after end of treatment.
The investigators will address these questions in a three-group randomized controlled trial (RCT). In all conditions, individuals who have smoking partners (i.e., targets) will receive usual care (combination fast and slow acting Nicotine Replacement Therapy + quitting resources). In two conditions, participants will receive incentives for abstinence at three time points (1, 3, and 6 months post-baseline). In the SFIT condition, only the target in a couple will be offered incentives; in the DFIT condition, both target and partner will be offered incentives. Primary efficacy outcome is % point-prevalence abstinence at 6 months post-baseline among targets. Secondary outcomes are point-prevalence abstinence at 1 and 3 months during the treatment and 6 months post-treatment (12-months post-baseline), as well as partner outcomes. The investigators will evaluate possible mechanisms of change including partner support and individual and partner motivation to quit as well as evaluate the cost and relative cost of each abstainer within and across condition. These data on the efficacy, mechanisms, and costs of FITs for DSCs will inform population level implementation and promote successful quitting in this treatment refractory population.
Detailed description
The proposed study investigates the efficacy of implementing Financial Incentivized Treatments (FITs) in dyads on smoking abstinence in DSCs. The core design is a three-group longitudinal design in which participants are randomized into one of three conditions (no-FIT control, SFIT (one couple member offered incentives) and DFIT (both couple members offered incentives and tracked across 12 months. During this time, participants will complete a baseline session, be offered quitting resources (e.g. psychoeducation, NRT), and complete four follow-ups (1, 3, 6 [primary efficacy timepoint], and 12 months scheduled post-baseline). In all conditions, all participants (both targets and partners) will receive combination fast- and slow-acting NRT (calibrated to their smoking heaviness and/or time to first cigarette) and access to quitting resources.
In all conditions, the target will be determined as the first person to make contact with the research team in response to study advertising. The investigators estimate 70% of targets will be female. The investigators will stratify to create approximately equal proportions of target sex by cell. Same sex couples will be independently stratified across conditions to attempt to balance proportionate representation (estimated prevalence of same sex couples = 8%). Because heaviness of smoking (<20 vs 20+ cigarettes/day) requires a different NRT regimen and heaviness of smoking is associated with different quit rates, the investigators will also stratify random assignment based on number of cigarettes per day. Collectively, these strategies will enhance the likelihood of equivalent composition by condition.
Targets will be randomly assigned to one of three conditions. Consistent with the R21 design, participants in the no-FIT control condition will not receive incentives. Targets in the SFIT condition will be offered financial incentives for biochemically verified abstinence ($200 at each of three follow-ups [1, 3, and 6 Month]). In the DFIT condition, both targets and partners will be offered financial incentives for abstinence. Thus, in this condition, the total financial incentives offered to the dyad are twice the amount as offered to participants in the SFIT condition. However, because partners are involved in learning about the incentives, partner involvement is relatively high in both conditions. Partner involvement and understanding of the situation will be assessed as a potential mechanism of FIT efficacy. This design extends our pilot study to examine the efficacy of FITs for long-term abstinence and then then examines whether offering incentives to both members adds additional benefit beyond offering incentives to one member of the couple.
A total of 450 DSC targets (900 total smokers) will be recruited from across the United States. In all conditions, the target will be determined as the first person to contact the research team in response to study advertising. Couples will be defined as two people involved in a romantic relationship for at least 6 months who are married or cohabiting. Inclusion criteria are: 1) age of 18+; 2) smoking of 5+ cigarettes/day; 3) relationship status of married to or living with a daily smoker of 5+ cigarettes who is also above the age of 18; and 4) romantic Exclusion criteria are: 1) less than 8th grade capacity to read and write in English; 2) recent hospitalization (past 6 months) 3) psychosis risk; 4) regular (4+ days weekly) use of e-cigarettes; 5) Contra-indication for NRT (e.g., pregnancy, heart disease); 6) Marijuana use. Inclusion and exclusion criteria apply to both members of each couple; both members of each couple must be eligible for the target to enroll. Inclusion and exclusion criteria apply to both members of each couple. Study participation will last 1 year, including an initial Baseline session, three incentivized follow-ups (1 Mth, 3 Mth, 6 Mth follow-ups) and an unincentivized follow-up (12 Mth). Both members of each couple will be assessed at each time point, regardless of condition. Assessments will be completed by targets and partners via remote video conference at Baseline, 1 Mth, 3 Mth, 6 Mth, and 1 year. The investigators will measure smoking history, point-prevalence abstinence, heaviness of smoking, nicotine dependence, and possible motivational and dyadic mechanisms and moderators of anticipated effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No-FIT Treatment-as-Usual (TAU) Condition | No intervention | –Participants in the no-FIT control condition will not receive incentives. |
| Single-Target FIT (SFIT) | Experimental | Behavioral: Financial Incentive Treatment (FIT)One couple member offered incentives. Targets in the SFIT condition will be offered financial incentives for biochemically verified abstinence ($200 at each of three follow-ups [1, 3, and 6 Month]). |
| Dyadic-FIT condition (DFIT) | Experimental | Behavioral: Financial Incentive Treatment (FIT)Both couple members offered incentives and tracked across 12 months. Both targets and partners will be offered financial incentives for abstinence. Thus, in this condition, the total financial incentives offered to the dyad are twice the amount as offered to participants in the SFIT condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) age of 18+; 2) smoking of 5+ cigarettes/day; 3) relationship status of married to or living with a daily smoker of 5+ cigarettes who is also above the age of 18; and 4) romantic relationship duration of at least six months.
Key exclusion criteria (2 listed)
- 1) less than 8th grade capacity to read and write in English; 2) recent hospitalization (past 6 months) 3) psychosis risk; 4) regular (4+ days weekly) use of e-cigarettes; 5) Contra-indication for NRT (e.g., pregnancy, heart disease); 6) Marijuana use.
- Inclusion and exclusion criteria apply to both members of each couple; both members of each couple must be eligible for the target to enroll.
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 |
|---|---|---|
| Financial Incentive Treatment (FIT)In the present study, the investigators will provide financial incentives of $200 for biochemically verified abstinence at each of three time points (1 month, 3 month, and 6 month) following baseline. Additionally, the investigators will provide a bonus of $200 for participants who demonstrate abstinence at each of the time points. This incentive value is consistent with recent research using macro-level financial incentives and incorporates both short-term and long-term incentives to shape behavior. | Behavioural | Dyadic-FIT condition (DFIT), Single-Target FIT (SFIT) |
Primary outcome
Point-Prevalence Abstinence at End of Treatment
Time frame: 6 Month
% of targets (intent to treat sample) who are abstinent (self-report no smoking past 7 days + expired carbon monoxide (CO) <= 5 ppm
5 secondary outcomes
Point-Prevalence Abstinence After Treatment
Time frame: 1 year
Point-Prevalence Abstinence at First Follow-up
Time frame: 1 month
Point-Prevalence Abstinence at Second Follow-up
Time frame: 3 month
Partner Point-Prevalence Abstinence
Time frame: 1 Month, 3 Month, 6 Month, 1 Year
Smoking Heaviness
Time frame: 1 Month, 3 Month, 6 Month, 1 Year
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 29 Apr 2026.
- Background: PubMed 37742229vanDellen MR, Wright JWC, Zhao B, Cullinan C, Beach SRH, Shen Y, Haskins LB, Schiavone WM, MacKillop JM. Partner-Involved Financial Incentives for Smoking Cessation in Dual-Smoker Couples: A Randomized Pilot Trial. Nicotine Tob Res. 2024 Jan 22;26(2):229-236. doi: 10.1093/ntr/ntad183.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared including key study variables (predictors and outcomes) through Open Science Framework (OSF).
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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.
Michelle R vanDellen, PhD principal investigator
University of Oklahoma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Financial Incentive Treatment (FIT) in people with Smoking, Cigarette, run by University of Oklahoma at 2 sites 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 1 inclusion and 2 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 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Michelle R vanDellen, PhD (762-499-4263, Michelle-vanDellen@ou.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point-Prevalence Abstinence at End of Treatment (time frame: 6 Month). 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 NCT06296849, 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 29 Apr 2026.