Tobacco Use CessationPhase 1/2NCT02596711
Project Impact 2: A Culturally Tailored Smoking Cessation Intervention for Latino Smokers
A Phase 1/2 study testing Nicotine Patch, Questionnaires and Carbon Monoxide (CO) Test in people with Tobacco Use Cessation and Cancer Prevention, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn how 3 different kinds of counseling treatments may help individuals to quit smoking. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation, Cancer Prevention
- What is being tested?
- Nicotine Patch, Questionnaires and Carbon Monoxide (CO) Test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2015to 22 Aug 2017
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults at least 18 years of age
- Current smoker (>5 cigarettes per day for the past 3 months)
- Able to speak and read English or Spanish
- Agree to participate in the study and be available for 6 weeks of treatment and 6 months of follow-up
- Willing to set a quit date within 2 weeks of enrollment date
- Identify as being of Latino heritage, ethnicity, or ancestry
Who cannot join
- Individuals suffering from any unstable medical condition precluding the use of NRT (Identified using the Medical History Questionnaire given at baseline)
- Currently using smokeless tobacco, electronic nicotine delivery systems (ENDS), nicotine replacement therapy, or other smoking cessation treatment
- Pregnant or nursing
- Suffering from a severe psychiatric disorder (assessed using self-reporting history of psychiatric diagnosis during the phone screening) that would interfere with participation
- Diagnosis of substance dependence other than nicotine (screened using DSM IV TR criteria) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition
- Individuals that do not have access to a working telephone
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this research study is to learn how 3 different kinds of counseling treatments may help individuals to quit smoking.
Read the detailed description
Baseline Visit:
If you agree to take part in this study, the following tests and procedures will be performed at the beginning of the study:
- You will complete 10 questionnaires about your demographics (age, race, sex, and so on), medical history, smoking status, alcohol use, religion, how "in control" you feel of your own life, and cultural background. These should take about 1½ hours to complete.
- You will complete a carbon monoxide (CO) test to measure the level of carbon monoxide in your body. This test involves blowing your breath through a hand-held device.
- You will learn how to keep a diary about your progress in your attempts to quit smoking. °You must bring this diary with you to every visit.
- You will be asked if you have smoked any non-tobacco substances in the last 2 days. If you have, you will provide an additional CO sample 2 days after the last time you smoked the substance.
- If you can become pregnant, you will have a urine pregnancy test. To take part in this study, you must not be pregnant.3
- The total length of the baseline visit will be approximately 2.5 hours.
Study Groups:
You will be randomly assigned (as in the roll of dice) into 1 of 3 study groups. You will have an equal chance of being in each group. This is done because no one knows if one study group is better, the same, or worse than the other group.
Counseling Sessions:
The study group that you are in will determine the way that health information is presented to you in one-on-one counseling sessions.
- If you are in Group 1, you will receive general health education. The counselor will discuss a health topic (such as sleep, nutrition, and exercise) and how it relates to you and your smoking. The counselor will also give you handouts about the health topic.
- If you are in Group 2, you and the counselor will discuss how your smoking and your culture may relate to each other. The counselor will also provide you with reading materials that highlight how aspects of your culture relate to health, smoking and quitting.
- If you are in Group 3, you will receive the same cultural counseling and handouts that Group 2 received. Also, you will have additional talks about the use of drugs to help you stop smoking and some common feelings that Latinos may experience with being unsuccessful when trying to quit. The counselor will also offer you a plan for using medication successfully.
All participants will attend 3 counseling sessions during the study. Each of these counseling sessions will be audio recorded. Your first counseling session will be at baseline. The other two counseling sessions will be at your Week 2 and Week 6 visits (described below).
All participants will be given a 12 week supply of nicotine patches and information about how to use the nicotine patch. At each study visit, you will be given the amount of patches that you need to last you to your next visit, plus a few extra in the event that a patch falls off or is damaged.
During your first counseling session, you will be asked to choose a quit date. This is simply a date that you would like to begin using the patch and make an attempt to not smoke.
Week 2 and Week 6 Study Visits:
At each of these study visits, all participants will have the following procedures:
- You will complete a brief interview about your progress and any side effects you may be having. This should take about 10 minutes to complete.
- You will complete 2 questionnaires about your tobacco use and satisfaction with the study. These should take about 10 minutes to complete.
- You will complete a CO test.
- You will be asked if you have smoked any other substances, such as marijuana, in the last 2 days. If you have, you will provide an additional CO sample 2 days after the last time you smoked the substance.
Follow-Up Visits:
About 3 months and 6 months after baseline, you will have a follow-up visit. At each of these visits, the following tests and procedures will be performed:
- You will complete the same set of questionnaires about your tobacco and alcohol use, culture, religion, and sense of control that you did at your baseline visit.
- You will complete a CO test.
- You will be asked if you have smoked any non-tobacco substances in the last 2 days. If you have, you will provide an additional CO sample 2 days after the last time you smoked the substance.
Length of Study:
Your study participation will be over after you complete the 6-month follow-up visit.
This is an investigational study. Up to 36 people will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Tobacco Use Cessation, Cancer Prevention
- Being tested
- Nicotine Patch, Questionnaires, Carbon Monoxide (CO) Test, Health Education and Handouts, Culturally Tailored Reading Materials
- Keywords
- Cancer Prevention, Tobacco Use Cessation, Nicotine Patch, NRT, Questionnaires, Surveys, Carbon Monoxide Test, CO, Health Education, Handouts, Pamphlets, Counseling sessions
- Medical subject headings
- Tobacco Use Cessation, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine PatchDrug
Also called NRT
Participants receive 4 weeks of 21 mg, 4 weeks of 14 mg, and 4 weeks of 7 mg patches.
QuestionnairesBehavioural
Also called Surveys
Questionnaires regarding tobacco and alcohol use, culture, religion, and sense of control completed at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline.
Carbon Monoxide (CO) TestOther
Carbon monoxide (CO) test given at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline.
Health Education and HandoutsBehavioural
Also called Pamphlets
Participants receive general health education and handouts.
Culturally Tailored Reading MaterialsBehavioural
Also called Pamphlets
Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting.
Counseling SessionsBehavioural
Participants attend 3 counseling sessions during the study.
| Study group | Role | What they receive |
|---|---|---|
| Health Education (HE) Group | Experimental | Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT). Receives: Drug: Nicotine Patch; Behavioral: Questionnaires; Other: Carbon Monoxide (CO) Test; Behavioral: Health Education and Handouts; Behavioral: Counseling Sessions |
| Culturally Tailored Smoking Cessation (CTSC) Group | Experimental | Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT). Receives: Drug: Nicotine Patch; Behavioral: Questionnaires; Other: Carbon Monoxide (CO) Test; Behavioral: Culturally Tailored Reading Materials; Behavioral: Counseling Sessions |
| Culturally Tailored Smoking + Adherence Enhancement (AE) Group | Experimental | Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT). Receives: Drug: Nicotine Patch; Behavioral: Questionnaires; Other: Carbon Monoxide (CO) Test; Behavioral: Culturally Tailored Reading Materials; Behavioral: Counseling Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility & Acceptability
The central aim of this pilot study was to evaluate the feasibility and acceptability of our treatment interventions. As such, we examined between-group differences on session satisfaction. After completing each session, participants anonymously rated their level of satisfaction with the counseling session. This investigator created scale (Session Satisfaction Scale) used a 5-point Likert scale (from 1 = "Extremely Unsatisfied" to 5 = "Extremely Satisfied"). Mean satisfaction scores were computed for each participant as the average of all session satisfaction scores. Higher scores indicating greater levels of satisfaction. Treatment group session satisfaction group means were tabulated by group (calculated as the average for all participants in each treatment group) and used as a proxy measure of overall intervention acceptability and feasibility.
Measured: Averaged across 3 study visits (Week 0 to Week 12)
Patch Adherence: Percentage of Days With Patch
Adherence to NRT patch (days of NRT patch use) collected with the Timeline followback interview procedure.
Measured: This outcome was collected at each study timepoint and measured the 12 weeks of NRT patch treatment.
Number of Abstinent Participants
Rates of biochemically verified 7-day point prevalence smoking abstinence. Collected with the Timeline Follow-back interview procedure and verified with a expired carbon monoxide testing with a Bedfont Smokelyzer monitor.
Measured: Collected at the 3- and 6-month follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study start2 Nov 2015
- Primary completion22 Aug 2017
- Study completion22 Aug 2017
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 Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Marcel A. de Dios, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596711
- Sponsor's protocol ID
- 2015-0585
- Other IDs
- K01CA160670, NCI-2016-00193
- Status last verified
- Mar 2020
- First submitted
- 2 Nov 2015
- Last updated
- 10 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
de Dios MA, Cano MA, Vaughan EL, Childress SD, McNeel MM, Harvey LM, Niaura RS. A pilot randomized trial examining the feasibility and acceptability of a culturally tailored and adherence-enhancing intervention for Latino smokers in the U.S. PLoS One. 2019 Jan 11;14(1):e0210323. doi: 10.1371/journal.pone.0210323. eCollection 2019.
PubMed 30633744
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Impact 2: A Culturally Tailored Smoking Cessation Intervention for Latino Smokers
- ClinicalTrials.gov ID
- NCT02596711
- Acronym / sponsor ID
- 2015-0585
- Conditions
- Tobacco Use Cessation, Cancer Prevention
- Keywords
- Cancer Prevention, Tobacco Use Cessation, Nicotine Patch, NRT, Questionnaires, Surveys, Carbon Monoxide Test, CO
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Nov 2015 (actual)
- Primary completion
- 22 Aug 2017 (actual)
- Study completion
- 22 Aug 2017 (actual)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Posted 10 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research study is to learn how 3 different kinds of counseling treatments may help individuals to quit smoking.
Detailed description
Baseline Visit:
If you agree to take part in this study, the following tests and procedures will be performed at the beginning of the study:
- You will complete 10 questionnaires about your demographics (age, race, sex, and so on), medical history, smoking status, alcohol use, religion, how "in control" you feel of your own life, and cultural background. These should take about 1½ hours to complete.
- You will complete a carbon monoxide (CO) test to measure the level of carbon monoxide in your body. This test involves blowing your breath through a hand-held device.
- You will learn how to keep a diary about your progress in your attempts to quit smoking. °You must bring this diary with you to every visit.
- You will be asked if you have smoked any non-tobacco substances in the last 2 days. If you have, you will provide an additional CO sample 2 days after the last time you smoked the substance.
- If you can become pregnant, you will have a urine pregnancy test. To take part in this study, you must not be pregnant.3
- The total length of the baseline visit will be approximately 2.5 hours.
Study Groups:
You will be randomly assigned (as in the roll of dice) into 1 of 3 study groups. You will have an equal chance of being in each group. This is done because no one knows if one study group is better, the same, or worse than the other group.
Counseling Sessions:
The study group that you are in will determine the way that health information is presented to you in one-on-one counseling sessions.
- If you are in Group 1, you will receive general health education. The counselor will discuss a health topic (such as sleep, nutrition, and exercise) and how it relates to you and your smoking. The counselor will also give you handouts about the health topic.
- If you are in Group 2, you and the counselor will discuss how your smoking and your culture may relate to each other. The counselor will also provide you with reading materials that highlight how aspects of your culture relate to health, smoking and quitting.
- If you are in Group 3, you will receive the same cultural counseling and handouts that Group 2 received. Also, you will have additional talks about the use of drugs to help you stop smoking and some common feelings that Latinos may experience with being unsuccessful when trying to quit. The counselor will also offer you a plan for using medication successfully.
All participants will attend 3 counseling sessions during the study. Each of these counseling sessions will be audio recorded. Your first counseling session will be at baseline. The other two counseling sessions will be at your Week 2 and Week 6 visits (described below).
All participants will be given a 12 week supply of nicotine patches and information about how to use the nicotine patch. At each study visit, you will be given the amount of patches that you need to last you to your next visit, plus a few extra in the event that a patch falls off or is damaged.
During your first counseling session, you will be asked to choose a quit date. This is simply a date that you would like to begin using the patch and make an attempt to not smoke.
Week 2 and Week 6 Study Visits:
At each of these study visits, all participants will have the following procedures:
- You will complete a brief interview about your progress and any side effects you may be having. This should take about 10 minutes to complete.
- You will complete 2 questionnaires about your tobacco use and satisfaction with the study. These should take about 10 minutes to complete.
- You will complete a CO test.
- You will be asked if you have smoked any other substances, such as marijuana, in the last 2 days. If you have, you will provide an additional CO sample 2 days after the last time you smoked the substance.
Follow-Up Visits:
About 3 months and 6 months after baseline, you will have a follow-up visit. At each of these visits, the following tests and procedures will be performed:
- You will complete the same set of questionnaires about your tobacco and alcohol use, culture, religion, and sense of control that you did at your baseline visit.
- You will complete a CO test.
- You will be asked if you have smoked any non-tobacco substances in the last 2 days. If you have, you will provide an additional CO sample 2 days after the last time you smoked the substance.
Length of Study:
Your study participation will be over after you complete the 6-month follow-up visit.
This is an investigational study. Up to 36 people will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Health Education (HE) Group | Experimental | Drug: Nicotine Patch, Behavioral: Questionnaires, Other: Carbon Monoxide (CO) Test, Behavioral: Health Education and Handouts, Behavioral: Counseling SessionsParticipants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT). |
| Culturally Tailored Smoking Cessation (CTSC) Group | Experimental | Drug: Nicotine Patch, Behavioral: Questionnaires, Other: Carbon Monoxide (CO) Test, Behavioral: Culturally Tailored Reading Materials, Behavioral: Counseling SessionsParticipants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT). |
| Culturally Tailored Smoking + Adherence Enhancement (AE) Group | Experimental | Drug: Nicotine Patch, Behavioral: Questionnaires, Other: Carbon Monoxide (CO) Test, Behavioral: Culturally Tailored Reading Materials, Behavioral: Counseling SessionsParticipants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults at least 18 years of age
- Current smoker (>5 cigarettes per day for the past 3 months)
- Able to speak and read English or Spanish
- Agree to participate in the study and be available for 6 weeks of treatment and 6 months of follow-up
- Willing to set a quit date within 2 weeks of enrollment date
Key exclusion criteria (6 listed)
- Individuals suffering from any unstable medical condition precluding the use of NRT (Identified using the Medical History Questionnaire given at baseline)
- Currently using smokeless tobacco, electronic nicotine delivery systems (ENDS), nicotine replacement therapy, or other smoking cessation treatment
- Pregnant or nursing
- Suffering from a severe psychiatric disorder (assessed using self-reporting history of psychiatric diagnosis during the phone screening) that would interfere with participation
- Diagnosis of substance dependence other than nicotine (screened using DSM IV TR criteria) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition
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: NRTParticipants receive 4 weeks of 21 mg, 4 weeks of 14 mg, and 4 weeks of 7 mg patches. | Drug | Culturally Tailored Smoking + Adherence Enhancement (AE) Group, Culturally Tailored Smoking Cessation (CTSC) Group, Health Education (HE) Group |
| QuestionnairesAlso: SurveysQuestionnaires regarding tobacco and alcohol use, culture, religion, and sense of control completed at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline. | Behavioural | Culturally Tailored Smoking + Adherence Enhancement (AE) Group, Culturally Tailored Smoking Cessation (CTSC) Group, Health Education (HE) Group |
| Carbon Monoxide (CO) TestCarbon monoxide (CO) test given at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline. | Other | Culturally Tailored Smoking + Adherence Enhancement (AE) Group, Culturally Tailored Smoking Cessation (CTSC) Group, Health Education (HE) Group |
| Health Education and HandoutsAlso: PamphletsParticipants receive general health education and handouts. | Behavioural | Health Education (HE) Group |
| Culturally Tailored Reading MaterialsAlso: PamphletsParticipants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. | Behavioural | Culturally Tailored Smoking + Adherence Enhancement (AE) Group, Culturally Tailored Smoking Cessation (CTSC) Group |
| Counseling SessionsParticipants attend 3 counseling sessions during the study. | Behavioural | Culturally Tailored Smoking + Adherence Enhancement (AE) Group, Culturally Tailored Smoking Cessation (CTSC) Group, Health Education (HE) Group |
Primary outcome
Intervention Feasibility & Acceptability
Time frame: Averaged across 3 study visits (Week 0 to Week 12)
The central aim of this pilot study was to evaluate the feasibility and acceptability of our treatment interventions. As such, we examined between-group differences on session satisfaction. After completing each session, participants anonymously rated their level of satisfaction with the counseling session. This investigator created scale (Session Satisfaction Scale) used a 5-point Likert scale (from 1 = "Extremely Unsatisfied" to 5 = "Extremely Satisfied"). Mean satisfaction scores were computed for each participant as the average of all session satisfaction scores. Higher scores indicating greater levels of satisfaction. Treatment group session satisfaction group means were tabulated by group (calculated as the average for all participants in each treatment group) and used as a proxy measure of overall intervention acceptability and feasibility.
Patch Adherence: Percentage of Days With Patch
Time frame: This outcome was collected at each study timepoint and measured the 12 weeks of NRT patch treatment.
Adherence to NRT patch (days of NRT patch use) collected with the Timeline followback interview procedure.
Number of Abstinent Participants
Time frame: Collected at the 3- and 6-month follow-up visits
Rates of biochemically verified 7-day point prevalence smoking abstinence. Collected with the Timeline Follow-back interview procedure and verified with a expired carbon monoxide testing with a Bedfont Smokelyzer monitor.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30633744de Dios MA, Cano MA, Vaughan EL, Childress SD, McNeel MM, Harvey LM, Niaura RS. A pilot randomized trial examining the feasibility and acceptability of a culturally tailored and adherence-enhancing intervention for Latino smokers in the U.S. PLoS One. 2019 Jan 11;14(1):e0210323. doi: 10.1371/journal.pone.0210323. eCollection 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Marcel A. de Dios, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nicotine Patch, Questionnaires and Carbon Monoxide (CO) Test in people with Tobacco Use Cessation and Cancer Prevention, run by M.D. Anderson Cancer Center 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 6 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 Mar 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 10 Mar 2020). 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?
Intervention Feasibility & Acceptability (time frame: Averaged across 3 study visits (Week 0 to Week 12)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02596711, 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 Mar 2020.