Smoking CessationEarly Phase 1NCT02942212
Health Literacy and Smoking Cessation in Low-SES Diverse Smokers - Project HALT II
A Early Phase 1 study testing Questionnaire, In-Depth Interviews and Breath Test in people with Smoking Cessation, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
In-Depth Interviews: The goal of this research study is to learn about ways to help people might have trouble understanding health information quit smoking. Pilot Study: The goal of this research study is to test 2 different approaches, Standard Treatment (ST) and Helping Adults with Health Literacy Trouble (HALT)… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Questionnaire, In-Depth Interviews and Breath Test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2018to 14 Dec 2018
- Phase
- Early Phase 1
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (IN-DEPTH INTERVIEWS - INCLUSION CRITERIA; 2-6)
- Age 25-65 years
- Current smoker (>/= 5 cigarettes/day for the last year)
- Limited or marginal HL (total score </=6 on the CHEW Questionnaire)
- Have a home address where information can be mailed and a working telephone
- English speaker
Show all 15Show fewer
- Currently attending Adult Basic Education (ABE) classes at Literacy Advance of Houston
- (PILOT STUDY - INCLUSION CRITERIA; 8-13)
- Age 25-65 years
- Current smoker (>/= 5 cigarettes/day for the last year; biochemically verified with expired carbon monoxide (CO) reading of >/=8 parts per million [ppm])
- Limited or marginal HL (total score </=6 on the CHEW Questionnaire)
- Motivated to quit smoking within the next 30 days
- Have a home address where information can be mailed and a working telephone
- English speaker
- Currently attending Adult Basic Education (ABE) classes at Literacy Advance of Houston
Who cannot join
- (IN-DEPTH INTERVIEWS - EXCLUSION CRITERIA; 2-5)
- Regular use of tobacco products other than cigarettes
- Current use of tobacco cessation medications
- Pregnancy or lactation
- Enrolled in another smoking cessation study/program
- (PILOT STUDY - EXCLUSION CRITERIA; 7-12)
Show all 12Show fewer
- Contraindication for nicotine patch
- Regular use of tobacco products other than cigarettes
- Current use of tobacco cessation medications
- Pregnancy or lactation
- A household member is enrolled in the study
- Enrolled in another smoking cessation study/program
Trial locations and contacts
1 site in 1 country.
About this study
In-Depth Interviews:
The goal of this research study is to learn about ways to help people might have trouble understanding health information quit smoking.
Pilot Study:
The goal of this research study is to test 2 different approaches, Standard Treatment (ST) and Helping Adults with Health Literacy Trouble (HALT) tailored treatment, for helping smokers who might have trouble understanding health information with quitting smoking.
Read the detailed description
In-Depth Interviews:
Study Visit:
If participant is eligible and agrees to take part, the following will occur at their visit:
Questionnaire:
Participant will complete a questionnaire on a computer that will include questions about their thoughts about smoking, their smoking history, their ability to understand health information, and basic questions about their age, education, and income. This may take up to 45 minutes to complete.
Individual In-Depth Interviews:
After completing the questionnaire, participant will take part in an individual, in-depth interview. As part of the interview, the study chair will ask participant about their smoking, any previous attempts at quitting, and what they would like to see included as part of a program to help smokers like them with quitting smoking.
The interview should last 30-45 minutes and will be audio-recorded. No identifying information will be included in recorded interviews (participant's name will not be used). Recordings will be transcribed (written down). Audio recordings will be permanently deleted within a year after the completion of data collection.
Length of Study Participation:
It may take up to 2 hours to complete this visit. Participation in this study will be over after participant completes the interview.
Pilot Study:
Baseline Visit:
If participant is eligible and agrees to take part in this study, the following will occur when they start the study (also called a baseline visit):
- Participant will complete a questionnaire on the computer that will include questions about their feelings, mood, health, thoughts about smoking, thoughts about quitting smoking, and their smoking history. It will also include questions about participant's age, education, and income. This may take up to 1 hour to complete.
- Participant will complete a breath test to help the research team learn about the amount of cigarette smoke they inhale. The breath test uses a disposable cardboard tube attached to a machine, and participant will be asked to blow a long, slow, steady breath into it.
- Participant will then be randomly assigned (as in the flip of a coin) into 1 of 2 study groups (explained below). This is done because no one knows if one study group is better, the same, or worse than the other group. There is an equal chance of being assigned to either group.
Study Groups:
If participant is in Group 1 (ST):
- Participant will receive a 6-week supply of nicotine patches and instructions on how to use them.
- Participant will receive brief advice to quit smoking.
- Participant will receive phone counseling for support in quitting smoking (5 sessions over the course of 6 weeks) with a counselor at the Texas Quitline, an organization that helps people quit smoking. Counseling is designed to help participant to improve their problem-solving and coping skills, and plan for quitting smoking. Calls are expected to last up to 45 minutes.
If participant is in Group 2 (HALT):
- Participant will receive a 6-week supply of nicotine patches and instructions on how to use them.
- Participant will receive brief advice to quit smoking.
- Participant will receive 5 individual, in-person counseling sessions for support in quitting smoking. Sessions are designed to help participant to improve their problem-solving and coping skills, overcome barriers to quitting smoking, and plan for quitting smoking. These sessions will take place at either of Literacy Advance's 2 main campuses over 6 weeks. Participant will attend sessions the week before they quit smoking, on the day that they quit, and 1, 2, and 4 weeks after quitting. Each of these sessions will last about 45 minutes.
Weekly In-Person Visits (Groups 1 and 2):
Participant will complete questionnaires in person and at Literacy Advance over 6 weeks (the week before they quit smoking, on the day that they quit, and 1, 2, and 4 weeks after quitting). These questionnaires will ask about participant's current smoking, motivation to quit smoking, confidence for quitting, stress, and emotions/mood. Participant will also complete a breath test to help researchers learn about the amount of cigarette smoke participant inhales. This should take about 30 minutes to complete.
3-Month In-Person Follow-Up Visit (Groups 1 and 2): Eight (8) weeks after the last counseling session (or 3 months after beginning the study), participant will attend an in-person, follow-up visit in which they will complete questionnaires and a breath test to help the researchers learn about the amount of cigarette smoke participant inhales. This should take about 30 minutes to complete.
Length of Study:
If participant does not quit smoking on their "Quit Day" (Week 0), they may continue participating in the study and may select another "Quit Day."
Participant will take part in the study for up to 3 months. Participation will be over when participant completes the study visit at Month 3.
This is an investigational study. The nicotine patch is FDA approved and commercially available.
Up to 50 participants will take part in this pilot study. Up to 80 participants overall will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Smoking Cessation
- Being tested
- Questionnaire, In-Depth Interviews, Breath Test, Nicotine Patches, Advice plus Phone Counseling
- Keywords
- Smoking Cessation, Nicotine patch, Nicoderm Committed Quitters, CQ, Nicoderm CQ, Questionnaires, Surveys, Interviews, Breath tests
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Participants complete a computerized questionnaire to assess demographics and smoking history.
In-Depth InterviewsBehavioural
Participants take part in individual in-depth interviews discussing smoking history, attempts to quit, and suggestions for smoking cessation program. The interview should last 30-45 minutes and is audio-recorded.
Breath TestOther
Participants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up.
Nicotine PatchesDrug
Also called Nicoderm Committed Quitters (CQ), Nicoderm CQ
Participants receive a 6-week supply of nicotine patches and instructions on how to use them. Patch therapy for participants who smoke >10 cigarettes/day consists of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day consists of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
Advice plus Phone CounselingBehavioural
Participants receive brief advice to quit smoking, as well as phone counseling for support in quitting smoking (5 sessions over the course of 6 weeks) with a counselor at the Texas Quitline.
Advice plus Counseling SessionsBehavioural
Participants receive brief advice to quit smoking, as well as 5 individual, in-person smoking cessation treatment counseling sessions.
Self Assessment QuestionnairesBehavioural
Also called Surveys
Participants complete self assessment questionnaires the week before quitting smoking, the day that they quit, and 1, 2, and 4 weeks after quitting, and at 3 month follow up.
| Study group | Role | What they receive |
|---|---|---|
| Project HALT II: In-Depth Interviews | Experimental | Participants complete a computerized questionnaire to assess demographics and smoking history.
Participants take part in individual in-depth interviews discussing smoking history, attempts to quit, and suggestions for smoking cessation program. Receives: Behavioral: Questionnaire; Behavioral: In-Depth Interviews |
| Project HALT II: Standard Treatment (ST) | Active comparator | Participants complete a computerized questionnaire to assess demographics and smoking history at baseline.
Participants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up.
Participants receive a 6-week supply of nicotine patches and instructions on how to use them. Participants receive brief advice to quit smoking. Participants receive phone counseling for support in quitting smoking (5 sessions over the course of 6 weeks) with a counselor at the Texas Quitline.
Participants complete self assessment questionnaires the week before quitting smoking, the day that they quit, and 1, 2, and 4 weeks after quitting, and at 3 month follow up. Receives: Behavioral: Questionnaire; Other: Breath Test; Drug: Nicotine Patches; Behavioral: Advice plus Phone Counseling; Behavioral: Self Assessment Questionnaires |
| Project HALT II: Tailored Treatment (HALT) | Experimental | Participants complete a computerized questionnaire to assess demographics and smoking history at baseline.
Participants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up.
Participants receive a 6-week supply of nicotine patches and instructions on how to use them. Participants receive brief advice to quit smoking. Participants scheduled to attend 5 individual, in-person smoking cessation treatment counseling sessions.
Participants complete self assessment questionnaires the week before quitting smoking, the day that they quit, and 1, 2, and 4 weeks after quitting, and at 3 month follow up. Receives: Behavioral: Questionnaire; Other: Breath Test; Drug: Nicotine Patches; Behavioral: Advice plus Counseling Sessions; Behavioral: Self Assessment Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Helping Adults with Health Literacy Trouble (HALT) versus Standard Treatment (ST) in Facilitating Abstinence from Smoking in Low Health Literacy (HL) Smokers
Efficacy defined as the proportion of participants who successfully quit smoking.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start14 Dec 2018
- Primary completion14 Dec 2018
- Study completion14 Dec 2018
Why it stopped: No activties have occurred and no participants have enrolled in this protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana S. Hoover, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942212
- Sponsor's protocol ID
- 2016-0267
- Other IDs
- NCI-2018-02698
- Status last verified
- Apr 2019
- First submitted
- 20 Oct 2016
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Literacy and Smoking Cessation in Low-SES Diverse Smokers - Project HALT II
- ClinicalTrials.gov ID
- NCT02942212
- Acronym / sponsor ID
- 2016-0267
- Conditions
- Smoking Cessation
- Keywords
- Smoking Cessation, Nicotine patch, Nicoderm Committed Quitters, CQ, Nicoderm CQ, Questionnaires, Surveys, Interviews
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No activties have occurred and no participants have enrolled in this protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 24 Oct 2016 (estimated)
- 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.
In-Depth Interviews:
The goal of this research study is to learn about ways to help people might have trouble understanding health information quit smoking.
Pilot Study:
The goal of this research study is to test 2 different approaches, Standard Treatment (ST) and Helping Adults with Health Literacy Trouble (HALT) tailored treatment, for helping smokers who might have trouble understanding health information with quitting smoking.
Detailed description
In-Depth Interviews:
Study Visit:
If participant is eligible and agrees to take part, the following will occur at their visit:
Questionnaire:
Participant will complete a questionnaire on a computer that will include questions about their thoughts about smoking, their smoking history, their ability to understand health information, and basic questions about their age, education, and income. This may take up to 45 minutes to complete.
Individual In-Depth Interviews:
After completing the questionnaire, participant will take part in an individual, in-depth interview. As part of the interview, the study chair will ask participant about their smoking, any previous attempts at quitting, and what they would like to see included as part of a program to help smokers like them with quitting smoking.
The interview should last 30-45 minutes and will be audio-recorded. No identifying information will be included in recorded interviews (participant's name will not be used). Recordings will be transcribed (written down). Audio recordings will be permanently deleted within a year after the completion of data collection.
Length of Study Participation:
It may take up to 2 hours to complete this visit. Participation in this study will be over after participant completes the interview.
Pilot Study:
Baseline Visit:
If participant is eligible and agrees to take part in this study, the following will occur when they start the study (also called a baseline visit):
- Participant will complete a questionnaire on the computer that will include questions about their feelings, mood, health, thoughts about smoking, thoughts about quitting smoking, and their smoking history. It will also include questions about participant's age, education, and income. This may take up to 1 hour to complete.
- Participant will complete a breath test to help the research team learn about the amount of cigarette smoke they inhale. The breath test uses a disposable cardboard tube attached to a machine, and participant will be asked to blow a long, slow, steady breath into it.
- Participant will then be randomly assigned (as in the flip of a coin) into 1 of 2 study groups (explained below). This is done because no one knows if one study group is better, the same, or worse than the other group. There is an equal chance of being assigned to either group.
Study Groups:
If participant is in Group 1 (ST):
- Participant will receive a 6-week supply of nicotine patches and instructions on how to use them.
- Participant will receive brief advice to quit smoking.
- Participant will receive phone counseling for support in quitting smoking (5 sessions over the course of 6 weeks) with a counselor at the Texas Quitline, an organization that helps people quit smoking. Counseling is designed to help participant to improve their problem-solving and coping skills, and plan for quitting smoking. Calls are expected to last up to 45 minutes.
If participant is in Group 2 (HALT):
- Participant will receive a 6-week supply of nicotine patches and instructions on how to use them.
- Participant will receive brief advice to quit smoking.
- Participant will receive 5 individual, in-person counseling sessions for support in quitting smoking. Sessions are designed to help participant to improve their problem-solving and coping skills, overcome barriers to quitting smoking, and plan for quitting smoking. These sessions will take place at either of Literacy Advance's 2 main campuses over 6 weeks. Participant will attend sessions the week before they quit smoking, on the day that they quit, and 1, 2, and 4 weeks after quitting. Each of these sessions will last about 45 minutes.
Weekly In-Person Visits (Groups 1 and 2):
Participant will complete questionnaires in person and at Literacy Advance over 6 weeks (the week before they quit smoking, on the day that they quit, and 1, 2, and 4 weeks after quitting). These questionnaires will ask about participant's current smoking, motivation to quit smoking, confidence for quitting, stress, and emotions/mood. Participant will also complete a breath test to help researchers learn about the amount of cigarette smoke participant inhales. This should take about 30 minutes to complete.
3-Month In-Person Follow-Up Visit (Groups 1 and 2): Eight (8) weeks after the last counseling session (or 3 months after beginning the study), participant will attend an in-person, follow-up visit in which they will complete questionnaires and a breath test to help the researchers learn about the amount of cigarette smoke participant inhales. This should take about 30 minutes to complete.
Length of Study:
If participant does not quit smoking on their "Quit Day" (Week 0), they may continue participating in the study and may select another "Quit Day."
Participant will take part in the study for up to 3 months. Participation will be over when participant completes the study visit at Month 3.
This is an investigational study. The nicotine patch is FDA approved and commercially available.
Up to 50 participants will take part in this pilot study. Up to 80 participants overall will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Project HALT II: In-Depth Interviews | Experimental | Behavioral: Questionnaire, Behavioral: In-Depth InterviewsParticipants complete a computerized questionnaire to assess demographics and smoking history. Participants take part in individual in-depth interviews discussing smoking history, attempts to quit, and suggestions for smoking cessation program. |
| Project HALT II: Standard Treatment (ST) | Active comparator | Behavioral: Questionnaire, Other: Breath Test, Drug: Nicotine Patches, Behavioral: Advice plus Phone Counseling, Behavioral: Self Assessment QuestionnairesParticipants complete a computerized questionnaire to assess demographics and smoking history at baseline. Participants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up. Participants receive a 6-week supply of nicotine patches and instructions on how to use them. Participants receive brief advice to quit smoking. Participants receive phone counseling for support in quitting smoking (5 sessions over the course of 6 weeks) with a counselor at the Texas Quitline. Participants complete self assessment questionnaires the week before quitting smoking, the day that they quit, and 1, 2, and 4 weeks after quitting, and at 3 month follow up. |
| Project HALT II: Tailored Treatment (HALT) | Experimental | Behavioral: Questionnaire, Other: Breath Test, Drug: Nicotine Patches, Behavioral: Advice plus Counseling Sessions, Behavioral: Self Assessment QuestionnairesParticipants complete a computerized questionnaire to assess demographics and smoking history at baseline. Participants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up. Participants receive a 6-week supply of nicotine patches and instructions on how to use them. Participants receive brief advice to quit smoking. Participants scheduled to attend 5 individual, in-person smoking cessation treatment counseling sessions. Participants complete self assessment questionnaires the week before quitting smoking, the day that they quit, and 1, 2, and 4 weeks after quitting, and at 3 month follow up. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- (IN-DEPTH INTERVIEWS - INCLUSION CRITERIA; 2-6)
- Age 25-65 years
- Current smoker (>/= 5 cigarettes/day for the last year)
- Limited or marginal HL (total score </=6 on the CHEW Questionnaire)
- Have a home address where information can be mailed and a working telephone
Key exclusion criteria (12 listed)
- (IN-DEPTH INTERVIEWS - EXCLUSION CRITERIA; 2-5)
- Regular use of tobacco products other than cigarettes
- Current use of tobacco cessation medications
- Pregnancy or lactation
- Enrolled in another smoking cessation study/program
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 |
|---|---|---|
| QuestionnaireAlso: SurveyParticipants complete a computerized questionnaire to assess demographics and smoking history. | Behavioural | Project HALT II: In-Depth Interviews, Project HALT II: Standard Treatment (ST), Project HALT II: Tailored Treatment (HALT) |
| In-Depth InterviewsParticipants take part in individual in-depth interviews discussing smoking history, attempts to quit, and suggestions for smoking cessation program. The interview should last 30-45 minutes and is audio-recorded. | Behavioural | Project HALT II: In-Depth Interviews |
| Breath TestParticipants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up. | Other | Project HALT II: Standard Treatment (ST), Project HALT II: Tailored Treatment (HALT) |
| Nicotine PatchesAlso: Nicoderm Committed Quitters (CQ), Nicoderm CQParticipants receive a 6-week supply of nicotine patches and instructions on how to use them. Patch therapy for participants who smoke >10 cigarettes/day consists of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day consists of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches. | Drug | Project HALT II: Standard Treatment (ST), Project HALT II: Tailored Treatment (HALT) |
| Advice plus Phone CounselingParticipants receive brief advice to quit smoking, as well as phone counseling for support in quitting smoking (5 sessions over the course of 6 weeks) with a counselor at the Texas Quitline. | Behavioural | Project HALT II: Standard Treatment (ST) |
| Advice plus Counseling SessionsParticipants receive brief advice to quit smoking, as well as 5 individual, in-person smoking cessation treatment counseling sessions. | Behavioural | Project HALT II: Tailored Treatment (HALT) |
| Self Assessment QuestionnairesAlso: SurveysParticipants complete self assessment questionnaires the week before quitting smoking, the day that they quit, and 1, 2, and 4 weeks after quitting, and at 3 month follow up. | Behavioural | Project HALT II: Standard Treatment (ST), Project HALT II: Tailored Treatment (HALT) |
Primary outcome
Efficacy of Helping Adults with Health Literacy Trouble (HALT) versus Standard Treatment (ST) in Facilitating Abstinence from Smoking in Low Health Literacy (HL) Smokers
Time frame: 3 months
Efficacy defined as the proportion of participants who successfully quit smoking.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 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.
Diana S. Hoover, 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 Early Phase 1 study testing Questionnaire, In-Depth Interviews and Breath Test in people with Smoking Cessation, 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 15 inclusion and 12 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: withdrawn, as of the sponsor's last update on 1 May 2019. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Efficacy of Helping Adults with Health Literacy Trouble (HALT) versus Standard Treatment (ST) in Facilitating Abstinence from Smoking in Low Health Literacy (HL) Smokers (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2019.