Cervical CancerNCT02157610
Smoking Cessation for Cervical Cancer Survivors
A study testing Self-Help Materials, Nicotine Patch and REDCap in people with Cervical Cancer and Tobacco Use, run by H. Lee Moffitt Cancer Center and Research Institute at 3 sites in United States.
Trial summary
The goal of this research study is to compare a program called Motivation And Problem-Solving (MAPS) to the standard treatment to help participants with a history of cervical cancer or high-grade cervical dysplasia quit smoking. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Tobacco Use, Smoking Cessation
- What is being tested?
- Self-Help Materials, Nicotine Patch and REDCap
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2015to Aug 2021
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Self-reported current smoker
- History of cervical cancer or high-grade cervical dysplasia
- Has a working telephone number
- Has a valid home address
- Speaks English, Spanish or both languages
Who cannot join
- Current use of tobacco cessation medications
- Self-report of being pregnant or lactating
- Another household member enrolled in the study
- Contraindication for nicotine patch use
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, 73104
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: Smoking Cessation for Cervical Cancer Survivors in a Safety Net Healthcare System
The goal of this research study is to compare a program called Motivation And Problem-Solving (MAPS) to the standard treatment to help participants with a history of cervical cancer or high-grade cervical dysplasia quit smoking.
Read the detailed description
Study Groups:
If you agree to take part in this study, you will be randomly assigned to 1 of 2 possible study groups. Randomization means that you are put in a group by chance, like the flip of a coin. A computer program will make this random assignment.
- If you are in Group 1, you will receive free self-help materials, and a referral to the Quitline.
- If you are in Group 2, you will receive free self-help materials, a referral to the Quitline, and 6 telephone counseling sessions over the next year. The Quitline provides free quit smoking services to eligible callers.
No matter which group you are in, you will also receive a 12-week supply of nicotine replacement therapy. The strength of the nicotine patches and lozenges you receive will depend on how much you smoke each day. You should use the nicotine patch as directed by the package instructions.
Unused and used patches have enough nicotine to poison children and pets. Be sure to fold the sticky ends together when you are done using the patch. In case of accidental overdose, call your doctor or a poison control center right away.
Even if you do not wish to use the nicotine patch, you will still be allowed to take part in the study.
Study Questionnaires:
You will be asked to complete questionnaires over the phone 5 times:
- Baseline
- Month 3
- Month 6
- Month 12
- Month 18
You will be asked about your feelings, moods, cervical cancer or dysplasia diagnosis, and smoking status. These calls should take about 45 minutes each time to complete.
Saliva Testing:
At Months 3, 6, 12 and 18, you may also be asked to provide a saliva sample to test for cotinine to confirm your smoking status. Cotinine is a chemical released in your body when it breaks down nicotine. You will receive a kit in the mail with supplies for testing. The research staff will call you to make sure that you received the kit and to discuss the instructions with you. If you have any questions about how to use the kit, you may contact the study staff during the study.
To collect the saliva, you will put a small piece of cotton in your mouth for a few minutes. You will be asked to mail the saliva sample back to the research staff, using a prepaid return envelope. You may be contacted by mail, telephone, and/or email during the study to be given reminders to send back the kit.
Telephone Counseling:
If you are in Group 2, you will have 6 telephone counseling sessions that may last up to 30 minutes each. These calls will occur over a 12-month period at times that are convenient for you. During the calls, you will be asked about how motivated you are to quit smoking, what barriers to quitting you may have, and factors that may be related to your smoking such as stress and family issues.
These sessions will be digitally recorded. The recordings will be used to help the researchers make sure that the counselors are following the correct procedures and to help the investigators better understand or improve the counseling.
Length of the Study:
Your participation in the study will end when you complete the final questionnaire call at Month 18.
If you wish to leave the study early, you should tell the study staff that you want to stop taking part in this research study. Once you tell the study staff that you want to stop participating, you will not receive follow-up questionnaire phone calls.
This is an investigational study. The nicotine patch used in this study is FDA approved and commercially available.
Up to 455 participants overall will take part in this research study.
In-Depth Interviews:
If you agree to take part in this study, you be asked to complete a questionnaire and will participate in an in-depth interview.
Demographic and Smoking History Questionnaire:
At the time of your visit you will be asked to complete a questionnaire in efforts to collect demographic and smoking history information. You may refuse to answer any question that makes you feel uncomfortable. The questionnaire may take up to 10 minutes to complete.
In-depth Interview:
You will be asked to discuss various parts of a new program designed to help women with cervical cancer quit smoking. You will be asked your thoughts on how important you think the program is, your feelings about it, and if you like it. The interview is designed to be done in a non-threatening, non-judgemental, and supportive way.
The interview should last about 2 hours.
In-depth interviews will be audio recorded and transcribed (written down).
Your participation in this study will be over when you complete the interview.
This is an investigational study.
Up to 30 women will take part in the interviews.
Up to 350 participants overall will take part in this research study. All will be enrolled at the Stephenson Cancer Center.
- Conditions
- Cervical Cancer, Tobacco Use, Smoking Cessation
- Being tested
- Self-Help Materials, Nicotine Patch, REDCap, Saliva Test, Telephone Counseling Sessions
- Keywords
- Cervical Cancer, Cervical Cancer Survivors, Smoking Cessation, Motivation And Problem-Solving, MAPS, Saliva test, Self help materials, Pamphlets, Texas Quitline, Nicotine patch, Questionnaires, Surveys, Telephone counseling sessions
- Medical subject headings
- Uterine Cervical Neoplasms, Tobacco Use, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Help MaterialsBehavioural
Also called Pamphlets
Participants receive free self-help materials mailed at baseline, 6, and 12 months. and a referral to the Oklahoma Quitline.
Nicotine PatchDrug
Participants receive a 12-week supply of nicotine patch. Nicotine patch regime based on participant's self-reported smoking rate. Participants who smoke >10 cigarettes/day receive 8 weeks of 21 mg, 2 week of 14 mg, and 2 week of 7 mg patches. Those who smoke <10 cigarettes/day receive 8 weeks of 14 mg and 4 weeks of 7 mg patches.
REDCapBehavioural
Also called Surveys
REDCap will be used to collect all questionnaires data over the phone. Questionnaires done at baseline to randomize, then at 3, 6, 12, and 18 months.
Saliva TestProcedure or surgery
Saliva test performed at 3, 6, 12, and 18 months.
Telephone Counseling SessionsBehavioural
6 telephone counseling sessions performed over 12 months. Sessions performed at baseline, 3, 6, 12, and 18 months. Sessions digitally recorded.
Nicotine lozengeDrug
Participants receive a 12-week supply of nicotine lozenges. All participants receive 12 weeks of 2mg lozenges.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment (ST) | Experimental | Participants receive free self-help materials mailed at baseline, 6, and 12 months. Participants receive a referral to the Oklahoma Quitline. Participants receive a 12-week supply of the nicotine patch and lozenge. Nicotine patch regime based on participant's self-reported smoking rate. REDCap will be used to collect all questionnaires data over the phone. Questionnaires done at baseline to randomize, then at 3, 6, 12, and 18 months. Saliva test performed at 3, 6, 12, and 18 months. Receives: Behavioral: Self-Help Materials; Drug: Nicotine Patch; Behavioral: REDCap; Procedure: Saliva Test; Drug: Nicotine lozenge |
| Motivation + Problem Solving (MAPS) | Experimental | Participants receive free self-help materials mailed at baseline, 6, and 12 months. Participants receive a referral to the Oklahoma Quitline.Participants receive a 12-week supply of the nicotine patch and lozenge. Nicotine patch regime based on participant's self-reported smoking rate. REDCap will be used to collect all questionnaires data over the phone. Questionnaires done at baseline to randomize, then at 3, 6, 12, and 18 months. Saliva test performed at 3, 6, 12, and 18 months. 6 telephone counseling sessions performed over 12 months. Sessions performed at baseline, 3, 6, 12, and 18 months. Sessions digitally recorded. Receives: Behavioral: Self-Help Materials; Drug: Nicotine Patch; Behavioral: REDCap; Procedure: Saliva Test; Behavioral: Telephone Counseling Sessions; Drug: Nicotine lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Smoking Abstinence
To test treatment effect at 18 months, logistic regression analysis conducted with abstinence as outcome variable, and treatment (a two-level categorical variable) as predictor, adjusting for covariates, specifically, factors used in the minimization procedures (race/ethnicity, language, age, education, income, cigarettes/day, cervical cancer stage, and time since diagnosis). A logit link and binomial variance function assumed for generalized linear mixed model (GLMM), regression and parameterize them with blocking on individual nested within treatment conditions. Treatment and time included, as well as their interaction, with adjustment for relevant covariates.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startJan 2015
- Primary completionAug 2021
- Study completionAug 2021
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 (2)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jennifer Vidrine, PHD, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157610
- Sponsor's protocol ID
- MCC-20134
- Other IDs
- R01CA172786, NCI-2015-00067, 2014-0204
- Status last verified
- Feb 2023
- First submitted
- 4 Jun 2014
- Last updated
- 20 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vidrine JI, Sutton SK, Wetter DW, Shih YT, Ramondetta LM, Elting LS, Walker JL, Smith KM, Frank-Pearce SG, Li Y, Jones SR, Kendzor DE, Simmons VN, Vidrine DJ. Efficacy of a Smoking Cessation Intervention for Survivors of Cervical Intraepithelial Neoplasia or Cervical Cancer: A Randomized Controlled Trial. J Clin Oncol. 2023 May 20;41(15):2779-2788. doi: 10.1200/JCO.22.01228. Epub 2023 Mar 15.
PubMed 36921237Jones SR, Vidrine DJ, Wetter DW, Shih YT, Sutton SK, Ramondetta LM, Elting LS, Walker JL, Smith KM, Frank-Pearce SG, Li Y, Simmons VN, Vidrine JI. Evaluation of the Efficacy of a Smoking Cessation Intervention for Cervical Cancer Survivors and Women With High-Grade Cervical Dysplasia: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Dec 30;10(12):e34502. doi: 10.2196/34502.
PubMed 34967755
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation for Cervical Cancer Survivors in a Safety Net Healthcare System
- ClinicalTrials.gov ID
- NCT02157610
- Acronym / sponsor ID
- MCC-20134
- Conditions
- Cervical Cancer, Tobacco Use, Smoking Cessation
- Keywords
- Cervical Cancer, Cervical Cancer Survivors, Smoking Cessation, Motivation And Problem-Solving, MAPS, Saliva test, Self help materials, Pamphlets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2015 (actual)
- Primary completion
- Aug 2021 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Posted 12 Apr 2023
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 compare a program called Motivation And Problem-Solving (MAPS) to the standard treatment to help participants with a history of cervical cancer or high-grade cervical dysplasia quit smoking.
Detailed description
Study Groups:
If you agree to take part in this study, you will be randomly assigned to 1 of 2 possible study groups. Randomization means that you are put in a group by chance, like the flip of a coin. A computer program will make this random assignment.
- If you are in Group 1, you will receive free self-help materials, and a referral to the Quitline.
- If you are in Group 2, you will receive free self-help materials, a referral to the Quitline, and 6 telephone counseling sessions over the next year. The Quitline provides free quit smoking services to eligible callers.
No matter which group you are in, you will also receive a 12-week supply of nicotine replacement therapy. The strength of the nicotine patches and lozenges you receive will depend on how much you smoke each day. You should use the nicotine patch as directed by the package instructions.
Unused and used patches have enough nicotine to poison children and pets. Be sure to fold the sticky ends together when you are done using the patch. In case of accidental overdose, call your doctor or a poison control center right away.
Even if you do not wish to use the nicotine patch, you will still be allowed to take part in the study.
Study Questionnaires:
You will be asked to complete questionnaires over the phone 5 times:
- Baseline
- Month 3
- Month 6
- Month 12
- Month 18
You will be asked about your feelings, moods, cervical cancer or dysplasia diagnosis, and smoking status. These calls should take about 45 minutes each time to complete.
Saliva Testing:
At Months 3, 6, 12 and 18, you may also be asked to provide a saliva sample to test for cotinine to confirm your smoking status. Cotinine is a chemical released in your body when it breaks down nicotine. You will receive a kit in the mail with supplies for testing. The research staff will call you to make sure that you received the kit and to discuss the instructions with you. If you have any questions about how to use the kit, you may contact the study staff during the study.
To collect the saliva, you will put a small piece of cotton in your mouth for a few minutes. You will be asked to mail the saliva sample back to the research staff, using a prepaid return envelope. You may be contacted by mail, telephone, and/or email during the study to be given reminders to send back the kit.
Telephone Counseling:
If you are in Group 2, you will have 6 telephone counseling sessions that may last up to 30 minutes each. These calls will occur over a 12-month period at times that are convenient for you. During the calls, you will be asked about how motivated you are to quit smoking, what barriers to quitting you may have, and factors that may be related to your smoking such as stress and family issues.
These sessions will be digitally recorded. The recordings will be used to help the researchers make sure that the counselors are following the correct procedures and to help the investigators better understand or improve the counseling.
Length of the Study:
Your participation in the study will end when you complete the final questionnaire call at Month 18.
If you wish to leave the study early, you should tell the study staff that you want to stop taking part in this research study. Once you tell the study staff that you want to stop participating, you will not receive follow-up questionnaire phone calls.
This is an investigational study. The nicotine patch used in this study is FDA approved and commercially available.
Up to 455 participants overall will take part in this research study.
In-Depth Interviews:
If you agree to take part in this study, you be asked to complete a questionnaire and will participate in an in-depth interview.
Demographic and Smoking History Questionnaire:
At the time of your visit you will be asked to complete a questionnaire in efforts to collect demographic and smoking history information. You may refuse to answer any question that makes you feel uncomfortable. The questionnaire may take up to 10 minutes to complete.
In-depth Interview:
You will be asked to discuss various parts of a new program designed to help women with cervical cancer quit smoking. You will be asked your thoughts on how important you think the program is, your feelings about it, and if you like it. The interview is designed to be done in a non-threatening, non-judgemental, and supportive way.
The interview should last about 2 hours.
In-depth interviews will be audio recorded and transcribed (written down).
Your participation in this study will be over when you complete the interview.
This is an investigational study.
Up to 30 women will take part in the interviews.
Up to 350 participants overall will take part in this research study. All will be enrolled at the Stephenson Cancer Center.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment (ST) | Experimental | Behavioral: Self-Help Materials, Drug: Nicotine Patch, Behavioral: REDCap, Procedure: Saliva Test, Drug: Nicotine lozengeParticipants receive free self-help materials mailed at baseline, 6, and 12 months. Participants receive a referral to the Oklahoma Quitline. Participants receive a 12-week supply of the nicotine patch and lozenge. Nicotine patch regime based on participant's self-reported smoking rate. REDCap will be used to collect all questionnaires data over the phone. Questionnaires done at baseline to randomize, then at 3, 6, 12, and 18 months. Saliva test performed at 3, 6, 12, and 18 months. |
| Motivation + Problem Solving (MAPS) | Experimental | Behavioral: Self-Help Materials, Drug: Nicotine Patch, Behavioral: REDCap, Procedure: Saliva Test, Behavioral: Telephone Counseling Sessions, Drug: Nicotine lozengeParticipants receive free self-help materials mailed at baseline, 6, and 12 months. Participants receive a referral to the Oklahoma Quitline.Participants receive a 12-week supply of the nicotine patch and lozenge. Nicotine patch regime based on participant's self-reported smoking rate. REDCap will be used to collect all questionnaires data over the phone. Questionnaires done at baseline to randomize, then at 3, 6, 12, and 18 months. Saliva test performed at 3, 6, 12, and 18 months. 6 telephone counseling sessions performed over 12 months. Sessions performed at baseline, 3, 6, 12, and 18 months. Sessions digitally recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- Self-reported current smoker
- History of cervical cancer or high-grade cervical dysplasia
- Has a working telephone number
- Has a valid home address
Key exclusion criteria (4 listed)
- Current use of tobacco cessation medications
- Self-report of being pregnant or lactating
- Another household member enrolled in the study
- Contraindication for nicotine patch use
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 |
|---|---|---|
| Self-Help MaterialsAlso: PamphletsParticipants receive free self-help materials mailed at baseline, 6, and 12 months. and a referral to the Oklahoma Quitline. | Behavioural | Motivation + Problem Solving (MAPS), Standard Treatment (ST) |
| Nicotine PatchParticipants receive a 12-week supply of nicotine patch. Nicotine patch regime based on participant's self-reported smoking rate. Participants who smoke >10 cigarettes/day receive 8 weeks of 21 mg, 2 week of 14 mg, and 2 week of 7 mg patches. Those who smoke <10 cigarettes/day receive 8 weeks of 14 mg and 4 weeks of 7 mg patches. | Drug | Motivation + Problem Solving (MAPS), Standard Treatment (ST) |
| REDCapAlso: SurveysREDCap will be used to collect all questionnaires data over the phone. Questionnaires done at baseline to randomize, then at 3, 6, 12, and 18 months. | Behavioural | Motivation + Problem Solving (MAPS), Standard Treatment (ST) |
| Saliva TestSaliva test performed at 3, 6, 12, and 18 months. | Procedure or surgery | Motivation + Problem Solving (MAPS), Standard Treatment (ST) |
| Telephone Counseling Sessions6 telephone counseling sessions performed over 12 months. Sessions performed at baseline, 3, 6, 12, and 18 months. Sessions digitally recorded. | Behavioural | Motivation + Problem Solving (MAPS) |
| Nicotine lozengeParticipants receive a 12-week supply of nicotine lozenges. All participants receive 12 weeks of 2mg lozenges. | Drug | Motivation + Problem Solving (MAPS), Standard Treatment (ST) |
Primary outcome
Percentage of Participants With Smoking Abstinence
Time frame: 18 months
To test treatment effect at 18 months, logistic regression analysis conducted with abstinence as outcome variable, and treatment (a two-level categorical variable) as predictor, adjusting for covariates, specifically, factors used in the minimization procedures (race/ethnicity, language, age, education, income, cigarettes/day, cervical cancer stage, and time since diagnosis). A logit link and binomial variance function assumed for generalized linear mixed model (GLMM), regression and parameterize them with blocking on individual nested within treatment conditions. Treatment and time included, as well as their interaction, with adjustment for relevant covariates.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36921237Vidrine JI, Sutton SK, Wetter DW, Shih YT, Ramondetta LM, Elting LS, Walker JL, Smith KM, Frank-Pearce SG, Li Y, Jones SR, Kendzor DE, Simmons VN, Vidrine DJ. Efficacy of a Smoking Cessation Intervention for Survivors of Cervical Intraepithelial Neoplasia or Cervical Cancer: A Randomized Controlled Trial. J Clin Oncol. 2023 May 20;41(15):2779-2788. doi: 10.1200/JCO.22.01228. Epub 2023 Mar 15.
- Background: PubMed 34967755Jones SR, Vidrine DJ, Wetter DW, Shih YT, Sutton SK, Ramondetta LM, Elting LS, Walker JL, Smith KM, Frank-Pearce SG, Li Y, Simmons VN, Vidrine JI. Evaluation of the Efficacy of a Smoking Cessation Intervention for Cervical Cancer Survivors and Women With High-Grade Cervical Dysplasia: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Dec 30;10(12):e34502. doi: 10.2196/34502.
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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.
Jennifer Vidrine, PHD principal investigator
H. Lee Moffitt Cancer Center and Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Help Materials, Nicotine Patch and REDCap in people with Cervical Cancer and Tobacco Use, run by H. Lee Moffitt Cancer Center and Research Institute at 3 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 6 inclusion and 4 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 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2023). 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?
Percentage of Participants With Smoking Abstinence (time frame: 18 months). 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 NCT02157610, which also lists 2 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 20 Jul 2023.