Smoking CessationNCT02906787
Behavioral Activation for Smoking Cessation and the Prevention of Post-Cessation Weight Gain
A study testing BAS+ and SC in people with Smoking Cessation and Weight Loss, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
The purpose of this research study is to better understand (1) why people gain weight when they quit smoking and (2) whether certain types of smoking cessation (i.e. quit smoking) counseling combined with the nicotine patch help people quit smoking and gain less weight. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Cessation, Weight Loss
- What is being tested?
- BAS+ and SC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2016to 28 Feb 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female treatment-seeking smokers who are between 18 and 65 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months.
- Plan to live in the area for the duration of the study (i.e. ~30 weeks/8 months).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
- Smokers who wish to make a permanent quit attempt in the next 1-2 months (treatment-seeking), because our prior work suggests that motivated subjects are more sensitive to medication effects on smoking behavior.
- Able to communicate fluently in English (i.e. speaking, writing, and reading).
- Provide a Carbon Monoxide (CO) breath test reading greater than or equal to 5 parts per million (ppm) at the Intake Visit.
Who cannot join
- Smoking Behavior.
- Regular use of nicotine containing products other than cigarettes (e.g. chewing tobacco, snuff, snus, cigars, e-cigs, etc.). Participants agreeing to abstain from using nicotine containing products other than cigarettes and the study-provided TN for the duration of trial will be considered eligible.
- Current enrollment or plans to enroll in another research and/or smoking cessation program over the duration of the study (i.e. ~30 weeks/8 months).
- Anticipated use (within the next ~30 weeks/8 months) of any nicotine substitutes and/or smoking cessation treatments/medications unless provided through the study.
- Provide a CO breath test reading less than 8 ppm at Intake Visit.
- Alcohol and Drug.
Show all 48Show fewer
- History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse. Counseling and support groups (e.g. Alcoholics Anonymous and Narcotics Anonymous) will not be considered medical treatment for the purposes of this protocol.
- Current alcohol consumption that exceeds 25 standard drinks/week.
- Breath alcohol reading (BrAC) greater than .000 at the Intake Visit.
- A positive urine drug screen (UDS) for cocaine, opiates, amphetamines, methamphetamines, phencyclidine (PCP), ecstasy (MDMA), barbiturates, benzodiazepines, methadone, and/or oxycodone at the Intake Visit.
- Medical.
- Women who are pregnant, breast feeding, or planning a pregnancy over the duration of the study period. Women must agree to use an adequate form of contraception or abstain from sexual intercourse for the duration and for at least one month after the end of the study.
- Current treatment of cancer or diagnosed with cancer (except basal or squamous-cell carcinoma not treated with chemotherapy and/or radiation) in the past 6 months.
- Poorly controlled, brittle, or pump-dependent Type I diabetes.
- Current peptic ulcer bleeding.
- Allergy to adhesive tape.
- Skin problems or sensitivities. Eligibility will be evaluated on a case-by-case basis by the Study Physician.
- Active hepatitis or poorly controlled kidney and/or liver disease.
- Uncontrolled hypertension (systolic blood pressure [SBP] greater than 159 and/or diastolic blood pressure [DBP] greater than 99
- History of abnormal heart rhythms, tachycardia, and/or cardiovascular disease (e.g. stroke, angina, heart attack) may result in ineligibility. These conditions will be evaluated on a case-by-case basis by the Study Physician.
- History of epilepsy or seizures. Eligibility will be evaluated on a case-by-case basis by the Study Physician.
- Serious or unstable disease within the past 6 months. Notable diseases will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician.
- Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing proper completion of the study procedures. Notable impairments will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician.
- Low or borderline intellectual functioning - determined by receiving a score of less than 75 on the Shipley Institute of Living Scale (SILS), which correlates with the Wechsler Adult Intelligence Scale-Revised (WAIS-R) Estimated Intelligence Quotient (IQ) Test.
- Applicable food allergies or disorders:
- Galactosemia, Notable milk allergy (lactose intolerant participants may proceed unless they experience severe symptoms), Notable soy allergy, Peanut allergy
- Psychiatric.
- Current diagnosis of major depression. Subjects with a history of major depression, in remission for 6 months or longer (may be stable on antidepressant medications), are eligible.
- Lifetime history of a suicide attempt.
- Lifetime history of schizophrenia, psychosis, and/or bipolar disorder.
- Medication.
- Current use or recent discontinuation (within the last 14 days) of:
- Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin Standard-Release, Chantix).
- Anti-psychotic medications.
- Prescription stimulants (e.g., Provigil, Ritalin, Adderall).
- Systemic steroids.
- Current use of:
- Nicotine replacement therapy (NRT).
- Heart medications such as digoxin, quinidine, and nitroglycerin.
- Daily use of:
- Opiate-containing medications for chronic pain.
- Inhaled corticosteroids.
- Benzodiazepines and/or Barbiturates.
- General Exclusion.
- Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact subject safety, study data, and/or the study design as determined by the Principal Investigator and/or Study Physician.
- Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the Principal Investigator and/or Study Physician. Subjects may be deemed ineligible for any of the aforementioned reasons at any point throughout the study, as well as during the initial telephone screen.
- Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/or Study Physician. Subjects may be deemed ineligible at any point throughout the study.
- Subjects failing to complete an in-person Baseline Visit will be excluded (no Principal Investigator determination required).
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this research study is to better understand (1) why people gain weight when they quit smoking and (2) whether certain types of smoking cessation (i.e. quit smoking) counseling combined with the nicotine patch help people quit smoking and gain less weight.
Read the detailed description
This is a randomized clinical trial of the efficacy of a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+) plus transdermal nicotine (TN) compared to standard smoking cessation counseling (SC) plus TN in treatment-seeking smokers. After completing an Intake Visit (~week -3), eligible smokers will be randomized (stratified by nicotine dependence, BMI and gender) to participate in 8 individual sessions of BAS+ or SC over a 10-week treatment period with two sessions prior to the target quit date (weeks -2, -1) and six sessions post-target quit date (TQD [week 0] and weeks 1, 2, 4, 6, and 8). Standard, 8-week; open-label TN will begin on the TQD. Moderators will be assessed pre-treatment. Mediating mechanisms will be assessed before, during, and at the end of treatment (EOT, week 8). Smoking will be assessed by self-report and biochemically confirmed (Carbon Monoxide [CO] < 5) at all in-center visits after quitting, at EOT (week 8), and at the 12- and 26-week follow-ups. Weight will be assessed at these same time points. Food intake will be measured by three consecutive days of 24-hour food recalls at Baseline [week -2] and 4-, 8-, and 12- and 26-weeks post-TQD. Smoking cessation and post-cessation weight gain (PCWG) are the primary outcomes and food intake is a secondary outcome at 26-weeks post-TQD. Consistent with intent-to-treat (ITT) analyses, the investigators will measure smoking cessation and weight gain in the full sample at the 26-week follow-up, evaluating a smoking status by treatment interaction for the PCWG analysis.
- Conditions
- Smoking Cessation, Weight Loss
- Being tested
- BAS+, SC
- Keywords
- Smoking Cessation, Weight Loss
- Medical subject headings
- Smoking Cessation, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAS+Behavioural
The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.
SCBehavioural
Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.
| Study group | Role | What they receive |
|---|---|---|
| BAS+ | Experimental | Participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+). Receives: Behavioral: BAS+ |
| SC | Placebo comparator | Participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC). Receives: Behavioral: SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cessation
Smoking abstinence (primary outcome) will be assessed and biochemically verified at the End of Treatment Visit (week 8), at 12 and 26 weeks after the target quit date. The primary smoking outcome variable will be 7-day point prevalence abstinence (no smoking, not even a puff, for at least 7 days prior to the assessment) biochemically verified by CO < 5 ppm at End of Treatment (week 8), and by saliva cotinine < 15ng/ml at the 12- and 26-week follow-up.
Measured: Through Study Completion (End of Treatment Visit, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit)
Weight Change
Weight will be measured by a physician's scale (pounds) at the beginning of every in-person visit through study completion. Participants will be wearing light clothing without shoes. Pre-cessation weight will be computed as the average of weights at the Intake and Baseline Visits prior to any change in smoking behavior. Weight change from Baseline to the 26-week follow-up will serve as a primary weight outcome variable.
Measured: Through Study Completion (Intake Visit, Baseline Visit, Pre-Quit Visit , Target Quit Date Visit, Mid-Tx. 1 Visit, Mid-Tx 2 Visit, Mid-Tx 3 Visit, Mid-Tx 4 Visit , End of Treatment, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit)
Sub-Study: Seven-day Point Prevalence Abstinence (Carbon Monoxide) at 12 Weeks Post Target Quit Date
Smoking abstinence was assessed and biochemically verified at the 12-week Follow-Up Visit (12 weeks post target quit date). Seven-day point prevalence abstinence (no smoking, not even a puff for the last 7 days prior to the assessment) was biochemically verified by a carbon monoxide (CO) reading <8 parts per million.
Measured: 12-Week Follow-Up Visit
Secondary outcomes (2)
Food Intake
Food intake (secondary outcome) will be assessed via 3 telephone-administered, 24-hour dietary recalls during the week after (or near) the Baseline Visit, Mid-Treatment 3 Visit (week 4), End of Treatment Visit (week 8) and the 12-week and 26-week follow-up Visits (n=15). A trained member of the research staff will use a multi-pass method with an interactive computerized software program, the Automated Self-Administered 24-hour Recall (ASA24®), to determine total kcal/day (outcome variable).
Measured: Through Study Completion (Baseline Visit, Mid-Tx 3 Visit, End of Treatment Visit, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit)
Sub-Study: fMRI BOLD Signal Change
T2*-weighted Blood Oxygen-Level-Dependent (BOLD) images will be acquired using a wholebrain, single-shot gradient-echo (GE) echo-planar imaging (EPI) sequence. BOLD images were captured (and subsequently analyzed) while participants complete a Food Cue-Induced Craving, Relative Reinforcing Value of Food, and Working Memory task inside the MRI Scanner.
Measured: Pre-Treatment fMRI Scan (~week 2), End of Treatment MRI Scan (~week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start13 Sep 2016
- Primary completion28 Feb 2021
- Study completion28 Feb 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 (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Janet Audrain-McGovern, Ph.D., Principal investigator, Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906787
- Sponsor's protocol ID
- 825425
- Other IDs
- R01CA206058
- Status last verified
- May 2024
- First submitted
- 9 Sep 2016
- Last updated
- 29 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Audrain-McGovern J, Wileyto EP, Ashare R, Albelda B, Manikandan D, Perkins KA. Behavioral activation for smoking cessation and the prevention of smoking cessation-related weight gain: A randomized trial. Drug Alcohol Depend. 2023 Mar 1;244:109792. doi: 10.1016/j.drugalcdep.2023.109792. Epub 2023 Feb 1.
PubMed 36739753
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Activation for Smoking Cessation and the Prevention of Post-Cessation Weight Gain
- ClinicalTrials.gov ID
- NCT02906787
- Acronym / sponsor ID
- 825425
- Conditions
- Smoking Cessation, Weight Loss
- Keywords
- Smoking Cessation, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Sep 2016 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Posted 16 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to better understand (1) why people gain weight when they quit smoking and (2) whether certain types of smoking cessation (i.e. quit smoking) counseling combined with the nicotine patch help people quit smoking and gain less weight.
Detailed description
This is a randomized clinical trial of the efficacy of a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+) plus transdermal nicotine (TN) compared to standard smoking cessation counseling (SC) plus TN in treatment-seeking smokers. After completing an Intake Visit (~week -3), eligible smokers will be randomized (stratified by nicotine dependence, BMI and gender) to participate in 8 individual sessions of BAS+ or SC over a 10-week treatment period with two sessions prior to the target quit date (weeks -2, -1) and six sessions post-target quit date (TQD [week 0] and weeks 1, 2, 4, 6, and 8). Standard, 8-week; open-label TN will begin on the TQD. Moderators will be assessed pre-treatment. Mediating mechanisms will be assessed before, during, and at the end of treatment (EOT, week 8). Smoking will be assessed by self-report and biochemically confirmed (Carbon Monoxide [CO] < 5) at all in-center visits after quitting, at EOT (week 8), and at the 12- and 26-week follow-ups. Weight will be assessed at these same time points. Food intake will be measured by three consecutive days of 24-hour food recalls at Baseline [week -2] and 4-, 8-, and 12- and 26-weeks post-TQD. Smoking cessation and post-cessation weight gain (PCWG) are the primary outcomes and food intake is a secondary outcome at 26-weeks post-TQD. Consistent with intent-to-treat (ITT) analyses, the investigators will measure smoking cessation and weight gain in the full sample at the 26-week follow-up, evaluating a smoking status by treatment interaction for the PCWG analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAS+ | Experimental | Behavioral: BAS+Participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+). |
| SC | Placebo comparator | Behavioral: SCParticipants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female treatment-seeking smokers who are between 18 and 65 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months.
- Plan to live in the area for the duration of the study (i.e. ~30 weeks/8 months).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
- Smokers who wish to make a permanent quit attempt in the next 1-2 months (treatment-seeking), because our prior work suggests that motivated subjects are more sensitive to medication effects on smoking behavior.
- Able to communicate fluently in English (i.e. speaking, writing, and reading).
Key exclusion criteria (48 listed)
- Smoking Behavior.
- Regular use of nicotine containing products other than cigarettes (e.g. chewing tobacco, snuff, snus, cigars, e-cigs, etc.). Participants agreeing to abstain from using nicotine containing products other than cigarettes and the study-provided TN for the duration of trial will be considered eligible.
- Current enrollment or plans to enroll in another research and/or smoking cessation program over the duration of the study (i.e. ~30 weeks/8 months).
- Anticipated use (within the next ~30 weeks/8 months) of any nicotine substitutes and/or smoking cessation treatments/medications unless provided through the study.
- Provide a CO breath test reading less than 8 ppm at Intake Visit.
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 |
|---|---|---|
| BAS+The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse. | Behavioural | BAS+ |
| SCOvereating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions. | Behavioural | SC |
Primary outcome
Smoking Cessation
Time frame: Through Study Completion (End of Treatment Visit, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit)
Smoking abstinence (primary outcome) will be assessed and biochemically verified at the End of Treatment Visit (week 8), at 12 and 26 weeks after the target quit date. The primary smoking outcome variable will be 7-day point prevalence abstinence (no smoking, not even a puff, for at least 7 days prior to the assessment) biochemically verified by CO < 5 ppm at End of Treatment (week 8), and by saliva cotinine < 15ng/ml at the 12- and 26-week follow-up.
Weight Change
Time frame: Through Study Completion (Intake Visit, Baseline Visit, Pre-Quit Visit , Target Quit Date Visit, Mid-Tx. 1 Visit, Mid-Tx 2 Visit, Mid-Tx 3 Visit, Mid-Tx 4 Visit , End of Treatment, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit)
Weight will be measured by a physician's scale (pounds) at the beginning of every in-person visit through study completion. Participants will be wearing light clothing without shoes. Pre-cessation weight will be computed as the average of weights at the Intake and Baseline Visits prior to any change in smoking behavior. Weight change from Baseline to the 26-week follow-up will serve as a primary weight outcome variable.
Sub-Study: Seven-day Point Prevalence Abstinence (Carbon Monoxide) at 12 Weeks Post Target Quit Date
Time frame: 12-Week Follow-Up Visit
Smoking abstinence was assessed and biochemically verified at the 12-week Follow-Up Visit (12 weeks post target quit date). Seven-day point prevalence abstinence (no smoking, not even a puff for the last 7 days prior to the assessment) was biochemically verified by a carbon monoxide (CO) reading <8 parts per million.
2 secondary outcomes
Food Intake
Time frame: Through Study Completion (Baseline Visit, Mid-Tx 3 Visit, End of Treatment Visit, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit)
Sub-Study: fMRI BOLD Signal Change
Time frame: Pre-Treatment fMRI Scan (~week 2), End of Treatment MRI Scan (~week 8)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36739753Audrain-McGovern J, Wileyto EP, Ashare R, Albelda B, Manikandan D, Perkins KA. Behavioral activation for smoking cessation and the prevention of smoking cessation-related weight gain: A randomized trial. Drug Alcohol Depend. 2023 Mar 1;244:109792. doi: 10.1016/j.drugalcdep.2023.109792. Epub 2023 Feb 1.
- Individual participant dataSharing planned: No
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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.
Janet Audrain-McGovern, Ph.D. principal investigator
Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAS+ and SC in people with Smoking Cessation and Weight Loss, run by Abramson Cancer Center at Penn Medicine 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 48 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 29 May 2024. 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. Some participants in this study may receive a placebo. 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 16 Feb 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?
Smoking Cessation (time frame: Through Study Completion (End of Treatment Visit, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit)). 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 NCT02906787, 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 May 2024.