Smoking CessationPhase 4PANSNCT02685072
Progesterone Augmentation of Nicotine Replacement Therapy Study
A Phase 4 study testing Progesterone (200 mgs BID) in people with Smoking Cessation, run by Yale University at 1 site in United States.
Trial summary
This will be a double-blind, placebo-controlled, pilot, randomized clinical trial. A total of 50 women who smoke and have regular menstrual cycles will be randomized to either progesterone (200 mgs BID) + Transdermal Nicotine Patch (TNP) or placebo + TNP for 8 weeks. TNP will be tapered after 4-6 weeks. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Progesterone (200 mgs BID)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2016to 12 Mar 2018
- Phase
- Phase 4
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18 - 45
- Smoking at least 5 cigarettes/ day for at least one year
- Regular menstrual cycles every 24-36 days for the previous 6 months
- Motivated to quit smoking (i.e., a rating of at least "7 "on a 10-point scale where 1 is not at all motivated and 10 is extremely motivated)
- In good health
- Using an acceptable, non-hormonal birth control
Who cannot join
- A history of major medical or psychological illnesses including:
- liver disease
- heart disease
- diabetes
- malignancy including history of breast cancer
- deep vein thrombosis
Show all 20Show fewer
- blood coagulation problems including a history or family history of thrombophilia
- liver failure
- cervical intra-epithelial lesions III or greater that are untreated
- other medical conditions that the physician investigators deems will make study participation unsafe for the subject
- current or past history bipolar disorder or schizophrenia
- current diagnosis of major depression
- panic disorder or post-traumatic stress disorder
- active drug (non-nicotine) and/or alcohol dependence
- currently undergoing treatment with another pharmacological agent for smoking cessation
- regular use of sedating medications including sleeping aids, antihistamines, and others use of nicotine from cigars, pipes, chewing tobacco
- pregnant
- breast- feeding or intending to become pregnant within 6 months
- allergy to nicotine patch or progesterone
- allergy to peanuts or other nuts.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine, Department of Psychiatry
New Haven, Connecticut, 06510
About this study
This will be a double-blind, placebo-controlled, pilot, randomized clinical trial. A total of 50 women who smoke and have regular menstrual cycles will be randomized to either progesterone (200 mgs BID) + Transdermal Nicotine Patch (TNP) or placebo + TNP for 8 weeks. TNP will be tapered after 4-6 weeks. Progesterone or matching placebo will be discontinued at the end of Week 8. All participants will also be provided behavioral treatment for smoking cessation. Participants will be inducted onto progesterone (or placebo) + TNP over a one-week period (Week 1) during the mid luteal phase, within a week before menses and the target quit date will be set for the 5 (+/-2) days after onset of menses. Participants will have post-trial follow-up visits at 1 and 3 months.The main study outcomes will be self- report of smoking abstinence, biochemically verified smoking abstinence, measures of cigarette craving and nicotine withdrawal, and measures of response inhibition.
Read the detailed description
This study seeks to determine if modifying the hormonal milieu of the menstrual cycle, through administration of exogenous progesterone, will improve the effectiveness of treatments for smoking cessation in women. Progesterone, a gonadal hormone, is used clinically for treatment of endometrial hyperplasia, amenorrhea, dysfunctional uterine bleeding, and for assisted reproduction in women. Progesterone also shows promise for the treatment of multiple central nervous system disorders including cocaine addiction, seizure disorder, and traumatic brain injury. As the next step, the investigators seek to determine if progesterone augments standard smoking cessation treatments (e.g., NRT) in regularly cycling women. The investigators hypothesize that co-treatment with progesterone, compared to placebo, will enhance the effectiveness NRT for smoking cessation. To test this hypothesis, the investigators propose an 8-week, double-blind, placebo-controlled clinical trial, which will randomize 50 smokers using a 1:1 assignment ratio to 400 mg/day progesterone or placebo. Consistent with the Clinical Practice Guidelines, all participants will also receive transdermal nicotine patch (TNP) plus brief counseling for smoking cessation during the study participation.
Specific Aim #1: To determine if progesterone +TNP is superior to placebo +TNP for prolonged and 7-day point prevalence of smoking abstinence rates at the end of 8 weeks of treatment and at 1 and 3 month follow-up time points. The investigators will also evaluate the safety and tolerability of progesterone treatment, compared to placebo. Our co-primary outcome measures will be 7-day point prevalence of smoking abstinence and breath CO at the end of treatment and 1- and 3-months after the end of the trial. Specific Aim #2: To determine if progesterone + TNP treatment, compared to placebo + TNP, improves response inhibitory function, as assessed by the Stroop, The Go/No Go task, and the Digit Symbol Task. Specific Aim # 3: To determine if progesterone + TNP treatment, compared to placebo + TNP, leads to a greater reduction in cigarette craving and nicotine withdrawal symptoms, as assessed by the Questionnaire on Smoking Urges-Brief (QSU-B) and the Minnesota Nicotine Withdrawal Scale (MNWS), respectively. Specific Aim #4: To evaluate with affective changes, as shown on the Positive and Negative Affect Schedule, mediates the effects of progesterone on smoking abstinence.
- Conditions
- Smoking Cessation
- Being tested
- Progesterone (200 mgs BID), Placebo
- Keywords
- Smoking Cessation, Nicotine Cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone (200 mgs BID)Drug
Also called Prometrium
Transdermal Nicotine Patch (TNP) + Progesterone
PlaceboDrug
TNP + Placebo
| Study group | Role | What they receive |
|---|---|---|
| TNP + Progesterone | Experimental | Transdermal Nicotine Patch + Progesterone (200 mgs BID) Receives: Drug: Progesterone (200 mgs BID) |
| TNP + Placebo | Placebo comparator | Transdermal Nicotine Patch + Placebo (for Progesterone) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day Point Prevalence of Smoking Abstinence
The 7-day point prevalence is defined by self-reported smoking abstinence for the last 7 days.
Measured: end of 8 weeks of treatment
Secondary outcomes (18)
Carbon Monoxide <10 Ppm
Smoking abstinence measured by breath CO
Measured: end of 8 weeks of treatment
Carbon Monoxide <10 Ppm
Smoking abstinence measured by breath CO
Measured: 1 month follow up
Carbon Monoxide <10 Ppm
Smoking abstinence measured by breath CO
Measured: 3 month follow up
Change in Stroop Measure of Inhibitory Function
The Stroop test assesses cognitive processing. The Level 3 Stroop Throughput score incorporates both accuracy and speed. In Level 3 of the Stroop test, a series of words representing colors are shown in a font color that is incongruent with the word (e.g. RED would be shown in blue font). Users are asked to press a response key associated with the color of the font, not the written word. Quicker and more accurate responses lead to higher scores. The lowest possible score is 0 (no correct responses). There is no defined maximum score, as the score depends upon both response time and number of correct responses. A Level 3 Stroop Throughput change score was calculated by subtracting baseline score from week 2 score. Higher positive scores represent greater improvement in scores at week 2 relative to baseline, and lower negative scores represent greater decline in scores from baseline to week 2.
Measured: baseline and week 2
Change in Go/No Go Task Measure of Inhibitory Function
Week 2 minus baseline. This task assesses the ability to withhold responses to an infrequently occurring target (No-Go trials). A total of 225 single digits (25 x 9 digits) are presented on a computer monitor for 250 ms each, immediately followed by a mask for 900 ms. Subjects must press a spacebar in response to every digit except the "3".
Go/No Go score is calculated as separation between the means of the signal and the noise distributions and is reported in standard deviation units, representing an overall indicator of performance since it accounts for correct responses and incorrect responses. Higher scores represent a better outcome. For the change score, higher positive scores represent greater improvement in scores between baseline and week 2, and lower negative scores represent greater decline in scores between baseline and week 2.
Measured: baseline and week 2
Change in Digit Symbol Task Measure of Inhibitory Function
The Code Substitution Test (a computerized adaptation/variant of the Digit Symbol Substitution Test) is a test of psychomotor performance. The Code Substitution-Learning Throughput Score incorporates both accuracy and speed. During the learning phase of this test, users are continuously shown a row of 9 digits that are paired with a symbol (the pairings are constant). Users are presented with a series of individual pairings and are asked to press a response key to indicate if the pairing is correct or not. Quicker and more accurate responses lead to higher scores. The lowest possible score is 0 (no correct responses). There is no defined maximum score, as the score depends upon both response time and number of correct responses. A change score was calculated by subtracting baseline score from week 2 score. Higher positive scores represent greater improvement in scores at week 2 relative to baseline, and lower negative scores represent greater decline in scores from baseline to week 2.
Measured: baseline and week 2
Positive and Negative Affect Schedule (PANAS) Total Score
The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.
Measured: Baseline
Positive and Negative Affect Schedule (PANAS) Total Score
The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.
Measured: Week 2
Positive and Negative Affect Schedule (PANAS) Total Score
The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.
Measured: Week 3
Positive and Negative Affect Schedule (PANAS) Total Score
The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.
Measured: Week 4
Positive and Negative Affect Schedule (PANAS) Total Score
The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.
Measured: Week 5
Positive and Negative Affect Schedule (PANAS) Total Score
The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.
Measured: Week 6
Positive and Negative Affect Schedule (PANAS) Total Score
The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.
Measured: Week 7
Positive and Negative Affect Schedule (PANAS) Total Score
The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.
Measured: Week 8
Positive and Negative Affect Schedule (PANAS) Total Score
The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.
Measured: 1 month follow up
Positive and Negative Affect Schedule (PANAS) Total Score
The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.
Measured: 3 month follow up
Prolonged Abstinence Post Trial
Abstinence from 2 weeks post quit date to the one month follow up
Measured: 1-month follow-up after end of treatment
Prolonged Abstinence Follow up
Abstinence from 2 weeks post quit date to 3 month follow up (total of 6-8 weeks during the trial and 3 month follow up)
Measured: 3-month follow-up after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study start7 Apr 2016
- Primary completion18 Dec 2017
- Study completion12 Mar 2018
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.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kimberly Yonkers, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685072
- Sponsor's protocol ID
- 1504015618
- Other IDs
- R21CA198187
- Acronym
- PANS
- Status last verified
- Jul 2019
- First submitted
- 17 Dec 2015
- Last updated
- 23 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: we will only make aggregate de-identified data available
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progesterone Augmentation of Nicotine Replacement Therapy Study
- ClinicalTrials.gov ID
- NCT02685072
- Acronym / sponsor ID
- PANS / 1504015618
- Conditions
- Smoking Cessation
- Keywords
- Smoking Cessation, Nicotine Cessation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Apr 2016 (actual)
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Posted 23 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a double-blind, placebo-controlled, pilot, randomized clinical trial. A total of 50 women who smoke and have regular menstrual cycles will be randomized to either progesterone (200 mgs BID) + Transdermal Nicotine Patch (TNP) or placebo + TNP for 8 weeks. TNP will be tapered after 4-6 weeks. Progesterone or matching placebo will be discontinued at the end of Week 8. All participants will also be provided behavioral treatment for smoking cessation. Participants will be inducted onto progesterone (or placebo) + TNP over a one-week period (Week 1) during the mid luteal phase, within a week before menses and the target quit date will be set for the 5 (+/-2) days after onset of menses. Participants will have post-trial follow-up visits at 1 and 3 months.The main study outcomes will be self- report of smoking abstinence, biochemically verified smoking abstinence, measures of cigarette craving and nicotine withdrawal, and measures of response inhibition.
Detailed description
This study seeks to determine if modifying the hormonal milieu of the menstrual cycle, through administration of exogenous progesterone, will improve the effectiveness of treatments for smoking cessation in women. Progesterone, a gonadal hormone, is used clinically for treatment of endometrial hyperplasia, amenorrhea, dysfunctional uterine bleeding, and for assisted reproduction in women. Progesterone also shows promise for the treatment of multiple central nervous system disorders including cocaine addiction, seizure disorder, and traumatic brain injury. As the next step, the investigators seek to determine if progesterone augments standard smoking cessation treatments (e.g., NRT) in regularly cycling women. The investigators hypothesize that co-treatment with progesterone, compared to placebo, will enhance the effectiveness NRT for smoking cessation. To test this hypothesis, the investigators propose an 8-week, double-blind, placebo-controlled clinical trial, which will randomize 50 smokers using a 1:1 assignment ratio to 400 mg/day progesterone or placebo. Consistent with the Clinical Practice Guidelines, all participants will also receive transdermal nicotine patch (TNP) plus brief counseling for smoking cessation during the study participation.
Specific Aim #1: To determine if progesterone +TNP is superior to placebo +TNP for prolonged and 7-day point prevalence of smoking abstinence rates at the end of 8 weeks of treatment and at 1 and 3 month follow-up time points. The investigators will also evaluate the safety and tolerability of progesterone treatment, compared to placebo. Our co-primary outcome measures will be 7-day point prevalence of smoking abstinence and breath CO at the end of treatment and 1- and 3-months after the end of the trial. Specific Aim #2: To determine if progesterone + TNP treatment, compared to placebo + TNP, improves response inhibitory function, as assessed by the Stroop, The Go/No Go task, and the Digit Symbol Task. Specific Aim # 3: To determine if progesterone + TNP treatment, compared to placebo + TNP, leads to a greater reduction in cigarette craving and nicotine withdrawal symptoms, as assessed by the Questionnaire on Smoking Urges-Brief (QSU-B) and the Minnesota Nicotine Withdrawal Scale (MNWS), respectively. Specific Aim #4: To evaluate with affective changes, as shown on the Positive and Negative Affect Schedule, mediates the effects of progesterone on smoking abstinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNP + Progesterone | Experimental | Drug: Progesterone (200 mgs BID)Transdermal Nicotine Patch + Progesterone (200 mgs BID) |
| TNP + Placebo | Placebo comparator | Drug: PlaceboTransdermal Nicotine Patch + Placebo (for Progesterone) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 18 - 45
- Smoking at least 5 cigarettes/ day for at least one year
- Regular menstrual cycles every 24-36 days for the previous 6 months
- Motivated to quit smoking (i.e., a rating of at least "7 "on a 10-point scale where 1 is not at all motivated and 10 is extremely motivated)
- In good health
Key exclusion criteria (20 listed)
- liver disease
- heart disease
- diabetes
- malignancy including history of breast cancer
- deep vein thrombosis
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 |
|---|---|---|
| Progesterone (200 mgs BID)Also: PrometriumTransdermal Nicotine Patch (TNP) + Progesterone | Drug | TNP + Progesterone |
| PlaceboTNP + Placebo | Drug | TNP + Placebo |
Primary outcome
7-day Point Prevalence of Smoking Abstinence
Time frame: end of 8 weeks of treatment
The 7-day point prevalence is defined by self-reported smoking abstinence for the last 7 days.
18 secondary outcomes
Carbon Monoxide <10 Ppm
Time frame: end of 8 weeks of treatment
Carbon Monoxide <10 Ppm
Time frame: 1 month follow up
Carbon Monoxide <10 Ppm
Time frame: 3 month follow up
Change in Stroop Measure of Inhibitory Function
Time frame: baseline and week 2
Change in Go/No Go Task Measure of Inhibitory Function
Time frame: baseline and week 2
Change in Digit Symbol Task Measure of Inhibitory Function
Time frame: baseline and week 2
Positive and Negative Affect Schedule (PANAS) Total Score
Time frame: Baseline
Positive and Negative Affect Schedule (PANAS) Total Score
Time frame: Week 2
Positive and Negative Affect Schedule (PANAS) Total Score
Time frame: Week 3
Positive and Negative Affect Schedule (PANAS) Total Score
Time frame: Week 4
Positive and Negative Affect Schedule (PANAS) Total Score
Time frame: Week 5
Positive and Negative Affect Schedule (PANAS) Total Score
Time frame: Week 6
Positive and Negative Affect Schedule (PANAS) Total Score
Time frame: Week 7
Positive and Negative Affect Schedule (PANAS) Total Score
Time frame: Week 8
Positive and Negative Affect Schedule (PANAS) Total Score
Time frame: 1 month follow up
Positive and Negative Affect Schedule (PANAS) Total Score
Time frame: 3 month follow up
Prolonged Abstinence Post Trial
Time frame: 1-month follow-up after end of treatment
Prolonged Abstinence Follow up
Time frame: 3-month follow-up after end of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. we will only make aggregate de-identified data available
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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.
Kimberly Yonkers, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Progesterone (200 mgs BID) in people with Smoking Cessation, run by Yale University 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 20 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 23 Jul 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 23 Jul 2019). 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?
7-day Point Prevalence of Smoking Abstinence (time frame: end of 8 weeks of treatment). 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 23 Jul 2019; AzTrials last refreshed its copy on 26 Oct 2026.