Smoking CessationNCT06654414
Adapting and Pilot Testing a Skills-based Smoking Cessation Intervention to Address Developmental and Health-related Stress Among Adults Who Smoke
A study testing PRIDE QUIT and Enhanced Treatment As Usual (ETAU) in people with Smoking Cessation and Depression, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
Smoking remains the leading preventable cause of death in the United States, and there are persistent and significant disparities in tobacco use among transgender and gender diverse (TGD) individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Depression, Anxiety
- What is being tested?
- PRIDE QUIT and Enhanced Treatment As Usual (ETAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Sep 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18+
- self-reported difference between sex assigned at birth and gender identity
- current use of combustible cigarettes (defined as self-reported 5 combustible cigarettes per day in any week in the past month and a carbon monoxide [CO] expired-air reading of ≥8ppm) OR current use of nicotine-containing e-cigarettes (defined by saliva cotinine level of ≥30ng/mL) with use of combustible cigarettes (5 cigarettes per day in any week in the past month)
- desire to stop using tobacco products (defined by ≥5 on the Motivational Aspects of Smoking Cessation Questionnaire)
- English-speaking.
Who cannot join
- unable to provide informed consent
- current interfering untreated or unstable major health condition (e.g., bipolar, current psychosis)
- current use of psychotherapy for smoking cessation
- participation in Aim 1a procedures.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 1 recruiting
- Active, not recruiting
Massachusetts General Hopsital
Boston, Massachusetts, 02114
- Active, not recruiting
Boston University - Charles River Campus
Boston, Massachusetts, 02215
- Recruiting
Fenway Health
Boston, Massachusetts, 02215
Elizabeth Loynd, 617-927-6216, eloynd@fenwayhealth.org
Elliott Weinstein, PhD, ERWEINSTEIN@mgh.harvard.edu
About this study
Smoking remains the leading preventable cause of death in the United States, and there are persistent and significant disparities in tobacco use among transgender and gender diverse (TGD) individuals. Stigma, discrimination, gender dysphoria, and other gender minority stressors likely contribute to these disparities, and the increased burden of gender minority stress may also be driving higher prevalence rates of anxiety and depression, both of which are more common among TGD individuals and among those who smoke relative to comparison samples. This study will (1) explore the ways in which gender minority stressors and associated anxiety and depression compromise smoking cessation among TGD individuals, identifying elements in an existing smoking cessation intervention that need to be adjusted to meet their unique needs; (2) adapt an existing smoking cessation intervention for TGD individuals; and (3) evaluate the feasibility and acceptability of the adapted intervention in a pilot randomized controlled trial.
Read the detailed description
Despite the substantial decrease in smoking prevalence over the past 50 years, persistent and significant disparities in tobacco use remain among clinical and non-clinical populations of adults who smoke. Cigarette use among clinical populations, including patients with HIV and those with significant developmental stress, ranges from approximately 40-70%, compared with 10-12% among non-clinical populations. Clinical populations with HIV and developmental stressors also show dramatically higher rates of e-cigarette use relative to non-clinical populations (26.5% vs. 5.5% in some samples of adults who smoke). Adults managing HIV and developmental stressors may be particularly vulnerable to the consequences of tobacco use through increased heart disease risk, and smoking may hinder recovery from HIV and other related illnesses. Differential responses to developmental stressors, the stress of managing HIV and its treatment, and co-occurring clinical concerns such as anxiety and depression further contribute to these differences in tobacco use. Anxiety and depression are major impediments to smoking cessation and are more prevalent among people with developmental stress and people living with HIV than in non-clinical samples. Anxiety symptoms co-occur with smoking at high rates and significantly impair cessation success. Similarly, depressed mood and major depressive disorder-both more common among people who smoke than among those who do not-are associated with reduced odds of cessation. The high prevalence of anxiety and depression among clinical populations of adults who smoke therefore leaves these individuals particularly vulnerable to cessation difficulties. A tailored smoking cessation intervention that builds cognitive-behavioral skills for cessation while also reducing stress and associated anxiety and depression symptoms has strong potential to mitigate tobacco use. We propose to adapt an existing smoking cessation intervention, QUIT, to address the unique needs of adults with developmental stress who smoke. In focus groups with individuals who use tobacco (N ≤ 32) and providers (N ≤ 8), we will explore the ways in which stress and associated anxiety/depression compromise cessation, and identify content in the current version of QUIT that does and does not meet participants' needs. Providers will also comment on anticipated implementation barriers. Following the ADAPT-ITT model, these qualitative data will inform adaptation of the intervention. We will then test the feasibility and acceptability of the adapted intervention (QUIT 2.0) in a pilot randomized controlled trial (RCT; N = 60), assessing for signals of clinically meaningful change in biologically verified 7-day point-prevalence abstinence, average number of cigarettes smoked, and stress, anxiety, depression, and distress tolerance. If QUIT 2.0 is feasible and acceptable, it will be ready for a hybrid efficacy/effectiveness trial. We will also include a non-randomized, retrospective comparison group-matched on age, sex, and average number of cigarettes smoked per day in the past week-consisting of adults with HIV who completed the original, un-adapted intervention (QUIT 1.0).
- Being tested
- PRIDE QUIT, Enhanced Treatment As Usual (ETAU)
- Keywords
- Smoking Cessation, Smoking, Tobacco Use, Tobacco Use Disorder, Substance-Related Disorder, Nicotine, Anxiety, Depression, Transgender Individuals, Gender Expansive Individuals, Gender Minority Stress, Distress Tolerance, Quitting, Cognitive Behavioral Therapy
- Medical subject headings
- Smoking Cessation, Depression, Anxiety Disorders, Tobacco Use Disorder, Smoking, Tobacco Use, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIDE QUITBehavioural
This is an adapted behavioral intervention based on the integrated treatment for smoking cessation, anxiety, and depressed mood, known as QUIT, for persons with HIV. Through our treatment adaption process of QUIT (guided by Aim 1 and 2 data), PRIDE QUIT will be a Cognitive-Behavioral therapy-based intervention tailored for transgender and gender diverse (TGD) individuals, aimed at to helping participants quit smoking and address gender minority stressors, anxiety, depression, and improve distress tolerance. There will be three major assessments: baseline (T1), at the end of the intervention (T2), and a three-month follow-up visit (T3). This intervention group will receive a pre-randomization general educational session (session 0) followed by 5 weekly sessions and a booster sessions 4 weeks after T2, with the quit day set between sessions 3 and 4.
Enhanced Treatment As Usual (ETAU)Behavioural
Brief counseling, American Cancer Society cessation resources (palm card with information on how to access the American Cancer Society website) after pre-randomization educational session (session 0,) the option of nicotine replacement therapy, and referral to the Quit Line.
| Study group | Role | What they receive |
|---|---|---|
| PRIDE QUIT | Experimental | Participants in this adapted intervention arm (n=30) will receive empirically-based, Cognitive-Behavioral therapy-based strategies, tailored for transgender and gender diverse (TGD) individuals, which aims to help participants quit smoking and address gender minority stressors, anxiety, depression, and improve distress tolerance. This intervention group will receive a general educational session (session 0) followed by 5 active weekly sessions and a booster session 4 weeks after T2 (approx. 14 weeks post-baseline), with the quit day set between sessions 3 and 4. Receives: Behavioral: PRIDE QUIT |
| Enhanced Treatment As Usual (ETAU) | Active comparator | Participants in this arm (n=30) will receive enhanced treatment as usual at Fenway Health. These participants will attend one session (brief counseling), will come to the clinic for weekly assessments only, and referral to the Quit Line. Receives: Behavioral: Enhanced Treatment As Usual (ETAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Acceptability will be assessed via the Client Satisfaction Questionnaire-4 (CSQ-4) which will be completed after every other treatment session. Items are scored using a 4-point Likert scale with (1) quite dissatisfied; (2) dissatisfied; (3) satisfied; (4) quite satisfied. The questions include: (1) To what extent has our program met your needs?; (2) Have the services you received helped you to deal more effectively with your problems?; (3) In an overall, general sense, how satisfied are you with the service you have received?; (4) If you were to seek help again, would you come back to our program? The intervention will be deemed acceptable if at least 75% of the participants rate 4+ items on the acceptability questionnaires with a 3 or a 4 on the Likert-style scale.
Measured: Through the end of treatment intervention, approximately 6 weeks
Feasibility of the Intervention
Feasibility of the intervention is a primary outcome measure that will be calculated based on three assessments: (1) interventionist fidelity to the protocol (via a review of 10% of session recordings to determine whether key themes were addressed), (2) session attendance, and (3) participant retention at follow-up. Feasibility will be demonstrated if at least (1) 80% of the reviewed sessions address all key themes, (2) 75% of the participants attend at least half of all treatment sessions; and (3) 70% of the participants complete the 3-month follow-up.
Measured: Through participants' enrollment, approximately 6 months
Secondary outcomes (6)
7-Day Point Prevalence Abstinence
7-day point prevalence abstinence will be verified via expired-air carbon monoxide (CO) assessed with a Smokerlyzer, with 5ppm indicating abstinence (24 hours to two weeks). Because CO expired-air readings are significantly lower among users of e-cigarettes, abstinence for those using mostly e-cigarettes at baseline will be verified by cotinine assessment via a NicConfirm Mouth Swab Cotinine test (30 ng/ml indicates abstinence of 1-4 days).
Measured: At the 3-month follow-up and 6-month follow-up
Gender Minority Stress
Gender minority stress will be measured via the internal experience subscales of the Gender Minority Stress and Resilience Measure (GMSRM), including non-affirmation of gender identity, internalized transphobia, negative expectations, nondisclosure, community connectedness, and pride. Participants respond to each statement using a five-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree."
Measured: At baseline assessment, 3-month follow-up, and 6-month follow-up
Average Number of Cigarettes Smoked Per Day in the Past Week
Average number of cigarettes smoked per day in the past week, assessed via self-report.
Measured: At baseline assessment, end of each treatment session (weekly for 5 weeks post-baseline), 3-month follow-up, and 6-month follow up
Anxiety Symptoms
- Anxiety symptoms will be assessed by the Generalized Anxiety Disorder 7-item (GAD-7). Likert style: Not at all (0) to Nearly every day (3); scores range from 0 to 21, with higher scores indicating greater levels of symptomatology. 2. Participants will also be asked to rate their anxiety on a scale from 0 to 10, with 0 being no anxiety and 10 being the worst possible anxiety.
Measured: (1) At baseline assessment, 3-month follow-up, and 6-month follow-up. (2) At baseline assessment, after each intervention session, 3-month follow-up, and 6-month follow-up
Depression Symptoms
- Depressive symptoms will be assessed by the Patient Health Questionnaire 8-item scale (PHQ-8). Likert style: Not at all (0) to Nearly every day (3); scores range from 0 to 24, with higher scores indicating greater levels of symptomatology. 2. Participants will also be asked to rate their depressive symptoms on a scale from 0 to 10, with 0 being no depressed mood and 10 being the worst possible depressed mood.
Measured: (1) At baseline assessment, 3-month follow-up, and 6-month follow-up. (2) At baseline assessment, after each intervention session, 3-month follow-up, and 6-month follow-up.
Distress Tolerance
Distress tolerance will be assessed using the Distress Tolerance Scale (DTS). Likert style: Strongly Agree (1) to Strongly Disagree (5); scores range from 16-80, with higher scores indicating greater levels of distress tolerance.
Measured: At baseline assessment, 3-month follow-up, and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start1 Sep 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
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 Massachusetts General HospitalThe 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Conall O'Cleirigh, Massachusetts General Hospital
- Investigators
- Conall M O'Cleirigh, PhD, Principal investigator, Massachusetts General Hospital, Behavioral Medicine ProgramAmelia Stanton, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654414
- Sponsor's protocol ID
- IRB2024-3
- Other IDs
- 1R21CA292185-01
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Based on the approved DSMP, we plan to only share deidentified data via a controlled access repository. No PHI, recordings, or unconsented human data will be made available to other investigators.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting and Pilot Testing a Skills-based Smoking Cessation Intervention to Address Developmental and Health-related Stress Among Adults Who Smoke
- ClinicalTrials.gov ID
- NCT06654414
- Acronym / sponsor ID
- IRB2024-3
- Keywords
- Smoking Cessation, Smoking, Tobacco Use, Tobacco Use Disorder, Substance-Related Disorder, Nicotine, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 23 Oct 2024 (actual)
- 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.
Smoking remains the leading preventable cause of death in the United States, and there are persistent and significant disparities in tobacco use among transgender and gender diverse (TGD) individuals. Stigma, discrimination, gender dysphoria, and other gender minority stressors likely contribute to these disparities, and the increased burden of gender minority stress may also be driving higher prevalence rates of anxiety and depression, both of which are more common among TGD individuals and among those who smoke relative to comparison samples. This study will (1) explore the ways in which gender minority stressors and associated anxiety and depression compromise smoking cessation among TGD individuals, identifying elements in an existing smoking cessation intervention that need to be adjusted to meet their unique needs; (2) adapt an existing smoking cessation intervention for TGD individuals; and (3) evaluate the feasibility and acceptability of the adapted intervention in a pilot randomized controlled trial.
Detailed description
Despite the substantial decrease in smoking prevalence over the past 50 years, persistent and significant disparities in tobacco use remain among clinical and non-clinical populations of adults who smoke. Cigarette use among clinical populations, including patients with HIV and those with significant developmental stress, ranges from approximately 40-70%, compared with 10-12% among non-clinical populations. Clinical populations with HIV and developmental stressors also show dramatically higher rates of e-cigarette use relative to non-clinical populations (26.5% vs. 5.5% in some samples of adults who smoke). Adults managing HIV and developmental stressors may be particularly vulnerable to the consequences of tobacco use through increased heart disease risk, and smoking may hinder recovery from HIV and other related illnesses. Differential responses to developmental stressors, the stress of managing HIV and its treatment, and co-occurring clinical concerns such as anxiety and depression further contribute to these differences in tobacco use. Anxiety and depression are major impediments to smoking cessation and are more prevalent among people with developmental stress and people living with HIV than in non-clinical samples. Anxiety symptoms co-occur with smoking at high rates and significantly impair cessation success. Similarly, depressed mood and major depressive disorder-both more common among people who smoke than among those who do not-are associated with reduced odds of cessation. The high prevalence of anxiety and depression among clinical populations of adults who smoke therefore leaves these individuals particularly vulnerable to cessation difficulties. A tailored smoking cessation intervention that builds cognitive-behavioral skills for cessation while also reducing stress and associated anxiety and depression symptoms has strong potential to mitigate tobacco use. We propose to adapt an existing smoking cessation intervention, QUIT, to address the unique needs of adults with developmental stress who smoke. In focus groups with individuals who use tobacco (N ≤ 32) and providers (N ≤ 8), we will explore the ways in which stress and associated anxiety/depression compromise cessation, and identify content in the current version of QUIT that does and does not meet participants' needs. Providers will also comment on anticipated implementation barriers. Following the ADAPT-ITT model, these qualitative data will inform adaptation of the intervention. We will then test the feasibility and acceptability of the adapted intervention (QUIT 2.0) in a pilot randomized controlled trial (RCT; N = 60), assessing for signals of clinically meaningful change in biologically verified 7-day point-prevalence abstinence, average number of cigarettes smoked, and stress, anxiety, depression, and distress tolerance. If QUIT 2.0 is feasible and acceptable, it will be ready for a hybrid efficacy/effectiveness trial. We will also include a non-randomized, retrospective comparison group-matched on age, sex, and average number of cigarettes smoked per day in the past week-consisting of adults with HIV who completed the original, un-adapted intervention (QUIT 1.0).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRIDE QUIT | Experimental | Behavioral: PRIDE QUITParticipants in this adapted intervention arm (n=30) will receive empirically-based, Cognitive-Behavioral therapy-based strategies, tailored for transgender and gender diverse (TGD) individuals, which aims to help participants quit smoking and address gender minority stressors, anxiety, depression, and improve distress tolerance. This intervention group will receive a general educational session (session 0) followed by 5 active weekly sessions and a booster session 4 weeks after T2 (approx. 14 weeks post-baseline), with the quit day set between sessions 3 and 4. |
| Enhanced Treatment As Usual (ETAU) | Active comparator | Behavioral: Enhanced Treatment As Usual (ETAU)Participants in this arm (n=30) will receive enhanced treatment as usual at Fenway Health. These participants will attend one session (brief counseling), will come to the clinic for weekly assessments only, and referral to the Quit Line. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 18+
- self-reported difference between sex assigned at birth and gender identity
- current use of combustible cigarettes (defined as self-reported 5 combustible cigarettes per day in any week in the past month and a carbon monoxide [CO] expired-air reading of ≥8ppm) OR current use of nicotine-containing e-cigarettes (defined by saliva cotinine level of ≥30ng/mL) with use of combustible cigarettes (5 cigarettes per day in any week in the past month)
- desire to stop using tobacco products (defined by ≥5 on the Motivational Aspects of Smoking Cessation Questionnaire)
- English-speaking.
Key exclusion criteria (4 listed)
- unable to provide informed consent
- current interfering untreated or unstable major health condition (e.g., bipolar, current psychosis)
- current use of psychotherapy for smoking cessation
- participation in Aim 1a procedures.
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 |
|---|---|---|
| PRIDE QUITThis is an adapted behavioral intervention based on the integrated treatment for smoking cessation, anxiety, and depressed mood, known as QUIT, for persons with HIV. Through our treatment adaption process of QUIT (guided by Aim 1 and 2 data), PRIDE QUIT will be a Cognitive-Behavioral therapy-based intervention tailored for transgender and gender diverse (TGD) individuals, aimed at to helping participants quit smoking and address gender minority stressors, anxiety, depression, and improve distress tolerance. There will be three major assessments: baseline (T1), at the end of the intervention (T2), and a three-month follow-up visit (T3). This intervention group will receive a pre-randomization general educational session (session 0) followed by 5 weekly sessions and a booster sessions 4 weeks after T2, with the quit day set between sessions 3 and 4. | Behavioural | PRIDE QUIT |
| Enhanced Treatment As Usual (ETAU)Brief counseling, American Cancer Society cessation resources (palm card with information on how to access the American Cancer Society website) after pre-randomization educational session (session 0,) the option of nicotine replacement therapy, and referral to the Quit Line. | Behavioural | Enhanced Treatment As Usual (ETAU) |
Primary outcome
Acceptability
Time frame: Through the end of treatment intervention, approximately 6 weeks
Acceptability will be assessed via the Client Satisfaction Questionnaire-4 (CSQ-4) which will be completed after every other treatment session. Items are scored using a 4-point Likert scale with (1) quite dissatisfied; (2) dissatisfied; (3) satisfied; (4) quite satisfied. The questions include: (1) To what extent has our program met your needs?; (2) Have the services you received helped you to deal more effectively with your problems?; (3) In an overall, general sense, how satisfied are you with the service you have received?; (4) If you were to seek help again, would you come back to our program? The intervention will be deemed acceptable if at least 75% of the participants rate 4+ items on the acceptability questionnaires with a 3 or a 4 on the Likert-style scale.
Feasibility of the Intervention
Time frame: Through participants' enrollment, approximately 6 months
Feasibility of the intervention is a primary outcome measure that will be calculated based on three assessments: (1) interventionist fidelity to the protocol (via a review of 10% of session recordings to determine whether key themes were addressed), (2) session attendance, and (3) participant retention at follow-up. Feasibility will be demonstrated if at least (1) 80% of the reviewed sessions address all key themes, (2) 75% of the participants attend at least half of all treatment sessions; and (3) 70% of the participants complete the 3-month follow-up.
6 secondary outcomes
7-Day Point Prevalence Abstinence
Time frame: At the 3-month follow-up and 6-month follow-up
Gender Minority Stress
Time frame: At baseline assessment, 3-month follow-up, and 6-month follow-up
Average Number of Cigarettes Smoked Per Day in the Past Week
Time frame: At baseline assessment, end of each treatment session (weekly for 5 weeks post-baseline), 3-month follow-up, and 6-month follow up
Anxiety Symptoms
Time frame: (1) At baseline assessment, 3-month follow-up, and 6-month follow-up. (2) At baseline assessment, after each intervention session, 3-month follow-up, and 6-month follow-up
Depression Symptoms
Time frame: (1) At baseline assessment, 3-month follow-up, and 6-month follow-up. (2) At baseline assessment, after each intervention session, 3-month follow-up, and 6-month follow-up.
Distress Tolerance
Time frame: At baseline assessment, 3-month follow-up, and 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes. Based on the approved DSMP, we plan to only share deidentified data via a controlled access repository. No PHI, recordings, or unconsented human data will be made available to other investigators.
Related trials for Smoking Cessation
Recruiting
Smoking Cessation in Patients With Cancer
Cancer, Tobacco Use
Not yet recruiting
Effectiveness Of Project EX: A Classroom-Based Smoking Prevention And Cessation Intervention Program
Focus of the Study is Smoking Cessation and Prevention, Smoking Prevention
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
Recruiting
Precision Treatment to Promote Smoking Cessation and Survival in Oncology Patients
Smoking Cessation, Smoking
RecruitingPhase 2
A Study of Nicotine Orodispersible Tablet on Craving Relief of Male and Female Smoker Volunteers
Smoking Cessation, Nicotine Replacements Therapy
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.
Conall M O'Cleirigh, PhD principal investigator
Massachusetts General Hospital, Behavioral Medicine Program
Amelia Stanton, PhD principal investigator
Boston University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRIDE QUIT and Enhanced Treatment As Usual (ETAU) in people with Smoking Cessation and Depression, run by Massachusetts General Hospital 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 5 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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Conall M O'Cleirigh, PhD (617-643-0385, cocleirigh@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: Through the end of treatment intervention, approximately 6 weeks). The study lists 2 primary outcomes in all. 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 8 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.