Tobacco UseTHRRPNCT04523948
Comparative Tobacco Interventions for Individuals With Severe and Persisting Behavioral Health Disorders
An observational study of Tobacco Use, run by Rose Research Center, LLC at 1 site in United States.
Trial summary
The aim of this pilot intervention is to examine the acceptability of a harm reduction intervention approach to tobacco use for individuals with serious behavioral health disorders and its association with a decrease in smoking. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tobacco Use
- What is being tested?
- Behavioral and pharmacological support to reduce combustible tobacco use.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2020to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Adult, Older adult
Study population: Adult individuals who are or have been served by public systems related to a mental health or substance use disorder and are currently using combustible tobacco.
Who may be able to join
- Individuals who are formerly or currently being served by San Francisco Bay Area Public Health behavioral health providers. These will include individuals with psychotic, affective, anxiety, personality and substance use disorders.
- Individuals who are not currently enrolled in another formal tobacco intervention or research study.
- Are at least 21 years of age and able to speak English*
- Who score in the "low to moderate dependence" range on the Fagerstrom Test of Nicotine Dependence
- Have used tobacco for at least two years
- Express willingness to participate at least weekly in the intervention strategy
Show all 10Show fewer
- Express a desire to make some change in their tobacco use pattern
- Express some reason to change their tobacco use pattern
- Have the cognitive capacity to be able to sign a consent to participate in the research
- A concerted effort will be made to recruit bilingual Chinese and Spanish language staff
Who cannot join
- The individual does not currently smoke tobacco
- Individuals younger than 21 years of age at the time of enrollment
- Who score in the "low" range on the Fagerstrom Test of Nicotine Dependence
- Have used tobacco for less than two years;
- Express unwillingness to participate at least weekly in the intervention strategy
- Decline an interest in making some change in their tobacco use pattern
- Do not indicate the cognitive capacity to be able to sign a consent to participate in the research
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
San Francisco Study Center
San Francisco, California, 94102
joni beemsterboer, mph, 628-239-5294, jonithrrp@gmail.com
kevin mcgirr, ms, mph, 415.290.3416, kevin.mcgirr@ucsf.edu
About this study
The aim of this pilot intervention is to examine the acceptability of a harm reduction intervention approach to tobacco use for individuals with serious behavioral health disorders and its association with a decrease in smoking. The intervention uses a "dynamic" approach to patient choice, allowing participants the option to explore different strategies for harm reduction, while providing support from counselors in the process. Therefore, the investigators have chosen an observational study design in order to document and explore the acceptability and outcomes of the intervention.
Read the detailed description
Background and Significance
The high rate of combustible tobacco use among persons with schizophrenia, affective, post traumatic stress and substance misuse disorders is well documented. Over 40% of the estimated 9.8 million Americans, or 4.0% of the total population, who have serious behavioral health disorders smoke cigarettes, at a rate two to three times higher than the general population. The adverse health consequences and abbreviated lifespan for these persons is also well documented. Given the greater rate of tobacco use, persons with behavioral health disorders are at greater risk for morbidity, e.g., respiratory and cardio-vascular illness, and pre-mature mortality. The relationship of individuals in these communities to combustible tobacco in its pharmacological, sensorimotor and behavioral aspects is compelling. There is a significant literature documenting the endorsement and benefit of nicotine and smoking behavior for individuals in these communities.
Clinical or personal context contribute to the barriers in making change, e.g., the social acceptability of smoking, lack of support, poor access to interventions, the need to mitigate stress and other symptoms of serious mental illness. The need for meaningful structure and daily engagement leads many to use tobacco to fill time and as a distraction. However, many individuals express a desire to quit or further reduce their tobacco consumption. Conventional tobacco interventions and approaches, e.g., smoking cessation, quit lines, informal telephone counseling, FDA approved Nicotine Replacement Therapies (NRTs) and medications have limited documented success. Existing evidence indicates that the combination of pharmacological intervention along with behavioral support is superior to either of these interventions alone. However the behavioral support aspect is usually limited to four to eight sessions.
Local Need
As documented by the State,California has led the way in the progressive decrease in combustible tobacco use. San Francisco County has a 10.8% rate of smoking. Over 25,000 adults received service on an annual basis from the San Francisco Department of Public Health. Of these service recipients at least 6028 adults or 24% (18 or older) are smokers, 5722 persons report having never smoked and for another 7926 (31.5%) smoking status is unknown. The larger department of public health offers smoking cessation services however there are no dedicated services targeting the behavioral health service user. Tobacco use is increasingly of concern for behavioral health program administrators and managers. Recruitment of programs for this research effort was met with enthusiasm and an unambiguous expression of a need for an intensive, harm reduction approach to tobacco intervention. The local Health Department division of Behavioral Health Services maintains a dedicated Harm Reduction policy regarding substance use behaviors.
Consultants were retained to conduct, record and analyze the experience, barriers, challenges and satisfaction with smoking and smoking cessation attempts for individuals with behavioral health disorders through the facilitation of four focus groups. In summary, focus group participants report an understanding of smoking as an addiction integral to their daily lives; that its pleasurable effects override health concerns; that cigarettes are a "friend" and something to pass time and overcome boredom; that they understood restrictions on smoking but also feel harassed or demeaned for smoking; and that not smoking requires "willpower" against a powerful addiction. Some felt that a "harm reduction" approach, e.g., gradual reduction was best and most acknowledge that relapse was a common experience. There was a wealth of experience with smoking cessation and a diversity of satisfaction with various intervention strategies. Gum and patch were generally reported as not satisfying; Chantix was found to be helpful and a curiosity about inhaler or vaping as long as it is safe. Individuals also reported on personal strategies to help with reduction or cessation. More generally, individuals wanted more information about the range of choices. Some noted that access through insurance was a barrier except for those who had both Medicaid and Medicare. It is notable that participants report that they did not appreciate preaching or lecturing about the need to stop smoking. The conclusion is that individuals express a desire to reduce or abstain from tobacco use and also express the need for more help in doing so. Interest in the various intervention choices is diverse however gradual reduction with some aide appears to be the modal choice.
Hypotheses
- A Harm Reduction approach will result in a decrease in daily combustible tobacco use when compared to baseline use.
- Support and harm reduction approaches will be important to acceptability.
Research Questions
- Does this Harm Reduction approach reduce combustible tobacco use when compared to baseline use?
- Which strategies or combination of strategies demonstrate a greater or lesser impact in combustible tobacco use?
- At what service intensity points, e.g., intervention dose as defined by number of weeks, does combustible tobacco use decrease?
- To what degree does this Harm Reduction approach retain individuals in this intervention, i.e., acceptability of intervention?
- What are participants' experiences with factors that enable success or barriers?
- Conditions
- Tobacco Use
- Being tested
- Behavioral and pharmacological support to reduce combustible tobacco use.
- Keywords
- Mental Heatlh, Substance Use, Harm Reduction
- Medical subject headings
- Tobacco Use, Substance-Related Disorders, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral and pharmacological support to reduce combustible tobacco use.Behavioural
Behavioral and pharmacological support to reduce combustible tobacco use.
| Study group | Role | What they receive |
|---|---|---|
| Cohort One | Subjects will be invited to participate in brief weekly in person or telehealth behavioral support with the objective of reducing their rate of combustible tobacco use. Subjects will also be offered the choice of various conventional nicotine replacement aids, snus, electronic cigarette, varenicline or bupropion. Receives: Behavioral: Behavioral and pharmacological support to reduce combustible tobacco use. | |
| Cohort Two | Subjects will be invited to participate in brief weekly in person or telehealth behavioral support with the objective of reducing their rate of combustible tobacco use. Subjects will also be offered the choice of various conventional nicotine replacement aids, snus, electronic cigarette, varenicline or bupropion. Receives: Behavioral: Behavioral and pharmacological support to reduce combustible tobacco use. | |
| Cohort Three | Subjects will be invited to participate in brief weekly in person or telehealth behavioral support with the objective of reducing their rate of combustible tobacco use. Subjects will also be offered the choice of various conventional nicotine replacement aids, snus, electronic cigarette, varenicline or bupropion. Receives: Behavioral: Behavioral and pharmacological support to reduce combustible tobacco use. | |
| Cohort Four | Subjects will be invited to participate in brief weekly in person or telehealth behavioral support with the objective of reducing their rate of combustible tobacco use. Subjects will also be offered the choice of various conventional nicotine replacement aids, snus, electronic cigarette, varenicline or bupropion. Receives: Behavioral: Behavioral and pharmacological support to reduce combustible tobacco use. | |
| Cohort Five | Subjects will be invited to participate in brief weekly in person or telehealth behavioral support with the objective of reducing their rate of combustible tobacco use. Subjects will also be offered the choice of various conventional nicotine replacement aids, snus, electronic cigarette, varenicline or bupropion. Receives: Behavioral: Behavioral and pharmacological support to reduce combustible tobacco use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cigarettes smoked
Self-reported number of cigarettes smoked per day
Measured: Change in number of cigarettes smoked per day will be assessed using two time frames: 1) Baseline to 6 months post baseline; and 2) Post intervention which is change from baseline to 12 months post baseline.
Nicotine Dependence
Fagerström Test for Nicotine Dependence, a self-reported scale rated from 0-10, with >=5 indicating dependence (Heatherton et al., 1991).
Measured: Change in nicotine dependence will be assessed using two time frames: 1) during the intervention, which is change from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline
Carbon Monoxide
Exhaled carbon monoxide level concentration reported in parts per million (ppm) using a breathalyzer assay
Measured: Change in carbon monoxide level will be assessed using two time frames: 1) during the intervention, which is change from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline
Salivary Tobacco Use
Salivary tobacco use level reported in nicotine metabolites (cotinine)
Measured: Change in salivary nicotine level will be assessed using two time frames: 1) during the intervention, which is change from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline
Secondary outcomes (3)
Smoking Decisional Balance
Smoking Decisional Balance is a 6-item self-reported scale which assesses readiness to change in terms of pros (scored from 3-15) and cons (scored from 3-15), based on the Transtheoretical Model of Behavior Change (https://habitslab.umbc.edu/publications/)
Measured: Change in smoking decisional balance will be assessed using two time frames: 1) during the intervention, which is change from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline
Challenges to Smoking Behavior Change
The Challenges to Smoking Behavior Change is a 21 item self-reported scale assessing intrinsic challenges (scored from 9-36) and extrinsic challenges (scored from 12-48) to quitting or reducing smoking (Thomas et al., 2016)
Measured: Change in challenges to smoking behavior change will be assessed on two occasions: 1) during the intervention from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline.
Working Alliance Inventory
The Working Alliance Inventory Short Revised version (Busseri \& Tyler, 2003) is a 12-item measure that captures three key therapeutic alliance aspects (Horvath \& Greenberg, 1989), each scored from 5-20: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond
Measured: Change in working alliance quality will be assessed using two time frames: 1) during the intervention, which is change from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start30 Jan 2020
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rose Research Center, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Foundation for a Smoke Free World INC
- Responsible party
- Sponsor
- Investigators
- Kevin McGirr, MS, MPH, Principal investigator, San Francisco Study Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523948
- Sponsor's protocol ID
- GG-0037
- Acronym
- THRRP
- Status last verified
- Sep 2021
- First submitted
- 23 Jul 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share IPD.
Publications
Dickerson F, Stallings CR, Origoni AE, Vaughan C, Khushalani S, Schroeder J, Yolken RH. Cigarette smoking among persons with schizophrenia or bipolar disorder in routine clinical settings, 1999-2011. Psychiatr Serv. 2013 Jan;64(1):44-50. doi: 10.1176/appi.ps.201200143.
PubMed 23280457Evins AE, Cather C, Laffer A. Treatment of tobacco use disorders in smokers with serious mental illness: toward clinical best practices. Harv Rev Psychiatry. 2015 Mar-Apr;23(2):90-8. doi: 10.1097/HRP.0000000000000063.
PubMed 25747922Glasheen C, Hedden SL, Forman-Hoffman VL, Colpe LJ. Cigarette smoking behaviors among adults with serious mental illness in a nationally representative sample. Ann Epidemiol. 2014 Oct;24(10):776-80. doi: 10.1016/j.annepidem.2014.07.009. Epub 2014 Jul 30.
PubMed 25169683Hartmann-Boyce J, Chepkin SC, Ye W, Bullen C, Lancaster T. Nicotine replacement therapy versus control for smoking cessation. Cochrane Database Syst Rev. 2018 May 31;5(5):CD000146. doi: 10.1002/14651858.CD000146.pub5.
PubMed 29852054Jensen AB, Hounsgaard L. "I only smoke when I have nothing to do": a qualitative study on how smoking is part of everyday life in a Greenlandic village. Int J Circumpolar Health. 2013 Aug 5;72. doi: 10.3402/ijch.v72i0.21657. eCollection 2013.
PubMed 23967409Lindson-Hawley N, Banting M, West R, Michie S, Shinkins B, Aveyard P. Gradual Versus Abrupt Smoking Cessation: A Randomized, Controlled Noninferiority Trial. Ann Intern Med. 2016 May 3;164(9):585-92. doi: 10.7326/M14-2805. Epub 2016 Mar 15.
PubMed 26975007Lindson-Hawley N, Hartmann-Boyce J, Fanshawe TR, Begh R, Farley A, Lancaster T. Interventions to reduce harm from continued tobacco use. Cochrane Database Syst Rev. 2016 Oct 13;10(10):CD005231. doi: 10.1002/14651858.CD005231.pub3.
PubMed 27734465Rae J, Pettey D, Aubry T, Stol J. Factors affecting smoking cessation efforts of people with severe mental illness: a qualitative study. J Dual Diagn. 2015;11(1):42-9. doi: 10.1080/15504263.2014.992096.
PubMed 25491704Schroeder SA, Morris CD. Confronting a neglected epidemic: tobacco cessation for persons with mental illnesses and substance abuse problems. Annu Rev Public Health. 2010;31:297-314 1p following 314. doi: 10.1146/annurev.publhealth.012809.103701.
PubMed 20001818Stead LF, Koilpillai P, Fanshawe TR, Lancaster T. Combined pharmacotherapy and behavioural interventions for smoking cessation. Cochrane Database Syst Rev. 2016 Mar 24;3(3):CD008286. doi: 10.1002/14651858.CD008286.pub3.
PubMed 27009521Twyman L, Bonevski B, Paul C, Bryant J. Perceived barriers to smoking cessation in selected vulnerable groups: a systematic review of the qualitative and quantitative literature. BMJ Open. 2014 Dec 22;4(12):e006414. doi: 10.1136/bmjopen-2014-006414.
PubMed 25534212Uppal N, Shahab L, Britton J, Ratschen E. The forgotten smoker: a qualitative study of attitudes towards smoking, quitting, and tobacco control policies among continuing smokers. BMC Public Health. 2013 May 3;13:432. doi: 10.1186/1471-2458-13-432.
PubMed 23641875
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Tobacco Interventions for Individuals With Severe and Persisting Behavioral Health Disorders
- ClinicalTrials.gov ID
- NCT04523948
- Acronym / sponsor ID
- THRRP / GG-0037
- Conditions
- Tobacco Use
- Keywords
- Mental Heatlh, Substance Use, Harm Reduction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rose Research Center, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Foundation for a Smoke Free World INC
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 24 Aug 2020 (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.
The aim of this pilot intervention is to examine the acceptability of a harm reduction intervention approach to tobacco use for individuals with serious behavioral health disorders and its association with a decrease in smoking. The intervention uses a "dynamic" approach to patient choice, allowing participants the option to explore different strategies for harm reduction, while providing support from counselors in the process. Therefore, the investigators have chosen an observational study design in order to document and explore the acceptability and outcomes of the intervention.
Detailed description
Background and Significance
The high rate of combustible tobacco use among persons with schizophrenia, affective, post traumatic stress and substance misuse disorders is well documented. Over 40% of the estimated 9.8 million Americans, or 4.0% of the total population, who have serious behavioral health disorders smoke cigarettes, at a rate two to three times higher than the general population. The adverse health consequences and abbreviated lifespan for these persons is also well documented. Given the greater rate of tobacco use, persons with behavioral health disorders are at greater risk for morbidity, e.g., respiratory and cardio-vascular illness, and pre-mature mortality. The relationship of individuals in these communities to combustible tobacco in its pharmacological, sensorimotor and behavioral aspects is compelling. There is a significant literature documenting the endorsement and benefit of nicotine and smoking behavior for individuals in these communities.
Clinical or personal context contribute to the barriers in making change, e.g., the social acceptability of smoking, lack of support, poor access to interventions, the need to mitigate stress and other symptoms of serious mental illness. The need for meaningful structure and daily engagement leads many to use tobacco to fill time and as a distraction. However, many individuals express a desire to quit or further reduce their tobacco consumption. Conventional tobacco interventions and approaches, e.g., smoking cessation, quit lines, informal telephone counseling, FDA approved Nicotine Replacement Therapies (NRTs) and medications have limited documented success. Existing evidence indicates that the combination of pharmacological intervention along with behavioral support is superior to either of these interventions alone. However the behavioral support aspect is usually limited to four to eight sessions.
Local Need
As documented by the State,California has led the way in the progressive decrease in combustible tobacco use. San Francisco County has a 10.8% rate of smoking. Over 25,000 adults received service on an annual basis from the San Francisco Department of Public Health. Of these service recipients at least 6028 adults or 24% (18 or older) are smokers, 5722 persons report having never smoked and for another 7926 (31.5%) smoking status is unknown. The larger department of public health offers smoking cessation services however there are no dedicated services targeting the behavioral health service user. Tobacco use is increasingly of concern for behavioral health program administrators and managers. Recruitment of programs for this research effort was met with enthusiasm and an unambiguous expression of a need for an intensive, harm reduction approach to tobacco intervention. The local Health Department division of Behavioral Health Services maintains a dedicated Harm Reduction policy regarding substance use behaviors.
Consultants were retained to conduct, record and analyze the experience, barriers, challenges and satisfaction with smoking and smoking cessation attempts for individuals with behavioral health disorders through the facilitation of four focus groups. In summary, focus group participants report an understanding of smoking as an addiction integral to their daily lives; that its pleasurable effects override health concerns; that cigarettes are a "friend" and something to pass time and overcome boredom; that they understood restrictions on smoking but also feel harassed or demeaned for smoking; and that not smoking requires "willpower" against a powerful addiction. Some felt that a "harm reduction" approach, e.g., gradual reduction was best and most acknowledge that relapse was a common experience. There was a wealth of experience with smoking cessation and a diversity of satisfaction with various intervention strategies. Gum and patch were generally reported as not satisfying; Chantix was found to be helpful and a curiosity about inhaler or vaping as long as it is safe. Individuals also reported on personal strategies to help with reduction or cessation. More generally, individuals wanted more information about the range of choices. Some noted that access through insurance was a barrier except for those who had both Medicaid and Medicare. It is notable that participants report that they did not appreciate preaching or lecturing about the need to stop smoking. The conclusion is that individuals express a desire to reduce or abstain from tobacco use and also express the need for more help in doing so. Interest in the various intervention choices is diverse however gradual reduction with some aide appears to be the modal choice.
Hypotheses
- A Harm Reduction approach will result in a decrease in daily combustible tobacco use when compared to baseline use.
- Support and harm reduction approaches will be important to acceptability.
Research Questions
- Does this Harm Reduction approach reduce combustible tobacco use when compared to baseline use?
- Which strategies or combination of strategies demonstrate a greater or lesser impact in combustible tobacco use?
- At what service intensity points, e.g., intervention dose as defined by number of weeks, does combustible tobacco use decrease?
- To what degree does this Harm Reduction approach retain individuals in this intervention, i.e., acceptability of intervention?
- What are participants' experiences with factors that enable success or barriers?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort One | – | Behavioral: Behavioral and pharmacological support to reduce combustible tobacco use.Subjects will be invited to participate in brief weekly in person or telehealth behavioral support with the objective of reducing their rate of combustible tobacco use. Subjects will also be offered the choice of various conventional nicotine replacement aids, snus, electronic cigarette, varenicline or bupropion. |
| Cohort Two | – | Behavioral: Behavioral and pharmacological support to reduce combustible tobacco use.Subjects will be invited to participate in brief weekly in person or telehealth behavioral support with the objective of reducing their rate of combustible tobacco use. Subjects will also be offered the choice of various conventional nicotine replacement aids, snus, electronic cigarette, varenicline or bupropion. |
| Cohort Three | – | Behavioral: Behavioral and pharmacological support to reduce combustible tobacco use.Subjects will be invited to participate in brief weekly in person or telehealth behavioral support with the objective of reducing their rate of combustible tobacco use. Subjects will also be offered the choice of various conventional nicotine replacement aids, snus, electronic cigarette, varenicline or bupropion. |
| Cohort Four | – | Behavioral: Behavioral and pharmacological support to reduce combustible tobacco use.Subjects will be invited to participate in brief weekly in person or telehealth behavioral support with the objective of reducing their rate of combustible tobacco use. Subjects will also be offered the choice of various conventional nicotine replacement aids, snus, electronic cigarette, varenicline or bupropion. |
| Cohort Five | – | Behavioral: Behavioral and pharmacological support to reduce combustible tobacco use.Subjects will be invited to participate in brief weekly in person or telehealth behavioral support with the objective of reducing their rate of combustible tobacco use. Subjects will also be offered the choice of various conventional nicotine replacement aids, snus, electronic cigarette, varenicline or bupropion. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult individuals who are or have been served by public systems related to a mental health or substance use disorder and are currently using combustible tobacco.
Key inclusion criteria (10 listed)
- Individuals who are formerly or currently being served by San Francisco Bay Area Public Health behavioral health providers. These will include individuals with psychotic, affective, anxiety, personality and substance use disorders.
- Individuals who are not currently enrolled in another formal tobacco intervention or research study.
- Are at least 21 years of age and able to speak English*
- Who score in the "low to moderate dependence" range on the Fagerstrom Test of Nicotine Dependence
- Have used tobacco for at least two years
Key exclusion criteria (7 listed)
- The individual does not currently smoke tobacco
- Individuals younger than 21 years of age at the time of enrollment
- Who score in the "low" range on the Fagerstrom Test of Nicotine Dependence
- Have used tobacco for less than two years;
- Express unwillingness to participate at least weekly in the intervention strategy
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 |
|---|---|---|
| Behavioral and pharmacological support to reduce combustible tobacco use.Behavioral and pharmacological support to reduce combustible tobacco use. | Behavioural | Cohort Five, Cohort Four, Cohort One, Cohort Three, Cohort Two |
Primary outcome
Number of cigarettes smoked
Time frame: Change in number of cigarettes smoked per day will be assessed using two time frames: 1) Baseline to 6 months post baseline; and 2) Post intervention which is change from baseline to 12 months post baseline.
Self-reported number of cigarettes smoked per day
Nicotine Dependence
Time frame: Change in nicotine dependence will be assessed using two time frames: 1) during the intervention, which is change from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline
Fagerström Test for Nicotine Dependence, a self-reported scale rated from 0-10, with >=5 indicating dependence (Heatherton et al., 1991).
Carbon Monoxide
Time frame: Change in carbon monoxide level will be assessed using two time frames: 1) during the intervention, which is change from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline
Exhaled carbon monoxide level concentration reported in parts per million (ppm) using a breathalyzer assay
Salivary Tobacco Use
Time frame: Change in salivary nicotine level will be assessed using two time frames: 1) during the intervention, which is change from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline
Salivary tobacco use level reported in nicotine metabolites (cotinine)
3 secondary outcomes
Smoking Decisional Balance
Time frame: Change in smoking decisional balance will be assessed using two time frames: 1) during the intervention, which is change from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline
Challenges to Smoking Behavior Change
Time frame: Change in challenges to smoking behavior change will be assessed on two occasions: 1) during the intervention from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline.
Working Alliance Inventory
Time frame: Change in working alliance quality will be assessed using two time frames: 1) during the intervention, which is change from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Background: PubMed 23280457Dickerson F, Stallings CR, Origoni AE, Vaughan C, Khushalani S, Schroeder J, Yolken RH. Cigarette smoking among persons with schizophrenia or bipolar disorder in routine clinical settings, 1999-2011. Psychiatr Serv. 2013 Jan;64(1):44-50. doi: 10.1176/appi.ps.201200143.
- Background: PubMed 25747922Evins AE, Cather C, Laffer A. Treatment of tobacco use disorders in smokers with serious mental illness: toward clinical best practices. Harv Rev Psychiatry. 2015 Mar-Apr;23(2):90-8. doi: 10.1097/HRP.0000000000000063.
- Background: PubMed 25169683Glasheen C, Hedden SL, Forman-Hoffman VL, Colpe LJ. Cigarette smoking behaviors among adults with serious mental illness in a nationally representative sample. Ann Epidemiol. 2014 Oct;24(10):776-80. doi: 10.1016/j.annepidem.2014.07.009. Epub 2014 Jul 30.
- Background: PubMed 29852054Hartmann-Boyce J, Chepkin SC, Ye W, Bullen C, Lancaster T. Nicotine replacement therapy versus control for smoking cessation. Cochrane Database Syst Rev. 2018 May 31;5(5):CD000146. doi: 10.1002/14651858.CD000146.pub5.
- Background: PubMed 23967409Jensen AB, Hounsgaard L. "I only smoke when I have nothing to do": a qualitative study on how smoking is part of everyday life in a Greenlandic village. Int J Circumpolar Health. 2013 Aug 5;72. doi: 10.3402/ijch.v72i0.21657. eCollection 2013.
- Background: PubMed 26975007Lindson-Hawley N, Banting M, West R, Michie S, Shinkins B, Aveyard P. Gradual Versus Abrupt Smoking Cessation: A Randomized, Controlled Noninferiority Trial. Ann Intern Med. 2016 May 3;164(9):585-92. doi: 10.7326/M14-2805. Epub 2016 Mar 15.
- Background: PubMed 27734465Lindson-Hawley N, Hartmann-Boyce J, Fanshawe TR, Begh R, Farley A, Lancaster T. Interventions to reduce harm from continued tobacco use. Cochrane Database Syst Rev. 2016 Oct 13;10(10):CD005231. doi: 10.1002/14651858.CD005231.pub3.
- Background: PubMed 25491704Rae J, Pettey D, Aubry T, Stol J. Factors affecting smoking cessation efforts of people with severe mental illness: a qualitative study. J Dual Diagn. 2015;11(1):42-9. doi: 10.1080/15504263.2014.992096.
- Background: PubMed 20001818Schroeder SA, Morris CD. Confronting a neglected epidemic: tobacco cessation for persons with mental illnesses and substance abuse problems. Annu Rev Public Health. 2010;31:297-314 1p following 314. doi: 10.1146/annurev.publhealth.012809.103701.
- Background: PubMed 27009521Stead LF, Koilpillai P, Fanshawe TR, Lancaster T. Combined pharmacotherapy and behavioural interventions for smoking cessation. Cochrane Database Syst Rev. 2016 Mar 24;3(3):CD008286. doi: 10.1002/14651858.CD008286.pub3.
- Background: PubMed 25534212Twyman L, Bonevski B, Paul C, Bryant J. Perceived barriers to smoking cessation in selected vulnerable groups: a systematic review of the qualitative and quantitative literature. BMJ Open. 2014 Dec 22;4(12):e006414. doi: 10.1136/bmjopen-2014-006414.
- Background: PubMed 23641875Uppal N, Shahab L, Britton J, Ratschen E. The forgotten smoker: a qualitative study of attitudes towards smoking, quitting, and tobacco control policies among continuing smokers. BMC Public Health. 2013 May 3;13:432. doi: 10.1186/1471-2458-13-432.
- Individual participant dataSharing planned: No. There is currently no plan to share IPD.
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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.
Kevin McGirr, MS, MPH principal investigator
San Francisco Study Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tobacco Use, run by Rose Research Center, LLC 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 10 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kevin McGirr, MS, MPH (415.290.3416, kevin.mcgirr@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cigarettes smoked (time frame: Change in number of cigarettes smoked per day will be assessed using two time frames: 1) Baseline to 6 months post baseline; and 2) Post intervention which is change from baseline to 12 months post baseline.). The study lists 4 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 NCT04523948, which also lists 12 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 28 Sep 2021.