Smoking CessationRITChNCT02785536
RITCH: Reducing Disparities in Tobacco Cessation Outcomes
A study testing RITCh Treatment and Standard Treatment in people with Smoking Cessation, run by The City College of New York at 1 site in United States.
Trial summary
Tobacco use is a leading contributor to racial and socioeconomic health disparities in the US primarily due to an unequal burden of tobacco-related disease from a disproportionate share of smokers in African American and lower socioeconomic (SES) groups. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- RITCh Treatment and Standard Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jun 2015
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- smoking cigarettes daily
- expressing a desire to quit smoking in the next 30 days
- no regular use of other tobacco products
- age 18 years or older
- no plans to move from the area in the next six months
- willing to comply with treatment
- able to engage in treatment
Who cannot join
- any contra-indication for use of the nicotine patch (i.e., uncontrolled high blood pressure, allergic reaction to patch adhesive, pregnancy, etc.),
- currently using mediations for smoking cessation (bupropion, varenicline, or any form of NRT)
- drinking more than 20 alcoholic drinks per week
- positive test on a urine screen for drugs of abuse at baseline (amphetamine, methamphetamine, cannabis, cocaine, opioids, methadone, etc.)
- current diagnosis that would prohibit engagement in brief CBT (active psychotic disorder, acute major depressive episode, significantly cognitively impaired)
- current regular use of other forms of tobacco other than smoking cigarettes
Trial locations and contacts
1 site in 1 country.
United States1 site
The City College of New York
New York, New York, 10031
About this study
Tobacco use is a leading contributor to racial and socioeconomic health disparities in the US primarily due to an unequal burden of tobacco-related disease from a disproportionate share of smokers in African American and lower socioeconomic (SES) groups. Unlike many other health risk behaviors, tobacco-related health disparities are increasing despite a large treatment network of free telephone and in-person counseling services, perhaps due to significant disparities in treatment outcomes. The goal of this project is to revise the standard treatment for tobacco dependence to address key factors associated with treatment outcome disparities and more fully meet the needs of lower SES and African American smokers thereby reducing socioeconomic disparities in tobacco dependence treatment outcomes, halting the alarming increase in tobacco-related health disparities, and reducing a leading cause of racial and socioeconomic health disparities in the US.
Read the detailed description
This study will be conducted in five phases. Each phase utilizes the results from the previous phase. Each phase is also associated with at least one specific aim.
Phase One (Aim One): Complete a revised version of a standard, widely utilized, multi-component, cognitive-behavior treatment manual for tobacco dependence to include commonly utilized, cognitive-behavioral interventions that specifically address the key factors associated with treatment outcome disparities.
Phase Two (Aim Two): Using the PEN-3 Model,1-3 target and tailor RITCh_1 to address the needs of smokers who are of lower SES as well as smokers who are minority, particularly African American. In this preparatory activity, the research team will tailor and target RITCh_1 using this well-accepted theoretical model and produce the second draft of the revised treatment, called RITCh_2. Human subjects are not involved with this phase of the research. No data will be collected.
Phase Three (Aim Three): Pilot test RITCh_2 with three treatment groups (5-10 participants per group) to assess understandability and acceptability and to ensure that it can be delivered in the same 60-minute per session time frame as the standard treatment. This is a qualitative study in which the investigators will pilot test RITCh_2 with 21 participants who will be consented as pilot study participants. See Pilot Study Informed Consent Form. Contact and demographic information will be collected from participants, but not baseline and outcome assessments. Participant feedback will be provided in a group format and will not be linked to identifying information. The research team will incorporate participant feedback into a third draft of the revised treatment, RITCh_3.
Phase Four (Aim Four): Compare the effects of SES on treatment outcomes in a socioeconomically and racially diverse group of participants treated with RITCh_3 and the standard treatment. The investigators will conduct a randomized controlled trial (n=253) comparing the efficacy of RITCh_3 to the standard treatment. Investigators will use a randomized treatment design and two methods for assessing abstinence (latency to relapse and six-month point prevalence abstinence rates) to compare the effects of SES and treatment condition on treatment outcomes. Investigators expect RITCh_3 to demonstrate fewer treatment outcome disparities than standard treatment.
Phase Five (Aim Five): Compare the effects of RITCH_3 and standard treatment on each of the key factors associated with treatment outcome disparities (see Aim One and Table 1). Using analysis of covariance and logistic regression as appropriate, investigators will analyze the effects of treatment condition on each of the key factors (see Table 1). The investigators expect participants treated with RITCh_3 to demonstrate more improvement on each of the key factors than participants treated with standard treatment.
- Conditions
- Smoking Cessation
- Being tested
- RITCh Treatment, Standard Treatment
- Keywords
- minority health, social class, healthcare disparities, tobacco use disorder
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RITCh TreatmentBehavioural
The RITCh treatment increased the emphasis on stress management, negative affect management and utilized language and activities to foster an internal locus of control. Activities were added to address impulsive decision-making, develop home smoking policies, increase the positive valance of treatment, and address barriers to use of the nicotine patches. The treatment materials were also tailored with numerous examples relevant to lower SES groups and African Americans. For example: stress management components specifically address financial stress, discrimination, and micro-aggressions; treatment utilization components include reinforcing the value of individual contributions to the group, structured positive feedback among group members at every session, sending "missed you" post cards signed by all group members to participants who miss a treatment session, specifically addressing myths about nicotine patch use, and practicing the application of nicotine patches together.
Standard TreatmentBehavioural
The components of the standard treatment include education and activities in which participants gain an understanding of the biopsychosocial underpinnings of tobacco dependence and the cue-urge-response cycle of smoking. Interventions include self-monitoring, guided scheduled rate reduction, treatment goal setting, medication education, stress management, cognitive and behavioral strategies for managing cravings and cues, problem-solving, conflict management, enhancing social support, relapse prevention, and cigarette refusal training. A participant workbook was provided that corresponded to the activities in the treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | Active comparator | The standard treatment was a well-established, manual-driven, multicomponent CBT for tobacco dependence that has been delivered in multiple modalities (i.e., group, individual, and telephone), used in numerous studies, and considered intensive, comprehensive, and consistent with the Public Health Service Clinical Practice Guideline. Receives: Behavioral: Standard Treatment |
| RITCh Treatment | Experimental | The RITCh treatment is an adaptation of the standard treatment which proactively addresses the needs and experiences of a diverse group of lower SES smokers as well as ensures that the treatment is culturally congruent and experientially resonant for African Americans while maintaining the same amount of treatment contact (i.e., six one-hour sessions). Receives: Behavioral: RITCh Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency to Relapse
Abstinence will be assessed with latency to relapse (days from Quit Date to relapse or 7 consecutive days of smoking after a 24 hour quit attempt)
Measured: 6 months following scheduled week 3 quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startJul 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- The City College of New York
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Tech Carilion School of Medicine and Research Institute
- Responsible party
- Principal investigator, Christine Sheffer, The City College of New York
- Investigators
- Christine E Sheffer, PhD, Principal investigator, CCNY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785536
- Sponsor's protocol ID
- #361627
- Acronym
- RITCh
- Status last verified
- Jun 2016
- First submitted
- 25 May 2016
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lunden SE, Pittman JC, Prashad N, Malhotra R, Sheffer CE. Cognitive, Behavioral, and Situational Influences on Relapse to Smoking After Group Treatment for Tobacco Dependence. Front Psychol. 2019 Jan 30;9:2756. doi: 10.3389/fpsyg.2018.02756. eCollection 2018.
PubMed 30761059
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RITCH: Reducing Disparities in Tobacco Cessation Outcomes
- ClinicalTrials.gov ID
- NCT02785536
- Acronym / sponsor ID
- RITCh / #361627
- Conditions
- Smoking Cessation
- Keywords
- minority health, social class, healthcare disparities, tobacco use disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- The City College of New YorkUniversity, hospital or other
- Collaborators
- Virginia Tech Carilion School of Medicine and Research Institute
- Study start
- Jul 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 May 2016 (estimated)
- 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.
Tobacco use is a leading contributor to racial and socioeconomic health disparities in the US primarily due to an unequal burden of tobacco-related disease from a disproportionate share of smokers in African American and lower socioeconomic (SES) groups. Unlike many other health risk behaviors, tobacco-related health disparities are increasing despite a large treatment network of free telephone and in-person counseling services, perhaps due to significant disparities in treatment outcomes. The goal of this project is to revise the standard treatment for tobacco dependence to address key factors associated with treatment outcome disparities and more fully meet the needs of lower SES and African American smokers thereby reducing socioeconomic disparities in tobacco dependence treatment outcomes, halting the alarming increase in tobacco-related health disparities, and reducing a leading cause of racial and socioeconomic health disparities in the US.
Detailed description
This study will be conducted in five phases. Each phase utilizes the results from the previous phase. Each phase is also associated with at least one specific aim.
Phase One (Aim One): Complete a revised version of a standard, widely utilized, multi-component, cognitive-behavior treatment manual for tobacco dependence to include commonly utilized, cognitive-behavioral interventions that specifically address the key factors associated with treatment outcome disparities.
Phase Two (Aim Two): Using the PEN-3 Model,1-3 target and tailor RITCh_1 to address the needs of smokers who are of lower SES as well as smokers who are minority, particularly African American. In this preparatory activity, the research team will tailor and target RITCh_1 using this well-accepted theoretical model and produce the second draft of the revised treatment, called RITCh_2. Human subjects are not involved with this phase of the research. No data will be collected.
Phase Three (Aim Three): Pilot test RITCh_2 with three treatment groups (5-10 participants per group) to assess understandability and acceptability and to ensure that it can be delivered in the same 60-minute per session time frame as the standard treatment. This is a qualitative study in which the investigators will pilot test RITCh_2 with 21 participants who will be consented as pilot study participants. See Pilot Study Informed Consent Form. Contact and demographic information will be collected from participants, but not baseline and outcome assessments. Participant feedback will be provided in a group format and will not be linked to identifying information. The research team will incorporate participant feedback into a third draft of the revised treatment, RITCh_3.
Phase Four (Aim Four): Compare the effects of SES on treatment outcomes in a socioeconomically and racially diverse group of participants treated with RITCh_3 and the standard treatment. The investigators will conduct a randomized controlled trial (n=253) comparing the efficacy of RITCh_3 to the standard treatment. Investigators will use a randomized treatment design and two methods for assessing abstinence (latency to relapse and six-month point prevalence abstinence rates) to compare the effects of SES and treatment condition on treatment outcomes. Investigators expect RITCh_3 to demonstrate fewer treatment outcome disparities than standard treatment.
Phase Five (Aim Five): Compare the effects of RITCH_3 and standard treatment on each of the key factors associated with treatment outcome disparities (see Aim One and Table 1). Using analysis of covariance and logistic regression as appropriate, investigators will analyze the effects of treatment condition on each of the key factors (see Table 1). The investigators expect participants treated with RITCh_3 to demonstrate more improvement on each of the key factors than participants treated with standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | Active comparator | Behavioral: Standard TreatmentThe standard treatment was a well-established, manual-driven, multicomponent CBT for tobacco dependence that has been delivered in multiple modalities (i.e., group, individual, and telephone), used in numerous studies, and considered intensive, comprehensive, and consistent with the Public Health Service Clinical Practice Guideline. |
| RITCh Treatment | Experimental | Behavioral: RITCh TreatmentThe RITCh treatment is an adaptation of the standard treatment which proactively addresses the needs and experiences of a diverse group of lower SES smokers as well as ensures that the treatment is culturally congruent and experientially resonant for African Americans while maintaining the same amount of treatment contact (i.e., six one-hour sessions). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- smoking cigarettes daily
- expressing a desire to quit smoking in the next 30 days
- no regular use of other tobacco products
- age 18 years or older
- no plans to move from the area in the next six months
Key exclusion criteria (6 listed)
- any contra-indication for use of the nicotine patch (i.e., uncontrolled high blood pressure, allergic reaction to patch adhesive, pregnancy, etc.),
- currently using mediations for smoking cessation (bupropion, varenicline, or any form of NRT)
- drinking more than 20 alcoholic drinks per week
- positive test on a urine screen for drugs of abuse at baseline (amphetamine, methamphetamine, cannabis, cocaine, opioids, methadone, etc.)
- current diagnosis that would prohibit engagement in brief CBT (active psychotic disorder, acute major depressive episode, significantly cognitively impaired)
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 |
|---|---|---|
| RITCh TreatmentThe RITCh treatment increased the emphasis on stress management, negative affect management and utilized language and activities to foster an internal locus of control. Activities were added to address impulsive decision-making, develop home smoking policies, increase the positive valance of treatment, and address barriers to use of the nicotine patches. The treatment materials were also tailored with numerous examples relevant to lower SES groups and African Americans. For example: stress management components specifically address financial stress, discrimination, and micro-aggressions; treatment utilization components include reinforcing the value of individual contributions to the group, structured positive feedback among group members at every session, sending "missed you" post cards signed by all group members to participants who miss a treatment session, specifically addressing myths about nicotine patch use, and practicing the application of nicotine patches together. | Behavioural | RITCh Treatment |
| Standard TreatmentThe components of the standard treatment include education and activities in which participants gain an understanding of the biopsychosocial underpinnings of tobacco dependence and the cue-urge-response cycle of smoking. Interventions include self-monitoring, guided scheduled rate reduction, treatment goal setting, medication education, stress management, cognitive and behavioral strategies for managing cravings and cues, problem-solving, conflict management, enhancing social support, relapse prevention, and cigarette refusal training. A participant workbook was provided that corresponded to the activities in the treatment sessions. | Behavioural | Standard Treatment |
Primary outcome
Latency to Relapse
Time frame: 6 months following scheduled week 3 quit date
Abstinence will be assessed with latency to relapse (days from Quit Date to relapse or 7 consecutive days of smoking after a 24 hour quit attempt)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2016.
- Derived from this study: PubMed 30761059Lunden SE, Pittman JC, Prashad N, Malhotra R, Sheffer CE. Cognitive, Behavioral, and Situational Influences on Relapse to Smoking After Group Treatment for Tobacco Dependence. Front Psychol. 2019 Jan 30;9:2756. doi: 10.3389/fpsyg.2018.02756. eCollection 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine E Sheffer, PhD principal investigator
CCNY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RITCh Treatment and Standard Treatment in people with Smoking Cessation, run by The City College of New York 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 7 inclusion and 6 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 1 Jul 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Latency to Relapse (time frame: 6 months following scheduled week 3 quit date). 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 NCT02785536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2016.