Smoking CessationPhase 1/2BREATHNCT04130698
Comparing Two Treatments That Both Target Smoking Cessation and Weight Loss at the Same Time.
A Phase 1/2 study testing Distress Tolerance and transdermal nicotine patch in people with Smoking Cessation and Weight Loss, run by Rhode Island College at 1 site in United States.
Trial summary
The study has two phases. In Phase 1, the investigators will revise and pilot the distress tolerance (DT) protocol that was originally developed and piloted in a previous study (2P20 GM103430, Spas, PI). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Smoking Cessation, Weight Loss
- What is being tested?
- Distress Tolerance and transdermal nicotine patch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 31 Jul 2022
- Phase
- Phase 1/2
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- between 18-64 years old
- have been a regular smoker for at least three years
- meet DSM-IV criteria for nicotine dependence
- smoke on average 10 cigarettes per day
- are overweight or obese (25<BMI<40)
- report motivation to quit smoking and lose weight
- speak English.
Who cannot join
- engaged in a smoking cessation or weight loss intervention
- use medications known to affect smoking cessation or weight loss
- have a medical condition that is a contraindication for transdermal nicotine patch (TNP)
- regularly use other tobacco products
- endorse active suicidal or homicidal ideation
- self-report or meet diagnostic criteria for an alcohol or drug dependence
- self-report or meet diagnostic criteria for an eating or neurocognitive disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island College
Providence, Rhode Island, 02908
About this study
Official title: Biobehavioral Regulation to Extinguish Smoking While Treating Another Health Risk
The study has two phases. In Phase 1, the investigators will revise and pilot the distress tolerance (DT) protocol that was originally developed and piloted in a previous study (2P20 GM103430, Spas, PI). Despite the 4-week post-intervention treatment outcomes demonstrating the DT protocol's association with smoking cessation and weight loss, several revisions to the DT protocol are important to improve the intervention. First, the investigators will include the overweight/obese smokers' group-level feedback that the investigators collected during the 7-week intervention and at the 4-week post-intervention individual interviews to tailor the DT protocol to meet the unique needs of smokers with excess weight. Subjects from the previous study revealed factors that led to current and/or previous successful smoking cessation and weight loss efforts, barriers to sustaining current and/or previous successful smoking cessation and weight loss efforts, and general feedback about DT intervention for both health risks. The investigators believe revising the DT protocol to include overweight/obese smokers' unique experience with the novel intervention and their acumen about these key factors will improve the intervention and its generalizability to smokers with excess weight. Additional revisions are described elsewhere. After the investigators pilot the revised DT protocol, the investigators will revise the active health control protocol comprised of standard treatment for smoking cessation and weight loss to ensure both protocols equate for intervention contact time. Although both protocols will have some similar content, to avoid any threats to internal validity, no DT-specific material will be included in the control. In Phase 2, the investigators will conduct a two-armed, preliminary randomized controlled trial (RCT) to compare the revised DT protocol's efficacy to the active health control protocol.
Read the detailed description
In Phase 1, the investigators will revise the distress tolerance (DT) protocol the investigators developed in a previous study. Currently, the DT protocol is comprised of 6 two-hour weekly group sessions. However, based on the data the investigators collected in the previous study, the investigators will revise the DT protocol to have 7 instead of 6 two-hour weekly group sessions. 6 subjects (1 group) will be recruited to pilot the revised DT protocol. All subjects in the pilot will receive the transdermal nicotine patch (TNP). Prior to initiating use of the TNP on quit day, all subjects will be educated about its use and instructed to comply with all the recommended guidelines for usage as outlined in the directions. Smokers who lapse during treatment will be encouraged to set a new quit date and continue to attempt to quit. Subjects who continue to smoke or lapse after quit day will not be instructed to discontinue the patch unless their smoking level reaches 4 cigarettes/day for 4 days. This recommendation is consistent with safe TNP use. Smoking cessation will be objectively verified by expired carbon monoxide levels and saliva cotinine assays. Specifically, subjects who self-report nicotine abstinence will provide an exhaled breath into a Bedfont Micro Smokerlyzer to measure carbon monoxide levels and provide an adequate amount of saliva for cotinine analyses. RAs will wear non-latex gloves and follow all safety protocols for data collection and storage for biochemical materials. the investigators will use an 8ppm cutoff for expired carbon monoxide levels for stated abstinence of 24 hours for 2 weeks and use a cutoff of 10ng/ml for saliva cotinine assays for stated abstinence of 2 weeks or more as cotinine may be incompletely metabolized before this time. Expired carbon monoxide results will be immediately available. Saliva samples will be frozen for shipment to the American Health Foundation (Valhalla, NY) for cotinine level determination by radioimmune assay. Detected values above the stated cutoffs will be considered indicative of smoking. Therefore, smoking cessation and weight loss will be assessed using expired carbon monoxide and weigh-ins during the intervention and saliva cotinine assays and weigh-ins at follow-ups. During Phase 1 post-intervention follow-up, the investigators will revise the active health control protocol comprised of standard treatment for smoking cessation and weight loss to make sure it equates for intervention contact time.
In Phase 2, 48 subjects (8 groups of 6) will be recruited. Both conditions will receive the TNP and follow the protocol previously outlined in Phase 1. Once 6 eligible subjects are recruited, random assignment will be used to determine which of the two treatment conditions the group will receive. We expect to recruit 6 subjects within two weeks, reducing the lag time between a subject's eligibility and starting the intervention. Compensation for subjects' time will also support timely recruitment. To ensure an equal number of groups are assigned to each of the two conditions, assignment will be completed by choosing from among a fixed pool of 8 entries (4 from each condition). Smoking cessation and weight loss outcomes will be assessed using biochemical measures and weigh-ins during the intervention and at follow-up.
- Conditions
- Smoking Cessation, Weight Loss
- Being tested
- Distress Tolerance, transdermal nicotine patch, Active Health Control
- Medical subject headings
- Smoking Cessation, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distress ToleranceBehavioural
The group-level intervention is comprised of one 2-hour weekly group sessions with overweight smokers to learn skills and strategies consistent with distress tolerance intervention to quit smoking and lose weight.
transdermal nicotine patchDrug
Also called the "patch"
Participants will use the patch for 8 weeks as outlined by the recommended usage for steps 1-3 going from 21mg for 4 weeks, 14mg for 1 week, and 7mg for 1 week.
Active Health ControlBehavioural
Also called Psychoeducation
The group-level intervention is comprised of one 2-hour weekly group sessions with overweight smokers to learn skills and strategies consistent with psychoeducation intervention to quit smoking and lose weight.
| Study group | Role | What they receive |
|---|---|---|
| Distress Tolerance | Experimental | Treatment rationale: RAs will explain that there are 3 (not 2 as in the control) key factors that maintain smoking behavior and excess weight: 1) learned habits, 2) the addictive properties of smoking and food, and 3) a way to manage distress. Therefore, to be effective, an intervention designed to simultaneously treat smoking cessation and weight loss must address all 3 key factors. This condition includes both key factors in the control but introduces the third key factor distress tolerance (DT). Toward that end, modules will include: a values discussion; experiential avoidance; distress tolerance; and mindfulness-based ways to manage distress.
Module 1: Orientation \& ACT; Module 2: Avoidance; Module 3: Cognitive Fusion vs. Defusion; Module 4: Self-As-Context; Module 5: Present-Moment-Awareness; and Module 6: Values and Committed Action. Receives: Behavioral: Distress Tolerance; Drug: transdermal nicotine patch |
| Active Health Control | Active comparator | Treatment rationale: RAs will explain that there are 2 key factors that maintain smoking behavior and excess weight: 1) learned habits and 2) the addictive properties of smoking and food. Therefore, to be effective, an intervention designed to simultaneously treat smoking cessation and weight loss must address both key factors. Toward that end, modules will include standard treatment on: the dangers of smoking, excess weight, unhealthy diets and sedentariness; the importance of healthy behaviors; and relaxation exercises to manage stress. These are all key aspects of standard treatment for smoking cessation and weight loss.
Module 1: Orientation and Health; Module 2: Game Plan; Module 3: Stress and Coping Strategies; Module 4: Physical Activity; Module 5: Changes in Activities, Habits and Lifestyle; and Module 6: Long-Term Rewards. Receives: Drug: transdermal nicotine patch; Behavioral: Active Health Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point-prevalence abstinence from smoking
saliva cotinine assays
Measured: 6-month follow-up assessments from the end of intervention.
5% lower weight from baseline.
weigh-ins
Measured: 6-month follow-up assessments from the end of intervention
Secondary outcomes (1)
Include latency to first smoking lapse and latency to smoking relapse
saliva cotinine assays
Measured: 6-month follow-up assessments from the end of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start1 Jun 2019
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022
Why it stopped: Due to COVID-19, public health guidelines prevent in-person group meetings.
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island College
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jayson J Spas, PhD, MS, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130698
- Sponsor's protocol ID
- 1819-1483
- Other IDs
- R15DA045917-01A1
- Acronym
- BREATH
- Status last verified
- Oct 2022
- First submitted
- 9 Oct 2019
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral Regulation to Extinguish Smoking While Treating Another Health Risk
- ClinicalTrials.gov ID
- NCT04130698
- Acronym / sponsor ID
- BREATH / 1819-1483
- Conditions
- Smoking Cessation, Weight Loss
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID-19, public health guidelines prevent in-person group meetings.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rhode Island CollegeUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 17 Oct 2019 (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 study has two phases. In Phase 1, the investigators will revise and pilot the distress tolerance (DT) protocol that was originally developed and piloted in a previous study (2P20 GM103430, Spas, PI). Despite the 4-week post-intervention treatment outcomes demonstrating the DT protocol's association with smoking cessation and weight loss, several revisions to the DT protocol are important to improve the intervention. First, the investigators will include the overweight/obese smokers' group-level feedback that the investigators collected during the 7-week intervention and at the 4-week post-intervention individual interviews to tailor the DT protocol to meet the unique needs of smokers with excess weight. Subjects from the previous study revealed factors that led to current and/or previous successful smoking cessation and weight loss efforts, barriers to sustaining current and/or previous successful smoking cessation and weight loss efforts, and general feedback about DT intervention for both health risks. The investigators believe revising the DT protocol to include overweight/obese smokers' unique experience with the novel intervention and their acumen about these key factors will improve the intervention and its generalizability to smokers with excess weight. Additional revisions are described elsewhere. After the investigators pilot the revised DT protocol, the investigators will revise the active health control protocol comprised of standard treatment for smoking cessation and weight loss to ensure both protocols equate for intervention contact time. Although both protocols will have some similar content, to avoid any threats to internal validity, no DT-specific material will be included in the control. In Phase 2, the investigators will conduct a two-armed, preliminary randomized controlled trial (RCT) to compare the revised DT protocol's efficacy to the active health control protocol.
Detailed description
In Phase 1, the investigators will revise the distress tolerance (DT) protocol the investigators developed in a previous study. Currently, the DT protocol is comprised of 6 two-hour weekly group sessions. However, based on the data the investigators collected in the previous study, the investigators will revise the DT protocol to have 7 instead of 6 two-hour weekly group sessions. 6 subjects (1 group) will be recruited to pilot the revised DT protocol. All subjects in the pilot will receive the transdermal nicotine patch (TNP). Prior to initiating use of the TNP on quit day, all subjects will be educated about its use and instructed to comply with all the recommended guidelines for usage as outlined in the directions. Smokers who lapse during treatment will be encouraged to set a new quit date and continue to attempt to quit. Subjects who continue to smoke or lapse after quit day will not be instructed to discontinue the patch unless their smoking level reaches 4 cigarettes/day for 4 days. This recommendation is consistent with safe TNP use. Smoking cessation will be objectively verified by expired carbon monoxide levels and saliva cotinine assays. Specifically, subjects who self-report nicotine abstinence will provide an exhaled breath into a Bedfont Micro Smokerlyzer to measure carbon monoxide levels and provide an adequate amount of saliva for cotinine analyses. RAs will wear non-latex gloves and follow all safety protocols for data collection and storage for biochemical materials. the investigators will use an 8ppm cutoff for expired carbon monoxide levels for stated abstinence of 24 hours for 2 weeks and use a cutoff of 10ng/ml for saliva cotinine assays for stated abstinence of 2 weeks or more as cotinine may be incompletely metabolized before this time. Expired carbon monoxide results will be immediately available. Saliva samples will be frozen for shipment to the American Health Foundation (Valhalla, NY) for cotinine level determination by radioimmune assay. Detected values above the stated cutoffs will be considered indicative of smoking. Therefore, smoking cessation and weight loss will be assessed using expired carbon monoxide and weigh-ins during the intervention and saliva cotinine assays and weigh-ins at follow-ups. During Phase 1 post-intervention follow-up, the investigators will revise the active health control protocol comprised of standard treatment for smoking cessation and weight loss to make sure it equates for intervention contact time.
In Phase 2, 48 subjects (8 groups of 6) will be recruited. Both conditions will receive the TNP and follow the protocol previously outlined in Phase 1. Once 6 eligible subjects are recruited, random assignment will be used to determine which of the two treatment conditions the group will receive. We expect to recruit 6 subjects within two weeks, reducing the lag time between a subject's eligibility and starting the intervention. Compensation for subjects' time will also support timely recruitment. To ensure an equal number of groups are assigned to each of the two conditions, assignment will be completed by choosing from among a fixed pool of 8 entries (4 from each condition). Smoking cessation and weight loss outcomes will be assessed using biochemical measures and weigh-ins during the intervention and at follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distress Tolerance | Experimental | Behavioral: Distress Tolerance, Drug: transdermal nicotine patchTreatment rationale: RAs will explain that there are 3 (not 2 as in the control) key factors that maintain smoking behavior and excess weight: 1) learned habits, 2) the addictive properties of smoking and food, and 3) a way to manage distress. Therefore, to be effective, an intervention designed to simultaneously treat smoking cessation and weight loss must address all 3 key factors. This condition includes both key factors in the control but introduces the third key factor distress tolerance (DT). Toward that end, modules will include: a values discussion; experiential avoidance; distress tolerance; and mindfulness-based ways to manage distress. Module 1: Orientation \& ACT; Module 2: Avoidance; Module 3: Cognitive Fusion vs. Defusion; Module 4: Self-As-Context; Module 5: Present-Moment-Awareness; and Module 6: Values and Committed Action. |
| Active Health Control | Active comparator | Drug: transdermal nicotine patch, Behavioral: Active Health ControlTreatment rationale: RAs will explain that there are 2 key factors that maintain smoking behavior and excess weight: 1) learned habits and 2) the addictive properties of smoking and food. Therefore, to be effective, an intervention designed to simultaneously treat smoking cessation and weight loss must address both key factors. Toward that end, modules will include standard treatment on: the dangers of smoking, excess weight, unhealthy diets and sedentariness; the importance of healthy behaviors; and relaxation exercises to manage stress. These are all key aspects of standard treatment for smoking cessation and weight loss. Module 1: Orientation and Health; Module 2: Game Plan; Module 3: Stress and Coping Strategies; Module 4: Physical Activity; Module 5: Changes in Activities, Habits and Lifestyle; and Module 6: Long-Term Rewards. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- between 18-64 years old
- have been a regular smoker for at least three years
- meet DSM-IV criteria for nicotine dependence
- smoke on average 10 cigarettes per day
- are overweight or obese (25<BMI<40)
Key exclusion criteria (7 listed)
- engaged in a smoking cessation or weight loss intervention
- use medications known to affect smoking cessation or weight loss
- have a medical condition that is a contraindication for transdermal nicotine patch (TNP)
- regularly use other tobacco products
- endorse active suicidal or homicidal ideation
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 |
|---|---|---|
| Distress ToleranceThe group-level intervention is comprised of one 2-hour weekly group sessions with overweight smokers to learn skills and strategies consistent with distress tolerance intervention to quit smoking and lose weight. | Behavioural | Distress Tolerance |
| transdermal nicotine patchAlso: the "patch"Participants will use the patch for 8 weeks as outlined by the recommended usage for steps 1-3 going from 21mg for 4 weeks, 14mg for 1 week, and 7mg for 1 week. | Drug | Active Health Control, Distress Tolerance |
| Active Health ControlAlso: PsychoeducationThe group-level intervention is comprised of one 2-hour weekly group sessions with overweight smokers to learn skills and strategies consistent with psychoeducation intervention to quit smoking and lose weight. | Behavioural | Active Health Control |
Primary outcome
7-day point-prevalence abstinence from smoking
Time frame: 6-month follow-up assessments from the end of intervention.
saliva cotinine assays
5% lower weight from baseline.
Time frame: 6-month follow-up assessments from the end of intervention
weigh-ins
1 secondary outcome
Include latency to first smoking lapse and latency to smoking relapse
Time frame: 6-month follow-up assessments from the end of intervention.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- 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.
Jayson J Spas, PhD, MS principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Distress Tolerance and transdermal nicotine patch in people with Smoking Cessation and Weight Loss, run by Rhode Island College 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 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: withdrawn, as of the sponsor's last update on 25 Oct 2022. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point-prevalence abstinence from smoking (time frame: 6-month follow-up assessments from the end of intervention.). 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 25 Oct 2022.