SmokingTAMINCT06713603
Technology Assisted Motivational Interviewing
A study testing TAMI Coach in people with Smoking and Smoking Cessation, run by University of California, San Francisco at 2 sites in United States.
Trial summary
Building on our successful pilot work to develop a Motivational Interviewing (MI)-capable chatbot and cessation coach, the investigators propose to address the problems of intrinsic motivation and social barriers to smoking cessation by evaluating a highly scalable and easily accessible digital-coaching intervention… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Smoking Cessation
- What is being tested?
- TAMI Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Sep 2025to 31 May 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
- A current Primary Care Provider patient
- Age 18 or older
- Smoke at least 1 cigarette per day for the past 7 consecutive days (and at least 100 lifetime)
- Have a digital device (phone, laptop, tablet)
- Moderately proficient in English
- Able to participate for 6-month trial
Who cannot join
- Current participation in a smoking cessation program
- Current use of Nicotine Replacement Therapy or smoking cessation pharmacotherapy
- Cognitive impairment that would preclude informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
San Francisco General Hospital
San Francisco, California, 94110
Jason Satterfield, PhD, 415-353-2104, Jason.Satterfield@ucsf.edu
- Recruiting
UCSF Adult Primary Care Mt. Zion Clinic
San Francisco, California, 94115
Jason Satterfield, PhD, 415-353-2104, Jason.Satterfield@ucsf.edu
About this study
Official title: Technology Assisted Motivational Interviewing Randomized Controlled Trial
Building on our successful pilot work to develop a Motivational Interviewing (MI)-capable chatbot and cessation coach, the investigators propose to address the problems of intrinsic motivation and social barriers to smoking cessation by evaluating a highly scalable and easily accessible digital-coaching intervention that 1) promotes readiness to change using a technology-assisted MI (TAMI) chatbot, 2) provides compelling and accessible multilingual education about smoking cessation tools, and 3) develops a tailored quit plan addressing social barriers to treatment initiation and sustainment.
- Conditions
- Smoking, Smoking Cessation
- Being tested
- TAMI Coach
- Keywords
- smoking, quit smoking, motivational interviewing, chatbot, cessation, coach, motivation, quit plan
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAMI CoachBehavioural
The investigators address the problems of intrinsic motivation, Evidence Based Practice (EBP) education, and referral tailoring using a digital-coaching intervention that 1) promotes readiness to change, 2) educates and builds confidence about EBP's, and 3) creates a tailored quit plan sensitive to social obstacles and needs.
| Study group | Role | What they receive |
|---|---|---|
| Technology Assisted Motivational Interviewing (TAMI) | Experimental | Individuals randomized to TAMI will interact with the fully automated, web-based MI-chatbot for the 6-month study period. Patients who continue to smoke will receive up to two text messages per week with the chatbot URL link to initiate additional conversations always beginning with an assessment of readiness to change but "remembering" prior conversations much like a clinician. Individuals in the preparation stage will move directly to EBP education, tailoring a quit plan and boosting both self-efficacy and outcome expectancies. Patients with sufficient confidence will be encouraged to set a quit date. Patients will be encouraged to include their PCP and/or state quitline. TAMI will provide support proximal to the quit date including guidance through common obstacles. TAMI will check back to assess treatment initiation, treatment sustainment (and/or cessation), or relapse. Patients who are unable to quit (or who relapse) will be encouraged to restart conversations with TAMI. Receives: Behavioral: TAMI Coach |
| Usual Care | No intervention | Individuals randomized to the Usual Care (UC) condition will receive a detailed educational handout on the health risks associated with smoking and information on Evidence Based Practice's (EBP) for cessation using the standard "Kick-It California" materials. Additional materials and referral resources regarding depression, stress, and other common barriers will be provided to all UC participants. Any UC individual can choose to quit at any time but they will not have access to TAMI. While this is not an "active" treatment condition, the handout and recurring assessments (at 3 and 6mo) may serve as reminders about the importance of quitting and may assist with finding support for co-occurring conditions or social needs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical verification of smoking abstinence
The primary clinical outcome is 7-day point prevalence abstinence (PPA) from smoking at 6-months. Abstinence will be biochemically verified with salivary cotinine.
To maximize the validity of our primary abstinence outcome, the investigators will require any participant in who reports abstinence at 6-month to complete salivary cotinine bio-verification using a mailed, commercially available test kit. Participants will be instructed to electronically send two photos - one of them giving a saliva sample and the other with the test results. Recent reviews of biochemical verification strategies have validated this methodology. People with at least 10 ng/ml cotinine in their saliva will be considered smokers. The investigators will ask participants to report any Nicotine Replacement Therapy use or vaping to identify false positives.
Measured: 6-month
Secondary outcomes (11)
Self reported smoking abstinence
Self-reported point prevalence abstinence (PPA) from smoking at 3-month
Measured: 3-month
Smoking reduction
Self reported smoking reduction (# cigs, >50% reductions, and # quit attempts). Change = (score at time point - score at baseline)
Measured: Baseline, 3-month, 6-month
Readiness to quit
Self reported changes in readiness to quit, and treatment initiation and sustainment. Possible scores range from 1 (not at all) to 10 (totally ready). Change = (score at time point - score at baseline)
Measured: Baseline, 3-month, 6-month
Smoking cessation outcome expectations
Self reported smoking cessation outcome expectations measuring how serious would the health consequences be if the participant developed a smoking-related disease. Possible scores range from 1 (Not at all) to 5 (Extremely serious). Change = (score at time point - score at baseline)
Measured: Baseline, 3-month, 6-month
Self-efficacy
The Smoking Self-Efficacy Questionnaire (SEQ-12) is a validated, self reported 12-item instrument that measures the confidence of current and former smokers in their ability to abstain from smoking in certain social or emotional situations. The SEQ-12 has two subscales measuring confidence in ability to refrain from smoking when facing internal stimuli (e.g., feeling depressed) and external stimuli (e.g., being with smokers). Possible scores range from 1 (not at all sure) to 5 (absolutely sure). The scores for each question are added together. A higher score indicates greater self-efficacy. Change = (score at time point - score at baseline)
Measured: Baseline, 3-month, 6-month
Chatbot engagement and usage
The Mobile App Rating Scale is a validated, self reported instrument measuring app quality across four dimensions: engagement, functionality, aesthetics and information quality. Possible scores range from 1 (not at all useful) to 4 (very useful. Change = (score at time point - score at baseline)
Measured: Baseline, 3-month, 6-month
Digital Health Literacy survey
The Digital Health Literacy instrument is a validated, self-reported 8-item instrument measuring digital health literacy in general adult populations. Possible scores range from 1 (strongly disagree) to 5 (strongly agree). Change = (score at time point - score at baseline)
Measured: Baseline, 3-month, 6-month
AHC Screening Tool
The Accountable Health Communities screening tool is a validated, self reported 10-item instrument assessing social needs. Change = (score at time point - score at baseline)
Measured: Baseline, 3-month, 6-month
Bayliss Disease Burden
Bayliss Disease Burden
The Bayliss Disease Burden Morbidity Assessment is a validated, self-reported instrument serving as a subjective measure of comorbidity that incorporates an assessment of disease severity. Possible scores range from 1 (not at all) to 5 (a lot). Disease burden is defined as the number of self-identified comorbid conditions weighted by the degree to which each interfered with their daily activities. Change = (score at time point - score at baseline)
Measured: Baseline, 3-month, 6-month
PHQ-8
The Personal Health Questionnaire Depression Scale is a validated, self-reported 8-item instrument assessing symptoms of depression. Possible scores range from 0 (not at all) to 3 (nearly every day). The scores for each question are added together. A higher score indicates greater depression. Change = (score at time point - score at baseline)
Measured: Baseline, 3-month, 6-month
Perceived Stress Scale
The Perceived Stress Scale is a validated, self-reported 10-item instrument assessing how stressful a person finds their life to be. Possible scores range from 0 (never) to 4 (very often). The scores for each question are added together. A higher score indicates greater perceived stress. Change = (score at time point - score at baseline)
Measured: Baseline, 3-month, 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start22 Sep 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
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 SmokingStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Model description
- Subjects will be randomized into intervention or usual care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Satterfield, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713603
- Sponsor's protocol ID
- 24-41634
- Other IDs
- T34IR7967
- Acronym
- TAMI
- Status last verified
- Oct 2025
- First submitted
- 30 Oct 2024
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This project is funded by the UC Tobacco-Related Disease Research Program (TRDRP) and will use the data sharing platform required for that consortia.
Publications
Borsari B, Meacham MC, Saiyed A, Kanzaveli T, Tsvetovat M, Cheng J, Hargrave-Bouagnon AS, Mirzadegan IA, Omeragic F, Layton J, Satterfield J. Protocol for a randomized clinical trial to evaluate the effectiveness of a technology-assisted motivational interviewing (TAMI) chatbot on smoking cessation. Contemp Clin Trials. 2025 Dec;159:108111. doi: 10.1016/j.cct.2025.108111. Epub 2025 Oct 22.
PubMed 41135811
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Assisted Motivational Interviewing Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06713603
- Acronym / sponsor ID
- TAMI / 24-41634
- Conditions
- Smoking, Smoking Cessation
- Keywords
- smoking, quit smoking, motivational interviewing, chatbot, cessation, coach, motivation, quit plan
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 3 Dec 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.
Building on our successful pilot work to develop a Motivational Interviewing (MI)-capable chatbot and cessation coach, the investigators propose to address the problems of intrinsic motivation and social barriers to smoking cessation by evaluating a highly scalable and easily accessible digital-coaching intervention that 1) promotes readiness to change using a technology-assisted MI (TAMI) chatbot, 2) provides compelling and accessible multilingual education about smoking cessation tools, and 3) develops a tailored quit plan addressing social barriers to treatment initiation and sustainment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized into intervention or usual care.
| Arm | Type | Receives |
|---|---|---|
| Technology Assisted Motivational Interviewing (TAMI) | Experimental | Behavioral: TAMI CoachIndividuals randomized to TAMI will interact with the fully automated, web-based MI-chatbot for the 6-month study period. Patients who continue to smoke will receive up to two text messages per week with the chatbot URL link to initiate additional conversations always beginning with an assessment of readiness to change but "remembering" prior conversations much like a clinician. Individuals in the preparation stage will move directly to EBP education, tailoring a quit plan and boosting both self-efficacy and outcome expectancies. Patients with sufficient confidence will be encouraged to set a quit date. Patients will be encouraged to include their PCP and/or state quitline. TAMI will provide support proximal to the quit date including guidance through common obstacles. TAMI will check back to assess treatment initiation, treatment sustainment (and/or cessation), or relapse. Patients who are unable to quit (or who relapse) will be encouraged to restart conversations with TAMI. |
| Usual Care | No intervention | –Individuals randomized to the Usual Care (UC) condition will receive a detailed educational handout on the health risks associated with smoking and information on Evidence Based Practice's (EBP) for cessation using the standard "Kick-It California" materials. Additional materials and referral resources regarding depression, stress, and other common barriers will be provided to all UC participants. Any UC individual can choose to quit at any time but they will not have access to TAMI. While this is not an "active" treatment condition, the handout and recurring assessments (at 3 and 6mo) may serve as reminders about the importance of quitting and may assist with finding support for co-occurring conditions or social needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A current Primary Care Provider patient
- Age 18 or older
- Smoke at least 1 cigarette per day for the past 7 consecutive days (and at least 100 lifetime)
- Have a digital device (phone, laptop, tablet)
- Moderately proficient in English
Key exclusion criteria (3 listed)
- Current participation in a smoking cessation program
- Current use of Nicotine Replacement Therapy or smoking cessation pharmacotherapy
- Cognitive impairment that would preclude informed consent
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 |
|---|---|---|
| TAMI CoachThe investigators address the problems of intrinsic motivation, Evidence Based Practice (EBP) education, and referral tailoring using a digital-coaching intervention that 1) promotes readiness to change, 2) educates and builds confidence about EBP's, and 3) creates a tailored quit plan sensitive to social obstacles and needs. | Behavioural | Technology Assisted Motivational Interviewing (TAMI) |
Primary outcome
Biochemical verification of smoking abstinence
Time frame: 6-month
The primary clinical outcome is 7-day point prevalence abstinence (PPA) from smoking at 6-months. Abstinence will be biochemically verified with salivary cotinine. To maximize the validity of our primary abstinence outcome, the investigators will require any participant in who reports abstinence at 6-month to complete salivary cotinine bio-verification using a mailed, commercially available test kit. Participants will be instructed to electronically send two photos - one of them giving a saliva sample and the other with the test results. Recent reviews of biochemical verification strategies have validated this methodology. People with at least 10 ng/ml cotinine in their saliva will be considered smokers. The investigators will ask participants to report any Nicotine Replacement Therapy use or vaping to identify false positives.
11 secondary outcomes
Self reported smoking abstinence
Time frame: 3-month
Smoking reduction
Time frame: Baseline, 3-month, 6-month
Readiness to quit
Time frame: Baseline, 3-month, 6-month
Smoking cessation outcome expectations
Time frame: Baseline, 3-month, 6-month
Self-efficacy
Time frame: Baseline, 3-month, 6-month
Chatbot engagement and usage
Time frame: Baseline, 3-month, 6-month
Digital Health Literacy survey
Time frame: Baseline, 3-month, 6-month
AHC Screening Tool
Time frame: Baseline, 3-month, 6-month
Bayliss Disease Burden
Time frame: Baseline, 3-month, 6-month
PHQ-8
Time frame: Baseline, 3-month, 6-month
Perceived Stress Scale
Time frame: Baseline, 3-month, 6-month
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 23 Oct 2025.
- Derived from this study: PubMed 41135811Borsari B, Meacham MC, Saiyed A, Kanzaveli T, Tsvetovat M, Cheng J, Hargrave-Bouagnon AS, Mirzadegan IA, Omeragic F, Layton J, Satterfield J. Protocol for a randomized clinical trial to evaluate the effectiveness of a technology-assisted motivational interviewing (TAMI) chatbot on smoking cessation. Contemp Clin Trials. 2025 Dec;159:108111. doi: 10.1016/j.cct.2025.108111. Epub 2025 Oct 22.
- Individual participant dataSharing planned: No. This project is funded by the UC Tobacco-Related Disease Research Program (TRDRP) and will use the data sharing platform required for that consortia.
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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.
Jason Satterfield, PhD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAMI Coach in people with Smoking and Smoking Cessation, run by University of California, San Francisco at 2 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 6 inclusion and 3 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 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Jason Satterfield, PhD (415-353-2104, Jason.Satterfield@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical verification of smoking abstinence (time frame: 6-month). 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 NCT06713603, 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 23 Oct 2025.