SmokingNCT05641974
Effect of Helpers Program On-line Training on Smoking Relapse and Social Networks
A study testing Helpers Stay Quit Training in people with Smoking and Cigarette Smoking, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect of the Helpers Stay Quit training on abstinence over time of newly abstinent smokers, and on the interactions they have with their personal network related to smoking and smoking cessation. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Cigarette Smoking
- What is being tested?
- Helpers Stay Quit Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 940 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2022to 27 Feb 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Abstinent from smoking for between 14 and 60 days
- Primary tobacco use is cigarettes
- Has access to Internet via computer or mobile device
- Self-described proficiency with English
- Willing and able to send/receive weekly text messages using personal mobile phone plan
Show all 12Show fewer
- Will allow Quitline to share their client data with research team
- Willing to complete online surveys at baseline, 3-, 6-, 9- and 12 months
- Willing to self-collect dried blood spot and send back to research team
- If assigned to Helpers Stay Quit condition, willing to complete training within 14 days
- If selected, willing to participate in qualitative interview
- Willing to forego any other training for tobacco cessation intervention/support (i.e., to become a cessation counselor/facilitator or support person, e.g., 'quit buddy') for the duration of their study enrollment
Who cannot join
- Any prior exposure to Helpers training or other cessation training in the previous 2 years
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz
Aurora, Colorado, 80045
About this study
The purpose of this study is to assess the effect of the Helpers Stay Quit training on abstinence over time of newly abstinent smokers, and on the interactions they have with their personal network related to smoking and smoking cessation.
Read the detailed description
Despite major gains in smoking cessation treatment, over half of recently quit smokers will relapse within the first year. To date, relapse prevention interventions have focused on the newly abstinent smoker ("abstainer"), and not attempted to directly or indirectly influence the abstainer's personal network, e.g. by helping the abstainer influence others in their personal network to quit. Personal networks exert powerful effects on initiating and maintaining smoking behavior, and can facilitate maintaining abstinence or trigger relapse. A "help others" intervention that seeks to increase the abstainer's ability to influence smokers in their personal network to quit - thereby creating a social environment more supportive of long-term abstinence - may have a beneficial effect on relapse. The Helpers Stay Quit intervention encourages abstainers to reinforce their own abstinence through helping others quit, and to proactively influence their personal network to be more conducive to long-term smoking abstinence. Helpers Stay Quit teaches abstainers how to encourage other tobacco users to quit and avoid relapse through a non-confrontational "helping conversation" that encourages quitting and use of evidence-based cessation aids (e.g. Quitlines, cessation medications) without confrontation and nagging. The investigator hypothesizes that Quitline abstainers exposed to Helpers Stay Quit will have higher 30-day and 7-day point prevalence abstinence than those receiving Quitline follow-up usual care, and that the effect of Helpers Stay Quit may be mediated by personal network characteristics. To test this hypothesis, the investigator proposes a pragmatic randomized controlled trial with embedded mixed-methods personal network study to assess the effect of Helpers Stay Quit training on proportion and duration of abstainers' abstinence over time, and on abstainer's personal network interactions related to smoking and smoking cessation. Metrics derived from the personal network study will be used for mediational analyses of overall, and gender-based effects of Helpers Stay Quit on smoking relapse.
- Conditions
- Smoking, Cigarette Smoking
- Being tested
- Helpers Stay Quit Training
- Keywords
- Smoking cessation, Relapse prevention
- Medical subject headings
- Smoking, Cigarette Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helpers Stay Quit TrainingBehavioural
The Helpers Stay Quit training emphasizes a tobacco-user centered, non-confrontational approach to encouraging others to quit smoking. Helpers Stay Quit trainees learn how to offer a 4-step "helping conversation". The four steps of a helping conversation parallel the 4 core training modules of Helpers Stay Quit (Awareness, Understanding, Helping, Relating). A key learning objective of Helpers Stay Quit, is for Helpers to learn how to manage their own expectations for the process and outcome of a helping conversation (e.g. Helpers are taught that they cannot "make" anyone quit, but they can offer non-judgmental support, and information about effective cessation aids). Consequently, Helpers are taught to manage their own behavior when helping others (e.g. avoiding nagging or pushing a tobacco-user to quit). The helping conversation focuses on encouraging behavior change that is aligned with the tobacco user's current willingness/readiness to take any action toward quitting.
| Study group | Role | What they receive |
|---|---|---|
| Helpers Stay Quit Training | Experimental | Research participants randomized to the experimental arm will receive the on-line Helpers Stay Quit training which provides training on how to help others quit smoking. Receives: Behavioral: Helpers Stay Quit Training |
| Usual Care | No intervention | Research participants randomized to the arm without intervention will receive Quitline usual care. They will be contacted for assessment of abstinence at 7 months after enrollment in services. If the participant has relapsed, the Quitline will attempt to re-engage the participant in cessation services (telephone and/or web-based). |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day and 30-day abstinence from using combustible tobacco at 6 months post-randomization
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
Measured: Self-reported data collected at 6 months post-randomization
7-day and 30-day abstinence from using combustible tobacco at 12 months post-randomization
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
Measured: Self-reported data collected at 12 months post-randomization
Secondary outcomes (5)
7-day and 30-day abstinence from using combustible tobacco at 3 months and 9 months post-randomization
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
Measured: Self-reported data collected at 3- and 9-months post-randomization
Time to first relapse
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
Measured: Weekly data collected months 1-6, bi-weekly data collected months 7-12 post-randomization
Number, timing, and duration of relapses
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
Measured: Weekly data collected months 1-6, bi-weekly data collected months 7-12 post-randomization
Number of helping conversations offered
Participants report the number of helping conversations (if any) offered within the specified timeframe.
Measured: Weekly data collected months 1-6; bi-weekly data collected months 7-12; data collected at 3-, 6-, 9-, and 12-months post-randomization
Biochemical confirmation of abstinence at 6 and 12 months on a subsample
Participants who report abstinence at 6- and 12-months (and no other exposure to nicotine) receive a dried blood spot kit which is returned and tested for cotinine.
Measured: Data collected and 6- and 12-months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start12 Dec 2022
- Primary completion31 Oct 2026 (estimated)
- Study completion27 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Colorado, DenverThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 940 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Myra Muramoto, MD, MPH, Principal investigator, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641974
- Sponsor's protocol ID
- 21-4624
- Other IDs
- 1R01CA248658-01A1
- Status last verified
- Feb 2026
- First submitted
- 21 Nov 2022
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Muramoto ML, Hopkins A, Bell M, Allen A, Nair U, Connolly TE. Results of a Feasibility Study of Helpers Stay Quit Training for Smoking Relapse Prevention. Nicotine Tob Res. 2021 Mar 19;23(4):711-715. doi: 10.1093/ntr/ntaa176.
PubMed 32966558Muramoto M, Hopkins A, McCarty C, Allen A, Dickinson LM, Connolly T, Spradley J, Ying J. Effect of Helpers Stay Quit Online Training on Preventing Smoking Relapse and Personal Networks: Protocol for a Pragmatic Randomized Controlled Trial and Embedded Mixed Methods Personal Network Study. JMIR Res Protoc. 2026 Jan 27;15:e82140. doi: 10.2196/82140.
PubMed 41591931
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Helpers Program On-line Training on Smoking Relapse and Social Networks
- ClinicalTrials.gov ID
- NCT05641974
- Acronym / sponsor ID
- 21-4624
- Conditions
- Smoking, Cigarette Smoking
- Keywords
- Smoking cessation, Relapse prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 940 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 27 Feb 2027 (estimated)
- First posted
- 8 Dec 2022 (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 purpose of this study is to assess the effect of the Helpers Stay Quit training on abstinence over time of newly abstinent smokers, and on the interactions they have with their personal network related to smoking and smoking cessation.
Detailed description
Despite major gains in smoking cessation treatment, over half of recently quit smokers will relapse within the first year. To date, relapse prevention interventions have focused on the newly abstinent smoker ("abstainer"), and not attempted to directly or indirectly influence the abstainer's personal network, e.g. by helping the abstainer influence others in their personal network to quit. Personal networks exert powerful effects on initiating and maintaining smoking behavior, and can facilitate maintaining abstinence or trigger relapse. A "help others" intervention that seeks to increase the abstainer's ability to influence smokers in their personal network to quit - thereby creating a social environment more supportive of long-term abstinence - may have a beneficial effect on relapse. The Helpers Stay Quit intervention encourages abstainers to reinforce their own abstinence through helping others quit, and to proactively influence their personal network to be more conducive to long-term smoking abstinence. Helpers Stay Quit teaches abstainers how to encourage other tobacco users to quit and avoid relapse through a non-confrontational "helping conversation" that encourages quitting and use of evidence-based cessation aids (e.g. Quitlines, cessation medications) without confrontation and nagging. The investigator hypothesizes that Quitline abstainers exposed to Helpers Stay Quit will have higher 30-day and 7-day point prevalence abstinence than those receiving Quitline follow-up usual care, and that the effect of Helpers Stay Quit may be mediated by personal network characteristics. To test this hypothesis, the investigator proposes a pragmatic randomized controlled trial with embedded mixed-methods personal network study to assess the effect of Helpers Stay Quit training on proportion and duration of abstainers' abstinence over time, and on abstainer's personal network interactions related to smoking and smoking cessation. Metrics derived from the personal network study will be used for mediational analyses of overall, and gender-based effects of Helpers Stay Quit on smoking relapse.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Helpers Stay Quit Training | Experimental | Behavioral: Helpers Stay Quit TrainingResearch participants randomized to the experimental arm will receive the on-line Helpers Stay Quit training which provides training on how to help others quit smoking. |
| Usual Care | No intervention | –Research participants randomized to the arm without intervention will receive Quitline usual care. They will be contacted for assessment of abstinence at 7 months after enrollment in services. If the participant has relapsed, the Quitline will attempt to re-engage the participant in cessation services (telephone and/or web-based). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 18 years or older
- Abstinent from smoking for between 14 and 60 days
- Primary tobacco use is cigarettes
- Has access to Internet via computer or mobile device
- Self-described proficiency with English
Key exclusion criteria (1 listed)
- Any prior exposure to Helpers training or other cessation training in the previous 2 years
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 |
|---|---|---|
| Helpers Stay Quit TrainingThe Helpers Stay Quit training emphasizes a tobacco-user centered, non-confrontational approach to encouraging others to quit smoking. Helpers Stay Quit trainees learn how to offer a 4-step "helping conversation". The four steps of a helping conversation parallel the 4 core training modules of Helpers Stay Quit (Awareness, Understanding, Helping, Relating). A key learning objective of Helpers Stay Quit, is for Helpers to learn how to manage their own expectations for the process and outcome of a helping conversation (e.g. Helpers are taught that they cannot "make" anyone quit, but they can offer non-judgmental support, and information about effective cessation aids). Consequently, Helpers are taught to manage their own behavior when helping others (e.g. avoiding nagging or pushing a tobacco-user to quit). The helping conversation focuses on encouraging behavior change that is aligned with the tobacco user's current willingness/readiness to take any action toward quitting. | Behavioural | Helpers Stay Quit Training |
Primary outcome
7-day and 30-day abstinence from using combustible tobacco at 6 months post-randomization
Time frame: Self-reported data collected at 6 months post-randomization
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
7-day and 30-day abstinence from using combustible tobacco at 12 months post-randomization
Time frame: Self-reported data collected at 12 months post-randomization
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
5 secondary outcomes
7-day and 30-day abstinence from using combustible tobacco at 3 months and 9 months post-randomization
Time frame: Self-reported data collected at 3- and 9-months post-randomization
Time to first relapse
Time frame: Weekly data collected months 1-6, bi-weekly data collected months 7-12 post-randomization
Number, timing, and duration of relapses
Time frame: Weekly data collected months 1-6, bi-weekly data collected months 7-12 post-randomization
Number of helping conversations offered
Time frame: Weekly data collected months 1-6; bi-weekly data collected months 7-12; data collected at 3-, 6-, 9-, and 12-months post-randomization
Biochemical confirmation of abstinence at 6 and 12 months on a subsample
Time frame: Data collected and 6- and 12-months post-randomization
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 15 Apr 2026.
- Background: PubMed 32966558Muramoto ML, Hopkins A, Bell M, Allen A, Nair U, Connolly TE. Results of a Feasibility Study of Helpers Stay Quit Training for Smoking Relapse Prevention. Nicotine Tob Res. 2021 Mar 19;23(4):711-715. doi: 10.1093/ntr/ntaa176.
- Derived from this study: PubMed 41591931Muramoto M, Hopkins A, McCarty C, Allen A, Dickinson LM, Connolly T, Spradley J, Ying J. Effect of Helpers Stay Quit Online Training on Preventing Smoking Relapse and Personal Networks: Protocol for a Pragmatic Randomized Controlled Trial and Embedded Mixed Methods Personal Network Study. JMIR Res Protoc. 2026 Jan 27;15:e82140. doi: 10.2196/82140.
- Individual participant dataSharing planned: Undecided
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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.
Myra Muramoto, MD, MPH principal investigator
University of Colorado School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helpers Stay Quit Training in people with Smoking and Cigarette Smoking, run by University of Colorado, Denver 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 12 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. 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?
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?
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 and 30-day abstinence from using combustible tobacco at 6 months post-randomization (time frame: Self-reported data collected at 6 months post-randomization). 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?
On the ClinicalTrials.gov record for NCT05641974, which also lists 2 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 15 Apr 2026.