Online Quit-Smoking Training for Preventing Smoking Relapse

Overseen By Tim Connolly, RN, MN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Prior cessation training, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online program called Helpers Stay Quit to determine its effectiveness in helping people who recently quit smoking remain smoke-free. Researchers aim to assess whether this program can prevent relapse and influence interactions with friends and family regarding smoking. Participants will receive either the Helpers Stay Quit training or standard support from a Quitline. Individuals who have not smoked for 14 to 60 days and primarily smoked cigarettes may be suitable candidates, especially if they have regular internet and text messaging access. As an unphased trial, this study provides a unique opportunity to contribute to research that could help others maintain a smoke-free life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Helpers Stay Quit Training is safe?

Research has shown that specific safety information for the Helpers Stay Quit Training is not available. This program helps people stop smoking by teaching them to support others in quitting. As a training program rather than a medicine or medical treatment, it carries no known physical risks. If it were unsafe, it likely wouldn't be used to aid smoking cessation. Overall, the program emphasizes learning and support, which typically pose very low risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Helpers Stay Quit Training because it offers a fresh approach to preventing smoking relapse by leveraging social support. Unlike traditional treatments like nicotine replacement therapy or medication, which focus on individual cessation, this online training empowers participants to assist others in quitting smoking. By fostering a supportive community, it aims to create a ripple effect that enhances the quitting process for everyone involved. This innovative method could provide a valuable complementary tool to existing smoking cessation strategies.

What evidence suggests that the Helpers Stay Quit Training is effective for preventing smoking relapse?

Research has shown that the Helpers Stay Quit training, which participants in this trial may receive, can help people remain smoke-free. In past studies, participants in this training experienced fewer relapses than those who did not. The training teaches individuals how to support others in quitting smoking, which also helps them stay smoke-free. Early results suggest that this method increases the likelihood of avoiding smoking again over time. This approach appears promising in helping recent quitters maintain their smoke-free status. ^{1 3 6 7 8}

Who Is on the Research Team?

Myra Muramoto, MD, MPH

Principal Investigator

University of Colorado School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 who smoke cigarettes, have quit smoking for 14-45 days, and are proficient in English. Participants need Internet access and must be willing to send weekly texts, complete online surveys, self-collect a blood sample, and possibly do an interview. They can't have had cessation training in the past 2 years.

Inclusion Criteria

Willing to self-collect dried blood spot and send back to research team

Willing and able to send/receive weekly text messages using personal mobile phone plan

I have not smoked for 2 to 8 weeks.

Exclusion Criteria

I haven't had any cessation training in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Helpers Stay Quit training or usual Quitline care

12 months

Online training sessions and regular follow-ups

Follow-up

Participants are monitored for abstinence and personal network interactions

12 months

Data collected at 3, 6, 9, and 12 months post-randomization

Extension

Participants may continue to receive support and monitoring for long-term abstinence

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Helpers Stay Quit Training

Trial Overview The study tests the Helpers Stay Quit online training program's effectiveness on maintaining non-smoking status among recent quitters and its impact on their social interactions regarding smoking habits.

How Is the Trial Designed?

Group I: Helpers Stay Quit Training Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 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 Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study involving 1785 participants, the standard quitline treatment was highly effective, with a 30-day quit rate of 61.2% at 12 months, demonstrating that traditional methods remain successful in helping smokers quit.

Adding an interactive voice response (IVR) system for relapse risk assessments did not significantly improve quit rates compared to standard treatment, indicating that while the IVR identified at-risk individuals, it did not enhance overall effectiveness in preventing relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial to prevent smoking relapse among recently quit smokers enrolled in employer and health plan sponsored quitlines. McDaniel, AM., Vickerman, KA., Stump, TE., et al.[2019]

A qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., et al.[2022]

Current methods for assessing psychotropic drug harms in clinical trials are inadequate, primarily relying on general questions and spontaneous patient reports, leading to inconsistent data.

The authors recommend that social workers play a crucial role in monitoring drug effects by gathering client feedback and using a detailed checklist to track treatment emergent effects, while also advocating for policies that reduce pharmaceutical companies' control over drug testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the assessment of psychotropic drug harms in clinical trials to improve social workers' role in medication monitoring. Hughes, S., Cohen, D.[2019]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

40% of the patient information leaflets for the 50 most prescribed drugs in England did not provide any information about the likelihood of adverse effects, failing to meet patient needs.

Only 8% of the leaflets included numerical indications of risk, while most used vague verbal descriptors that could lead to overestimating the risk of adverse effects, highlighting a significant gap in effective communication of drug safety information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adequacy of patient information on adverse effects: an assessment of patient information leaflets in the UK. Carrigan, N., Raynor, DK., Knapp, P.[2022]

A study involving 3971 participants showed that web-based tailored behavioral smoking cessation materials significantly improved continuous abstinence rates compared to non-tailored materials, with rates of 29.0% vs. 23.9% at 6 weeks and 22.8% vs. 18.1% at 12 weeks.

Participants using the tailored program reported higher satisfaction levels, indicating that personalized support in smoking cessation can enhance both effectiveness and user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a web-based computer-tailored smoking cessation program as a supplement to nicotine patch therapy. Strecher, VJ., Shiffman, S., West, R.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7976929/

Results of a Feasibility Study of Helpers Stay Quit Training ... HSQ, delivered to newly abstinent smokers who received standard quitline treatment, was associated with less self-reported relapse. These promising preliminary ...

2. mhealth.jmir.org mhealth.jmir.org/2022/11/e41658

Outcomes of a Comprehensive Mobile Smoking Cessation ... This study aimed to compare engagement, retention, attitudes toward quitting smoking, smoking behavior, and participant feedback between Pivot and QuitGuide.

3. helpersbehavioralhealth.org helpersbehavioralhealth.org/pages/helper-s-research

Helpers Research Studies The Helpers Stay Quit study showed the relapse prevention intervention led to an increased likelihood of maintaining abstinence. CAM Web. Online Tobacco ...

4. researchgate.net researchgate.net/publication/344370792_Results_of_a_Feasibility_Study_of_Helpers_Stay_Quit_Training_for_Smoking_Relapse_Prevention

Results of a Feasibility Study of Helpers Stay Quit Training ... Conclusions: HSQ, delivered to newly abstinent smokers who received standard quitline treatment, was associated with less self-reported relapse. These promising ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05181072

Identify the Usefulness of In-person and Virtual Quit ... The study's primary hypothesis is that the smoking cessation rate will be equal to or higher in the virtual peer-motivation arm than the in-person and self-help ...

6. withpower.com withpower.com/trial/phase-recurrence-11-2022-36aa9

Online Quit-Smoking Training for Preventing ... There is no specific safety data available for the Online Quit-Smoking Training or its related programs like Helpers Stay Quit Training. However, general ...

7. clinicaltrial.be clinicaltrial.be/fr/details/189320?per_page=100&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_eligible=0&only_active=0

Effect of Helpers Program On-line Training on Smoking Rel... The investigator hypothesizes that Quitline abstainers exposed to Helpers Stay Quit will have higher 30-day and 7-day point prevalence ...

8. helpersstayquit.org helpersstayquit.org/

Helpers Stay Quit The Stay Quit Research Study is aimed at testing an innovative approach to helping people stay quit from smoking tobacco.