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

940 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Helpers Stay Quit Training for preventing smoking relapse?

Research shows that online support and interactive interventions can help people quit smoking. For example, using web-based programs alongside other treatments like nicotine patches has been effective. Additionally, sustained use of online platforms with social support has been linked to higher rates of quitting smoking. ^{1 2 3 4 5}

Is the Online Quit-Smoking Training generally safe for humans?

There is no specific safety data available for the Online Quit-Smoking Training or its related programs like Helpers Stay Quit Training. However, general issues with assessing safety in clinical trials include inconsistent data collection and reporting of adverse events, which can make it difficult to fully understand the safety of interventions. ^{6 7 8 9 10}

How is the Helpers Stay Quit Training treatment different from other smoking relapse prevention treatments?

Helpers Stay Quit Training is unique because it focuses on online training to prevent smoking relapse, which may include personalized feedback and planning strategies to support individuals in maintaining their quit status. This approach is different from traditional methods that often rely on in-person counseling or medication. ^{4 11 12 13 14}

Research Team

Myra Muramoto, MD, MPH

Principal Investigator

University of Colorado School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Online support for smoking cessation: a systematic review of the literature. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a web-based computer-tailored smoking cessation program as a supplement to nicotine patch therapy. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Improving Adherence to Smoking Cessation Treatment: Smoking Outcomes in a Web-based Randomized Trial. [2019]

4. England 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. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Initial evaluation of a real-world Internet smoking cessation system. [2022]

6. England 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Assessing harmful effects in systematic reviews. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

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

10. New Zealand pubmed.ncbi.nlm.nih.gov

Adequacy of patient information on adverse effects: an assessment of patient information leaflets in the UK. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Using Diverse Communication Strategies to Re-Engage Relapsed Tobacco Quitline Users in Treatment, New York State, 2014. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Smoking cessation via the internet: a randomized clinical trial of an internet intervention as adjuvant treatment in a smoking cessation intervention. [2022]

13. Canada pubmed.ncbi.nlm.nih.gov

Preventing smoking relapse via Web-based computer-tailored feedback: a randomized controlled trial. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of an interactive internet smoking cessation program with long-term follow-up. [2023]