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Smoking CessationNCT01544153

Improving Adherence to Web-Based Cessation Programs: A Social Network Approach

A study testing WEB, Social Network and Nicotine Replacement Therapy (NRT) in people with Smoking Cessation, run by Truth Initiative at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will compare the efficacy of an interactive, evidence-based smoking cessation website (WEB) alone and in conjunction with 1) a theory-driven, empirically-informed social network (SN) protocol designed to integrate participants into the online community, and 2) access to a 4-week supply of free NRT. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoking Cessation
What is being tested?
WEB, Social Network and Nicotine Replacement Therapy (NRT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,292 participants
Where
1 siteUnited States
Study dates
Feb 2012to Aug 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Age 18 years and older
  • Current smoker
  • Registered user on BecomeAnEX.org

Who cannot join

  • Pregnant or breastfeeding
  • Cardiovascular conditions
  • Current use of any stop smoking medication

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Truth Initiative

    Washington D.C., District of Columbia, 20001

Other trials in United States

About this study

This study will compare the efficacy of an interactive, evidence-based smoking cessation website (WEB) alone and in conjunction with 1) a theory-driven, empirically-informed social network (SN) protocol designed to integrate participants into the online community, and 2) access to a 4-week supply of free NRT.

Read the detailed description

This study will compare the efficacy of an interactive, evidence-based smoking cessation website (WEB) alone and in conjunction with 1) a theory-driven, empirically-informed social network (SN) protocol designed to integrate participants into the online community, and 2) access to a 4-week supply of free NRT. Using a 2 (SN integration, no SN) x 2 (access to free NRT, no access) randomized, controlled factorial design with repeated measures at baseline, 3, and 9 months, this study will recruit N=5,000 new members of a Web-based smoking cessation program and randomize them to: 1) WEB, 2) WEB+SN, 3) WEB+NRT, or 4) WEB+SN+NRT.

Aim 1: To evaluate the comparative efficacy of WEB+SN, WEB+NRT, and WEB+SN+NRT versus WEB alone with regard to self-reported 30-day point prevalence abstinence at the primary endpoint of 9 months and at secondary endpoint of 3 months. Hypothesis 1a: All three intervention conditions will outperform WEB. Hypothesis 1b: WEB+SN+NRT will outperform WEB+SN and WEB+NRT.

Aim 2: To examine whether the impact of treatment condition on cessation is mediated by greater adherence to problem solving/skills training tools, social support, and pharmacotherapy. Hypothesis 2: WEB+SN+NRT will have the greatest impact on treatment adherence, which will yield higher quit rates than the other treatments.

Exploratory Aim: To advance theory and identify the processes through which social network integration and provision of free NRT influence treatment adherence. Specifically, exploratory analyses will examine whether social support and social norms are active elements in the pathway to adherence, along with other known mediators of abstinence such as self-efficacy.

Being tested
WEB, Social Network, Nicotine Replacement Therapy (NRT)
Keywords
Web based behavioral intervention, Adherence, Smoking cessation, Social network, Nicotine replacement therapy, Social support
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WEBBehavioural

    Also called BecomeAnEX

    Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.

  • Social NetworkBehavioural

    Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.

  • Nicotine Replacement Therapy (NRT)Behavioural

    Also called NicoDerm CQ, Nicorette Gum, Nicorette Lozenge, Nicorette Mini-Lozenge

    A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own.

Study groups in NCT01544153
Study groupRoleWhat they receive
WEB onlyOtherControl group receiving no additional intervention
Receives: Behavioral: WEB
WEB+SNExperimentalWEB plus social network intervention.
Receives: Behavioral: WEB; Behavioral: Social Network
WEB+NRTExperimentalWEB plus nicotine replacement therapy product.
Receives: Behavioral: WEB; Behavioral: Nicotine Replacement Therapy (NRT)
WEB+SN+NRTExperimentalWEB plus social network intervention and nicotine replacement therapy product.
Receives: Behavioral: WEB; Behavioral: Social Network; Behavioral: Nicotine Replacement Therapy (NRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-reported 30-day Point Prevalence Abstinence

    In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding "No", 30day point prevalence abstinence.

    Measured: 9 months post-randomization

Secondary outcomes (1)

  1. Self-reported 30-day Point Prevalence Abstinence

    In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding "No", 30day point prevalence abstinence

    Measured: 3 months post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionDec 2015
  4. Study completionAug 2017

Resources

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
Factorial
Masking
Single blind
Who is masked
Participant
Enrolment
5,292 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01544153
Sponsor's protocol ID
1R01CA155489
Other IDs
1R01CA155489
Status last verified
Sep 2026
First submitted
28 Feb 2012
Last updated
21 Oct 2026
Data monitoring committee
No
Individual data sharing
No: No current plans, but interested researchers may contact Principal Investigator for additional discussion.

Publications

  • Graham AL, Cha S, Papandonatos GD, Cobb NK, Mushro A, Fang Y, Niaura RS, Abrams DB. Improving adherence to web-based cessation programs: a randomized controlled trial study protocol. Trials. 2013 Feb 17;14:48. doi: 10.1186/1745-6215-14-48.

    PubMed 23414086

  • Graham AL, Cha S, Cobb NK, Fang Y, Niaura RS, Mushro A. Impact of seasonality on recruitment, retention, adherence, and outcomes in a web-based smoking cessation intervention: randomized controlled trial. J Med Internet Res. 2013 Nov 7;15(11):e249. doi: 10.2196/jmir.2880.

    PubMed 24201304

  • Pearson JL, Stanton CA, Cha S, Niaura RS, Luta G, Graham AL. E-Cigarettes and Smoking Cessation: Insights and Cautions From a Secondary Analysis of Data From a Study of Online Treatment-Seeking Smokers. Nicotine Tob Res. 2015 Oct;17(10):1219-27. doi: 10.1093/ntr/ntu269. Epub 2014 Dec 26.

    PubMed 25542911

  • Cha S, Erar B, Niaura RS, Graham AL. Baseline Characteristics and Generalizability of Participants in an Internet Smoking Cessation Randomized Trial. Ann Behav Med. 2016 Oct;50(5):751-761. doi: 10.1007/s12160-016-9804-x.

    PubMed 27283295

  • Graham AL, Papandonatos GD, Cha S, Erar B, Amato MS. Improving Adherence to Smoking Cessation Treatment: Smoking Outcomes in a Web-based Randomized Trial. Ann Behav Med. 2018 Mar 15;52(4):331-341. doi: 10.1093/abm/kax023.

    PubMed 29878062

Questions about this trial

What is this clinical trial studying?

A study testing WEB, Social Network and Nicotine Replacement Therapy (NRT) in people with Smoking Cessation, run by Truth Initiative 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 3 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: finished, as of the sponsor's last update on 21 Oct 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?

Yes. Results are posted in the registry (first posted 10 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Self-reported 30-day Point Prevalence Abstinence (time frame: 9 months post-randomization). 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 NCT01544153, which also lists 5 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 21 Oct 2026.

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