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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01602536
Other study ID # 1R34DA030538-01A1
Secondary ID
Status Completed
Phase N/A
First received May 17, 2012
Last updated December 4, 2015
Start date January 2012
Est. completion date June 2014

Study information

Verified date December 2015
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

In Phase I (N=40), we developed a treatment protocol for smoking cessation and relapse prevention that used virtual quit-smoking Twitter groups and Twitter-enabled interactive peer messaging. We tested and refined this protocol using two quit-smoking Twitter groups. In Phase II (N=160), we conducted a two-arm (test vs. control) randomized controlled trial of the treatment protocol created in Phase I. In Phase III (N=80) we ran additional quit-smoking Twitter groups and tested various interventions to increase engagement in the intervention, e.g., peer leaders. This research provided crucial data about the viability and methodology to be used in a larger randomized controlled trial that would directly measure smoking behavior.


Description:

Smoking relapse rates remain high, innovative strategies are needed to lower them, and web-based social networking may help like Twitter. This developmental research examined whether providing virtual (web-based) social support to smokers, through Twitter-enabled interactive peer texting, could help smokers quit and avoid relapses. Twitter is a free social networking and micro-blogging service, one of the most advanced and novel technologies available today that can provide social support to smokers, and it provides free texting to groups. It is global and has many features that are associated with treatment success including interactive, multi-way, live messaging and mobile accessibility, because the messages go instantly to mobile phones and to the web. It can provide an innovative way to reach smokers who might otherwise not seek treatment, and it can be extended to other health domains.

In Phase II which took place from June 2012 through 2013, we conducted a two-condition randomized controlled trial (Aim 2). All participants in this trial (N=160) received 8 weeks of free nicotine patches, referral to the NCI's online Smokefree.gov Quit Guide, and instruction to set a quit date within 1 week of study start. Participants were also randomly assigned at the individual level to one of two conditions: (1) a virtual quit-smoking Twitter group condition where the group members were instructed to use Twitter-enabled interactive peer messaging to help them quit and stay quit, or (2) a control group condition where the group members were not given this instruction or a Twitter group. In total, there were 4 Twitter groups and 4 control groups with 20 smokers randomly assigned to each group (i.e., N=80 test, N=80 control). The primary outcome was self-reported 7-day point prevalence abstinence that was sustained at 7, 30 and 60 days after the quit date. Participants' tweets, their virtual and face-to-face social networks, and several other possible mediating and moderating variables were also analyzed.


Recruitment information / eligibility

Status Completed
Enrollment 280
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 59 Years
Eligibility Inclusion Criteria:

- must have smoked 100 cigarettes during their lifetime

- must currently smoke 5 or more cigarettes a day

- must be in the preparation stage of quitting smoking

- ages 18-59 years

- English speaking

- have a mobile phone with an unlimited texting plan and internet access

- use text messaging at least once a week

- use Facebook daily

- have an active email account

- live in the continental USA

Exclusion Criteria:

- a medical condition that is contra-indicated for nicotine replacement therapy:

- pregnant

- breast feeding

- a recent heart attack

- an irregular heartbeat

- high blood pressure not controlled with medication

- skin allergies to adhesive tape or serious skin problems

- taking a prescription medicine for depression or anxiety

- use drugs or marijuana regularly

- live in the same household with another participant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
smoking cessation aides
All participants will receive 8 weeks of free nicotine patches, referral to the NCI's online Smokefree.gov Quit Guide, and instruction to set a quit date within 8 days of study start.
Twitter
Twitter quit-smoking group

Locations

Country Name City State
United States Hosted Study Website Tweet2Quit@Merage.Uci.Edu Irvine California
United States University of California Irvine Irvine California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary self-reported 7-day point prevalence abstinence from smoking that was sustained at 7, 30 and 60 days after the quit date 60 days after quit date No
Secondary level of engagement based on tweet volume 100 days total No
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