Penn State TXT2Quit Study

Nicotine Dependence, Cigarettes Clinical Trial

Official title:

Pilot Randomized Trial of an Automated Smoking Cessation Intervention Via Mobile Phone Text Messages as an Adjunct to Varenicline in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367391
• Other study ID #: 41720
• Status: Completed
• Phase: N/A
• First received: February 13, 2015
• Last updated: October 8, 2015
• Start date: January 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is evaluating the feasibility and short term smoking cessation outcomes of an automated smoking cessation intervention delivered via mobile phone text messaging as an adjunct to Varenicline in a primary care setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Smoke >4 cigarettes/day for at least 6 months

• Age 21+

• Want to quit and ready to try in next 30 days

• Willing to quit all forms of tobacco (including e-cigs)

• Willing to use Chantix to try to quit

• Have a cell phone able to receive text messages

• Willing to attend 3 visits and use varenicline for smoking cessation

• Plan to live in local area for next 6 months

• Read and write in English

• Women not pregnant and taking steps to avoid

• Able to understand and willing to sign consent

Exclusion Criteria:

• History of allergic reaction or other adverse event while using varenicline

• Used a smoking cessation aid/medicine in past 1 month (including e-cigs)

• Currently pregnant or nursing

• Does not have a mobile phone that can send and receive text messages or unwilling to receive study texts

• Uncontrolled serious mental illness or substance abuse or inpatient treatment for these in the past 6 months

• Uses non-cigarette tobacco products and does not plan to quit all tobacco.

• Has a history of kidney problems or receives dialysis

• Had any thoughts that they would be better off dead or of deliberate self-harm in the prior 4 weeks

• Had a heart attack in the past 4 weeks

• Mental conditions that would prohibit the participant from completing the protocol

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Dependence, Cigarettes

Intervention

Behavioral:
• Motivational Text Messages
Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
• Control
Usual Care. All participants receive the active medication, Varenicline.

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Point prevalence of 7-day tobacco abstinence biochemically validated by exhaled CO < 10ppm at Visit 3 (12 weeks after target quit day)		12 weeks	No
Primary	Sustained abstinence at the 12-week follow up		12 weeks	No
Primary	Number of days of varenicline use		12 weeks	No
Primary	Number of active smoking cessation activities used		12 weeks	No
Secondary	Continuous lapse-free tobacco abstinence from 4 weeks to 12 weeks, biochemically validated at Visit 2 and Visit 3.		12 weeks	No
Secondary	Time (in days) to relapse after the target quit day		12 weeks	No
Secondary	Medication compliance		12 weeks	No
Secondary	Total score on the Positive Smoking Cessation Activities measure		12 weeks	No