Evaluation of a Computer-Delivered 5 A's Intervention for Smoking

Smoking Clinical Trial

Official title:

Evaluation of a Computer-Delivered 5 A's Intervention for Smoking

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01383278
• Other study ID #: SBIRTCSVCU
• Secondary ID: R01DA026091
• Status: Terminated
• Phase: N/A
• First received: June 24, 2011
• Last updated: December 18, 2015
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2015
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a 2-group RCT in 380 tobacco-using medical patients that will compare a single session, computer-directed 5 A's intervention for smoking (experimental condition) to screening and resource provision (control condition). Follow-up visits will occur at 1 and 3 months post study enrollment. Measures will focus on tobacco use and related psychosocial outcomes (e.g. mood, stress). We will compare resources used and economic costs needed to implement each intervention.

The Investigators hypothesize that patients receiving the computer-directed intervention will have significantly higher tobacco abstinence rates at 3 months post study enrollment compared to the control group. If indeed the computerized intervention increases tobacco abstinence rates compared to the control group, this intervention could be used to increase access to treatment for the millions of US smokers, ultimately reducing tobacco mortality and morbidity rates in this country.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 - 65 years

• Primary care patient

• Smoked at least one cigarette per day for the past seven days or at least 10 cigarettes total during the past week

• Smoked at least 100 cigarettes (lifetime)

• Had no recent (past 90 days) use of other forms of tobacco (pipes, cigars, NRT)

• Able to speak English

Exclusion Criteria:

• Pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Computer-directed 5 A's intervention for smoking
Computer-directed 5 A's intervention for smoking
• Screening and resource provision
Screening and resource provision

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tobacco use	The primary outcome variable for this study will be smoking cessation at 3 month follow-up as measured by self-report, salivary cotinine and carbon monoxide levels.	3 months post-randomization	No
Secondary	Mood and stress	By using the K-10 Instrument	3 months post-randomization	No
Secondary	Resource utilization and economic costs		3 months post-randomization	No