Internet-based Group Contingency Management to Promote Smoking Abstinence

Cigarette Smoking Clinical Trial

Official title:

Internet-based Group Contingency Management to Promote Smoking Abstinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181661
• Other study ID #: 1R21DA029162
• Secondary ID: 1R21DA029162
• Status: Completed
• Phase: N/A
• First received: August 12, 2010
• Last updated: September 23, 2014
• Start date: August 2010
• Est. completion date: August 2013

Study information

• Verified date: September 2014
• Source: National Development and Research Institutes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to develop and test an Internet-based group contingency management program designed to promote smoking cessation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• self-reported smoker

• ability to use the Internet

• permission to contact applicant by phone

Exclusion Criteria:

• self-report of a history of or current severe or unstable medical or psychiatric illness that would interfere with the study

• inability to avoid high levels of ambient CO (e.g., occupational exposure; lives with a another smoker who smokes in the home)

Study Design

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

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• Full Group Contingency
This group (n = 20) will earn vouchers based only on team (n = 4) performance. Only if all members of the team submit a negative sample (CO = 4 ppm), will they each earn a voucher.
• Mixed Group Contingency
This group (n = 20) will earn vouchers based on both individual and team (n = 4) performance. If an individual submits a negative sample (CO = 4 ppm), s/he will earn a voucher. Additionally, bonus vouchers will be earned if all team members submit negative samples.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	National Development and Research Institutes	New York City	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Development and Research Institutes, Inc.	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breath CO	Twice daily breath CO samples obtained during baseline and treatment	8 weeks	No
Secondary	Point prevalence measure of abstinence	Abstinence will be defined as: (a) CO sample = 4 ppm; (b) cotinine < 50 ng/ml; and (c) reporting not smoking, not even a puff in the last 7 days.	at the end of treatment (approximately week 4) and at 3 month follow-up	No
Secondary	Duration of abstinence during treatment.	The longest duration of sustained abstinence (CO = 4 ppm) based on the twice-daily breath samples during the treatment period.	3 weeks	No
Secondary	Rate of social exchanges	The number of comments posted on the discussion forum during treatment.	3 weeks	No