Internet-based Group Contingency Management to Promote Smoking Abstinence

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

Jesse Dallery, National Development and Research Institutes, Inc.

ClinicalTrials.gov Identifier:

NCT01181661

First received: August 12, 2010

Last updated: April 30, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 12, 2010

Last Updated Date

April 30, 2013

Start Date ^ICMJE

August 2010

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Breath CO [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Twice daily breath CO samples obtained during baseline and treatment

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01181661 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Point prevalence measure of abstinence [ Time Frame: at the end of treatment (approximately week 4) and at 3 month follow-up ] [ Designated as safety issue: No ]
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.
Duration of abstinence during treatment. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
The longest duration of sustained abstinence (CO ≤ 4 ppm) based on the twice-daily breath samples during the treatment period.
Rate of social exchanges [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
The number of comments posted on the discussion forum during treatment.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Internet-based Group Contingency Management to Promote Smoking Abstinence

Official Title ^ICMJE

Internet-based Group Contingency Management to Promote Smoking Abstinence

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Cigarette Smoking

Intervention ^ICMJE

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.
Behavioral: 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.

Study Arm (s)

Experimental: 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.

Intervention: Behavioral: Full Group Contingency
Experimental: 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.

Intervention: Behavioral: Mixed Group Contingency

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01181661

Other Study ID Numbers ^ICMJE

1R21DA029162, 1R21DA029162

Has Data Monitoring Committee

Responsible Party

Jesse Dallery, National Development and Research Institutes, Inc.

Study Sponsor ^ICMJE

National Development and Research Institutes, Inc.

Collaborators ^ICMJE

National Institute on Drug Abuse (NIDA)

Investigators ^ICMJE

Principal Investigator:

Jesse Dallery, PhD

National Development and Research Institutes, Inc.

Information Provided By

National Development and Research Institutes, Inc.

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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