NCT01181661

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

3 years

First QC Date

August 12, 2010

Last Update Submit

September 23, 2014

Conditions

Keywords

CigaretteSmokingNicotineContingency ManagementVoucher ReinforcementSmoking AbstinenceInternetInternet-based TreatmentGroup Contingencies

Outcome Measures

Primary Outcomes (1)

  • Breath CO

    Twice daily breath CO samples obtained during baseline and treatment

    8 weeks

Secondary Outcomes (3)

  • Point prevalence measure of abstinence

    at the end of treatment (approximately week 4) and at 3 month follow-up

  • Duration of abstinence during treatment.

    3 weeks

  • Rate of social exchanges

    3 weeks

Study Arms (2)

Full Group Contingency

EXPERIMENTAL

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: Full Group Contingency

Mixed Group Contingency

EXPERIMENTAL

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.

Behavioral: Mixed Group Contingency

Interventions

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.

Full 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.

Mixed Group Contingency

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • self-reported smoker
  • ability to use the Internet
  • permission to contact applicant by phone

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Florida

Gainesville, Florida, 32611, United States

Location

National Development and Research Institutes

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Cigarette SmokingSmoking

Condition Hierarchy (Ancestors)

Tobacco SmokingBehaviorTobacco Use

Study Officials

  • Jesse Dallery, PhD

    National Development and Research Institutes, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 12, 2010

First Posted

August 13, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations