NCT00926939

Brief Summary

The purpose of the study is to evaluate a sustainable and broadly accessible treatment delivery model (Motiv8) for smoking cessation based on abstinence-reinforcement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

June 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2009

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

4.9 years

First QC Date

June 23, 2009

Last Update Submit

April 13, 2015

Conditions

Keywords

CigaretteNicotineSmokingContingency ManagementVoucher reinforcementSmoking AbstinenceInternet-based treatment

Outcome Measures

Primary Outcomes (2)

  • CO sample of ≤ 4ppm

    4 weeks, 7 weeks during intervention; 3 months and 6 months after intervention

  • Participant reporting not smoking, not even a puff in the last 7 days.

    4 weeks, 7 weeks during intervention; 3 months and 6 months after intervention

Secondary Outcomes (2)

  • Twice-daily breath CO samples obtained during treatment period.

    First 4 weeks of treatment

  • The longest duration of sustained abstinence based on the twice-daily breath samples during the treatment period.

    First 4 weeks of treatment

Study Arms (2)

Abstinence Contingent (AC)

EXPERIMENTAL

This group will receive vouchers contingent on smoking reduction and smoking abstinence (confirmed through video submissions). Abstinence is defined as a CO sample of 4ppm or less.

Behavioral: Reinforcement for the abstinence of smoking

Submission Contingent (SC)

EXPERIMENTAL

This group receives vouchers for submitting videos of their CO breath test.

Behavioral: Reinforcement for submission of videos with CO sample

Interventions

Participants in this intervention group will receive vouchers contingent upon a CO sample of 4ppm or less.

Abstinence Contingent (AC)

This intervention group will receive vouchers contingent on their submission of videos of their CO breath tests.

Submission Contingent (SC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-reported smoker
  • Permission to contact applicant by phone
  • Ability to use the internet

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Development and Research Institutes

New York, New York, 10010, United States

Location

Related Links

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

June 23, 2009

First Posted

June 24, 2009

Study Start

June 1, 2009

Primary Completion

May 1, 2014

Study Completion

August 1, 2014

Last Updated

April 14, 2015

Record last verified: 2015-04

Locations