Technological Innovations in Behavioral Treatments for Cigarette Smoking

April 13, 2015 updated by: Jesse Dallery, National Development and Research Institutes, Inc.
The purpose of the study is to evaluate a sustainable and broadly accessible treatment delivery model (Motiv8) for smoking cessation based on abstinence-reinforcement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Smokers are randomly assigned to one of two groups: an Abstinence Contingent (AC) group and a Submission Contingent (SC) group. The AC group receives vouchers for abstaining from smoking (measured by a carbon monoxide monitor and confirmed through video-submission), and the SC group receives vouchers for submitting videos of their carbon monoxide breath tests. Both groups take videos of their CO-monitoring on a secure website designed for the study, as well as receive standard care counseling and education related to smoking cessation. The main intervention lasts four weeks, and a three-week maintenance phase will follow. Assessments will be conducted at intake, week four (end of the main treatment phase), and at three and six months after the intervention period is completed

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York City, New York, United States, 10010
        • National Development and Research Institutes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Abstinence Contingent (AC)
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
Participants in this intervention group will receive vouchers contingent upon a CO sample of 4ppm or less.
Experimental: Submission Contingent (SC)
This group receives vouchers for submitting videos of their CO breath test.
Behavioral: Reinforcement for submission of videos with CO sample
This intervention group will receive vouchers contingent on their submission of videos of their CO breath tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CO sample of ≤ 4ppm
Time Frame: 4 weeks, 7 weeks during intervention; 3 months and 6 months after intervention
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.
Time Frame: 4 weeks, 7 weeks during intervention; 3 months and 6 months after intervention
4 weeks, 7 weeks during intervention; 3 months and 6 months after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Twice-daily breath CO samples obtained during treatment period.
Time Frame: First 4 weeks of treatment
First 4 weeks of treatment
The longest duration of sustained abstinence based on the twice-daily breath samples during the treatment period.
Time Frame: First 4 weeks of treatment
First 4 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Development and Research Institutes, Inc.

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Jesse Dallery, PhD, National Development and Research Institutes, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

June 23, 2009

First Submitted That Met QC Criteria

June 23, 2009

First Posted (Estimate)

June 24, 2009

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R01DA023469 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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