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Technological Innovations in Behavioral Treatments for Cigarette Smoking

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jesse Dallery, National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier:
NCT00926939
First received: June 23, 2009
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention
Cigarette Smoking
Behavioral: Reinforcement for the abstinence of smoking
Behavioral: Reinforcement for submission of videos with CO sample

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Technological Innovations in Behavioral Treatments for Cigarette Smoking

Resource links provided by NLM:


Further study details as provided by National Development and Research Institutes, Inc.:

Primary Outcome Measures:
  • CO sample of ≤ 4ppm [ Time Frame: 4 weeks, 7 weeks during intervention; 3 months and 6 months after intervention ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Twice-daily breath CO samples obtained during treatment period. [ Time Frame: First 4 weeks of treatment ] [ Designated as safety issue: No ]
  • The longest duration of sustained abstinence based on the twice-daily breath samples during the treatment period. [ Time Frame: First 4 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926939

Locations
United States, New York
National Development and Research Institutes
New York City, New York, United States, 10010
Sponsors and Collaborators
National Development and Research Institutes, Inc.
Investigators
Principal Investigator: Jesse Dallery, PhD National Development and Research Institutes, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Jesse Dallery, Principal Investigator, National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier: NCT00926939     History of Changes
Other Study ID Numbers: R01DA023469, R01DA023469
Study First Received: June 23, 2009
Last Updated: October 15, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by National Development and Research Institutes, Inc.:
Cigarette
Nicotine
Smoking
Contingency Management
Voucher reinforcement
Smoking Abstinence
Internet-based treatment

ClinicalTrials.gov processed this record on November 20, 2014