Technological Innovations in Behavioral Treatments for Cigarette Smoking
This study is currently recruiting participants.
Verified April 2013 by National Development and Research Institutes, Inc.
Sponsor:
National Development and Research Institutes, Inc.
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: April 5, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00926939
Contacts
| Contact: Bethany Riaff, PhD | 212-845-4458 | raiff@ndri.org |
| Contact: Patrick Kurdila, BS | 352-273-2151 | ufsmokelab@gmail.com |
Locations
| United States, New York | |
| National Development and Research Institutes | Recruiting |
| New York City, New York, United States, 10010 | |
| Contact: Lisa Bernhard bernhard@ndri.org | |
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: | April 5, 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 |
Additional relevant MeSH terms:
|
Smoking Habits |
ClinicalTrials.gov processed this record on May 16, 2013