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NCT00926939 Clinical Trial

Technological Innovations in Behavioral Treatments for Cigarette Smoking

Cigarette Smoking Clinical Trial

Official title:
Technological Innovations in Behavioral Treatments for Cigarette Smoking

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00926939
Other study ID # R01DA023469
Secondary ID R01DA023469
Status Completed
Phase N/A
First received June 23, 2009
Last updated April 13, 2015
Start date June 2009
Est. completion date August 2014

Study information
Verified date April 2015
Source National Development and Research Institutes, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Federal Government
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 96
Est. completion date August 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Reinforcement for the abstinence of smoking
Participants in this intervention group will receive vouchers contingent upon a CO sample of 4ppm or less.
• 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.

Locations
Country Name City State
United States National Development and Research Institutes New York City New York

Sponsors (2)
Lead Sponsor Collaborator
National Development and Research Institutes, Inc. National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary CO sample of = 4ppm 4 weeks, 7 weeks during intervention; 3 months and 6 months after intervention No
Primary 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 No
Secondary Twice-daily breath CO samples obtained during treatment period. First 4 weeks of treatment No
Secondary The longest duration of sustained abstinence based on the twice-daily breath samples during the treatment period. First 4 weeks of treatment No
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