CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,816 enrolled
Drug / intervention
Nicotine patches +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01502306
NCT01502306Phase 3Completed
CompareCT.gov

A Randomized Trial of Medi-Cal Beneficiaries Calling the California Smokers' Helpline

University of California, San Diego·interventional·Posted Dec 30, 2011·Updated Feb 13, 2020

In Brief

A Phase 3 clinical trial evaluating Telephone counseling, Nicotine patches, and 1 other intervention for Smoking Cessation. Completed, enrolled 3,816 participants across 1 site.

Detailed Summary

California Smokers' Helpline will conduct a randomized trial to evaluate 3 strategies of services and/or incentives on smoking cessation rates. This project has the following specific aims: 1. To increase tobacco cessation among Medi-Cal beneficiaries who currently smoke, and to improve the management of diabetes and other chronic disease by means of tobacco cessation. 2. Demonstrate that tobacco cessation benefits that are well promoted and barrier free and include modest incentives, are effective in reducing smoking prevalence, lowering Medi-Cal health care costs, and improving health outcomes for diabetes management in particular.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesUnited States
CollaboratorsCenters for Medicare and Medicaid Services, University of California, San Francisco, California Department of Public Health, California Department of Health Services

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 30, 2011
Enrollment StartJun 1, 2012
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.5 years ago

Interventions

Telephone counselingbehavioral

Telephone counseling is conducted in the appropriate language (Spanish and English) by counselors at the California Smokers' Helpline. Counselors use a structured protocol and there is a record for each call. Quantitative information that will be available for analysis include: timing, length, and frequency of counseling calls.

Nicotine patchesdrug

Clients will be screened for contraindications to nicotine patch use, and a doctor's approval will be necessary before patches are sent if a contraindication exists.

Incentivebehavioral

They will be given their choice of gift cards from one of 4 major business chains: Wal-Mart, Target, Vons/Safeway, or Ralph's/Kroger card.