Telephone-Delivered Interventions for Smoking Cessation (TALK)

January 16, 2020 updated by: Fred Hutchinson Cancer Center
The purpose of this study is to demonstrate that Acceptance and Commitment Therapy's (ACT) implementation outcomes are at least as good as those of traditional cognitive behavioral therapy (CBT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1275

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
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center

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:

  1. ages 18 and older
  2. smokes at least ten cigarettes per day (to be eligible for NRT) and has done so for at least the past 12 months
  3. wants to quit smoking in the next 30 days
  4. if concurrently using any other nicotine or tobacco products wants to quit using them within the next 30 days
  5. willing to be randomly assigned to either group
  6. willing and able to speak and read in English
  7. willing and medically eligible to use NRT
  8. resides in the U.S., and expects to continue for at least 12 months
  9. not participating in other smoking cessation interventions (including our own intervention trials)
  10. has regular access to a telephone.

Exclusion Criteria:

The exclusion criteria are opposite of the inclusion criteria listed above.

In addition we will exclude:

  1. anyone who is pregnant or breast feeding
  2. has had a heart attack in the past 30 days
  3. has unstable angina
  4. has evidence of arrhythmia in the past 6 months
  5. has a history of severe skin reaction to adhesive patches.

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: TALK study group
This is the experimental arm of the study. This includes 5 weekly sessions of experimental therapy via telephone. Therapy description withheld to protect the integrity of the study.
Behavioral: Telephone Delivered Intervention
Active Comparator: TALK control group
This is the control arm of the study. This includes 5 weekly sessions of control therapy via telephone.Therapy description withheld to protect the integrity of the study.
Behavioral: Telephone Delivered Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 day point prevalence abstinence
Time Frame: 12 months
No smoking in the past 30 days, as reported at 12 month post treatment
12 months

Collaborators and Investigators

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

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Institute on Drug Abuse (NIDA)
National Cancer Institute (NCI)
Consumer Wellness Solutions

Investigators

  • Principal Investigator: Jonathan B Bricker, Ph.D., Fred Hutchinson Cancer Center

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.

General Publications

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 (Actual)

November 2, 2015

Primary Completion (Actual)

August 8, 2018

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

April 16, 2015

First Submitted That Met QC Criteria

April 16, 2015

First Posted (Estimate)

April 21, 2015

Study Record Updates

Last Update Posted (Actual)

January 21, 2020

Last Update Submitted That Met QC Criteria

January 16, 2020

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 8298 (CTEP)
  • P30CA015704 (U.S. NIH Grant/Contract)
  • NCI-2018-02635 (Registry Identifier: NCI / CTRP)
  • RG1001154 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
  • R01DA038411 (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.

Clinical Trials on Smoking

Clinical Trials on Telephone Delivered Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe