Telephone-Delivered Interventions for Smoking Cessation

NCT ID: NCT02421991

Last Updated: 2020-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-02

Study Completion Date

2019-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Telephone Delivered Intervention

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Telephone Delivered Intervention

Intervention Type BEHAVIORAL

Interventions

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Telephone Delivered Intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.


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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Consumer Wellness Solutions

INDUSTRY

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan B Bricker, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

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Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.

Reference Type DERIVED
PMID: 35420700 (View on PubMed)

Other Identifiers

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NCI-2018-02635

Identifier Type: REGISTRY

Identifier Source: secondary_id

RG1001154

Identifier Type: OTHER

Identifier Source: secondary_id

R01DA038411

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

8298

Identifier Type: -

Identifier Source: org_study_id

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