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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02421991
Other study ID # 8298
Secondary ID NCI-2018-02635RG
Status Completed
Phase N/A
First received
Last updated
Start date November 2, 2015
Est. completion date December 31, 2019

Study information

Verified date November 2019
Source Fred Hutchinson Cancer Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 1275
Est. completion date December 31, 2019
Est. primary completion date August 8, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Telephone Delivered Intervention


Locations

Country Name City State
United States Fred Hutchinson Cancer Research Center Seattle Washington

Sponsors (4)

Lead Sponsor Collaborator
Fred Hutchinson Cancer Research Center Alere Wellbeing, National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 30 day point prevalence abstinence No smoking in the past 30 days, as reported at 12 month post treatment 12 months
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