Improving Smoking Cessation Quitlines: Pilot Study of Acceptance Therapy

Smoking Clinical Trial

— TALK  

Official title:

Improving Smoking Cessation Quitlines: Pilot Study of Acceptance Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01525420
• Other study ID #: 7445
• Status: Completed
• Phase: N/A
• First received: January 31, 2012
• Last updated: May 7, 2014
• Start date: March 2012
• Est. completion date: March 2013

Study information

• Verified date: May 2014
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate that Acceptance Therapy (ACT's) implementation outcomes are at least as good as those of traditional cognitive behavioral therapy (CBT).

Implementation outcomes:

• end of treatment and 6-month follow-up data retention rates;

• intervention implementation quality;

• number & length of calls completed.

Comparison of each arm's implementation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. aged 18 and older;

2. smokes at least 10 cigarettes daily and has done so for at least the past 12 months;

3. wants to quit smoking in the next 30 days;

4. willing to be randomly assigned to either group;

5. willing and able to speak and read in English;

6. willing and medically eligible to use nicotine replacement therapy (NRT),

7. currently resides in the U.S., and expects to continue for at least 12 months;

8. not participating in other smoking cessation interventions;

9. has regular access to a telephone.

10. has regular access to an email address.

Exclusion Criteria:

• The Exclusion criteria are the opposite of the Inclusion criteria listed above. In addition, the following exclusion criteria also apply:

1. another member of household enrolled in the study;

2. currently using medication or nicotine replacement products to help with quitting smoking;

3. currently using any non-cigarette tobacco products;

4. pregnant or breastfeeding;

5. had a heart attack in last 30 days;

6. within the last 6 months, diagnosed with angina, heart pain, or irregular heartbeat;

7. serious adverse reactions to nicotine patches including anaphylaxis and related symptoms such as hives, respiratory difficulty, and/or angioedema.

Study Design

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

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Acceptance Therapy (ACT)
ACT

Other:
• Cognitive Behavioral Therapy (CBT)
CBT

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	Alere Wellbeing

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Stopped Smoking by 6 Month Post Treatment	30-Day point prevalence abstinence at 6 months post treatment	6 months	No
Secondary	7-day and 24-hour Point Prevalence Quit Rates	7-day and 24-hour point prevalence quit rates	6-month	No