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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00104481
Other study ID # 2R15CA077732-02A1
Secondary ID 2R15CA077732-02A
Status Completed
Phase Phase 1/Phase 2
First received March 1, 2005
Last updated December 7, 2011
Start date January 2005
Est. completion date August 2007

Study information

Verified date March 2007
Source American University
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 evaluate the effectiveness of group therapy for cigarette smoking cessation. The group meets for 8 sessions and includes education and group discussion about the effects of smoking and ways to cope with withdrawal symptoms and other challenges to maintaining abstinence. In one condition, the groups also learn techniques based on cognitive therapy, to help cope with negative feelings.


Description:

The comparison condition is the same length as the cognitive behavior therapy condition but omits the cognitive restructuring component. In both conditions, smokers prepare for a quit date by using scheduled reduced smoking, which involves smoking on a set schedule that gradually reduces the number of cigarettes smoked. Post-treatment assessments occur one week after the end of treatment, and at 3-month followup.

Pre- and post-treatment assessments include measures of coping skills and emotional acceptance, as well as smoking rate.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Regular daily smokers interested in quitting

Exclusion Criteria:

- Significant suicidal ideation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
cognitive behavior therapy


Locations

Country Name City State
United States American University Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
American University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Haaga DA, Thorndike FP, Friedman-Wheeler DG, Pearlman MY, Wernicke RA. Cognitive coping skills and depression vulnerability among cigarette smokers. Addict Behav. 2004 Aug;29(6):1109-22. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary cigarette smoking abstinence
Secondary cognitive coping skills
Secondary depressive symptoms
Secondary acceptance
Secondary distress tolerance
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