Mood Management Phone Counseling in Smoking Cessation

Cigarette Smoking Clinical Trial

Official title:

Mood Management Phone Counseling in Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00500877
• Other study ID #: 1RO1DA017947
• Secondary ID: R01DA017947
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2007
• Last updated: July 19, 2016
• Start date: February 2007
• Est. completion date: June 2008

Study information

• Verified date: July 2016
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Information obtained from this study will help us to have a better idea of how phone counseling may facilitate the process of quitting smoking for individuals with a history of recurrent depression.

Description:

Adult smokers with a history of recurrent major depression (MDD) report higher levels of depressive symptoms when presenting for smoking cessation treatment and have poor smoking outcomes relative to other smokers. Carefully conducted clinical trials have supported the efficacy of cognitive-behavioral mood management treatment for depression in improving smoking cessation outcomes in this high-risk group. Although efficacious, these intensive group treatments require significant resources and thus may have limited impact outside of specialized smoking cessation programs. In the present study we will develop and obtain preliminary data on the efficacy of proactive telephone counseling for smoking cessation that integrates cognitive-behavioral mood management skills training for depression (MM). Smokers with a history of recurrent MDD will be randomly assigned to the proactive telephone counseling for smoking cessation with mood management (MM) or a standard proactive telephone counseling (ST) comparison condition. We expect that this program of research will result in the development of a specialized, efficacious treatment with broad reach into a significant subpopulation of smokers at greatest risk for difficulties quitting, and will therefore have important clinical and public health significance in decreasing the overall prevalence of cigarette smoking.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• history of two or more past episodes of depression

• regular cigarette smoker for at least one year

• currently smoking 10 or more cigarettes each day

• want to quit smoking

Exclusion Criteria:

• Current Depressive Episode

• Current Alcohol of Substance abuse

• Pregnant, planning to become pregnant

Study Design

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

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• Mood Management Phone Counseling for Smoking Cessation
Phone counseling addressed mood management and smoking cessation

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Abstinence		6 months	No