Mood and Smoking: A Comparison of Smoking Cessation Treatments

Smoking Cessation Clinical Trial

Official title:

CSP #725 - Mood and Smoking: A Comparison of Smoking Cessation Treatments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00075972
• Other study ID #: 725
• Status: Completed
• Phase: N/A
• First received: January 12, 2004
• Last updated: June 25, 2015
• Start date: March 2003
• Est. completion date: March 2006

Study information

• Verified date: June 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Objectives:

The long term objectives of this research program are:

1. To advance the mission of the VHA Boston Healthcare System to deliver comprehensive quality healthcare that meets the needs of patients (in this case, who have been unresponsive to standard smoking cessation treatment) through research and clinical care.

2. To expand upon our knowledge of the feasibility and effectiveness of commonly-used treatments for nicotine dependence.

3. To further explore variables related to mood and coping that may contribute to or prevent successful reduction and cessation of smoking behavior among veterans.

The short-term objectives of this project are:

1. To evaluate the feasibility and effectiveness of two adjunctive treatments (a mood-focused exposure-based treatment, Mood Tolerance, with Nicotine Replacement Therapy [MTNRT] and mood-focused affect-management treatment, Mood Management, with Nicotine Replacement Therapy [MMNRT]) aimed at reduction and cessation of smoking behavior among veterans who were previously non-responders to smoking cessation treatment in the VA.

2. To inform equivocal findings in the literature regarding the role of mood as trigger for smoking behavior.

3. To explore selected mood, coping, and individual difference variable that may be predictive of successful abstinence from cigarettes among veterans.

Description:

Objectives:

The short-term objectives of this project are:

1. To evaluate the effectiveness of two adjunctive treatments (mood-focused exposure-based treatment, Mood Tolerance, with Nicotine Replacement Therapy [MT-NRT] and mood-focused affect-management treatment, Mood Management, with NRT [MM-NRT] aimed at reduction and cessation of smoking behavior among veterans who were previously non-responders to smoking cessation treatment.

2. To examine specific variables that may serve as mechanisms of action for successful treatment (i.e., mood and coping variables).

The long-term objectives of this research program are:

1. To advance the mission of the VA to deliver comprehensive quality healthcare that meets the needs of patients who have been unresponsive to standard smoking cessation treatment, through research and clinical care.

2. To reduce the exorbitant healthcare costs of nicotine dependence (ND) to the VA, and to improve veterans' physical and psychological well-being, healthcare utilization, and mortality rates.

3. To evaluate effectiveness of common treatments for ND.

4. To explore mechanisms of action related to efficacy of treatment for ND among veterans (i.e., changes in mood and coping.)

Research Design:

This is a two-cell, single-blind, randomized, treatment outcome study.

Methodology:

One hundred and twenty-eight smoking outpatients who have previously participated in standard group smoking cessation treatment (treatment non-responders, with NRT) will be recruited through the VA Boston Outpatient Health Psychology Clinic. Advertising flyers posted throughout the Boston VA Medical Center and Outpatient Clinic will be used to supplement this recruitment.

Baseline Assessment:

Interested and eligible patients will sign an informed consent form, which will be thoroughly reviewed with each participant and co-signed by the investigators. Baseline evaluation of the participants will take approximately 90 minutes. This evaluation will include assessment of smoking-related variables, moods, and affect-regulation and coping strategies, as well as carbon monoxide (CO) levels in expired breath.

Treatment:

Participants will be randomly assigned to one of the two treatments. This will involve meeting with a pharmacist, primary care physician, psychiatrist, or nurse practitioner to be screened for use of nicotine replacement therapy (NRT; transdermal patch) and to initiate NRT use. A member of the research team will continue to monitor the participant's physical health during the course of the treatment. In addition, the participant will attend treatment groups once a week for 15 weeks. These treatment groups will be conducted by a member of the research team or clinical students supervised by the PI. Each of these groups will last 90 minutes.

Follow-Up:

The first follow-up appointment will take place in the week after completion of the treatment. Additional follow-up assessments will take place at 3-, 6-, 9-, and 12-months subsequent to the first follow-up appointment. These assessments will be almost identical to the baseline assessment, and will last approximately 90 minutes.

Findings:

Thirty-four participants have been enrolled in this study; 12 of whom are currently actively involved in the protocol. No data have been analyzed or presented yet.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Outpatient veteran smokers who have previously failed a smoking cessation treatment program with nicotine replacement therapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Mood Management
• Mood Tolerance
• Nicotine Replacement Therapy
• Smoking Cessation

Intervention

Behavioral:
• Mood Tolearance

• Mood Management

Drug:
• Nicotine Replacement therapy

Locations

Country	Name	City	State
United States	Boston VA Healthcare System	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States,