Mood and Smoking: A Comparison of Smoking Cessation Treatments

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00075972
First received: January 12, 2004
Last updated: January 20, 2009
Last verified: April 2007
  Purpose

Objectives: The long term objectives of this research program are: 1) to advance the mission of the VA 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, and 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, and 3) to explore selected mood, coping, and individual difference variable that may be predictive of successful abstinence from cigarettes among veterans.


Condition Intervention
Smoking Cessation
Mood Tolerance
Mood Management
Nicotine Replacement Therapy
Behavioral: Mood Tolearance
Behavioral: Mood Management
Drug: Nicotine Replacement therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Official Title: CSP #725 - Mood and Smoking: A Comparison of Smoking Cessation Treatments

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 128
Study Start Date: March 2003
Estimated Study Completion Date: March 2006
Detailed 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, and 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 the effectiveness of common treatments for ND, and 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075972

Locations
United States, Massachusetts
Boston VA Healthcare System
Boston, Massachusetts, United States, 02103
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00075972     History of Changes
Other Study ID Numbers: 725
Study First Received: January 12, 2004
Last Updated: January 20, 2009
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014