NCT00075972

Brief Summary

Objectives: The long term objectives of this research program are:

  1. 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. 2.To expand upon our knowledge of the feasibility and effectiveness of commonly-used treatments for nicotine dependence.
  3. 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.
  4. 4.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.
  5. 5.To inform equivocal findings in the literature regarding the role of mood as trigger for smoking behavior.
  6. 6.To explore selected mood, coping, and individual difference variable that may be predictive of successful abstinence from cigarettes among veterans.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2004

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

June 26, 2015

Status Verified

June 1, 2015

First QC Date

January 12, 2004

Last Update Submit

June 25, 2015

Conditions

Smoking CessationMood ToleranceMood ManagementNicotine Replacement Therapy

Interventions

Mood TolearanceBEHAVIORAL
Mood ManagementBEHAVIORAL
Nicotine Replacement therapyDRUG

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Outpatient veteran smokers who have previously failed a smoking cessation treatment program with nicotine replacement therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Boston VA Healthcare System

Boston, Massachusetts, 02103, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

January 12, 2004

First Posted

January 14, 2004

Study Start

March 1, 2003

Study Completion

March 1, 2006

Last Updated

June 26, 2015

Record last verified: 2015-06

Locations

US(1)