Overview

This trial is active, not recruiting.

Condition smoking cessation
Treatment btscs
Phase phase 1/phase 2
Sponsor University of Maryland
Collaborator National Institutes of Health (NIH)
Start date April 2008
End date March 2011
Trial size 50 participants
Trial identifier NCT00690131, 1R34MH080814-01A1, 29891

Summary

This 3-year study will involve the design and small-scale clinical trial of a behavioral treatment program for smoking cessation in people with severe mental illness (called Behavioral Treatment for Smoking Cessation in Serious and Persistent Mental Illness or BTSCS) in two psychosocial rehabilitation programs (PRPs) in Baltimore. Our aims are: (1) Develop intervention materials and examine feasibility, acceptability, and safety; (2) Measure the effects of the intervention at post-treatment and 3-month follow-up on rates of smoking cessation, number of quit attempts, rates of smoking reduction and intention/motivation to quit smoking.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
btscs
BTSCS includes: (1) A behavioral group emphasizing motivational enhancement, skills training, education, and relapse prevention; (2) Contingency management with financial incentives to reinforce reductions in smoking; (3) Supported use of Bupropion or nicotine replacement therapy that is integrated with clients' psychiatric care in participants who are interested; and (4) Smoking cessation care coordination to increase treatment engagement and retention.
(No Intervention)

Primary Outcomes

Measure
Smoking abstinence: percentage of participants reporting abstinence reported in the 7-day interval at post-treatment and follow-up
time frame: 7-day interval at post-treatment and follow-up
Smoking abstinence: average percentage of biweekly sessions with negative expired carbon monoxide (CO) levels (< 8 ppm)
time frame: from baseline to post treatment
Number of smoking quit attempts: self-reported number of quit attempts (for at least 24 hours) at post treatment and 3 month follow-up
time frame: time from baseline to post treatment and baseline to 3 month follow-up

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Severe and Persistent Mental Illness (schizophrenia, schizoaffective disorder or other severe mental disorder including bipolar disorder, major depression, or severe anxiety disorder). - Age between 18 and 75 years. - Current smokers who smoke at least 10 cigarettes per day. - Must have been seen by a psychiatrist at least every 3 months for the last 6 months. Exclusion Criteria: - Meet criteria for current alcohol/substance dependence (other than nicotine). - Documented mental retardation, history of severe head injury with LOC, severe and untreated seizure disorder

Additional Information

Official title An Integrated Approach to Smoking Cessation in SMI
Principal investigator Melanie E Bennett, Ph.D.
Description Smoking is the leading cause of preventable death in the United States, contributing to increased rates of lung cancer and heart disease, and adding complications to other health problems. Over 70% of people with serious mental illnesses (SMI) smoke, a rate that is double that of the general population and remains high despite decreases in overall smoking rates. Smoking contributes to elevated morbidity and mortality in SMI, has other life-threatening consequences, and increases health care costs in SMI. While treating smoking is a critical step in improving the health of people with SMI, there are features of SMI that make treatment difficult (low motivation to quit, symptoms, barriers to attendance, cognitive deficits, poor social functioning). Stop-smoking groups have had limited success in achieving smoking cessation (SC), likely because they have not been tailored for people with SMI. SC for SMI must address the deficits and barriers to change found in this population, and must be integrated with mental health services. This study will involve the design and small-scale clinical trial of a behavioral treatment program for SC in people with SMI called Behavioral Treatment for Smoking Cessation in Serious and Persistent Mental Illness (BTSCS) in two psychosocial rehabilitation programs (PRPs) in Baltimore. We will first provide basic education for PRP staff regarding smoking cessation in SMI to promote smoking cessation as a goal of mental health treatment. We will then pilot test BTSCS with components that include: (1) A behavioral group emphasizing motivational enhancement, skills training, education, and relapse prevention; (2) Contingency management with financial incentives to reinforce reductions in smoking; (3) Supported use of Bupropion or nicotine replacement therapy that is integrated with clients' psychiatric care in participants who are interested; and (4) Smoking cessation care coordination to increase treatment engagement and retention. Our primary aims are: (1) Develop intervention materials and examine feasibility, acceptability, and safety; (2) Measure the effects of the intervention at post-treatment and 3-month follow-up on rates of smoking cessation, number of quit attempts, rates of smoking reduction and intention/motivation to quit smoking.
Trial information was received from ClinicalTrials.gov and was last updated in June 2008.
Information provided to ClinicalTrials.gov by University of Maryland.