CClinicalTrials.gg
CompletedNCT00960375Updated Aug 18, 2015Results posted

Smoking Cessation for Veterans With Severe and Persistent Mental Illness

A Phase 2/3 interventional study of BTSCS and StSST in Schizoaffective Disorder, Schizophrenia and Affective Psychosis, Bipolar, sponsored by US Department of Veterans Affairs. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-08-18.

Sponsored by US Department of Veterans Affairs · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
179
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The investigators have developed an intervention called Behavioral Treatment of Smoking Cessation in SPMI (BTSCS), an innovative intervention that supplements pharmacotherapy and education with contingency management and a multifaceted behavioral group treatment program that lasts for three months (24 group meetings). BTSCS is designed to address the cognitive, motivational, and social support problems characteristic of people with SPMI.

The investigators propose to conduct a randomized trial for persons with SPMI that compares (1) BTSCS: a 6-month manualized smoking cessation program adapted from an effective substance abuse treatment program for this population to (2) StSST: a standard manualized smoking cessation program which reflects current best practices.

Read the detailed description

Smoking is the leading cause of preventable death in the United States. Smoking contributes to increased rates of diseases such as lung cancer and heart disease, and adds dangerous complications to health problems such as diabetes and obesity. Despite widespread recognition of the devastating health effects of smoking, over 70% of people with schizophrenia and other serious and persistent mental illnesses (SPMI) smoke cigarettes, a rate that is at least double that of the general population and remains high despite decreases in rates of smoking in the general population. These extraordinary smoking rates contribute to elevated morbidity and mortality, have other life-threatening health-related consequences, and increase health care costs for treating smoking related illnesses in this population. Treating smoking is critical in improving the health of people with SPMI.

The newly revised VA/Department of Defense Clinical Practice Guideline for the Management of Tobacco Use outlines the VHA's comprehensive program for smoking cessation. Beginning in 1997, the VA central office directed that the Agency for Health Care Policy and Research (AHCPR) smoking cessation guideline (the 5 A's - Ask, Advise, Assess, Assist, Arrange) be implemented in all its health care facilities. Reinforcing their commitment to increasing veterans' access to evidence-based smoking cessation interventions, the VHA recently released a new policy mandating that smoking cessation treatment be made available without restriction at all VA sites. Our previous study implementing the 5A's in community mental health clinics has found reduced smoking and increased use of smoking cessation aids such as nicotine replacement therapy (NRT), but no only modest increases in abstinence. Implementation of the 5 A's was limited by inability to adequately assist patients to stop smoking. Consideration of how best to supplement the "Assist" and "Arrange" phases reveals the troubling observation that existing "best practice" treatments for smoking cessation have limited effectiveness for persons with SPMI. The most widely tested treatments consist generally of adaptations of American Lung Association (ALA) or comparable 10-14 session weekly groups supplemented by either nicotine replacement therapy (NRT) or Bupropion. Such programs produce low abstinence rates (0-25%) at end of intervention. Sustained abstinence is virtually non-existent. Abstinence at 6-month or 1-year follow-up points ranges from 0-10%.

We have developed an intervention the treatment of cocaine and heroin use disorders among persons with SPMI, called Behavioral Treatment for Substance Abuse in Serious and Persistent Mental Illness (BTSAS). BTSAS was developed with a series of National Institute on Drug Abuse (NIDA-funded treatment development grants as a treatment program for substance abuse that accommodated the cognitive and motivational impairments that characterize SPMI. The goal was to incorporate strategies that have been found to be effective in reducing drug use more generally, but to tailor them to meet the needs of people with SPMI. BTSAS provides a model for this application's test of an innovative smoking cessation treatment. Our basic premise is that we must first acknowledge nicotine dependence as an addiction with characteristics common to other substance addictions, and then specify the additional biological, social, cognitive, psychological and environmental barriers to quitting smoking for people with SPMI. We must then fully optimize available technologies for addiction in general and smoking cessation in particular to address these deficits. Existing approaches to smoking cessation for persons with SPMI do not use the full range of biological, contingency management, social modeling and behavioral tools that have been shown to work in treating other addictions in this population. Further, research on treatment of substance use disorders in persons with SPMI has suggested that, for best outcomes, interventions may need to be more intensive that what is provided for other groups of substance abusers. Applied to smoking, this suggests that for people with SPMI, smoking cessation may need to be more intensive than the 9 weekly sessions typical of conventional smoking cessation programs.

Based on our work developing BTSAS, and the above features of smoking in SPMI, we have developed an intervention called Behavioral Treatment of Smoking Cessation in SPMI (BTSCS), an innovative intervention that supplements pharmacotherapy and education with breath carbon monoxide monitoring and a multifaceted behavioral group treatment program that lasts for three months (24 sessions). BTSCS is designed to address the cognitive, motivational, and social support problems characteristic of people with SPMI. We propose to conduct a randomized clinical trial comparing BTSCS to a standard smoking cessation treatment.

Specific Aims: To determine if BTSCS is more effective in producing abstinence from smoking than a manualized smoking cessation program that reflects current best practices (StSST).

Hypothesis 1: BTSCS will result in greater rates of abstinence than StSST as shown by:

  1. A higher percentage of negative expired carbon monoxide levels at biweekly treatment sessions
  2. Increased days of abstinence reported at biweekly treatment sessions
  3. A higher percentage of negative expired carbon monoxide levels immediately post-treatment.
  4. A higher percentage of participants reporting abstinence in the 7-day interval preceding the post-treatment assessment.

Secondary Aims: We will assess the effectiveness of BTSCS on a set of intermediate outcomes including a reduction in smoking severity and improvement in readiness to quit smoking among smokers who have not been able to quit. We will also assess if increased treatment attendance and use of NRT's and bupropion moderate the hypothesized increases in abstinence.

02

Conditions studied

  • Schizoaffective Disorder
  • Schizophrenia
  • Affective Psychosis, Bipolar
  • Affective Disorders, Psychotic

Keywords

  • smoking cessation
  • serious mental illness
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 179 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • DSM-IV diagnosis of severe and persistent mental illness (SPMI) including a diagnosis of a psychotic disorder in keeping with criteria established by the Serious Mental Illness Treatment Research and Evaluation Center (SMITREC) -Schizophrenic disorders, affective psychoses and other psychotic diagnoses. We also include individuals with a diagnosis of Major Depression with psychotic features and PTSD.
  • Age 18-75
  • Nicotine dependence as defined by a score of 5 or higher on the Fagerstrom Tolerance Scale OR Participants who currently smoke at least 10 cigarettes per day
  • Participants will not meet criteria for current alcohol/substance dependence (other than nicotine)
  • Willingness ability to provide consent to participate.

Exclusion criteria

Exclusion Criteria:

  • Documented history of severe neurological disorder or severe head trauma with loss of consciousness
  • Severe or profound mental retardation by chart review.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
179 participants (actual)

Study arms

  • Experimental
    BTSCS

    BTSCS lasts 3 months, includes two 60-minute group meetings per week (24 group meetings total), and is delivered in small groups of 4-8 participants run by a trained interventionist. BTSCS includes: (1) An individual motivational enhancement meeting during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Breath carbon monoxide monitoring and goal-setting at the beginning of each meeting; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.

    Behavioral: BTSCS

  • Active comparator
    StSST

    The StSST program is adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meet twice per week for 3 months (24 sessions total). Participants complete a breath carbon monoxide test at the start of each group meeting. StSST groups provide education about smoking and support for quitting.

    Behavioral: StSST

Interventions

  • BehavioralBTSCS

    BTSCS lasts 3 months, includes two 60-minute group meetings per week (24 group meetings total), and is delivered in small groups of 4-8 participants run by a trained interventionist. BTSCS includes: (1) An individual motivational enhancement meeting during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Breath carbon monoxide monitoring and goal-setting at the beginning of each meeting; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.

  • BehavioralStSST

    The StSST program is adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meet twice per week for 3 months (24 sessions total). Participants complete a breath carbon monoxide (CO) test at the start of each group. StSST groups provide education about smoking and support for quitting.

06

What researchers measure

Primary outcomes

  1. Number of Cigarettes Smoked Per Day

    Number of cigarettes smoked per day for the last 7 days

    Time frame: day

  2. Abstinence From Tobacco

    Self-reported abstinence from tobacco + breath CO \< 10 ppm

    Time frame: 7 days

07

Results

Posted Jun 23, 2015
Limitations and caveats
The sample was mostly male, African-American, and recruited at VAMCs; it is unclear if findings would generalize to community settings. Many declined to participate; the sample represents persons with SMI who are interested in quitting.

Participant flow

Participants attended outpatient mental health programs at the Baltimore, Perry Point, and Washington DC VA Medical Centers. Participants had DSM-IV diagnoses of schizophrenia spectrum disorders, affective psychosis, other psychotic disorder, major depression with psychotic features, or post-traumatic stress disorder.

Participant flow — Overall Study
MilestoneBTSCSStSST
Started9287
Completed7265
Not completed2022
Withdrew: Lost to follow-up2022

Outcome measures

PrimaryNumber of Cigarettes Smoked Per Day

Number of cigarettes smoked per day for the last 7 days

Time frame:
day
Reported as:
Mean · number of cigarettes
Number of Cigarettes Smoked Per Day
number of cigarettesBTSCSStSST
Number of Cigarettes Smoked Per Day15.4 ± 9.814.9 ± 10.0
Statistical analysis
  • BTSCS vs StSST · ANOVA · p = 0.489
PrimaryAbstinence From Tobacco

Self-reported abstinence from tobacco + breath CO \< 10 ppm

Time frame:
7 days
Reported as:
Number · participants
Abstinence From Tobacco
participantsBTSCSStSST
Abstinence From Tobacco106
Statistical analysis
  • BTSCS vs StSST · ANOVA · p = 0.685

Adverse events

Collected over Adverse events were collected for each participant for the duration of their study participation (9 months).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BTSCS—0/92 (0%)0/92 (0%)
StSST—0/87 (0%)0/87 (0%)

Baseline characteristics

179 participants were randomized: 92 to BTSCS and 87 to StSST.

Age, Continuous
Age, Continuous(years)BTSCSStSSTTotal
Mean55.4 ± 13.054.1 ± 7.054.8 ± 7.2
Sex: Female, Male
Sex: Female, Male(Participants)BTSCSStSSTTotal
Female15419
Male7783160
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)BTSCSStSSTTotal
Hispanic or Latino202
Not Hispanic or Latino9087177
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BTSCSStSSTTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American6562127
White231740
More than one race000
Unknown or Not Reported4812
Region of Enrollment
Region of Enrollment(participants)BTSCSStSSTTotal
United States9287179
08

Study locations

2 sites
  • Washington DC VA Medical Center, Washington, DC
    Washington, District of Columbia 20422, United States
  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
    Baltimore, Maryland 21201, United States
09

References and documents

Publications

  • Bennett ME, Brown CH, Li L, Himelhoch S, Bellack A, Dixon L. Smoking Cessation in Individuals With Serious Mental Illness: A Randomized Controlled Trial of Two Psychosocial Interventions. J Dual Diagn. 2015;11(3-4):161-73. doi: 10.1080/15504263.2015.1104481. PubMed 26457385 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00960375
Lead sponsor
US Department of Veterans Affairs
Responsible party
Sponsor
First posted
Aug 17, 2009
Start date
Apr 2010
Primary completion
Mar 2014
Completion
Dec 2014
Results posted
Jun 23, 2015
Last update
Aug 18, 2015

Study contacts

Melanie E Bennett
principal investigator · Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion