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VIP Smoking Cessation Intervention for Adults With Serious Mental Illness (VIP)

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ClinicalTrials.gov Identifier: NCT03950427
Recruitment Status : Not yet recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Collaborator:
Tobacco Related Disease Research Program
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This is a research study about a smoking cessation program tailored for adults with serious mental illness (SMI). The program uses a Videogame-based Physical (VIP) activity, smoking cessation counseling, and medication (bupropion),

Condition or disease Intervention/treatment Phase
Smoking Cessation Smoking, Tobacco Mental Illness Tobacco Use Disorder Behavioral: Videogame-based physical activity Behavioral: sedentary videogame Drug: Bupropion Behavioral: Counseling Phase 4

Detailed Description:

The purpose of this study is to learn more about how adults with serious mental illness respond to a smoking cessation program combining a Videogame-based Physical activity, counseling for smoking cessation, and a medication (bupropion) for smoking cessation.

Study participants will receive counseling to quit smoking and a medication to help decrease cravings and withdrawal. Additionally, participants will be randomly selected to participate in either a videogame-based physical activity group or a videogame group where the participants sit to play the games.

Participants will be in this study for 12 weeks total. There are 3 assessment visits (2 hours each) at the beginning of the study, 6 weeks after starting, and at the end of the 12 weeks. There will be 8 30- minute counseling sessions during the 12 weeks. The hour-long videogame groups will be held 3 times a week for 12 weeks (36 sessions). Upon completion of the 12-week program, there will be a 1-2 hour group interview. The total time commitment is 48 hours over the course of the 12-week study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a pilot 2-arm RCT to examine the feasibility and potential efficacy of an application of a videogame based group physical activity intervention for smoking cessation in adults with SMI.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VIP Smoking Cessation Intervention for Adults With Serious Mental Illness
Estimated Study Start Date : July 8, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Bupropion

Arm Intervention/treatment
Active Comparator: Videogame-based Physical Activity Group

The videogame-based physical activity group, will play active videogames using the Kinect for Xbox 360 game system. Each videogame group will be facilitated by the study coordinator, the principal investigator or other study staff.

Participants in this group will also receive bupropion and counseling for smoking cessation.

Behavioral: Videogame-based physical activity
videogame-based physical activity

Drug: Bupropion
Bupropion

Behavioral: Counseling
Counseling for smoking cessation

Placebo Comparator: Sedentary Videogame Group

The sedentary videogame group will play videogames while seated using the Xbox 360 game system (without the Kinect sensor). Each sedentary videogame group will be facilitated by study staff.

Participants in this group will also receive bupropion and counseling for smoking cessation.

Behavioral: sedentary videogame
sedentary videogame

Drug: Bupropion
Bupropion

Behavioral: Counseling
Counseling for smoking cessation




Primary Outcome Measures :
  1. Total number of videogame sessions attended [ Time Frame: 12-weeks ]
    Feasibility will be measured with a total count of sessions attended. The GSR will document participant attendance.

  2. Total minutes of videogame sessions attended [ Time Frame: 12-weeks ]
    Feasibility will be measured with a sum of minutes attended. The GSR will monitor and document the times when participants enter and leave the sessions.

  3. Week-6 Self-report acceptability rankings of the videogames [ Time Frame: administered at week 6 ]
    This internally developed acceptability questionnaire has 7 questions. Three questions use a 1 to 5 scale with 1 indicating least acceptable and 5 indicating most acceptable, for a possible total range of 3-15. The remaining open-ended questions are scored using qualitative thematic analysis.

  4. Week-12 Self-report acceptability rankings of the videogames -week 12 [ Time Frame: administered at week 12. ]
    This internally developed acceptability questionnaire has 7 questions. Three questions use a 1 to 5 scale with 1 indicating least acceptable and 5 indicating most acceptable, for a possible total range of 3-15. The remaining open-ended questions are scored using qualitative thematic analysis. Used to measure change from week-6 to week-12.

  5. Tobacco reduction and abstinence [ Time Frame: administered at week 6. ]
    The investigators will ask about the number of cigarettes, even a puff, smoked in the past week (7-day abstinence) or use of any form of tobacco or alternative tobacco product e.g., e-cigarette or heat not burn. Salivary cotinine levels will be measured to determine abstinence from smoking.

  6. Tobacco reduction and abstinence [ Time Frame: administered at week 12. ]
    The investigators will ask about the number of cigarettes, even a puff, smoked in the past week (7-day abstinence) or use of any form of tobacco or alternative tobacco product e.g., e-cigarette or heat not burn. Salivary cotinine levels will be measured to determine abstinence from smoking.

  7. Baseline Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Baseline interview with the participant and observations of the participant's behavior over the previous 2-3 days. ]
    The Semi-Structured Interview for Brief Psychiatric Rating Scale is completed by the PI or trained research staff and assesses the number and severity of psychiatric symptoms. It consists of 24 items that are rated from 1 (not present) to 7 (extremely severe), and the items are summed for a total psychopathology score, with a possible range from 24-168 and a higher score indicating a higher severity of illness. The score will be used to measure change between the baseline, 6-week, and 12-week time points.

  8. Week-6 Brief Psychiatric Rating Scale (BPRS) [ Time Frame: interview at week-6 with the participant and observations of the participant's behavior over the previous 2-3 days. ]
    The Semi-Structured Interview for Brief Psychiatric Rating Scale is completed by the PI or trained research staff and assesses the number and severity of psychiatric symptoms. It consists of 24 items that are rated from 1 (not present) to 7 (extremely severe), and the items are summed for a total psychopathology score, with a possible range from 24-168 and a higher score indicating a higher severity of illness. The score will be used to measure change between the baseline, 6-week, and 12-week time points.

  9. Week-12 Brief Psychiatric Rating Scale (BPRS) [ Time Frame: interview at week-12 with the participant and observations of the participant's behavior over the previous 2-3 days. ]
    TThe Semi-Structured Interview for Brief Psychiatric Rating Scale is completed by the PI or trained research staff and assesses the number and severity of psychiatric symptoms. It consists of 24 items that are rated from 1 (not present) to 7 (extremely severe), and the items are summed for a total psychopathology score, with a possible range from 24-168 and a higher score indicating a higher severity of illness. The score will be used to measure change between the baseline, 6-week, and 12-week time points.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of a SMI*
  • 18 years and older
  • Smoking at least five cigarettes per day for the past 6 months
  • Willingness to set a quit date
  • Not currently taking bupropion or using NRT
  • Current participant in the residential or day treatment program at a Progress Foundation program with the intention to continue in the residential or day treatment program for at least the 12 week intervention period
  • Capacity to consent.

    • SMI is characterized by the American Psychological Association as distinct conditions that require routine management, produce functional impairment, and interfere with quality of life. Individuals that typically meet the criteria of SMI have illnesses that include schizophrenia, schizoaffective disorder, psychotic disorders, major depressive disorders, bipolar disorders, and borderline personality disorder.

Exclusion Criteria:

  • Currently pregnant or breastfeeding
  • Diagnosis of seizure disorder, history of anorexia/bulimia, undergoing abrupt discontinuation of ethanol or sedatives, other conditions that increase seizure risk (e.g., AV malformation, severe head injury, CNS tumor)
  • use of MAO inhibitors (concurrently or within 14 days of discontinuing either bupropion or the MAO inhibitor)
  • Planning to become pregnant during the study period
  • Previous participation in the videogame-based physical activity intervention.
  • Known medical conditions or other physical problems that need special attention in an exercise program (e.g. prior myocardial infarction, uncontrolled hypertension, history of angioplasty, history of angina, use of nitroglycerin to treat angina)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950427


Contacts
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Contact: Heather Leutwyler, PhD 415-514-1524 heather.leutwyler@ucsf.edu
Contact: Erin Hubbard, MPH 415-502-7774 erin.hubbard@ucsf.edu

Locations
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United States, California
UCSF
San Francisco, California, United States, 94143-0610
Sponsors and Collaborators
University of California, San Francisco
Tobacco Related Disease Research Program
Investigators
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Principal Investigator: Heather Leutwyler, PhD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03950427     History of Changes
Other Study ID Numbers: T29IP0235
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:
smoking cessation
serious mental illness

Additional relevant MeSH terms:
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Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors