Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Persistence Targeted Smoking Cessation in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03873337
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Marc L. Steinberg, Ph.D., Rutgers, The State University of New Jersey

Brief Summary:
The investigators will conduct a randomized clinical trial to test the feasibility, initial efficacy, and mechanisms of action of our PTSC-S intervention.

Condition or disease Intervention/treatment Phase
Tobacco Use Tobacco Smoking Tobacco Use Cessation Tobacco Use Disorder Schizophrenia Schizoaffective Disorder Behavioral: Persistence Targeted Smoking Cessation in Schizophrenia Behavioral: Clearing the Air Drug: Nicotine patch Phase 4

Detailed Description:

The investigators will conduct a randomized clinical trial to test the feasibility, initial efficacy, and mechanisms of action of our PTSC-S intervention as compared to a time-matched intervention that does not address task persistence.

The investigators hypothesize that participants will attend at least 60% of PTSC-S treatment sessions and that those attending the PTSC-S treatment sessions will have a larger percentage of abstinent days and larger rates of prolonged- and 7-day point prevalence abstinence (all biochemically verified with CO<8ppm) at end-of-treatment and 3-months post quit-date as compared to those attending an active, time-matched control intervention based on the NCI's Clearing the Air intervention.

The investigators hypothesize that PTSC-S will result in greater task persistence than will a control treatment and that greater changes in task persistence will be related to greater abstinence rates. While a Stage 1b therapy development study such as this is likely to be underpowered to detect mediation, the investigators will nevertheless test an exploratory mediational hypothesis that PTSC-S has its effect on smoking abstinence primarily through its effect on task persistence.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We will randomized participants to one of two counseling interventions, "Persistence Targeted Smoking Cessation for Schizophrenia (PTSC-S)" or a modified version of "Clearing the Air (CTA)"
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessors will not be informed to which intervention the participants are randomized.
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Persistence Targeted Smoking Cessation in Schizophrenia (PTSC-S)
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : March 10, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NRT + Persistence Targeted Smoking Cessation in Schizophrenia
Participants randomized to this intervention will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of cessation counseling with a focus on task persistence.
Behavioral: Persistence Targeted Smoking Cessation in Schizophrenia
All participants will receive 8 weeks of smoking cessation counseling

Drug: Nicotine patch
All participants will receive 10 weeks of nicotine patch

Active Comparator: NRT + Modified Clearing the Air
Participants randomized to this intervention will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of cessation counseling that does not focus on task persistence.
Behavioral: Clearing the Air
All participants will receive 8 weeks of smoking cessation counseling

Drug: Nicotine patch
All participants will receive 10 weeks of nicotine patch




Primary Outcome Measures :
  1. Prolonged abstinence at 3-month followup [ Time Frame: 3-months post target quit date ]
    Prolonged abstinence with a 2-week grace period following the target quit date until 3-months post quit-date, biochemically verified with CO<8ppm


Secondary Outcome Measures :
  1. Prolonged abstinence at end-of-counseling [ Time Frame: End-of-counseling (8 weeks) ]
    Prolonged abstinence with a 2-week grace period following the target quit date until end-of-counseling, biochemically verified with CO<8ppm

  2. Seven-day point prevalence abstinence at 3-month follow-up [ Time Frame: 3-months post-target quit date ]
    No smoking on the 7 days before the 3-month follow-up, biochemically verified with CO<8ppm

  3. Seven-day point prevalence abstinence at end-of-counseling [ Time Frame: End-of-counseling (8 weeks) ]
    No smoking on the 7 days before the final counseling session, biochemically verified with CO<8ppm


Other Outcome Measures:
  1. Attendance [ Time Frame: 8 weeks of counseling with a 2-week grace period to make up missed sessions (10 weeks) ]
    Participants in the PTSC-S intervention will attend at least 60% of their sessions

  2. Task Persistence [ Time Frame: End-of-counseling (8 weeks) ]
    Participants in the PTSC-S intervention will demonstrate greater task persistence at end-of-counseling as compared to those receiving the CTA intervention

  3. Mediation [ Time Frame: End-of-counseling (8 weeks) ]
    We will evaluate a mediational model in which PTSC-S has its effect on abstinence via increases in task persistence.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be between 18 - 70 years old
  • Must indicate willingness to make a quit attempt in the next 30 days
  • Must smoke at least 5 cigarettes (including those labeled "little cigars") per day for past month
  • Expired breath carbon monoxide (CO) > 5 to ensure daily cigarette use
  • Must have a diagnosis of Schizophrenia or Schizoaffective Disorder on Structured Clinical Interview (SCID-5)
  • Psychiatric illness must be stable, as indicated by no hospitalizations in previous 8 weeks, and a stable psychotropic medication regimen including a stable antipsychotic dose for 8 weeks

Exclusion Criteria:

  • Must not currently (in past 10 days) be taking varenicline (Chantix),
  • Must not currently (in past 10 days) be taking bupropion (Zyban/Wellbutrin) to quit smoking.
  • Must not be taking any nicotine preparations (gum, lozenge, patch, spray, inhaler) daily over the last 10 days
  • Must not report myocardial infarction, unstable angina pectoris, or significant cardiac arrhythmia (including atrial fibrillation) in the past 30 days.
  • Women must not be pregnant, "test positive" on a pregnancy test, nursing, or planning on becoming pregnant in the next three months. Women who can become pregnant may be included if using effective birth control.
  • Must not have pending legal matters with potential to result in jail time
  • Must not be planning on moving outside local area in next 3-months

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): NCT03873337


Contacts
Layout table for location contacts
Contact: Jessica Research Coordinator 732-235-4600 jco74@rwjms.rutgers.edu

Locations
Layout table for location information
United States, New Jersey
Division of Addiction Psychiatry Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Jessica Study Coordinator    732-235-4341    jco74@rwjms.rutgers.edu   
Principal Investigator: Marc L Steinberg, Ph.D.         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Institute on Drug Abuse (NIDA)
Investigators
Layout table for investigator information
Principal Investigator: Marc L Steinberg, Ph.D. Rutgers Robert Wood Johnson Medical School

Layout table for additonal information
Responsible Party: Marc L. Steinberg, Ph.D., Associate Professor of Psychiatry, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03873337     History of Changes
Other Study ID Numbers: Pro2018001696
R33DA041163 ( U.S. NIH Grant/Contract )
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Requests for de-identified data from qualified researchers will be considered once the study has been completed.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will become available once the study has been completed and primary and secondary outcomes have been published.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Marc L. Steinberg, Ph.D., Rutgers, The State University of New Jersey:
tobacco
cigarette
schizophrenia
schizoaffective disorders
smoking cessation

Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Schizophrenia
Psychotic Disorders
Tobacco Use Disorder
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action