Cigarette Smoking in Smokers With and Without a Diagnosis of Schizophrenia
Phase: NA
Conditions: Tobacco Dependence, Schizophrenia
Sponsor: University of Maryland, Baltimore

The following document is the IRB-approved study protocol. It was downloaded on Dec 28, 2022.  
The last Continuing Review approved the study from April 19, 2022 through April 18, 2023.  

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University of Maryland, Baltimore
              Institutional Review Board (IRB)
Phone:  (410) 706-5037
Fax:     (410) 706-4189
Email:  hrpo@umaryland.edu
APPROVAL OF RESEARCH NOTIFICATION
OF NOTE: The Principal Investigator should review the University of Maryland Baltimore criteria for 
performing research during the current COVID-19 pandemic emergency. Understand that IRB approval of 
this research does not suggest that performance of this research under current guidelines is allowed. Failure 
to comply with the UMB President's directives would be considered non-compliance.  The UMB Research 
directives can be found at https://www.umaryland.edu/coronavirus/ .  If you need clarification or guidance 
please call the Human Research Protections Office at 410-706-5037.
Date: April 21, 2022
To: Britta Hahn
RE: HCR-HP-00086422-3
Type of Submission: Continuing Review
Type of IRB Review: Full Board
Approval for this project is valid from 4/19/2022 to 4/18/2023
This is to certify that the University of Maryland, Baltimore (UMB) Institutional Review Board (IRB) approved the 
continuing review report for the above referenced protocol entitled, “Cigarette Smoking in Smokers With and 
Without a Diagnosis of Schizophrenia”.
The IRB made the following determinations regarding this submission:
- Written informed consent is required. Only the valid IRB-approved informed consent form(s) in CICERO can be 
used.
- A waiver of HIPAA authorization for release of the PHI identified in the CICERO application has been reviewed 
and approved for recruitment purposes only.
This study is approved to enroll 160 local participants.
This study is approved to enroll 160 worldwide participants.
Below is a list of the documents attached to your application that have been approved:
DSMB minutes 2021(0.01)
Consent and HIPAA form
Eligibility Checklist for HP-00086422_2 v7-14-2021-1626273388214
NIDA grant application
Research Match Contact Message
Telephone screening script
Flyer with tear-offs with transportation
Flyer without tear-offs with transportation
Flyer without tear-offs VA

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Flyer with tear-offs VA
Flyer with tear-offs
Flyer without tear-offs
Nicoderm CQ
NOT-DA-14-004: NIDA Research Cigarettes
FDA Letter of No Concerns
Evaluation to sign consent
Structured Clinical Interview for DSM
Modified Cigarette Evaluation Questionnaire
Psychiatric Medication Form
Nicotine Use Questionnaire
Nicotine Dependence Questionnaire
Questionnaire for Smoking Urges
Non-Psychiatric Medication Form
Affect-based Withdrawal Scale
Cigarette Discrimination Questionnaire
Side effects checklist
Minnesota Tobacco Withdrawal Scale
Medical History Pre-screen
Wechsler Test of Adult Reading
MCCB Reasoning/Problem solving (Mazes)
WASI Vocabulary subtest
WASI Matrix Reasoning
Debriefing Letter
UMB-COVID-Risk-Statement-09.2020-FINAL.docx
In conducting this research you are required to follow the requirements listed in the INVESTIGATOR MANUAL.  
Investigators are reminded that the IRB must be notified of any changes in the study.  In addition, the PI is 
responsible for ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring 
that such changes in approved research, during the period for which IRB approval has already been given, may not 
be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the 
subject (45 CFR 46.103(4)(iii)).  The PI must also inform the IRB of any new and significant information that may 
impact a research participant’s safety or willingness to continue in the study and any unanticipated problems 
involving risks to participants or others.
DHHS regulations at 45 CFR 46.109 (e) require that continuing review of research be conducted by the IRB at 
intervals appropriate to the degree of risk and not less than once per year. The regulations make no provision for 
any grace period extending the conduct of the research beyond 4/18/2023.  You will receive continuing review 
email reminder notices prior to this date; however, it is your responsibility to submit your continuing review report 
in a timely manner to allow adequate time for substantive and meaningful IRB review and assure that this study is 
not conducted beyond 4/18/2023.  Investigators should submit continuing review reports in the electronic system at 
least six weeks prior to this date.
Research activity in which the VA Maryland Healthcare System (VAMHCS) is a recruitment site or in which VA 
resources (i.e., space, equipment, personnel, funding, data) are otherwise involved, must also be approved by the 
VAMHCS Research and Development Committee prior to initiation at the VAMHCS.  Contact the VA Research 
Office at 410-605-7000 ext. 6568 for assistance.
The UMB IRB is organized and operated according to guidelines of the International Council on Harmonization, the 
United States Office for Human Research Protections and the United States Code of Federal Regulations and 
operates under Federal Wide Assurance No. FWA00007145.
If you have any questions about this review or questions, concerns, and/or suggestions regarding the Human 
Research Protection Program (HRPP), please do not hesitate to contact the Human Research Protections Office 
(HRPO) at (410) 706-5037 or HRPO@umaryland.edu.