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Very Low Nicotine Cigarettes in Smokers With Schizophrenia

Primary Purpose

Tobacco Dependence

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Very low nicotine content cigarettes

standard nicotine content cigarettes

About this trial

This is an interventional basic science trial for Tobacco Dependence

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-70
Schizophrenia, schizoaffective disorder or bipolar disorder
Smoke an average of at least 10 cigarettes per day for at least 1 year
Breath carbon monoxide (CO) levels >8 ppm (if ≤ 8 ppm, then nicotine (NicAlert) Strip > 2)

Exclusion Criteria:

Pregnant or nursing
Seeking treatment for smoking
Medical contraindications

Sites / Locations

Brown University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

0.8 mg nicotine with 10.5 mg tar

0.03 mg nicotine with 9 mg tar

Arm Description

SPECTRUM Cigarette: 0.8 (±0.15) mg nicotine yield with 9 (±1.5) mg tar (standard nicotine and tar yields of commercially-available cigarettes; control condition)

SPECTRUM Cigarette: 0.03 mg (± 0.02) nicotine yield with 9 mg (± 1.5) tar

Outcomes

Primary Outcome Measures

Number of cigarettes smoked per day

Secondary Outcome Measures

Full Information

NCT ID

NCT02019459

First Posted

December 18, 2013

Last Updated

April 5, 2018

Sponsor

Brown University

Collaborators

National Institute on Drug Abuse (NIDA), University of Pittsburgh

1. Study Identification

Unique Protocol Identification Number

NCT02019459

Brief Title

Very Low Nicotine Cigarettes in Smokers With Schizophrenia

Official Title

Very Low Nicotine Cigarettes in Smokers With Schizophrenia

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

November 17, 2014 (Actual)

Primary Completion Date

August 31, 2017 (Actual)

Study Completion Date

August 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brown University

Collaborators

National Institute on Drug Abuse (NIDA), University of Pittsburgh

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Smokers with serious mental illness including those with schizophrenia and bipolar disorder infrequently attempt and attain sustained smoking abstinence and have a 25-year shorter lifespan due to smoking-related illness. This study will examine whether reducing the nicotine content of cigarettes to non-addicting levels is a viable method of reducing smoking in smokers with serious mental illness. Smokers will be randomized to one of two experimental conditions: 1) very low nicotine content (VLNC) cigarettes or 2) normal nicotine content (NNC) cigarettes. Participants will be assessed for patterns of tobacco use, biomarkers of exposure, subjective responses (e.g., satisfaction, craving, withdrawal symptoms), psychiatric symptoms, cognitive performance, smoking cue reactivity and smoking topography.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tobacco Dependence

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.8 mg nicotine with 10.5 mg tar

Arm Type

Active Comparator

Arm Description

SPECTRUM Cigarette: 0.8 (±0.15) mg nicotine yield with 9 (±1.5) mg tar (standard nicotine and tar yields of commercially-available cigarettes; control condition)

Arm Title

0.03 mg nicotine with 9 mg tar

Arm Type

Experimental

Arm Description

SPECTRUM Cigarette: 0.03 mg (± 0.02) nicotine yield with 9 mg (± 1.5) tar

Intervention Type

Other

Intervention Name(s)

Very low nicotine content cigarettes

Intervention Type

Other

Intervention Name(s)

standard nicotine content cigarettes

Primary Outcome Measure Information:

Title

Number of cigarettes smoked per day

Time Frame

End of 6 week intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-70 Schizophrenia, schizoaffective disorder or bipolar disorder Smoke an average of at least 10 cigarettes per day for at least 1 year Breath carbon monoxide (CO) levels >8 ppm (if ≤ 8 ppm, then nicotine (NicAlert) Strip > 2) Exclusion Criteria: Pregnant or nursing Seeking treatment for smoking Medical contraindications

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer Tidey, Ph.D.

Organizational Affiliation

Brown University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brown University

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02912

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Very Low Nicotine Cigarettes in Smokers With Schizophrenia

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