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Effects of Smoking Cues on Tobacco Craving Responses and the Reinforcing Efficacy of Cigarettes in Smokers With and Without Schizophrenia

Primary Purpose

Schizophrenia, Nicotine Dependence

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Smoking Cues

Neutral Cues

About this trial

This is an interventional diagnostic trial for Schizophrenia focused on measuring Smoking, Nicotine, Schizophrenia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for Schizophrenia Patients
1. 18-64 year old males and females
2. Smoking at least 10 cigarettes per day for at least 1 year
3. Urinary cotinine level ≥ 100 ng/ml (NicAlert® reading ≥ 3)
4. Current DSM-IV diagnosis of schizophrenia and stable medication regimen (see above)
5. Medically healthy as determined by screening criteria
Inclusion Criteria for Healthy Volunteers
1. 18-64 year old males and females
2. Smoking at least 10 cigarettes per day for at least 1 year
3. Urinary cotinine level ≥ 100 ng/ml (NicAlert® reading ≥ 3)
4. Medically and psychologically healthy as determined by screening criteria
Exclusion Criteria for Schizophrenia Patients
1. Current interest in reducing or quitting tobacco use
2. Treatment for tobacco dependence in the past 3 months
3. Use of nicotine replacement products, bupropion, or varenicline in the past 3 months
4. Consumption of more than 15 alcoholic drinks per week during the past month
5. Use of any illicit drug more than twice per week during the past month
6. Current use of any medication that would interfere with the protocol in the opinion of MAI (e.g., medications that would interfere with the cue reactivity portion of the study including, but not limited to, antidepressants, first-generation antipsychotics, and mood stabilizers)
7. Under the influence of a drug or alcohol at experimental sessions
8. Pregnant, nursing, or become pregnant during the study
Exclusion Criteria for Healthy Volunteers
1. Current interest in reducing or quitting tobacco use
2. Treatment for tobacco dependence in the past 3 months
3. Use of nicotine replacement products, bupropion, or varenicline in the past 3 months
4. Consumption of more than 15 alcoholic drinks per week during the past month
5. Use of any illicit drug more than twice per week during the past month
6. Current use of any medication that would interfere with the protocol in the opinion of MAI (e.g., medications that would interfere with the cue reactivity portion of the study including, but not limited to, antidepressants, antipsychotics, and mood stabilizers)
7. Under the influence of a drug or alcohol at experimental sessions
8. Pregnant, nursing, or become pregnant during the study

Sites / Locations

Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cues

Arm Description

Outcome Measures During cue trials, primary measures include craving (TCQ-SF, VAS), mood (mood form, VAS), and autonomic (heart rate, blood pressure, skin conductance and temperature) responsivity. During self-administration trials, primary measures include breakpoint (final ratio completed), total number of responses, and number of cigarette puffs earned and taken. Secondary measures include baseline smoking history, mood form, TCQ-SF, CO, FTND, and urinary cotinine and 3-hydroxycotinine (3-HC).

Outcomes

Primary Outcome Measures

To compare the effects of smoking versus neutral cues on craving, mood, and autonomic responsivity in smokers with schizophrenia and smokers without schizophrenia.

Secondary Outcome Measures

Full Information

NCT ID

NCT00770237

First Posted

October 7, 2008

Last Updated

August 15, 2019

Sponsor

University of Maryland, Baltimore

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00770237

Brief Title

Effects of Smoking Cues on Tobacco Craving Responses and the Reinforcing Efficacy of Cigarettes in Smokers With and Without Schizophrenia

Official Title

Effects of Smoking Cues on Tobacco Craving Responses and the Reinforcing Efficacy of Cigarettes in Smokers With and Without Schizophrenia

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

October 2008 (Actual)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Maryland, Baltimore

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

In this study, we will compare cue-reactivity in smokers with and without schizophrenia and the influence of smoking cues on responding for cigarette puffs under a PR schedule of reinforcement. Given the high prevalence of smoking among individuals with schizophrenia, understanding some of the environmental factors that serve to maintain nicotine dependence is a critical step in improving smoking cessation treatment outcomes. Establishing and validating a laboratory model of cue-elicited responsivity and cigarette self- administration will allow the investigation of the efficacy of anti-craving medications in people with schizophrenia. Specific Aims 1) To compare the effects of smoking versus neutral cues on craving, mood, and autonomic responsivity in smokers with schizophrenia and smokers without schizophrenia. 2) To compare the effects of smoking versus neutral cues on the reinforcing efficacy of tobacco cigarettes in smokers with schizophrenia and smokers without schizophrenia. Outcome Measures During cue trials, primary measures include craving (TCQ-SF, VAS), mood (mood form, VAS), and autonomic (heart rate, blood pressure, skin conductance and temperature) responsivity. During self-administration trials, primary measures include breakpoint (final ratio completed), total number of responses, and number of cigarette puffs earned and taken. Secondary measures include baseline smoking history, mood form, TCQ-SF, CO, FTND, and urinary cotinine and 3-hydroxycotinine (3-HC). The ratio of 3-HC/cotinine is a phenotypic biomarker of the rate of nicotine metabolism, which has been shown to be associated with level of nicotine dependence, various smoking behaviors, and treatment outcome (Ho & Tyndale, 2007). We will correlate the primary measures with the 3-HC/cotinine ratio to explore possible relationships for future study.

6. Conditions and Keywords

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

Schizophrenia, Nicotine Dependence

Keywords

Smoking, Nicotine, Schizophrenia

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cues

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Smoking Cues

Intervention Description

In the smoking cue condition, a pack of the participants preferred brand of cigarettes, a lighter, and an ashtray will be under the tray cover. In the neutral cue condition, a pack of unsharpened pencils, a pencil sharpener, and a small notepad will be under the cover. When instructed, the participant will lift the cover on the tray. In the smoking cue condition, participants will take one cigarette out of the pack, light it without puffing, hold it for 1 minute, extinguish the cigarette, and replace the cover on the tray.

Intervention Type

Behavioral

Intervention Name(s)

Neutral Cues

Intervention Description

In the neutral cue condition, participants will take one pencil out of the pack, sharpen it, hold it for 1 minute as if to write on the notepad, and then replace the cover. Participants will complete the VAS during cue exposure and the TCQ-SF, VAS, and mood form immediately and 15 minutes after cue presentation; physiological measures will be recorded continuously.

Primary Outcome Measure Information:

Title

To compare the effects of smoking versus neutral cues on craving, mood, and autonomic responsivity in smokers with schizophrenia and smokers without schizophrenia.

Time Frame

7-10 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria for Schizophrenia Patients 18-64 year old males and females Smoking at least 10 cigarettes per day for at least 1 year Urinary cotinine level ≥ 100 ng/ml (NicAlert® reading ≥ 3) Current DSM-IV diagnosis of schizophrenia and stable medication regimen (see above) Medically healthy as determined by screening criteria Inclusion Criteria for Healthy Volunteers 18-64 year old males and females Smoking at least 10 cigarettes per day for at least 1 year Urinary cotinine level ≥ 100 ng/ml (NicAlert® reading ≥ 3) Medically and psychologically healthy as determined by screening criteria Exclusion Criteria for Schizophrenia Patients Current interest in reducing or quitting tobacco use Treatment for tobacco dependence in the past 3 months Use of nicotine replacement products, bupropion, or varenicline in the past 3 months Consumption of more than 15 alcoholic drinks per week during the past month Use of any illicit drug more than twice per week during the past month Current use of any medication that would interfere with the protocol in the opinion of MAI (e.g., medications that would interfere with the cue reactivity portion of the study including, but not limited to, antidepressants, first-generation antipsychotics, and mood stabilizers) Under the influence of a drug or alcohol at experimental sessions Pregnant, nursing, or become pregnant during the study Exclusion Criteria for Healthy Volunteers Current interest in reducing or quitting tobacco use Treatment for tobacco dependence in the past 3 months Use of nicotine replacement products, bupropion, or varenicline in the past 3 months Consumption of more than 15 alcoholic drinks per week during the past month Use of any illicit drug more than twice per week during the past month Current use of any medication that would interfere with the protocol in the opinion of MAI (e.g., medications that would interfere with the cue reactivity portion of the study including, but not limited to, antidepressants, antipsychotics, and mood stabilizers) Under the influence of a drug or alcohol at experimental sessions Pregnant, nursing, or become pregnant during the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deanna L Kelly, Pharm.D, BCPP

Organizational Affiliation

University of Maryland, College Park

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Stephen J Heishman, Ph.D.

Organizational Affiliation

National Institute on Drug Abuse (NIDA)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP)

City

Catonsville

State/Province

Maryland

ZIP/Postal Code

21228

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Effects of Smoking Cues on Tobacco Craving Responses and the Reinforcing Efficacy of Cigarettes in Smokers With and Without Schizophrenia

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