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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
MPRC, University of Maryland
ClinicalTrials.gov Identifier:
NCT00770237
First received: October 7, 2008
Last updated: September 12, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Schizophrenia
Nicotine Dependence
Behavioral: Smoking Cues
Behavioral: Neutral Cues

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Effects of Smoking Cues on Tobacco Craving Responses and the Reinforcing Efficacy of Cigarettes in Smokers With and Without Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of Maryland:

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. [ Time Frame: 7-10 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: October 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cues
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).
Behavioral: Smoking Cues
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.
Behavioral: Neutral Cues
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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770237

Locations
United States, Maryland
Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP)
Catonsville, Maryland, United States, 21228
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Deanna L Kelly, Pharm.D, BCPP University of Maryland
Principal Investigator: Stephen J Heishman, Ph.D. National Institute on Drug Abuse (NIDA)
  More Information

No publications provided

Responsible Party: MPRC, Deanna L. Kelly, Pharm.D., BCPP, University of Maryland
ClinicalTrials.gov Identifier: NCT00770237     History of Changes
Other Study ID Numbers: HP-00042356, NIDA 430
Study First Received: October 7, 2008
Last Updated: September 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Smoking
Nicotine
Schizophrenia

Additional relevant MeSH terms:
Tobacco Use Disorder
Schizophrenia
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 20, 2014