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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Nicotine Dependence
• Intervention / Treatment: Behavioral: Smoking Cues; Behavioral: Neutral Cues

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Catonsville, Maryland, United States, 21228
      • Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To compare the effects of smoking versus neutral cues on craving, mood, and autonomic responsivity in smokers with schizophrenia and smokers without schizophrenia.	7-10 Days

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Stephen J Heishman, Ph.D., National Institute on Drug Abuse (NIDA); Principal Investigator: Deanna L Kelly, Pharm.D, BCPP, University of Maryland, College Park

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: October 7, 2008
• First Submitted That Met QC Criteria: October 8, 2008
• First Posted (Estimate): October 9, 2008

Study Record Updates

• Last Update Posted (Actual): August 19, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Schizophrenia; Smoking; Nicotine
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Tobacco Use Disorder
• Other Study ID Numbers: HP-00042356; NIDA 430