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

NCT00770237 | Completed

• 2 other identifiers: HP-00042356NIDA 430
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Nicotine Dependence

Keywords

Smoking; Nicotine; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cues

EXPERIMENTAL

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; Behavioral: Neutral Cues

Interventions

Smoking Cues BEHAVIORAL

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.

Cues

Neutral Cues BEHAVIORAL

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.

Cues

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

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

Catonsville, Maryland, 21228, United States

Location

MeSH Terms

Conditions

Schizophrenia; Tobacco Use Disorder; Smoking

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior

Study Officials

• Deanna L Kelly, Pharm.D, BCPP

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

• Stephen J Heishman, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deanna L. Kelly, Pharm.D., BCPP

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 9, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 19, 2019

Record last verified: 2019-08

Locations

US (1)