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

NCT ID: NCT00770237

Last Updated: 2019-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-12-31

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

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Smoking Cues

Intervention Type: 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.

Neutral Cues

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

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

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

MPRC

Deanna L. Kelly, Pharm.D., BCPP

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deanna L Kelly, Pharm.D, BCPP

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Stephen J Heishman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Institute on Drug Abuse (NIDA)

Locations

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

Catonsville, Maryland, United States

Countries

United States

Other Identifiers

NIDA 430

Identifier Type: -

Identifier Source: secondary_id

HP-00042356

Identifier Type: -

Identifier Source: org_study_id