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| ID | Type | Description | Link |
|---|---|---|---|
| 3R01DA054276-03S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Roswell Park Cancer Institute | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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The proposed research will characterize withdrawal among people with schizophrenia who vape daily compared to people with schizophrenia who smoke combustible cigarettes daily, filling critical gaps in the understanding of electronic nicotine delivery systems (ENDS) dependence and contributing to the development of vaping cessation interventions amongst people with schizophrenia, the leading preventable cause of death in the US.
Although withdrawal is considered a key feature of nicotine/tobacco addiction that contributes to difficulty quitting smoking and likely electronic nicotine delivery systems (ENDS; e.g., electronic cigarettes), there is currently no research on ENDS withdrawal in people with schizophrenia. The proposed supplement will conduct a systematic and comprehensive characterization of withdrawal in a sample of people with SCZ who vape daily compared to those who smoke daily, filling gaps in our understanding of ENDS dependence/withdrawal for people with SCZ and contributing to the identification of intervention targets for ENDS use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily use of ENDS | Other | Participants who use nicotine-containing ENDS daily or near-daily but who do NOT smoke combustible cigarettes daily or near-daily. |
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| Daily use of combustible cigarettes | Other | Participants who smoke combustible cigarettes daily or near-daily but do NOT use nicotine-containing ENDS daily or near-daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acute (24-hour) abstinence | Behavioral | Participants will be asked to abstain from all tobacco/nicotine for 24 hours prior to the visit |
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| Measure | Description | Time Frame |
|---|---|---|
| Wisconsin Smoking Withdrawal Scale - anger 0.5 | anger subscale score | 0.5 hours |
| Wisconsin Smoking Withdrawal Scale - anger 2.5 | anger subscale scores | 2.5 hours |
| Wisconsin Smoking Withdrawal Scale - anxiety 0.5 | anxiety subscale scores | 0.5 hours |
| Wisconsin Smoking Withdrawal Scale - anxiety 2.5 | anxiety subscale scores | 2.5 hours |
| Wisconsin Smoking Withdrawal Scale - sad 0.5 | sadness subscale scores | 0.5 hours |
| Wisconsin Smoking Withdrawal Scale - sad 2.5 | sadness subscale scores | 2.5 hours |
| Wisconsin Smoking Withdrawal Scale - conc 0.5 | difficulty concentrating subscale scores | 0.5 hours |
| Wisconsin Smoking Withdrawal Scale - conc 2.5 | difficulty concentrating subscale scores | 2.5 hours |
| Wisconsin Smoking Withdrawal Scale - sleep 0.5 |
| Measure | Description | Time Frame |
|---|---|---|
| modified Cigarette evaluation questionnaire | Subjective/sensory effects of smoking expectancies will be assessed with widely used smoking measures (the modified Cigarette Evaluation Questionnaire, the short form of the Smoking Consequences Questionnaire, and the Smoking Abstinence Questionnaire) and adaptations and extensions of these measures for vaping. | 3.5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cotinine | assay cotinine from urine sample collected at the start of each visit in order to assess the degree of compliance with the abstinence manipulation | 0.25 hours |
| Expired-air carbon monoxide | biochemical measure related to past 24-hour smoking |
Inclusion Criteria:
Current Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Larry Hawk, PhD | Contact | 716-645-0192 | lhawk@buffalo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Larry Hawk, PhD | University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo | Recruiting | Buffalo | New York | 14260 | United States |
We plan to make the full de-identified data set with metadata available through the National Addiction and HIV Data Archive Program (NAHDAP).
Data will be shared at approximately the same time as the acceptance for publication of the main findings from the final dataset. The dataset will have a permanent digital object identifier and will be available as long as the NAHDAP is available.
Per NAHDAP
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| ID | Term |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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All participants will complete two visits, one following 24-hour abstinence, the other while smoking/vaping as usual.
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| Ad libitum smoking/vaping | Behavioral | Participants will be asked to smoke/vape as usual during the 24 hours prior to the visit |
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sleep subscale scores |
| 0.5 hours |
| Wisconsin Smoking Withdrawal Scale - sleep 2.5 | sleep subscale scores | 2.5 hours |
| Wisconsin Smoking Withdrawal Scale - appetite 0.5 | appetite subscale scores | 0.5 hours |
| Wisconsin Smoking Withdrawal Scale - appetite 2.5 | appetite subscale scores | 2.5 hours |
| Mood and Physical Symptoms Scale 0.5 | single-item indicators of withdrawal facets | 0.5 hours |
| Mood and Physical Symptoms Scale 2.5 | single-item indicators of withdrawal facets | 2.5 hours |
| Minnesota Nicotine Withdrawal Scale 0.5 | single-item indicators of withdrawal facets | 0.5 hours |
| Minnesota Nicotine Withdrawal Scale 2.5 | single-item indicators of withdrawal facets | 2.5 hours |
| Positive and Negative Affect Scale NA 0.5 | negative affect subscale score | 0.5 hours |
| Positive and Negative Affect Scale PA 2.5 | positive affect subscale score | 2.5 hours |
| Positive and Negative Affect Scale PA 0.5 | positive affect subscale score | 0.5 hours |
| Positive and Negative Affect Scale NA 2.5 | negative affect subscale score | 2.5 hours |
| Snaith-Hamilton Pleasure Scale 0.5 | Total score | 0.5 |
| Snaith-Hamilton Pleasure Scale 2.5 | Total score | 2.5 hours |
| Questionnaire on Vaping Craving 0.5 | total craving score | 0.5 hours |
| Questionnaire on Vaping Craving 2.5 | total craving score | 2.5 hours |
| Questionnaire on Smoking Urges - Brief 0.5 | total craving score | 0.5 |
| Questionnaire on Smoking Urges - Brief 2.5 | total craving score | 2.5 |
| PhenX Toolkit Insomnia Severity Index 0.5 | 7-item scale, with coverage of perceived impairment and interference with daily functioning | 0.5 |
| PhenX Toolkit Insomnia Severity Index 2.5 | 7-item scale, with coverage of perceived impairment and interference with daily functioning | 2.5 hours |
| Restlessness ratings 0.5 | 3-item scale | 0.5 |
| Restlessness ratings 2.5 | 3-item scale | 2.5 hours |
| Restlessness and Agitation Questionnaire 2.5 | 11-item self-report scale total of behavioral indicators (supplemental evaluation of observer ratings) | 2.5 hours |
| Restlessness and Agitation Questionnaire 0.5 | 11-item self-report scale total of behavioral indicators (supplemental evaluation of observer ratings) | 0.5 hours |
| Identical Pairs Continuous Performance Task | Sustained attention, or vigilance, is the ability to maintain alertness to detect infrequent target stimuli during a long, monotonous task (e.g., Mackworth, 1948). We will use a version of the identical-pairs continuous performance task (Cornblatt et al., 1988) in which participants attend to a series of 800 4-digit numbers on a computer monitor (100-ms stimulus duration; 1500-ms ISI). Participants are asked to press the keyboard space bar only when the stimulus is identical to the immediately preceding stimulus (10% targets; Cooper et al., 2020; Rhodes & Hawk, 2016). Percent correct hits (target detections) is the primary outcome. | Lab visits: ~2 hours |
| n-back working memory task | The n-back task (Strand et al., 2012; Rhodes & Hawk, 2016) requires indicating whether each stimulus in a rapidly presented series matches the location of the stimulus presented n stimuli before (n=0,1,2). Stimuli are small grey circles (100 ms; 30% targets). The focus here is on conditions that place marked demands on the "central executive" by requiring ongoing mental manipulation (i.e., n=2; see Baddeley, 2003). Brief practice with a 1- back will be followed by 2 100-trial blocks of the 2- back. Accuracy is the primary outcome. | Lab visit ~ 2hours |
| Stop signal reaction time task | We will employ the stop-signal paradigm (Logan et al., 1984), which provides a relatively pure index response inhibition (e.g., Nigg, 2001). In our typical task (e.g., Hawk et al., 2018; Rhodes & Hawk, 2016), participants button press to indicate whether the "go" signal (<-- or -->) is pointing left or right. After a brief "go" practice, the stop signal (100-ms tone) is introduced, and participants complete 3 64-trail bocks during with they are asked to respond as quickly as possible but to not respond on stop signal trials (25% of trials). The stop signal occurs after go signal onset and adjusts dynamically across trials to yield ~50% inhibition (Logan et al., 1997). The primary outcome is stop signal reaction time (SSRT), an estimate of the speed of inhibition. | Lab visits: ~2 hours |
| Spatial Delayed Response Task | The SDR is a brief delayed-response spatial working memory task in which the participant is presented with a series of 3 screens on each trial. Screen 1 presents a dot (target stimulus) presented for at 1 of 16 locations on the computer screen. Screen 2 presents a "distractor task" that entails a sham attention task, appearing for variable 5 or 30 second delay. The distractor task involves a series of shapes presented on the screen and participants are asked to click the spacebar on the keyboard when they see a diamond, until the delay is finished. Screen 3 prompts the subject to identify the location of the target stimulus presented on Screen 1 using the mouse. Participants are prompted to respond as fast as possible, the task does not progress until the location response is recorded. Note that because the SDR was previously not sensitive to nicotine abstinence in non-psychiatric controls (Sacco, et al., 2005), we will only assess SDR changes | 2 hours |
| kcal consumed | Fat, protein, and carbohydrate calories consumed | 3 hours |
| Hypothetical Commodity Purchase Tasks vaping intensity 0.5 | intensity of demand | 0.5 hours |
| Hypothetical Commodity Purchase Tasks vaping intensity 2.5 | intensity of demand | 2.5 hours |
| Hypothetical Commodity Purchase Tasks vaping persistence 0.5 | persistence of demand | 0.5 hours |
| Hypothetical Commodity Purchase Tasks vaping persistence 2.5 | persistence of demand | 2.5 hours |
| Hypothetical Commodity Purchase Tasks smoking intensity 0.5 | intensity of demand | 0.5 hours |
| Hypothetical Commodity Purchase Tasks smoking intensity 2.5 | intensity of demand | 2.5 hours |
| Hypothetical Commodity Purchase Tasks smoking persistence 0.5 | persistence of demand | 0.5 hours |
| Hypothetical Commodity Purchase Tasks smoking persistence 2.5 | persistence of demand | 2.5 hours |
| Positive and Negative Syndrome Scale positive 3 | positive syndrome subscale | 3 hours |
| Positive and Negative Syndrome Scale negative 3 | negative syndrome subscale | 3 hours |
| Positive and Negative Syndrome Scale general 3 | general syndrome subscale | 3 hours |
| modified e-Cigarette evaluation questionnaire | Subjective/sensory effects of vaping expectancies will be assessed with widely used smoking measures (the modified Cigarette Evaluation Questionnaire, the short form of the Smoking Consequences Questionnaire, and the Smoking Abstinence Questionnaire) and adaptations and extensions of these measures for vaping. | 3.5 hours |
| Somatic / side effect checklist 0.5 | Assesses a range of somatic symptoms (e.g., headaches, fatigue) | 0.5 hours |
| Somatic / side effect checklist 2.5 | Assesses a range of somatic symptoms (e.g., headaches, fatigue) | 2.5 hours |
| Heart rate 30 | Heart rate, in beats per minute | 30 minutes |
| Heart rate 60 | Heart rate, in beats per minute | 60 minutes |
| Heart rate 90 | Heart rate, in beats per minute | 90 minutes |
| Heart rate 120 | Heart rate, in beats per minute | 120 minutes |
| Heart rate 150 | Heart rate, in beats per minute | 150 minutes |
| Heart rate 180 | Heart rate, in beats per minute | 180 minutes |
| 0.25 hours |