University at Buffalo
Buffalo, New York, 14260, United States
Location status: Recruiting
NCT Number: NCT06944847
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.
Interested in participating?
Request Info21 year–50 year
All sexes
Interventional
Not applicable
Buffalo, New York, 14260, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Current Exclusion Criteria:
Participants will be asked to abstain from all tobacco/nicotine for 24 hours prior to the visit
Participants will be asked to smoke/vape as usual during the 24 hours prior to the visit
Time frame: 0.5 hours
anger subscale score
Time frame: 2.5 hours
anger subscale scores
Time frame: 0.5 hours
anxiety subscale scores
Time frame: 2.5 hours
anxiety subscale scores
Time frame: 0.5 hours
sadness subscale scores
Time frame: 2.5 hours
sadness subscale scores
Time frame: 0.5 hours
difficulty concentrating subscale scores
Time frame: 2.5 hours
difficulty concentrating subscale scores
Time frame: 0.5 hours
sleep subscale scores
Time frame: 2.5 hours
sleep subscale scores
Time frame: 0.5 hours
appetite subscale scores
Time frame: 2.5 hours
appetite subscale scores
Time frame: 0.5 hours
single-item indicators of withdrawal facets
Time frame: 2.5 hours
single-item indicators of withdrawal facets
Time frame: 0.5 hours
single-item indicators of withdrawal facets
Time frame: 2.5 hours
single-item indicators of withdrawal facets
Time frame: 0.5 hours
negative affect subscale score
Time frame: 2.5 hours
positive affect subscale score
Time frame: 0.5 hours
positive affect subscale score
Time frame: 2.5 hours
negative affect subscale score
Time frame: 0.5
Total score
Time frame: 2.5 hours
Total score
Time frame: 0.5 hours
total craving score
Time frame: 2.5 hours
total craving score
Time frame: 0.5
total craving score
Time frame: 2.5
total craving score
Time frame: 0.5
7-item scale, with coverage of perceived impairment and interference with daily functioning
Time frame: 2.5 hours
7-item scale, with coverage of perceived impairment and interference with daily functioning
Time frame: 0.5
3-item scale
Time frame: 2.5 hours
3-item scale
Time frame: 2.5 hours
11-item self-report scale total of behavioral indicators (supplemental evaluation of observer ratings)
Time frame: 0.5 hours
11-item self-report scale total of behavioral indicators (supplemental evaluation of observer ratings)
Time frame: Lab visits: ~2 hours
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.
Time frame: Lab visit ~ 2hours
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.
Time frame: Lab visits: ~2 hours
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.
Time frame: 2 hours
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
Time frame: 3 hours
Fat, protein, and carbohydrate calories consumed
Time frame: 0.5 hours
intensity of demand
Time frame: 2.5 hours
intensity of demand
Time frame: 0.5 hours
persistence of demand
Time frame: 2.5 hours
persistence of demand
Time frame: 0.5 hours
intensity of demand
Time frame: 2.5 hours
intensity of demand
Time frame: 0.5 hours
persistence of demand
Time frame: 2.5 hours
persistence of demand
Time frame: 3 hours
positive syndrome subscale
Time frame: 3 hours
negative syndrome subscale
Time frame: 3 hours
general syndrome subscale
Time frame: 3.5 hours
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.
Time frame: 3.5 hours
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.
Time frame: 0.5 hours
Assesses a range of somatic symptoms (e.g., headaches, fatigue)
Time frame: 2.5 hours
Assesses a range of somatic symptoms (e.g., headaches, fatigue)
Time frame: 30 minutes
Heart rate, in beats per minute
Time frame: 60 minutes
Heart rate, in beats per minute
Time frame: 90 minutes
Heart rate, in beats per minute
Time frame: 120 minutes
Heart rate, in beats per minute
Time frame: 150 minutes
Heart rate, in beats per minute
Time frame: 180 minutes
Heart rate, in beats per minute
Time frame: 0.25 hours
assay cotinine from urine sample collected at the start of each visit in order to assess the degree of compliance with the abstinence manipulation
Time frame: 0.25 hours
biochemical measure related to past 24-hour smoking
Contact information is provided by the study sponsor or research team.
State University of New York at Buffalo
Other
A Laboratory Study of Behavior and Performance Among People Who Vape Nicotine and/or Smoke Cigarettes - Schizophrenia Supplement
Acronym: VASP-S
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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