Acute Abstinence From Cigarettes vs E-cigarettes (ENDS)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAcute (24-hour) abstinence
Participants will be asked to abstain from all tobacco/nicotine for 24 hours prior to the visit
BEHAVIORALAd libitum smoking/vaping
Participants will be asked to smoke/vape as usual during the 24 hours prior to the visit
Sponsors
State University of New York at Buffalo
Roswell Park Cancer Institute
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
All participants will complete two visits, one following 24-hour abstinence, the other while smoking/vaping as usual.
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 6+ months of daily/near-daily nicotine vaping or cigarette smoking * 200+ ng/mL cotinine on a commercially-available quick screen * stable antipsychotic medication dose (no changes in past 6 months). Current
Exclusion criteria
* intention to quit daily/near-daily vaping/smoking in the next month * current (2+ days out of the past 7) use of pipe tobacco, hookah/shisha, smokeless tobacco, dissolvable tobacco, nicotine pouches. For vaping group only, current (2+ days out of past 7) use of cigars, cigarillos, or filtered cigars that are filled with tobacco or a mix of tobacco and marijuana * current use of any smoking cessation medication * current severe substance dependence other than tobacco/nicotine (including cannabis; NIDA Modified ASSIST of 27+) * current (past 2 weeks) suicidal ideation with intent and/or plan * pregnancy (intake urine screen) * florid psychosis or severe cognitive symptoms (score of ≥5 on PANSS items delusions (P1), hallucinatory behavior (P3), or unusual thought content (G9), conceptual disorganization (P2), abstract thinking (N5), or poor attention (G11) or a score ≥6 on grandiosity (P5) or suspiciousness (P6)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minnesota Nicotine Withdrawal Scale 0.5 | 0.5 hours | single-item indicators of withdrawal facets |
| Mood and Physical Symptoms Scale 2.5 | 2.5 hours | single-item indicators of withdrawal facets |
| Wisconsin Smoking Withdrawal Scale - anger 0.5 | 0.5 hours | anger subscale score |
| Wisconsin Smoking Withdrawal Scale - anger 2.5 | 2.5 hours | anger subscale scores |
| Wisconsin Smoking Withdrawal Scale - anxiety 0.5 | 0.5 hours | anxiety subscale scores |
| Wisconsin Smoking Withdrawal Scale - anxiety 2.5 | 2.5 hours | anxiety subscale scores |
| Wisconsin Smoking Withdrawal Scale - sad 0.5 | 0.5 hours | sadness subscale scores |
| Wisconsin Smoking Withdrawal Scale - sad 2.5 | 2.5 hours | sadness subscale scores |
| Wisconsin Smoking Withdrawal Scale - conc 0.5 | 0.5 hours | difficulty concentrating subscale scores |
| Wisconsin Smoking Withdrawal Scale - conc 2.5 | 2.5 hours | difficulty concentrating subscale scores |
| Wisconsin Smoking Withdrawal Scale - sleep 0.5 | 0.5 hours | sleep subscale scores |
| Wisconsin Smoking Withdrawal Scale - sleep 2.5 | 2.5 hours | sleep subscale scores |
| Wisconsin Smoking Withdrawal Scale - appetite 0.5 | 0.5 hours | appetite subscale scores |
| Wisconsin Smoking Withdrawal Scale - appetite 2.5 | 2.5 hours | appetite subscale scores |
| Mood and Physical Symptoms Scale 0.5 | 0.5 hours | single-item indicators of withdrawal facets |
| Minnesota Nicotine Withdrawal Scale 2.5 | 2.5 hours | single-item indicators of withdrawal facets |
| Positive and Negative Affect Scale NA 0.5 | 0.5 hours | negative affect subscale score |
| Positive and Negative Affect Scale PA 2.5 | 2.5 hours | positive affect subscale score |
| Positive and Negative Affect Scale PA 0.5 | 0.5 hours | positive affect subscale score |
| Positive and Negative Affect Scale NA 2.5 | 2.5 hours | negative affect subscale score |
| Snaith-Hamilton Pleasure Scale 0.5 | 0.5 | Total score |
| Snaith-Hamilton Pleasure Scale 2.5 | 2.5 hours | Total score |
| Questionnaire on Vaping Craving 0.5 | 0.5 hours | total craving score |
| Questionnaire on Vaping Craving 2.5 | 2.5 hours | total craving score |
| Questionnaire on Smoking Urges - Brief 0.5 | 0.5 | total craving score |
| Questionnaire on Smoking Urges - Brief 2.5 | 2.5 | total craving score |
| PhenX Toolkit Insomnia Severity Index 0.5 | 0.5 | 7-item scale, with coverage of perceived impairment and interference with daily functioning |
| PhenX Toolkit Insomnia Severity Index 2.5 | 2.5 hours | 7-item scale, with coverage of perceived impairment and interference with daily functioning |
| Restlessness ratings 0.5 | 0.5 | 3-item scale |
| Restlessness ratings 2.5 | 2.5 hours | 3-item scale |
| Restlessness and Agitation Questionnaire 2.5 | 2.5 hours | 11-item self-report scale total of behavioral indicators (supplemental evaluation of observer ratings) |
| Restlessness and Agitation Questionnaire 0.5 | 0.5 hours | 11-item self-report scale total of behavioral indicators (supplemental evaluation of observer ratings) |
| Identical Pairs Continuous Performance Task | 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. |
| n-back working memory task | 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. |
| Stop signal reaction time task | 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. |
| Spatial Delayed Response Task | 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 |
| kcal consumed | 3 hours | Fat, protein, and carbohydrate calories consumed |
| Hypothetical Commodity Purchase Tasks vaping intensity 0.5 | 0.5 hours | intensity of demand |
| Hypothetical Commodity Purchase Tasks vaping intensity 2.5 | 2.5 hours | intensity of demand |
| Hypothetical Commodity Purchase Tasks vaping persistence 0.5 | 0.5 hours | persistence of demand |
| Hypothetical Commodity Purchase Tasks vaping persistence 2.5 | 2.5 hours | persistence of demand |
| Hypothetical Commodity Purchase Tasks smoking intensity 0.5 | 0.5 hours | intensity of demand |
| Hypothetical Commodity Purchase Tasks smoking intensity 2.5 | 2.5 hours | intensity of demand |
| Hypothetical Commodity Purchase Tasks smoking persistence 0.5 | 0.5 hours | persistence of demand |
| Hypothetical Commodity Purchase Tasks smoking persistence 2.5 | 2.5 hours | persistence of demand |
| Positive and Negative Syndrome Scale positive 3 | 3 hours | positive syndrome subscale |
| Positive and Negative Syndrome Scale negative 3 | 3 hours | negative syndrome subscale |
| Positive and Negative Syndrome Scale general 3 | 3 hours | general syndrome subscale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| modified Cigarette evaluation questionnaire | 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. |
| modified e-Cigarette evaluation questionnaire | 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. |
| Somatic / side effect checklist 0.5 | 0.5 hours | Assesses a range of somatic symptoms (e.g., headaches, fatigue) |
| Somatic / side effect checklist 2.5 | 2.5 hours | Assesses a range of somatic symptoms (e.g., headaches, fatigue) |
| Heart rate 30 | 30 minutes | Heart rate, in beats per minute |
| Heart rate 60 | 60 minutes | Heart rate, in beats per minute |
| Heart rate 90 | 90 minutes | Heart rate, in beats per minute |
| Heart rate 120 | 120 minutes | Heart rate, in beats per minute |
| Heart rate 150 | 150 minutes | Heart rate, in beats per minute |
| Heart rate 180 | 180 minutes | Heart rate, in beats per minute |
Countries
United States
Contacts
CONTACTLarry Hawk, PhD
PRINCIPAL_INVESTIGATORLarry Hawk, PhD
University at Buffalo
Outcome results
None listed