Vaping and Smoking for Schizophrenia

(VASP-S Trial)

Overseen By Larry Hawk, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Must be taking: Antipsychotics

Must not be taking: Smoking cessation

Disqualifiers: Severe substance dependence, Pregnancy, Suicidal ideation, Florid psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand nicotine withdrawal in people with schizophrenia who vape or smoke cigarettes daily. Researchers seek to determine how quitting (acute 24-hour abstinence) affects these two groups differently, aiding in the development of better quitting methods for people with schizophrenia. Participants must have vaped or smoked regularly for at least six months and should not plan to quit soon. As an unphased trial, this study provides a unique opportunity to contribute to research that could lead to improved quitting strategies for those with schizophrenia.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your antipsychotic medication dose has been stable for at least 6 months.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that electronic nicotine delivery systems (ENDS), such as vapes, expose users to harmful substances, increasing the risk of breathing problems and leading to nicotine addiction. However, some studies suggest that high-strength nicotine e-cigarettes might help people with schizophrenia quit or reduce smoking.

Smoking regular cigarettes is a major cause of preventable death, particularly for those with schizophrenia. It is linked to symptoms like depression and stress and can lead to more hospital visits.

Both vaping and smoking carry risks, but they differ. Prospective trial participants should consider these risks and discuss them with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of vaping and smoking on individuals with schizophrenia, offering new insights into how nicotine influences this condition. Unlike standard treatments for schizophrenia, which typically involve antipsychotic medications to manage symptoms, this trial investigates the effects of acute (24-hour) abstinence from nicotine. By examining different groups—those who use e-cigarettes (ENDS) daily versus those who smoke traditional cigarettes—scientists hope to understand the distinct effects these habits have on mental health. This approach could lead to more personalized strategies for managing nicotine use in people with schizophrenia, potentially improving their overall treatment outcomes.

What evidence suggests that this trial's treatments could be effective for schizophrenia?

This trial will compare the effects of daily use of nicotine-containing ENDS with daily use of combustible cigarettes in individuals with schizophrenia. Research has shown that e-cigarettes, also known as electronic nicotine delivery systems (ENDS), can lead to addiction and exposure to harmful chemicals, potentially increasing the risk of lung diseases. However, high-strength nicotine e-cigarettes might help people with schizophrenia reduce or quit smoking. In contrast, smoking regular cigarettes is linked to more hospital visits, stress, and depression in this population. Studies suggest that individuals with schizophrenia need special support to quit smoking. Both vaping and smoking carry risks, but stopping or reducing their use can improve health. ^{2 3 4 5 6}

Who Is on the Research Team?

Larry Hawk, PhD

Principal Investigator

University at Buffalo

Are You a Good Fit for This Trial?

This trial is for individuals with schizophrenia who vape daily or smoke combustible cigarettes daily. It aims to understand nicotine dependence and develop vaping cessation interventions.

Inclusion Criteria

200+ ng/mL cotinine on a commercially-available quick screen

I have been vaping or smoking almost every day for at least 6 months.

My antipsychotic medication dose has been stable for the last 6 months.

Exclusion Criteria

Pregnancy (intake urine screen)

Current (2+ days out of the past 7) use of pipe tobacco, hookah/shisha, smokeless tobacco, dissolvable tobacco, nicotine pouches

Current severe substance dependence other than tobacco/nicotine (including cannabis; NIDA Modified ASSIST of 27+)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including various psychological and physiological measures

1 day

1 visit (in-person)

Withdrawal Characterization

Systematic and comprehensive characterization of withdrawal symptoms in participants who vape or smoke

2-3 hours per session

Multiple lab visits

Follow-up

Participants are monitored for any changes in withdrawal symptoms and overall health

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acute (24-hour) abstinence
• Ad libitum smoking/vaping

Trial Overview The study examines withdrawal symptoms in people with schizophrenia when they abstain from vaping or smoking for 24 hours, compared to their usual consumption (smoking/vaping as much as they want).

How Is the Trial Designed?

Group I: Daily use of combustible cigarettes Experimental Treatment 2 Interventions

Participants who smoke combustible cigarettes daily or near-daily but do NOT use nicotine-containing ENDS daily or near-daily.

Group II: Daily use of ENDS Experimental Treatment 2 Interventions

Participants who use nicotine-containing ENDS daily or near-daily but who do NOT smoke combustible cigarettes daily or near-daily.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Roswell Park Cancer Institute

Collaborator

Trials

427

Recruited

40,500+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7267811/

Tobacco smoking, related harm and motivation to quit ... Amongst smokers with schizophrenia spectrum disorders, smoking is associated with depressive symptoms, increased hospitalizations, stress, poor treatment ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2802812

Tobacco Use, Nicotine Dependence, and Cessation ... Findings of this study suggest that tobacco cessation interventions tailored for community-dwelling adults with psychosis are urgently needed.

3. sciencedirect.com sciencedirect.com/science/article/pii/S092099642400121X?dgcid=api_sd_search-api-endpoint

Tobacco smoking and nicotine vaping in persons with first ... Impact of tobacco, alcohol and cannabis use on treatment outcomes among patients experiencing first episode psychosis: data from the national RAISE-ETP study.

4. academic.oup.com academic.oup.com/ntr/article/23/7/1113/6168972

Single-Arm, Open-Label, Pilot, and Feasibility Study of a High ... At 12-month follow-up, 50% of people with schizophrenia who smoked cigarettes had reduced their cigarettes per day (CPD) by 50%, and a further ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06944847

Vaping and Smoking Project in People With Schizophrenia The proposed research will characterize withdrawal among people with schizophrenia who vape daily compared to people with schizophrenia who smoke combustible ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8186418/

A Single-Arm, Open-Label, Pilot, and Feasibility Study of a ... At 12-month follow-up, 50% of people with schizophrenia who smoked cigarettes had reduced their cigarettes per day (CPD) by 50%, and a further ...