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

Trial Summary

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.

What data supports the effectiveness of the treatment for smoking cessation in individuals with schizophrenia?

Research shows that many people with schizophrenia want to quit smoking, and treatments like nicotine replacement therapy, varenicline, and bupropion, combined with behavioral support, are effective and well-tolerated. These treatments help reduce smoking and improve the chances of quitting, even though the overall success rate is lower compared to the general population. ^{1 2 3 4 5}

Is vaping and smoking safe for people with schizophrenia?

Research shows that smoking is common among people with schizophrenia, and while quitting is challenging, smoking cessation aids are generally safe and well-tolerated. Electronic cigarettes are also being studied for their safety and effectiveness in this group, but more large-scale trials are needed to confirm their safety. ^{1 2 4 5 6}

How does the treatment of acute abstinence differ for schizophrenia?

The treatment of acute (24-hour) abstinence for schizophrenia is unique because it focuses on short-term smoking cessation, which can help manage nicotine withdrawal symptoms and potentially reduce medication side effects. This approach is different from standard long-term smoking cessation strategies, which often involve pharmacotherapy and behavioral treatments over several weeks. ^{1 2 4 7 8}

What is the purpose of this trial?

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.

Research Team

Larry Hawk, PhD

Principal Investigator

University at Buffalo

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Achieving Smoking Cessation in Individuals with Schizophrenia: Special Considerations. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Smoking in schizophrenia: recent findings about an old problem. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Schizophrenia and nicotine use: report of a pilot smoking cessation program and review of neurobiological and clinical issues. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Effects of contingency management and bupropion on cigarette smoking in smokers with schizophrenia. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Worldwide prevalence of smoking cessation in schizophrenia patients: A meta-analysis of comparative and observational studies. [2021]

6. Egypt pubmed.ncbi.nlm.nih.gov

Cigarette Smoking and Schizophrenia: Etiology, Clinical, Pharmacological, and Treatment Implications. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Antipsychotic Treatment and Tobacco Craving in People With Schizophrenia. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Nicotine withdrawal and psychiatric symptoms in cigarette smokers with schizophrenia. [2015]